nctid,group_id,healthy_volunteers,gender,age,phase,ade_num_at_risk,eligibility_criteria,group_description,drug_info_source,intervention_name,smiles,atc_code,label_Blood and lymphatic system disorders,label_Cardiac disorders,"label_Congenital, familial and genetic disorders",label_Ear and labyrinth disorders,label_Endocrine disorders,label_Eye disorders,label_Gastrointestinal disorders,label_General disorders and administration site conditions,label_Hepatobiliary disorders,label_Immune system disorders,label_Infections and infestations,"label_Injury, poisoning and procedural complications",label_Investigations,label_Metabolism and nutrition disorders,label_Musculoskeletal and connective tissue disorders,"label_Neoplasms benign, malignant and unspecified (incl cysts and polyps)",label_Nervous system disorders,"label_Pregnancy, puerperium and perinatal conditions",label_Psychiatric disorders,label_Renal and urinary disorders,label_Reproductive system and breast disorders,"label_Respiratory, thoracic and mediastinal disorders",label_Skin and subcutaneous tissue disorders,label_Social circumstances,label_Surgical and medical procedures,label_Vascular disorders,label_Product issues
NCT00007020,NCT00007020_EG000,No,All,Child | Adult | Older Adult,Phase 3,79,"PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Clinical or biochemical evidence of liver disease, unexplained fat-soluble vitamin malabsorption, or peroxisomal dysfunction that compromises bile acid biosynthesis

Inclusion criteria for enrollment were:

Infants < age 3 months
Children presenting for evaluation of cholestasis defined as a conjugated bilirubin > 2mg/dl or increased serum bile acids
Older subjects of any age with cholestatic liver disease if urine screens suggested that they had inborn errors of bile acid metabolism
Confirmation of a diagnosis of an inborn error of bile acid synthesis based upon urine analysis by FAB-MS to determine whether specific abnormalities in bile acid synthesis are indicated
The patient and/or parent/legal guardian must have signed the written informed consent document before study start.
The patient must be willing and able to comply with all study assessments and procedures.",All patients entered into the study and treated with Cholic Acid. 85 patients enrolled in the study and 79 received treatment (safety set).,ChEMBL:CHEMBL205596 | DrugBank:DB02659 | PubChem:221493,Cholic Acid,[H][C@@]1(O)CC[C@@]2(C)[C@@]([H])(C1)C[C@@]([H])(O)[C@@]1([H])[C@]3([H])CC[C@]([H])([C@]([H])(C)CCC(=O)O)[C@@]3(C)[C@@]([H])(O)C[C@]21[H],A05AA03,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00022763,NCT00022763_EG000,No,All,Child,Phase 2,52,"Inclusion Criteria

Patients may be eligible for this study if they:

Are 3 through 16 years of age and have the consent of parent or guardian.
Have a viral load of at least 5000 copies/ml.
Have taken at least 2 of the 3 licensed anti-HIV drug classes for at least 3 months.
Have been on stable therapy for at least 4 weeks.","Participants in stratum A (age >= 3 years and less than 12 years received Enfuvirtide Subcutaneously BID at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose) and in stratum B (age >= 12 years and less than 17 years received Enfuvirtide Subcutaneously BID at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose).",ChEMBL:CHEMBL525076 | PubChem:16130199,ENFUVIRTIDE,CC[C@H](C)[C@H](NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CO)NC(=O)[C@H](Cc1cnc[nH]1)NC(=O)[C@@H](NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CO)NC(=O)[C@@H](NC(=O)[C@H](Cc1ccc(O)cc1)NC(C)=O)[C@@H](C)O)[C@@H](C)CC)C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](CO)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](CCC(N)=O)C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CC(=O)O)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](Cc1c[nH]c2ccccc12)C(=O)N[C@@H](C)C(=O)N[C@@H](CO)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](Cc1c[nH]c2ccccc12)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](Cc1c[nH]c2ccccc12)C(=O)N[C@@H](Cc1ccccc1)C(N)=O,J05AX07,1.0,0.0,0.0,1.0,0.0,1.0,1.0,1.0,0.0,1.0,1.0,1.0,1.0,1.0,1.0,0.0,1.0,0.0,0.0,1.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT00024102,NCT00024102_EG002,No,Female,Older Adult,Phase 3,299,"Patients with operable, histologically confirmed adenocarcinoma of the female breast.

TNM Stage per AJCC Cancer Staging Manual 6th edition:

T1-4 (Tumor size > 1 cm), N0, M0 or T1-4, N1-3, M0
Patients with bilateral, synchronous breast cancer are eligible as long as one primary tumor meets the criteria above.

Patients with HER2/neu positive, negative or unknown disease are eligible for this trial.

Patients whose tumors are HER2 positive by either immunohistochemistry 3+ staining or demonstrate gene amplification by FISH will be eligible to receive trastuzumab, as outlined in the protocol.

Age 65 years or older
Performance status 0-2 (Common Toxicity Criteria).

Prior treatment:

Surgical resection -

All tumor should be removed by either a modified radical mastectomy or a lumpectomy. Patients must be registered ≤ 84 days from mastectomy or within 84 days of axillary dissection if patient's most extensive breast surgery was a breast sparing procedure.
Node dissection: Axillary node dissection is not required. Management of the axilla is at the discretion of the treating physician. There is no restriction on eligibility based on the number of nodes removed.
Mastectomy: There should be no evidence of gross or microscopic invasive tumor at the surgical resection margins noted in the final surgery or pathology reports for patients who have had a modified radical mastectomy. Patients with close margins (tumor < 1 mm from margin) are eligible.
Segmental mastectomy (lumpectomy): Although clear margins are preferable, DCIS or LCIS at the surgical resection margin will not render a patient who has undergone a segmental mastectomy ineligible for this study. Invasive tumor at the final resection margin will render a patient ineligible.
No prior chemotherapy for this malignancy.
Patients with a history of hypersensitivity to 5-FU or known dihydropyrimidine dehydrogenase (DPD) deficiency are not eligible to participate.
Patients may receive up to four weeks of tamoxifen therapy for this malignancy and still be eligible for study entry. Patients who received tamoxifen or raloxifene for purposes of chemoprevention (e.g., Breast Cancer Prevention Trial) or for other indications (including previous breast cancer) are eligible. Tamoxifen or raloxifene therapy should be discontinued before the patient is enrolled on this study.

Required Initial Laboratory Data:

Granulocytes > 1,500/µl
Platelet count ≥100,000/µl
Calculated Creatinine Clearance > 30 mL/min
Total bilirubin ≤ ULN",Capecitabine (2000 mg/m^2 in 2 doses days 1-14) repeated every 21 days for 6 cycles,ChEMBL:CHEMBL1773 | DrugBank:DB01101 | PubChem:42066809 | PubChem:60953,Capecitabine,CCCCCOC(=O)Nc1nc(=O)n([C@@H]2O[C@H](C)[C@@H](O)[C@H]2O)cc1F,L01BC06,1.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT00027378,NCT00027378_EG000,No,All,Child | Adult,Phase 2,50,"Inclusion Criteria:

Meets criteria for alcohol use disorder and major depressive disorder.

Exclusion Criteria:

Meets criteria for bipolar disorder, schizoaffective disorder, or schizophrenia.
Hyper- or hypothyroidism, significant cardiac, neurologic, or renal impairment, and those with significant liver disease.
Receiving antipsychotic or antidepressant medication in the month prior to entering the study.
Use of any illicit substance abuse or dependence other than cannabis abuse (and alcohol abuse).
History of intravenous drug use.
Pregnancy, inability or unwillingness to use contraceptive methods.
Inability to read or understand study forms
Less than 15 years of age or over 18 years of age will be excluded.","Subjects were treated with the medication fluoxetine (15 mg to 30 mg) plus Treatment as Usual (TAU), which included Cognitive Behavioral Therapy and Motivational Enhancement Therapy (CBT/MET) psychotherapy.",ChEMBL:CHEMBL41 | DrugBank:DB00472 | PubChem:3386,Fluoxetine,CNCCC(Oc1ccc(C(F)(F)F)cc1)c1ccccc1,N06AB03 | N06CA03,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00063232,NCT00063232_EG000,No,All,Adult | Older Adult,Phase 2,26,"INCLUSION CRITERIA:

Age at entry at least 18 years.
Serum alanine (ALT) or aspartate (AST) aminotransferase activities that are above the upper limits of normal.
Evidence of steatohepatitis on liver biopsy done within the previous 12 months with a NASH activity score of at least 4 (of a total possible score of 16) including a score of at least 1 each for steatosis, hepatocellular injury and parenchymal inflammation. Histological criteria of steatohepatitis include: (1) macrovesicular steatosis, (2) acinar zone 3 hepatocellular injury (ballooning degeneration), (3) parenchymal and (4) portal inflammation. Additionally helpful, but not required, features include the presence of (5) Mallory's hyaline and (6) pericellular and/or sinusoidal fibrosis that predominantly involves zone 3.
Written informed consent.

EXCLUSION CRITERIA:

Evidence of another form of liver disease.

Hepatitis B as defined as presence of hepatitis B surface antigen (HBsAg).
Hepatitis C as defined by presence of hepatitis C virus (HCV) RNA in serum.
Autoimmune hepatitis as defined by anti-nuclear antibody (ANA) of 1:160 or greater and liver histology consistent with autoimmune hepatitis or previous response to immunosuppressive therapy.
Autoimmune cholestatic liver disorders as defined by elevation of alkaline phosphatase and anti-mitochondrial antibody of greater than 1:80 or liver histology consistent with primary biliary cirrhosis or elevation of alkaline phosphatase and liver histology consistent with sclerosing cholangitis.
Wilson disease as defined by ceruloplasmin below the limits of normal and liver histology consistent with Wilson disease.
Alpha-1-antitrypsin deficiency as defined by alpha-1-antitrypsin level less than normal and liver histology consistent with alpha-1-antitrypsin deficiency.
Hemochromatosis as defined by presence of 3+ or 4+ stainable iron on liver biopsy and homozygosity for C282Y or compound heterozygosity for C282Y/H63D.
Drug-induced liver disease as defined on the basis of typical exposure and history.
Bile duct obstruction as shown by imaging studies.
History of excess alcohol ingestion, averaging more than 30 gm/day (3 drinks per day) in the previous 10 years, or history of alcohol intake averaging greater than 10 gm/day (1drink per day: 7 drinks per week) in the previous one year.
Contraindications to liver biopsy: platelet counts less than 75,000/mm(3) or prothrombin time greater than 16 seconds.
Decompensated liver disease, Child-Pugh score greater than or equal to 7 points.
History of gastrointestinal bypass surgery or ingestion of drugs known to produce hepatic steatosis including corticosteroids, high-dose estrogens, methotrexate, tetracycline or amiodarone in the previous 6 months.
Presence of diabetes mellitus as defined by: fasting plasma glucose of greater than or equal to 126 mg/dl on two separate occasion, or diabetic symptoms with a random plasma glucose of greater than or equal to 200 mg/dl (34).
Use of anti-diabetic drugs, including insulin, biguanides, sulfonylureas, or thiazolidinediones in the previous 6 months.
Significant systemic or major illnesses other than liver disease, including congestive heart failure, coronary artery disease, cerebrovascular disease, pulmonary disease with hypoxia, renal failure, organ transplantation, serious psychiatric disease, malignancy that, in the opinion of the investigator would preclude treatment with metformin and adequate follow up.
Positive test for anti-HIV.
Active substance abuse, such as alcohol, inhaled or injection drugs within the previous one year.
Pregnancy or inability to practice adequate contraception in women of childbearing potential.
Evidence of hepatocellular carcinoma: alpha-fetoprotein levels greater than 200 ng/ml and/or liver mass on imaging study that is suggestive of liver cancer.
Any other condition, which, in the opinion of the investigators would impede competence or compliance or possibly hinder completion of the study.
History of hypersensitivity reactions to metformin.
Serum creatinine greater than 1.5 mg/dl in men and greater than 1.4 mg/dl in women.","Participants will undergo a complete medical examination, a series of lab tests, and a liver biopsy. They will then start taking a single 500-mg tablet of metformin once a day for 2 weeks, then the same dosage twice a day for 2 more weeks, if they tolerate the first dosage. The dosage will increase to 1,000 mg twice a day for the remaining 44 weeks of the study. After 1 year, participants will undergo a repeat medical examination and liver biopsy.",ChEMBL:CHEMBL1431 | DrugBank:DB00331 | PubChem:4091,Metformin,CN(C)C(=N)NC(=N)N,A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00079183,NCT00079183_EG000,No,All,Child | Adult | Older Adult,Phase 2,44,"Inclusion Criteria:

Biopsy-confirmed diagnosis of clinical extensive chronic GVHD with inadequate response to previous treatment and where secondary systemic therapy is indicated because of

Clinical progression of signs and symptoms of chronic GVHD in a previously involved organ, or
Development of signs and symptoms of chronic GVHD in a previously uninvolved organ, or
Absence of improvement after 3 months of primary treatment, or
Continued need for treatment with prednisone at doses >= 1.0 mg/kg/day for more than 2 months, without qualification for type of donor, graft or conditioning regimen
Patient or guardian able and willing to provide informed consent
Stated willingness to use contraception in women of child-bearing potential (Food and Drug Administration [FDA] requirement)
Stated willingness of the patient to comply with study procedures and reporting requirements
Stated willingness of the physician most involved in management of chronic GVHD (the ""managing physician,"") to comply with study procedures and reporting requirements

Exclusion Criteria:

Fungal or viral infection with no radiographic evidence of improvement during continued appropriate antimicrobial therapy
Cytomegalovirus (CMV) antigenemia unresponsive to antiviral therapy
Active disseminated varicella zoster virus (VZV) infection with persistent non-crusted lesions
Inability to tolerate oral medications
Absolute neutrophil count (ANC) < 1500/uL
Platelet count < 50,000/uL
Persistent or recurrent malignancy, including histopathologic evidence of myeloma or lymphoma; patients with breakpoint cluster region-abelson (bcr/abl) detected by polymerase chain reaction (PCR) assay as the only evidence of persistent chronic myeloid leukemia may be enrolled
Pregnancy
Known history of hypersensitivity to sirolimus","Study participants receive sirolimus added once daily to their baseline combination therapy of prednisone plus either cyclosporine or tacrolimus at the discretion of the managing physician. Treatment other than cyclosporine (or tacrolimus) and prednisone must be discontinued when administration of sirolimus is started. Topical therapy, including psoralen and UVA irradiation (PUVA), glucocorticoid creams, topical tacrolimus, oral beclomethasone, topical azathioprine and ophthalmic glucocorticoids may be given at the discretion of the managing physician in consultation with the transplant center.",ChEMBL:CHEMBL413 | DrugBank:DB00877 | PubChem:134760597 | PubChem:138404388 | PubChem:21944094 | PubChem:5284616,Sirolimus,COC1CC2CCC(C)C(O)(O2)C(=O)C(=O)N2CCCCC2C(=O)OC(C(C)CC2CCC(O)C(OC)C2)CC(=O)C(C)C=C(C)C(O)C(OC)C(=O)C(C)CC(C)C=CC=CC=C1C,L01EG04 | L04AA10 | S01XA23,1.0,1.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,1.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0
NCT00088452,NCT00088452_EG000,Accepts Healthy Volunteers,All,Child,Phase 3,155,"Inclusion Criteria:

Diagnosis: Clinical diagnosis of Childhood Absence Epilepsy consistent with the International League against Epilepsy Proposal for Revised Classification of Epilepsies and Epileptic Syndromes (3).
EEG: Interictal EEG demonstrating bilateral synchronous symmetrical approximate 3 Hz spike waves on a normal background with at least one burst lasting >/= (greater than or equal to) 3 seconds.
Age > 2.5 years and < 13 years of age at study entry.
Body weight >/= (greater than or equal to) 10 kilograms.
Body Mass Index: BMI for age =/< 99th percentile (based on the CDC BMI for age growth curves for boys/girls [http://www.cdc.gov/growthcharts], Appendix 1).
Hepatic:
AST/ALT < 2.5 times the upper limit of normal
Total bilirubin < 1.5 times the upper limit of normal.
Hematologic:
Absolute neutrophil count >/= (greater than or equal to) 1500/mm3.
Platelets >/= (greater than or equal to) 120, 000 /mm3.
Female subjects must be premenarchal at the time of enrollment and must be willing to practice abstinence for the duration of the study.
Parent/legal guardian(s) willing to sign an IRB approved informed consent.
Subject assent (when appropriate and as dictated by local IRB).

Exclusion Criteria:

Treatment for CAE with anti-seizure medications (AED) for a period of greater than 7 days prior to randomization.
History of a major psychiatric disease (e.g., psychosis, major depression).
History of autism or pervasive development disorder.
History of non-febrile seizures other than typical absence seizures. This includes a history of an afebrile generalized tonic clonic seizure.
Clinical signs and symptoms consistent with a diagnosis of juvenile absence epilepsy or juvenile myoclonic epilepsy as delineated by the International League against Epilepsy Proposal for Revised Classification of Epilepsies and Epileptic Syndromes (3).
History of recent or present significant or medical disease, i.e., cardiovascular, hepatic, renal, gynecologic, musculoskeletal, metabolic, or endocrine.
History of a severe dermatologic reaction (e.g., Stevens Johnson, toxic epidermolysis necrosis) to medication.
Subject or parent/legal guardian might not be reasonably expected to be compliant with or to complete the study.
Participation in a trial of an investigational drug or device within 30 days prior to screening.
Use of systemic contraceptive for any indication, including acne.","Ethosuximide

Frequency and Duration: twice a day, every day for the duration of the study treatment

Formulation: Two formulations were used (actual formulation used was dependent on the patient's weight and ability to swallow): 250mg Zarontin capsules OR 250 mg/5 mL Zarontin syrup

Dosing: Ethosuximide was titrated in predetermined increments every 1-2 weeks during a 16-week titration period. The titration continued until the patient a) achieved seizure freedom by clinical and EEG criteria, b) reached the maximal allowed study drug dose, c) reached the maximal tolerated dose, or d) developed dose-exiting criteria (treatment failure), whichever came first. Maximum allowed dose: 60 mg/kg/day or 2000 mg/day (whichever was lower)

Ethosuximide: Ethosuximide is a common treatment for childhood absence epilepsy.",ChEMBL:CHEMBL696 | DrugBank:DB00593 | PubChem:3291,Ethosuximide,CCC1(C)CC(=O)NC1=O,N03AD01 | N03AD51,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00094770,NCT00094770_EG001,No,All,Adult | Older Adult,Phase 3,584,"Inclusion Criteria:

Patients who are at least 18 years of age and not older than 78 with type 2 diabetes mellitus",The Glipizide group includes data from patients randomized to receive treatment with glipizide initiated at a dose of 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control.,ChEMBL:CHEMBL1073 | DrugBank:DB01067 | PubChem:3478,Glipizide,Cc1cnc(C(=O)NCCc2ccc(S(=O)(=O)NC(=O)NC3CCCCC3)cc2)cn1,A10BB07,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0
NCT00095875,NCT00095875_EG001,No,All,Adult | Older Adult,Phase 3,75,"List of Inclusion Criteria:

Histologically or cytologically confirmed squamous cell carcinoma of the head and neck

Stage III or IV* disease

One of the following primary tumor sites:

Oral cavity

No mandible invasion
Oropharynx
Hypopharynx
Larynx

The following primary tumor sites are excluded:

Nasal cavity
Paranasal cavity
Nasopharynx NOTE: *No evidence of distant metastases by chest x-ray, abdominal ultrasound, or CT scan (for patients with liver function test abnormalities) or bone scan (for patients with local symptoms)
At least 1 uni- or bi-dimensionally measurable lesion

PATIENT CHARACTERISTICS:

Age

Over 18

Performance status

WHO 0-1

Life expectancy

Not specified

Hematopoietic

Neutrophil count > 1,500/mm^3
Platelet count > 100,000/mm^3
Hemoglobin > 10 g/dL

Hepatic

Bilirubin normal
AST or ALT within eligibility range
Alkaline phosphatase within eligibility range

Renal

Creatinine clearance > 60 mL/min

Cardiovascular

No unstable cardiac disease despite treatment
No myocardial infarction within the past 6 months

Pulmonary

No chronic obstructive pulmonary disease, defined as requiring hospitalization for pneumonia or respiratory decompensation within the past year

Obstruction caused by the tumor allowed

Neurologic

No symptomatic peripheral neuropathy > grade 2
No symptomatic altered hearing > grade 2
No history of significant neurologic or psychiatric disorders, including dementia or seizures

Other

No active drug addiction, including alcohol, cocaine, or intravenous drugs within the past 6 months
No other malignancy within the past 5 years except adequately treated carcinoma in situ of the cervix, basal cell or squamous cell skin cancer, or other cancer curatively treated by surgery alone
No active, clinically significant, uncontrolled infection
No autoimmune disease requiring therapy
No unhealed or clinically active peptic ulcer disease
No hypercalcemia
No other serious illness or medical condition
No involuntary weight loss > 25% of body weight within the past 2 months
HIV negative
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for at least 3 months after study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

No prior chemotherapy

Endocrine therapy

Not specified

Radiotherapy

No prior radiotherapy

Surgery

No prior organ transplantation

No prior surgery for this cancer

Biopsy allowed

Other

More than 30 days since prior participation in another investigational study
No other concurrent anticancer therapy","Patients receive cisplatin IV on weeks 1 and 4 and undergo concurrent radiotherapy once or twice daily, 5 days a week, for 6 weeks.

cisplatin : Given IV

radiation therapy : Patients undergo radiation therapy once or twice daily, 5 days a week, for up to 7 weeks",DrugBank:DB00515 | PubChem:5460033 | PubChem:5702198,Cisplatin,Cl[Pt]Cl.N.N,L01XA01,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00105066,NCT00105066_EG001,No,All,Adult | Older Adult,Phase 2,50,"Inclusion Criteria:

Participants with the Metabolic Syndrome, which is defined as having 3 or more of the following 5 alterations:

Abdominal obesity (waist measurement >39.8 inches in men, >34.4 inches in women)
Elevated triglycerides (>150 mg/dl)
Low HDL or ""good"" cholesterol (<40 mg/dl in men or <50 mg/dl in women)
Elevated blood pressure (>130/85) or treatment for high blood pressure
Elevated fasting blood sugar (>100 mg/dl)

Exclusion Criteria:

Diabetes treated with medication
Blood pressure >160/100 mmHg
Clinical Congestive Heart Failure
Anemia with hematocrit <32%
Asthma or Chronic Obstructive Pulmonary Disease (COPD) requiring daily medication or use of home oxygen therapy
Major surgery planned within the next six months
A recent, unexplained weight loss of >10% of body weight in the past 6 months
A known allergy or hypersensitivity to Metformin
History of hepatitis or cirrhosis
History of kidney disease (defined as serum creatinine >1.4 mg/dL in men, >1.3 mg/dL in women)
Pregnancy or the absence of an effective method of contraception
Illicit drug or alcohol abuse
Cancer requiring treatment currently or recently completed treatment in the last 2 months","Metformin : 850mg tablet once a day for one month, then twice a day for 3 months",ChEMBL:CHEMBL1431 | DrugBank:DB00331 | PubChem:4091,Metformin,CN(C)C(=N)NC(=N)N,A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00105508,NCT00105508_EG000,No,All,Adult | Older Adult,Phase 3,252,"Inclusion Criteria:

The subject is an out-patient.
The subject presents with a diagnosis of idiopathic Parkinson's disease.
Prior therapy with all registered Parkinsonian medication is allowed.

Exclusion Criteria:

(For female subjects) The subject is pregnant or lactating.
The subject is participating in another clinical study or has done so within the past 30 days.
The subject has received neurosurgical intervention related to PD.
The subject has relevant renal impairment.
The subject has relevant hepatic impairment.
The subject is suffering from any dementia or psychiatric illness.
The subject has a history of allergic asthma.",Subjects received sarizotan 1 milligram orally twice daily for 24 weeks.,ChEMBL:CHEMBL220808 | DrugBank:DB06454 | PubChem:6918388,Sarizotan,Fc1ccc(-c2cncc(CNC[C@H]3CCc4ccccc4O3)c2)cc1,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00105521,NCT00105521_EG003,No,All,Adult | Older Adult,Phase 3,102,"Inclusion Criteria:

The participant is an out-patient
The participant presents with a diagnosis of idiopathic Parkinson's disease
Prior therapy with all registered Parkinsonian medication is allowed

Exclusion Criteria:

(For female participants) The participant is pregnant or lactating
The participant is participating in another clinical study or has done so within the past 30 days
The participant has received neurosurgical intervention related to Parkinson's disease
The participant has relevant renal impairment
The participant has relevant hepatic impairment
The participant is suffering from any dementia or psychiatric illness
The participant has a history of allergic asthma",Participants received sarizotan 10 mg/day (given in 2 divided daily doses) up to Week 12.,ChEMBL:CHEMBL220808 | DrugBank:DB06454 | PubChem:6918388,Sarizotan,Fc1ccc(-c2cncc(CNC[C@H]3CCc4ccccc4O3)c2)cc1,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00109772,NCT00109772_EG000,No,All,Adult | Older Adult,Phase 2,87,"Inclusion Criteria:

Age >= 18 years at the time of signing the informed consent form
Understand and voluntarily sign an informed consent form
A diagnosis of CRPS Type 1, as defined by modified International Association for the Study of Pain criteria for at least a one-year duration. Unilateral involvement of a distal limb (hand or foot) with or without proximal spread must be present. In the presence of upper and lower limb involvement, the most severely affected limb will be designated the CRPS-affected limb.
Screening: CRPS pain intensity score in the CRPS-affected limb must be at least 4 on an 11-point (0-10) Pain Intensity Numerical Rating Scale (PI-NRS).
Randomization: Average PI-NRS score for randomization purposes will be based on AM and PM assessments made during the 7 days prior to randomization. At least eight PI-NRS scores during this 7-day period are required and the Average PI-NRS score in the CRPS-affected limb during this period must be at least 4 on an 11-point (0-10) PI-NRS.
Measurable (by electrophysiology methods) sural, median sensory, median motor and peroneal motor nerves at the screening nerve conduction study.
Opioid analgesics, non-opioid analgesics, non-steroidal anti-inflammatory drugs, anticonvulsants, antidepressant drugs and other non-drug therapies may be continued provided that the subject is on stable doses/regimens for at least four weeks prior to the start of the Treatment Phase (Visit 2).
Able to adhere to the study visit schedule and other protocol requirements.
Women of childbearing potential (WCBP) must agree to practice complete abstinence from heterosexual intercourse or to use two methods of contraception beginning 4 weeks prior to the start of study drug (Day 1) while on study drug (including dose interruptions) and 4 weeks after the last dose of study drug. The two methods of contraception must include one highly effective method (i.e. intrauterine device [IUD], hormonal [birth control pills, injections, or implants only if used in conjunction with a low-dose (81 mg/day) aspirin regimen], tubal ligation, partner's vasectomy) and one additional effective (barrier) method (i.e. latex condom, diaphragm, cervical cap). If a hormonal method (birth control pills, injections, or implants) or IUD is not medically possible for the subject, two of the barrier methods will be acceptable.
Women of childbearing potential (WCBP) must have two negative pregnancy tests (sensitivity of at least 50 mlU/mL) prior to starting study drug treatment. The first test should be performed within 10-14 days and the second within 24 hours of starting study drug. Once treatment has started, it is recommended that subjects have weekly pregnancy test during the first 4 weeks of treatment. Thereafter, subjects are required to have pregnancy testing every 4 weeks in females with regular menstrual cycles and every 2 weeks in females with irregular cycles.
Males (including those who have had a vasectomy) must use barrier contraception (latex condoms) when engaging in reproductive sexual activity with WCBP while on study drug and for 4 weeks after the last dose of study drug.

Exclusion Criteria:

The presence of any of the following will exclude a subject from study enrollment:

History of deep vein thrombosis (DVT) or stroke in the past 5 years.
Documented peripheral neuropathies to include diabetic neuropathy and other metabolic or toxic neuropathies.
Current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematological, endocrine, pulmonary, cardiac, neurological or cerebral disease.
Any other serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
White blood cell count (WBC) < 3.5*10^9/L at screening.
Bilirubin, alanine transaminase (ALT), aspartate transaminase (AST) or alkaline phosphatase levels more than two times the upper limit of the normal range at screening.
Abnormal thyroid function test values at screening.
Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
Use of concomitant medication(s), which could increase the risk for developing DVT, except for steroid-based contraceptives (oral injectable, implantable) and hormone replacement therapies only if used in conjunction with a low-dose (81 mg/day) aspirin regimen.
Concurrent use of thalidomide.
Prior development of an allergic reaction/hypersensitivity while taking thalidomide.
Prior development of a moderate or severe rash or any desquamation while taking thalidomide.
Prior treatment with lenalidomide.",10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure.,ChEMBL:CHEMBL848 | DrugBank:DB00480 | PubChem:216326,Lenalidomide,Nc1cccc2c1CN(C1CCC(=O)NC1=O)C2=O,L04AX04,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,1.0,1.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT00115804,NCT00115804_EG000,No,All,Child | Adult,Phase 3,6,"Inclusion Criteria:

Female or male outpatients 13 to 18 years of age.
Fulfillment of the American College of Rheumatology (ACR) criteria for primary fibromyalgia.
Ability to understand and cooperate with study procedures.
Provision of parental written informed consent and verbal and written assent from the adolescent for participation in the study.

Exclusion Criteria:

Unwillingness or inability on the part of the parent to provide written informed consent or for the adolescent to provide verbal and written assent.
Lifetime history of psychosis, hypomania or mania.
Diagnosis of alcohol or substance abuse or dependence within 6 months prior to screening visit.
Patients judged to be at serious suicide or homicide risk.
Girls who are pregnant or lactating. Girls of childbearing potential who are not using a medically accepted method of contraception (including barrier or hormonal methods).
Clinically unstable medical or psychiatric conditions that could interfere with the absorption, metabolism, excretion, or safety of fluoxetine or interfere with the assessment of disease severity.
Inability to exclude traumatic injury, regional or structural rheumatic disease, or infectious arthropathy as the etiology of their relevant fibromyalgia symptoms and that would interfere with interpretation of outcome measures (e.g., osteoarthritis, bursitis, tendonitis).
History of an autoimmune disease or inflammatory arthritis, such as systemic lupus erythematosis (SLE) or rheumatoid arthritis (RA).
Treatment with a monoamine oxidase inhibitor, tricyclic, selective serotonin reuptake inhibitor (SSRI) antidepressant, or lithium within 2 weeks prior to beginning study medication.
Treatment with analgesic medication (with the exception of acetaminophen and over-the-counter NSAIDs) within one week prior to beginning study medication.
Treatment with any other excluded medication that cannot be discontinued at the screening visit.
Previous treatment with fluoxetine.
Treatment with any investigational medications within 30 days prior to screening.",Fluoxetine was started at 10 mg/day and adjusted based on pain efficacy and tolerability.,ChEMBL:CHEMBL41 | DrugBank:DB00472 | PubChem:3386,Fluoxetine,CNCCC(Oc1ccc(C(F)(F)F)cc1)c1ccccc1,N06AB03 | N06CA03,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00122447,NCT00122447_EG002,Accepts Healthy Volunteers,All,Adult | Older Adult,Not Applicable,17,"Inclusion Criteria:

Impaired glucose tolerance

Exclusion Criteria:

Diagnosis of diabetes
Taking an ACE inhibitor (ACE-I), angiotensin II receptor blocker (ARB), or aspirin
Have systolic blood pressure >140 mm Hg
Have a chronic inflammatory disorder (i.e. rheumatoid arthritis, inflammatory bowel disease, sinusitis)
Vascular disease (cardiac, peripheral, cerebral)
Renal insufficiency or hepatic abnormalities
Gastrointestinal bleeding (defined as gastric or duodenal ulcer, hematemesis, and/or blood in the stool) or significant other upper gastrointestinal problems (i.e. gastritis) within the previous 6 months
Anemia or a history of bleeding disorder
Have a history of ARB or aspirin allergy
Have the syndrome of asthma, rhinitis, and nasal polyps
Have other medical problems which would preclude taking potential study medications for 12 months
Are pregnant or have a positive pregnancy test
Are breast feeding
Are unable or unwilling to tolerate having one catheter in each arm for 4 hours
Have health status such that the envisioned blood sampling would confer a physiologic risk
Have other physical, social, or behavioral problems which would decrease the likelihood that they would remain in the study for 12 months
Do not appear capable of giving informed consent",Antioxidant,ChEMBL:CHEMBL33864 | DrugBank:DB00166 | PubChem:6112 | PubChem:864,Lipoic acid,O=C(O)CCCCC1CCSS1,A16AX01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00123955,NCT00123955_EG000,No,All,Adult | Older Adult,Phase 3,42,"Inclusion Criteria:

Ambulatory
Medically stable
Ages 60 or older
Diagnosis of diastolic heart failure

Exclusion Criteria:

Valvular heart disease
Significant change in cardiac medication within the past 4 weeks
Uncontrolled hypertension
Recent or debilitating stroke
Cancer or other noncardiovascular conditions with life expectancy less than 2 years
Anemia
Elevated serum potassium
Renal insufficiency
Psychiatric disease (uncontrolled major psychoses, depression, dementia, or personality disorder)
Allergy to spironolactone; currently taking spironolactone or any aldosterone antagonist
Plans to leave area within 1 year
Refuses informed consent
Failure to pass screening tests: pulmonary function, echocardiogram, or exercise
Contra-indications to magnetic resonance imaging [MRI] (indwelling metal-containing prosthesis; pacemaker or defibrillator; history of welding occupation; uncontrollable claustrophobia)","Spironolactone

Spironolactone: 25mg tablet daily for 9 months",ChEMBL:CHEMBL1393 | DrugBank:DB00421 | PubChem:5833,Spironolactone,[H][C@]12CC[C@]3(C)[C@]4(CCC(=O)O4)CC[C@@]3([H])[C@]1([H])[C@]([H])(SC(C)=O)CC1=CC(=O)CC[C@@]12C,C03DA01,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00127712,NCT00127712_EG000,No,All,Adult | Older Adult,Phase 4,65,"Inclusion Criteria:

Males or females over the age of 40
Scheduled to undergo pneumonectomy or lobectomy

Exclusion Criteria:

History (hx) of atrial fibrillation
Prior severe side effects from amiodarone
Elevated liver enzymes >3 times the upper limit of normal (UNL)
QTc interval > 450 ms
Receiving class Ia or class III antiarrhythmics",Determine if amiodarone is effective for prevention of atrial fibrillation ater pulmonary resection surgery,ChEMBL:CHEMBL633 | DrugBank:DB01118 | PubChem:2157,Amiodarone,CCCCc1oc2ccccc2c1C(=O)c1cc(I)c(OCCN(CC)CC)c(I)c1,C01BD01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT00128206,NCT00128206_EG001,No,All,Adult | Older Adult,Phase 3,180,"Inclusion Criteria:

The inclusion criteria for this study will be San Francisco Jail inmates, age 18 or older (the jail does not house juveniles) having evidence of M. tuberculosis infection by positive tuberculin skin test (a documented reactive tuberculin skin test to 0.1 mL containing 5 Tuberculin Units) who meet current national criteria for therapy for tuberculosis infection and can provide informed consent.

Exclusion Criteria:

Ineligible for either therapy regimen for any of the following reasons:

history of treatment-limiting reaction to isoniazid or rifamycins;
pregnancy or breast feeding;
active tuberculosis;
an aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >3 times the upper limit of normal;
bilirubin >2 times the upper limit of normal;
platelets <150 K/mm3;
taking protease inhibitors or nonnucleoside reverse transcriptase inhibitors (NNRTIs);
Unable to communicate in English or Spanish;
Unable or unwilling to provide informed consent;
Not in the routine level of jail security for any reason (housed in ""special security"" areas);
Any condition that, in the best judgment of the investigator, would pose a risk to the subject during the study.",rifampin (600 mg orally) given daily for 4 months,ChEMBL:CHEMBL374478 | DrugBank:DB01045 | PubChem:135398735 | PubChem:135403807 | PubChem:135441414 | PubChem:135449527 | PubChem:135476790 | PubChem:135512673 | PubChem:135550179 | PubChem:135876149 | PubChem:135900090 | PubChem:135921123 | PubChem:135921134 | PubChem:135925261 | PubChem:135925741 | PubChem:135932822 | PubChem:136122621 | PubChem:136136478 | PubChem:136246612 | PubChem:136601293 | PubChem:136619758 | PubChem:136709103 | PubChem:137016821 | PubChem:137086834 | PubChem:137225336 | PubChem:137270779 | PubChem:137286743 | PubChem:137287990 | PubChem:154825551 | PubChem:163059759,RIFAMPIN,COC1C=COC2(C)Oc3c(C)c(O)c4c(O)c(c(C=NN5CCN(C)CC5)c(O)c4c3C2=O)NC(=O)C(C)=CC=CC(C)C(O)C(C)C(O)C(C)C(OC(C)=O)C1C,J04AB02 | J04AM02 | J04AM05 | J04AM06 | J04AM07 | J04BA50 | J04BA51,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT00128921,NCT00128921_EG000,No,All,Adult | Older Adult,Phase 2,10,"Inclusion Criteria:

History of histologically documented MM with relapsed or progressive disease after at least one line of prior therapy.

Patient has measurable disease in which to capture response, defined as one or more of the following:

Serum M-protein level > 1.0 gm/dl (10.0 g/L) measured by serum protein electrophoresis or immunoglobulin electrophoresis; or
Urinary M-protein excretion > 1000 mg/24 hours; or
Bone marrow plasmacytosis of > 30% by bone marrow aspirate and/or biopsy; or
Serum free light chains (by the Freelite test) > 2 X the upper limit of normal, in the absence of renal failure.
Evidence of active disease by radiographic techniques
Performance status (PS) of <= 2 as per Southwest Oncology Group scale, unless PS of 3-4 based solely on bone pain.
Patients must have a platelet count >= 50,000/mm3, and an absolute neutrophil count of at least 1,000/μl.
Patients must have adequate renal function defined as creatinine clearance > 30ml/min.
Patients must have adequate hepatic function defined as serum transaminases and direct bilirubin < 2 X the upper limit of normal.
Pregnant or nursing women may not participate. Women of childbearing potential must have a negative pregnancy test documented within one week of registration. Women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.
Male or female adults of at least 18 years of age.
Patients must have signed and Institutional Review Board approved written informed consent form and demonstrate willingness to meet follow-up schedule and study procedure obligations

Exclusion Criteria:

Chemotherapy or radiotherapy received within the previous 4 weeks.
Has received previous bortezomib therapy
Significant neurotoxicity, defined as grade > 2 neurotoxicity per National Cancer Institute Common Toxicity Criteria.
Platelet count < 50,000/mm3, or ANC < 1,000/μl
Polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes syndrome.
Patient has hypersensitivity to bortezomib, boron, or mannitol
Clinically significant hepatic dysfunction as noted by bilirubin or AST >3 times the upper normal limit or clinically significant concurrent hepatitis.
New York Hospital Association Class III or Class IV heart failure.
Myocardial infarction within the last 6 months.
Non-secretory multiple myeloma, unless the patient has measurable lesions on computed tomography, magnetic resonance imaging and/or positron emission tomography.
Uncontrolled, active infection.
Patients with a history of treatment for clinically significant ventricular cardiac arrhythmias.
Poorly controlled hypertension, diabetes mellitus, or other serious or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol.
Pregnant or potential for pregnancy. Women of childbearing potential will have a pregnancy [beta-HCG] test at screening, and will be required to use a medically approved contraceptive method. Pregnancy testing will be performed prior to administration of each cycle of study drug.
Breast-feeding women may not participate.",treatment: 1.3 mg/m^2,ChEMBL:CHEMBL325041 | DrugBank:DB00188 | PubChem:387447,Bortezomib,CC(C)C[C@H](NC(=O)[C@H](Cc1ccccc1)NC(=O)c1cnccn1)B(O)O,L01XG01 | L01XX32,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00130039,NCT00130039_EG000,No,All,Adult | Older Adult,Phase 4,232,"Inclusion Criteria:

Cerebral infarction within 2 weeks from the onset or TIA with corresponding acute ischemic brain lesions on MRI within 2 weeks from the onset
Age: more than 35 years of age
Patient with significant focal stenosis in the M1 segment of middle cerebral artery (MCA) or basilar artery (BA) with acute ischemic lesions on magnetic resonance imaging (MRI) within the vascular territory of the stenosed artery.

Exclusion Criteria:

Patients with any contraindications to the treatment with antiplatelet therapy
Patients with potential cardiac embolic source; prosthetic valve, atrial fibrillation, atrial flutter, left atrial/atrial appendage thrombus, sick sinus syndrome, left ventricular thrombus, dilated cardiomyopathy, akinetic or hypokinetic left ventricular segment, atrial myxoma, Infective endocarditis, mitral valve stenosis or prolapse, mitral annuls calcification, left atrial turbulence, nonbacterial endocarditis, congestive heart failure, recent myocardial infarction (within 4 weeks)
Patients with more than 50% stenosis in the parent artery of symptomatic stenosis
Bleeding diathesis
Chronic liver disease (ALT > 100 or AST > 100) or chronic renal disease (creatinine > 3.0mg/dl)
Anemia (hemoglobin < 10mg/dl) or thrombocytopenia (platelet count less than 100,000/mm3)
Nonatherosclerotic vasculopathy; patients with clinical characteristics suggesting arterial dissection, moyamoya disease, Takayasu's arteritis, radiation associated angiopathy, and other vasculitis.
Severe stroke: NIH stroke scale : more than 16
Pregnant or lactating patients
Chronic user of NSAIDs
Thrombolytic therapy for the symptomatic stenosis
Symptomatic stenosis scheduled for angioplasty
Patients with pacemaker or any other contraindications to MRI",cilostazol 100mg twice a day plus placebo of clopidogrel,ChEMBL:CHEMBL799 | DrugBank:DB01166 | PubChem:2754,Cilostazol,O=C1CCc2cc(OCCCCc3nnnn3C3CCCCC3)ccc2N1,B01AC23,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0
NCT00130533,NCT00130533_EG000,No,Female,Adult | Older Adult,Phase 3,436,"Inclusion Criteria:

Written informed consent.
Histological diagnoses of operable invasive adenocarcinoma of the breast (T1-T3). Tumours must be HER2 negative. Time window between end of adjuvant chemotherapy and study randomization must be less than 8 weeks. In patients receiving adjuvant radiotherapy, time window allowed between last session and randomisation is 4 weeks.
Surgery must consist of mastectomy or conservative surgery with axillary lymph node dissection. Margins free of disease and ductal carcinoma in-situ (DCIS) are required. Lobular carcinoma is not considered a positive margin.
Node negative patients with tumour size > 2 cm.
Positive axillary lymph nodes defined as at least 1 out of 6 nodes with presence of disease. If sentinel node technique is used, sentinel node can be the only node affected. Patients belonging to the following classifications are eligible: pN1a (Metastases in 1-3 axillary lymph nodes, at least one metastasis greater than 2.0 mm), pN2a (Metastases in 4-9 axillary lymph nodes (at least one tumor deposit greater than 2 mm)), pN3a (Metastases in 10 or more axillary lymph nodes [at least one tumor deposit greater than 2 mm]; or metastases to the infraclavicular [level III axillary lymph] nodes).
Status of hormone receptors in primary tumour. Negative results must be available before the end of adjuvant chemotherapy.
Patients must not present evidence of metastatic disease.
Negative status of HER2 in primary tumour, known before randomization.
Adjuvant chemotherapy consisting of a minimum of 6 courses with anthracyclines and/or taxanes.
Age >= 18 and <= 70 years old.
Performance status (Karnofsky index) >= 80.
Laboratory results (within 14 days prior to randomization):

Hematology:

neutrophils >= 1.5 x 10e9/l;
platelets >= 100x 10e9/l;
hemoglobin >= 10 mg/dl

Hepatic function:

total bilirubin <= 1 upper normal limit (UNL);
Aspartate aminotransferase (AST or SGOT) and Alanine aminotransferase (ALT or SGPT) <= 2.5 UNL;
alkaline phosphatase <= 2.5 UNL.
If values of SGOT and SGPT > 1.5 UNL are associated to alkaline phosphatase > 2.5 UNL, patient is not eligible.

Renal Function:

creatinine <= 175 µmol/l (2 mg/dl).
creatinine clearance >= 60 ml/min.

Pharmacogenetics:

one blood sample is needed for single nucleotide polymorphism (SNP) assessment.
Patients able to comply with treatment and study follow-up.
Negative pregnancy test done in the 14 previous days to randomization.

Exclusion Criteria:

Prior therapy with anthracyclines or taxanes (paclitaxel or docetaxel) for any malignancy.
Pregnant or lactating women. Adequate contraceptive methods must be used during chemotherapy and hormone therapy treatments. Negative pregnancy test in the 14 previous days to randomization.
Bilateral invasive breast cancer.
Any T4 or M1 tumour.
Axillary lymph nodes: patients belonging to the following classifications are excluded: pN1b (Metastases in internal mammary nodes with micrometastases or macrometastases detected by sentinel lymph node biopsy but not clinically detected), pN1c (Metastases in 1-3 axillary lymph nodes and in internal mammary lymph nodes with micrometastases or macrometastases detected by sentinel lymph node biopsy but not clinically detected), pN2b (Metastases in clinically detected internal mammary lymph nodes in the absence of axillary lymph node metastases), pN3b (Metastases in clinically detected ipsilateral internal mammary lymph nodes in the presence of one or more positive axillary lymph nodes; or in more than three axillary lymph nodes and in internal mammary lymph nodes with micrometastases or macrometastases detected by sentinel lymph node biopsy but not clinically detected), pN3c (Metastases in ipsilateral supraclavicular lymph nodes).
Any other serious medical pathology, such as congestive heart failure, unstable angina, history of myocardial infarction during the previous year, uncontrolled hypertension or high risk arrhythmias.
History of neurological or psychiatric disorders, which could preclude the patients to free informed consent.
Active uncontrolled infection.
Active peptic ulcer, unstable diabetes mellitus.
Previous or current history of neoplasms different to breast cancer, except for skin carcinoma, cervical in situ carcinoma, or any other tumour curatively treated and without recurrence in the last 10 years; ductal in situ carcinoma in the same breast; lobular in situ carcinoma.
History of hypersensitivity to capecitabine, fluorouracil.
Patients lacking physical integrity of upper gastrointestinal tract or with history of bad absorption syndrome.
History of dihydropyrimidine dehydrogenase (DPD) deficiency.
Anticoagulant treatment with coumadin anticoagulants.
Current treatment with sorivudine or its chemical family.
Concomitant treatment with other investigational products. Participation in other clinical trials with a non-marketed drug in the 30 previous days before randomization.
Concomitant treatment with other therapy for cancer.
Males.","1000 mgrs/m2 twice a day, tablets, 8 cycles

Capecitabine",ChEMBL:CHEMBL1773 | DrugBank:DB01101 | PubChem:42066809 | PubChem:60953,Capecitabine,CCCCCOC(=O)Nc1nc(=O)n([C@@H]2O[C@H](C)[C@@H](O)[C@H]2O)cc1F,L01BC06,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT00131664,NCT00131664_EG002,No,All,Adult | Older Adult,Phase 3,104,"Inclusion Criteria:

Type 2 diabetes patients
18 - 75 years old
Type 2 diabetes mellitus (DM) drug naïve or on submaximal oral monotherapy < 3 years

A1C criteria at screening:

7.1-10% for drug naïve patients after failure of diet control and life-style modification
7.1 - 9% on single therapy (e.g. not more 10 mg of Glyburide or 4 mg of Amaryl™ or 1000mg of Metformin) who will start after 2 weeks wash-out. During wash out the following will be done: i) diet and life style modification ii) Angiotensin converting enzyme inhibitor (ACE), aspirin (80 mg), and statin if appropriate
Signed informed consent

Exclusion Criteria:

Type 1 diabetes
Subjects currently treated with insulin
Subject treated for previous 3 month with any thiazolidinedione (TZD)
Evidence of clinically significant concomitant illnesses which are not controlled by medication and/or may limit participation in the study as judged by the investigator
Subjects who have hypersensitivity to any components of study drugs
Participation in a clinical trial and/or intake of an investigational drug within 30 days prior to screening.
Pregnant or nursing females
Females of childbearing potential who are not on adequate birth control
Liver enzymes (Alanine Aminotransferase (ALT) > 2.5 times upper limit of normal)
Renal impairment: serum creatinine ≥ 136umol/L (males) and ≥ 124 umol/L (females)
Congestive Heart Failure (CHF class III/IV)
Weight >160 kg","Metformin Arm: initial dose of 500 mg BID was titrated up to 850 mg BID at month 2. At month 4, it was further titrated up to 1000 mg BID. At month 6 (visit 6), patients not achieving target received additional specified drug therapy: Amaryl™ was added and titrated up to 4 mg OD maximum dose for an additional 6 months.",ChEMBL:CHEMBL1431 | DrugBank:DB00331 | PubChem:4091,Metformin,CN(C)C(=N)NC(=N)N,A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00131677,NCT00131677_EG000,Accepts Healthy Volunteers,Male,Adult,Phase 2,186,"Inclusion Criteria:

Healthy biologic male (male at birth)
18-60 years of age
HIV-1 negative by licensed, commercially available, FDA-approved whole blood rapid enzyme immunoassay (EIA) at screening and enrollment
Reports any anal sex with a man in the last 12 months
Able to understand and pass comprehension assessment questionnaire
Able to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures
Able to understand English
Adequate renal function: calculated creatinine clearance of at least 70 mL/min
Hepatic transaminases (AST and ALT) less than or equal to 2x upper limit of normal (ULN)
Total bilirubin less than or equal to 1.5 mg/dL
Absolute neutrophil count at least 1,500/mm3;
Platelets at least 100,000/mm3;
Hemoglobin at least 9.5 g/dL
Serum amylase less than or equal to 1.5 x ULN
Biochemical profile: within normal limits for serum phosphorus, potassium, sodium, and calcium.
Hepatitis B surface antigen negative
Normal urine dipstick or urinalysis (UA)

Exclusion Criteria:

Active untreated syphilis
Current uncontrolled hypertension (blood pressure > 160/100 mmHg)
Mutually monogamous for > one year with a known HIV antibody negative partner
History of chronic renal disease, known osteoporosis, osteomalacia, or osteopenia
Current or expected participation in other longitudinal HIV behavioral or biomedical research study
Current HIV antiretroviral use
Receiving or planning to receive on-going therapy with any nephrotoxic agents or experimental/investigational agents
Previous or expected requirements for the administration of immunosuppressive/ immunomodulatory therapy (e.g. chronic systemic steroids, interferon, interleukins, chemotherapy, radiation).
Evidence of a gastrointestinal malabsorption syndrome or chronic nausea or vomiting which may confer an inability to receive an orally administered medication.
Current alcohol or substance abuse judged by the investigator to potentially interfere with participant compliance.
Imminently life-threatening medical conditions (malignancy, immunosuppressive disease [e.g. lymphoma]), or other serious disease or conditions (e.g. cardiovascular, renal, diabetes) within the last 5 years or that are unstable and/or require chronic medication that would impede compliance with study requirements and complicate the interpretation of adverse events
Expected to be non-compliant with study visits or planning to move within 24 months to an area where the study will not be conducted
Any other clinical or social condition, prior therapy, occupation, or other responsibility, that, in the opinion of the investigator, would interfere with, or serve as a contraindication to study participation or compliance with the dosing requirements.","Active arm: assigned to take TDF, 300mg po daily.",PubChem:5486830 | PubChem:6398764,Tenofovir Disoproxil Fumarate,CC(C)OC(=O)OCOP(=O)(COC(C)Cn1cnc2c(N)ncnc21)OCOC(=O)OC(C)C.O=C(O)C=CC(=O)O,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0
NCT00141778,NCT00141778_EG002,No,All,Adult | Older Adult,Phase 2 | Phase 3,147,"Inclusion Criteria:

Undergoing elective valvular heart surgery, coronary artery bypass grafting
If female, must be postmenopausal for at least 1 year, status-post surgical sterilization, or if of childbearing potential, utilizing adequate birth control and willing to undergo urine beta-hcg testing prior to drug treatment and throughout the study

Exclusion Criteria

History of AF other than remote paroxysmal AF
Ejection fraction less than 30%
Evidence of coagulopathy (INR greater than 1.7 without warfarin therapy)
Emergency surgery
History of ACE inhibitor-induced angioedema
Low blood pressure (systolic blood pressure less than 100 mmHg and evidence of hypoperfusion)
Hyperkalemia (potassium level greater than 5.0 milliequivalents (mEq)/L at study entry)
Impaired kidney function (serum creatinine level greater than 1.6 mg/dl)
Any underlying or acute disease requiring regular medication that could possibly cause complications or make implementation of the study or interpretation of the study results difficult
Inability to discontinue current ACE inhibitor, AT1 receptor antagonist, or aldosterone receptor antagonist therapy
History of alcohol or drug abuse
Treatment with any investigational drug in the month prior to study entry
Mental condition that makes it impossible to understand the nature, scope and possible consequences of the study
Inability to comply with the study procedures (e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study)
Pregnant or breastfeeding",Mineralocorticoid Receptor (MR) Antagonist group,ChEMBL:CHEMBL1393 | DrugBank:DB00421 | PubChem:5833,Spironolactone,[H][C@]12CC[C@]3(C)[C@]4(CCC(=O)O4)CC[C@@]3([H])[C@]1([H])[C@]([H])(SC(C)=O)CC1=CC(=O)CC[C@@]12C,C03DA01,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00142519,NCT00142519_EG000,No,All,Adult | Older Adult,Phase 2,50,"Inclusion Criteria:

Retroperitoneal lymph node dissection
Planned post-operative analgesia with PCA at 1 mg continuous infusion and 1 mg every 10 minutes
18 years of age or older
English-speaking
Give informed consent to participate in this study

Exclusion Criteria:

Known hypersensitivity to methadone or morphine
Patients with past or present history of substance abuse
Patients with a history of methadone treatment
Patients with a history of chronic pain requiring daily analgesic use for more than 3 months
Patients treated with opioids within one month from the scheduled surgery
Creatinine clearance less than 50 mg/kg (using Cockcroft-Gault Equation).
Neurologic or psychiatric disease sufficient, in the doctor's opinion, to compromise data collection","methadone

Methadone: Upon the 1st request for analgesic medication morphine 2 mg, upon the 2nd request for analgesic medication morphine 2 mg",ChEMBL:CHEMBL350719 | ChEMBL:CHEMBL651 | DrugBank:DB00333 | DrugBank:DB15198 | PubChem:4095 | PubChem:643985,Methadone,CCC(=O)C(CC(C)N(C)C)(c1ccccc1)c1ccccc1,N02AC52 | N07BC02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00149643,NCT00149643_EG000,No,All,Child | Adult,Phase 2,70,"Inclusion Criteria:

DSM-IV diagnosis of current marijuana abuse or dependence, confirmed by SCID-SUD
DSM-IV diagnosis of current major depressive disorder, confirmed by the K-SADS
Marijuana use of at least two days within the week prior to enrollment
Demonstrated adequate levels of depressive symptoms within the week prior to enrollment

Exclusion Criteria:

DSM-IV diagnosis of bipolar disorder, schizoaffective disorder, or schizophrenia
Hypo or hyperthyroidism
Significant cardiac, neurological, or kidney impairment
Liver disease (SGOT, SGPT, or gamma-GTP greater than 3 times the normal level)
Use of antipsychotic or antidepressant medication in the month prior to enrollment
DSM-IV dependence on any substance except marijuana or nicotine; alcohol dependence, or history of drug use
History of significant medication side effects from any SSRI antidepressant
Pregnant
Unable to use adequate contraceptive methods for the duration of the study
Inability to read or understand English","Gelatin capsules Fluoxetine 10mg, 1 capsule every a.m. Medication will be increased by one capsule, to a daily dose of fluoxetine 20mg, 2 capsules barring side effects.",ChEMBL:CHEMBL41 | DrugBank:DB00472 | PubChem:3386,Fluoxetine,CNCCC(Oc1ccc(C(F)(F)F)cc1)c1ccccc1,N06AB03 | N06CA03,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00156065,NCT00156065_EG002,No,All,Adult | Older Adult,Phase 3,43,"Inclusion Criteria:

Completed the short-term 041023 trial (NCT00156104)
Continued to meet all demographic and procedural inclusion criteria of the short-term trial upon entry into this long-term extension trial
Sign a written informed consent for the 041513 trial.
Demonstrated an acceptable degree of compliance with trial medication in the short-term trials in the opinion of the investigator

Exclusion Criteria:

CGI-S (Clinical Global Impressions of Severity of Illness) score of greater than or equal to 6 (severely psychotic)
Occurrence(s) of AEs (adverse events) or other clinically significant findings that would prohibit their continuation
Met any of exclusion criteria regarding medical/psychiatric status listed in the 041023 short-term trial
Met exclusion criteria for medication status in short-term trials except for antidepressants and mood stabilizers.",Haloperidol 2-8 mg BID in Original Study and in Current Long-Term Extension,ChEMBL:CHEMBL54 | DrugBank:DB00502 | PubChem:3559,Haloperidol,O=C(CCCN1CCC(O)(c2ccc(Cl)cc2)CC1)c1ccc(F)cc1,N05AD01,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00162032,NCT00162032_EG000,No,All,Child,Phase 3,329,"Inclusion Criteria:

Males or females between 4 and 16
Meet the epidemiological definition of Kawasaki Disease or have a diagnosis of incomplete KD, including evidence of coronary artery disease as determined by their physician.
Be able to exercise adequately to achieve 85% age predicted maximum heart rate

Exclusion Criteria:

Terminal illness where expected survival is < 6 months",Arm A children 4-11 years of age,PubChem:22617237,Technetium (99mTc) sestamibi,[C-]#[N+]CC(C)(C)OC.[C-]#[N+]CC(C)(C)OC.[C-]#[N+]CC(C)(C)OC.[C-]#[N+]CC(C)(C)OC.[C-]#[N+]CC(C)(C)OC.[C-]#[N+]CC(C)(C)OC.[Tc],,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00162032,NCT00162032_EG001,No,All,Child,Phase 3,116,"Inclusion Criteria:

Males or females between 4 and 16
Meet the epidemiological definition of Kawasaki Disease or have a diagnosis of incomplete KD, including evidence of coronary artery disease as determined by their physician.
Be able to exercise adequately to achieve 85% age predicted maximum heart rate

Exclusion Criteria:

Terminal illness where expected survival is < 6 months",Arm B adolescents 12-16 years of age,PubChem:22617237,Technetium (99mTc) sestamibi,[C-]#[N+]CC(C)(C)OC.[C-]#[N+]CC(C)(C)OC.[C-]#[N+]CC(C)(C)OC.[C-]#[N+]CC(C)(C)OC.[C-]#[N+]CC(C)(C)OC.[C-]#[N+]CC(C)(C)OC.[Tc],,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00162370,NCT00162370_EG000,No,Female,Adult | Older Adult,Phase 4,400,"Inclusion Criteria:

Peri or Post menopausal women either:

without symptoms but with risk factors for heart disease OR
experiencing atypical chest pain, OR
experiencing exertional dyspnea AND 2 or more risk factors for CAD
Must be able to perform an exercise stress test

Peri-or post-menopausal (including surgical menopause) based on history.

Post-menopausal is defined as females age 40-65 who self-report the absence of menstrual periods for at least 12 months.
Peri-menopausal is defined as females age 40-65 who self-report the absence or irregularity of menstrual periods for 6-12 months.
Surgical menopause is defined as females who have had a bilateral salpingo-oophorectomy with or without hysterectomy.

Exclusion Criteria:

Previous confirmed heart disease","Open-lable, non-randomized, Phase IV trial with Definity to determine the prognostic value of stress echocardiogrophy as a screening exam in peri-, post-menopausal females with an intermediate likelihood of coronary artery disease to identify patients at higher risk of experiencing future cardiac events.

Perflutren Lipid Microsphere Injectable Suspension: Activated DEFINITY 10ug/kg by bolus injection",ChEMBL:CHEMBL1663 | DrugBank:DB00556 | PubChem:6432,Perflutren,FC(F)(F)C(F)(F)C(F)(F)F,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00165841,NCT00165841_EG000,No,All,Adult | Older Adult,Phase 2,103,"Key Inclusion Criteria:

Male or female patients, 18 to 65 years of age.
If female, not of childbearing potential by reason of surgery, radiation or menopause, or of childbearing potential, but using an approved method of contraception since the last menstrual period, for example, intrauterine device (IUD), implant, double barrier method, or oral contraceptives for at least one cycle. Females of childbearing potential must have a negative urine pregnancy test before medication is dispensed.
Patients must report a minimum three-month history of GERD symptoms. GERD symptoms are defined as heartburn with or without regurgitation or other associated GERD symptoms.
Patients must have at least 4 days with heartburn per week in each of the 2 weeks prior to Screening.
Patients must have no esophagitis, with no proton pump inhibitors (PPIs, prescription or OTC), H2 blockers (prescription or OTC) or prokinetics within 14 days, prior to the endoscopy.

Key Exclusion Criteria:

Evidence of significant hepatic, renal, respiratory, endocrine, hematologic, neurologic, psychiatric or cardiovascular system abnormalities, unless the Sponsor and Investigator agree that the nature and severity of any abnormality is unlikely to interfere with the conduct of the study, the interpretation of study results, or the health of the patient during the study.
Females must not be pregnant, lactating or have a positive urine eta human chorionic gonadotropin (B-hCG) laboratory result.
Patients with a history of allergy or sensitivity to proton pump inhibitors or to their inactive ingredients.
Patients with known gastric ulcer, duodenal ulcer, infectious or inflammatory conditions of the small or large intestine, malabsorption syndromes, obstruction, a history of gastrointestinal malignancy, or prior gastric or intestinal surgery (including vagotomy).
Patients who have a history of Barrett's esophagus, esophageal stricture, or pyloric stenosis.
Patients with a history of endoscopically-proven esophagitis any time in the past.
Patients who have taken proton pump inhibitors (PPIs, prescription or OTC), H2 blockers (prescription or OTC) or prokinetics within 14 days, prior to Screening endoscopy, or any of these medications within 7 days prior to the single-blind placebo run-in period.","Orally, once daily for 7- to 14-day courses intermittently during the 6-month Double-blind Maintenance Treatment Phase.",ChEMBL:CHEMBL1219 | DrugBank:DB01129 | PubChem:5029,Rabeprazole,COCCCOc1ccnc(CS(=O)c2nc3ccccc3[nH]2)c1C,A02BC04 | A02BC54 | A02BD12 | A02BD13 | M01AA05 | M02AA03,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT00165841,NCT00165841_EG001,No,All,Adult | Older Adult,Phase 2,97,"Key Inclusion Criteria:

Male or female patients, 18 to 65 years of age.
If female, not of childbearing potential by reason of surgery, radiation or menopause, or of childbearing potential, but using an approved method of contraception since the last menstrual period, for example, intrauterine device (IUD), implant, double barrier method, or oral contraceptives for at least one cycle. Females of childbearing potential must have a negative urine pregnancy test before medication is dispensed.
Patients must report a minimum three-month history of GERD symptoms. GERD symptoms are defined as heartburn with or without regurgitation or other associated GERD symptoms.
Patients must have at least 4 days with heartburn per week in each of the 2 weeks prior to Screening.
Patients must have no esophagitis, with no proton pump inhibitors (PPIs, prescription or OTC), H2 blockers (prescription or OTC) or prokinetics within 14 days, prior to the endoscopy.

Key Exclusion Criteria:

Evidence of significant hepatic, renal, respiratory, endocrine, hematologic, neurologic, psychiatric or cardiovascular system abnormalities, unless the Sponsor and Investigator agree that the nature and severity of any abnormality is unlikely to interfere with the conduct of the study, the interpretation of study results, or the health of the patient during the study.
Females must not be pregnant, lactating or have a positive urine eta human chorionic gonadotropin (B-hCG) laboratory result.
Patients with a history of allergy or sensitivity to proton pump inhibitors or to their inactive ingredients.
Patients with known gastric ulcer, duodenal ulcer, infectious or inflammatory conditions of the small or large intestine, malabsorption syndromes, obstruction, a history of gastrointestinal malignancy, or prior gastric or intestinal surgery (including vagotomy).
Patients who have a history of Barrett's esophagus, esophageal stricture, or pyloric stenosis.
Patients with a history of endoscopically-proven esophagitis any time in the past.
Patients who have taken proton pump inhibitors (PPIs, prescription or OTC), H2 blockers (prescription or OTC) or prokinetics within 14 days, prior to Screening endoscopy, or any of these medications within 7 days prior to the single-blind placebo run-in period.","Orally, once daily for 7- to 14-day courses intermittently during the 6-month Double-blind Maintenance Treatment Phase.",ChEMBL:CHEMBL1219 | DrugBank:DB01129 | PubChem:5029,Rabeprazole,COCCCOc1ccnc(CS(=O)c2nc3ccccc3[nH]2)c1C,A02BC04 | A02BC54 | A02BD12 | A02BD13 | M01AA05 | M02AA03,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00167245,NCT00167245_EG000,No,All,Adult | Older Adult,Phase 2,83,"Inclusion Criteria:

Male and females, 18 years or older.
Meets DSM(Diagnostic and Statistical Manual)-IV criteria for current diagnoses of cocaine and alcohol dependence, determined by the SCID (Structured Clinical Interview for the DSM)-IV.
In the past 30 days, used no less than $200-worth of cocaine and meets the following drinking criteria as measured by the Timeline Followback (TLFB) (Sobell and Sobell, 1995) a. drank within 30 days of intake day, b. reports a minimum of 48 standard alcoholic drinks (avg. 12 drinks/wk) in a consecutive 30-day period over the 90-day period prior to starting intake (i.e., a minimum of 40% days drinking), and c. has 2 or more days of heavy drinking (defined as 5 or more drinks per day in males and 4 or more drinks per day in females) in this same pre-treatment period.
Two consecutive days of abstinence from cocaine and alcohol, determined by self-reports and confirmed by negative urine toxicology screens, a negative breathalyzer tests, and collateral report, a Clinical Institute Withdrawal Scale for Alcohol (CIWA-AR) (Sullivan et al., 1989) score below eight,. Subjects will be encouraged to achieve 3 consecutive days of abstinence, however, subjects who have achieved 2 consecutive days of abstinence will be included with the approval of the principal investigator. We anticipate that these subjects will comprise less than 5% of total enrolled subjects. Subjects will be given 2 additional weeks beyond the screening week to attain the appropriate period of cocaine and alcohol abstinence prior to randomization.
Lives a commutable distance from the Treatment Research Center (TRC) and agrees to attend all research visits including follow-up visits.
Speaks, understands, and prints in English.

Exclusion Criteria:

Abstinent from cocaine or alcohol for 30 consecutive days prior to signing consent form.
Meets DSM-IV criteria for dependence on any substance other than cocaine and alcohol (except nicotine and cannabis), determined by the SCID.
Needs treatment with any psychoactive medications including any anti-seizure medications (with the exception of Benadryl used sparingly, if necessary, for sleep).
Current use of phenytoin or any drug of similar class.
Meets DSM-IV criteria for schizophrenia or any psychotic disorder, or organic mental disorder. Subject meets current DSM-IV diagnosis of any other clinically significant psychiatric disorder that will interfere with study participation.
Has evidence of a history of significant hematological, pulmonary, endocrine, cardiovascular, renal or gastrointestinal disease.
Severe physical or medical illnesses such as AIDS, active hepatitis, significant hepatocellular injury as evidenced by elevated bilirubin levels (>1.3), or elevated levels (over 3.5x normal) of aspartate aminotransferase (AST), and serum glutamic-pyruvic transaminase (SGPT) after the required 3 days of abstinence, or severe renal disease, severe respiratory diseases or severe diarrhea with resulting metabolic acidosis, serum bicarbonate (< 20 milliequivalent (mEq)/L)
History of epilepsy or seizure disorder.
Use of an investigational medication in the 30 days prior to randomization.
History of nephrolithiasis (kidney stones).
History of hypersensitivity to topiramate.
Is female and tests positive on a pregnancy test, is contemplating pregnancy in the next 6 months, is nursing, or is not using an effective contraceptive method (if relevant). Acceptable methods of contraception include barrier methods (diaphragm or condom with spermicide, intrauterine progesterone contraceptive system, levonorgestrel implant, and medroxyprogesterone acetate contraceptive injection).
Current use of a carbonic anhydrase inhibitor.
A history of glaucoma","topiramate

Topiramate : 300mg/day for 13 weeks",ChEMBL:CHEMBL220492 | DrugBank:DB00273 | PubChem:5284627,Topiramate,[H][C@@]12OC(C)(C)O[C@]1([H])CO[C@@]1(COS(N)(=O)=O)OC(C)(C)O[C@]12[H],A08AA51 | N03AX11,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT00167544,NCT00167544_EG000,No,All,Child,Phase 2,31,"Inclusion Criteria:

Patient in the Memorial Hermann Children's Hospital (MHCH) neonatal intensive care unit with a birth weight ≤ 1000 grams.
Ventilator-dependent between 10 and 21 days of age.
Respiratory index score (RIS: mean airway pressure x fraction of inspired oxygen) of ≥ 2.0 that is increasing or stable for the previous 24 hours or a RIS ≥ 3.0 if improvement noted in the past 24 hours.

Exclusion Criteria:

Prior postnatal steroid treatment.
Evidence of sepsis or necrotizing enterocolitis.
Known major congenital anomalies of the cardiopulmonary or central nervous system.
Infants being treated with indomethacin or those likely to require treatment in the next 7 days as judged by the treating physician.
Inability or unwillingness of parent or legal guardian/representative to give written informed consent.
Gestational age < 23 weeks.","Subjects randomized by the investigational drug pharmacist to hydrocortisone arm received a 7 day course of intravenous (IV) hydrocortisone sodium succinate (Solu-Cortef) every 12 hours (3 mg/kg per day for first 4 days, 2 mg/kg per day for 2 days and 1 mg/kg per day for 1 day; total of 17 mg/kg over 7 days). The IV route was preferred.",ChEMBL:CHEMBL389621 | DrugBank:DB00741 | PubChem:5754,Hydrocortisone,[H][C@@]12CC[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)CC[C@@]21C,A01AC03 | A07EA02 | C05AA01 | D07AA02 | D07BA04 | D07CA01 | D07XA01 | H02AB09 | R01AD60 | S01BA02 | S01BB01 | S01CA03 | S01CB03 | S02BA01 | S02CA03 | S03CA04,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00176423,NCT00176423_EG000,No,All,Adult,Phase 4,42,"Inclusion Criteria:

DSM-IV diagnosis of either schizophrenia or schizoaffective disorder.
Males and females
Age: 18 and 60
Caucasian or Non-Caucasian
Subjects will be currently treated with one of the following new generation antipsychotics: olanzapine, risperidone, quetiapine, ziprasidone, or aripiprazole.
Subjects will meet a priori criteria for cognitive impairment severity. The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) will be used to determine the level of cognitive impairment. Patients will meet entry criteria if they have a RBANS total score of 90 or less (one standard deviation below the normal control mean).

Exclusion Criteria:

History of an organic brain disease
History of DSM-IV alcohol or substance abuse (within the last month), or DSM-IV alcohol or substance dependence (within the last six months).
Pregnant women and women taking oral contraceptives (because of the theoretical risk of breakthrough ovulation).
Current treatment with galantamine or other acetylcholinesterase inhibitor (e.g. donepezil)
History of a second or third degree atrioventricular (AV) block.
Persons with chronic medical conditions, which are unstable.","galantamine, 24mgs, p.o., qday

galantamine: see arm/group description",ChEMBL:CHEMBL659 | DrugBank:DB00674 | PubChem:9651,Galantamine,[H][C@]12C[C@@H](O)C=C[C@]13CCN(C)Cc1ccc(OC)c(c13)O2,N06DA04,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00176423,NCT00176423_EG001,No,All,Adult,Phase 4,44,"Inclusion Criteria:

DSM-IV diagnosis of either schizophrenia or schizoaffective disorder.
Males and females
Age: 18 and 60
Caucasian or Non-Caucasian
Subjects will be currently treated with one of the following new generation antipsychotics: olanzapine, risperidone, quetiapine, ziprasidone, or aripiprazole.
Subjects will meet a priori criteria for cognitive impairment severity. The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) will be used to determine the level of cognitive impairment. Patients will meet entry criteria if they have a RBANS total score of 90 or less (one standard deviation below the normal control mean).

Exclusion Criteria:

History of an organic brain disease
History of DSM-IV alcohol or substance abuse (within the last month), or DSM-IV alcohol or substance dependence (within the last six months).
Pregnant women and women taking oral contraceptives (because of the theoretical risk of breakthrough ovulation).
Current treatment with galantamine or other acetylcholinesterase inhibitor (e.g. donepezil)
History of a second or third degree atrioventricular (AV) block.
Persons with chronic medical conditions, which are unstable.","placebo, 3 tablets, p.o., qday

galantamine: see arm/group description",ChEMBL:CHEMBL659 | DrugBank:DB00674 | PubChem:9651,Galantamine,[H][C@]12C[C@@H](O)C=C[C@]13CCN(C)Cc1ccc(OC)c(c13)O2,N06DA04,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00187681,NCT00187681_EG000,Accepts Healthy Volunteers,All,Adult,Phase 4,20,"Inclusion Criteria:

Previous participation in the Study Of Pharmacogenetics In Ethnically Diverse Populations (SOPHIE) study.
Between the ages of 18 and 40.
Possess a specific OCT1 genotype.

Exclusion Criteria:

Taking any medications other than vitamins
Individuals with anemia (hemoglobin < 12 g/dL), an elevation in liver enzymes to higher than double the respective normal value, or elevated creatinine concentrations (males ≥ 1.5 mg/dL, females ≥ 1.4 mg/dL)
Pregnant at time of study.",Subjects with OCT1-reference alleles to be doses with 2 doses of Metformin (total 1850 mg).,ChEMBL:CHEMBL1431 | DrugBank:DB00331 | PubChem:4091,Metformin,CN(C)C(=N)NC(=N)N,A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00187681,NCT00187681_EG001,Accepts Healthy Volunteers,All,Adult,Phase 4,20,"Inclusion Criteria:

Previous participation in the Study Of Pharmacogenetics In Ethnically Diverse Populations (SOPHIE) study.
Between the ages of 18 and 40.
Possess a specific OCT1 genotype.

Exclusion Criteria:

Taking any medications other than vitamins
Individuals with anemia (hemoglobin < 12 g/dL), an elevation in liver enzymes to higher than double the respective normal value, or elevated creatinine concentrations (males ≥ 1.5 mg/dL, females ≥ 1.4 mg/dL)
Pregnant at time of study.",Subjects with OCT1-reference alleles to be doses with 2 doses of Metformin (total 1850 mg).,ChEMBL:CHEMBL1431 | DrugBank:DB00331 | PubChem:4091,Metformin,CN(C)C(=N)NC(=N)N,A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00187720,NCT00187720_EG000,Accepts Healthy Volunteers,All,Adult,Phase 4,23,"Inclusion Criteria:

Subjects have previously participated in the Study Of Pharmacogenetics In Ethnically Diverse Populations (SOPHIE) study.
18-40 years old
Possess a pre-specified genotype for OCT2

Exclusion Criteria:

Taking any regular medications other than vitamins.
Individuals with anemia (hemoglobin < 12 g/dL), an elevation in liver enzymes to higher than double the respective normal value, or elevated creatinine concentrations (males ≥ 1.5 mg/dL, females ≥ 1.4 mg/dL)
Pregnant or breastfeeding",Subjects with OCT2-reference genotype will be given a single oral dose of 850 mg of metformin,ChEMBL:CHEMBL1431 | DrugBank:DB00331 | PubChem:4091,Metformin,CN(C)C(=N)NC(=N)N,A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00187720,NCT00187720_EG001,Accepts Healthy Volunteers,All,Adult,Phase 4,23,"Inclusion Criteria:

Subjects have previously participated in the Study Of Pharmacogenetics In Ethnically Diverse Populations (SOPHIE) study.
18-40 years old
Possess a pre-specified genotype for OCT2

Exclusion Criteria:

Taking any regular medications other than vitamins.
Individuals with anemia (hemoglobin < 12 g/dL), an elevation in liver enzymes to higher than double the respective normal value, or elevated creatinine concentrations (males ≥ 1.5 mg/dL, females ≥ 1.4 mg/dL)
Pregnant or breastfeeding",Subjects with OCT2-variant genotype will be given a single oral dose of 850 mg of metformin,ChEMBL:CHEMBL1431 | DrugBank:DB00331 | PubChem:4091,Metformin,CN(C)C(=N)NC(=N)N,A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00189202,NCT00189202_EG000,No,All,Adult | Older Adult,Phase 2 | Phase 3,49,"Inclusion Criteria:

African American recipient race
Solitary cadaveric or living donor renal transplantation
Age ≥18years at the time of transplantation
Negative pregnancy serum test in females with childbearing potential

Exclusion Criteria:

Age < 18 years at the time of transplantation
Multi-organ transplant recipient
Currently taking steroids
White Blood Cell Count < 3,000
Platelet count < 100,000
Triglycerides >400mg/dL
Cholesterol > 350 mg/dL
Unwillingness to comply with study procedures
Allergic reaction to sirolimus Allergy to polyclonal antilymphocyte drugs (Thymoglobulin)","Thymoglobulin induction, sirolimus and no maintenance corticosteroid.

Sirolimus: Thymoglobulin induction, sirolimus and no maintenance corticosteroid",ChEMBL:CHEMBL413 | DrugBank:DB00877 | PubChem:134760597 | PubChem:138404388 | PubChem:21944094 | PubChem:5284616,Sirolimus,COC1CC2CCC(C)C(O)(O2)C(=O)C(=O)N2CCCCC2C(=O)OC(C(C)CC2CCC(O)C(OC)C2)CC(=O)C(C)C=C(C)C(O)C(OC)C(=O)C(C)CC(C)C=CC=CC=C1C,L01EG04 | L04AA10 | S01XA23,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00189306,NCT00189306_EG000,No,All,Adult | Older Adult,Phase 3,169,"Inclusion Criteria:

Have at least 1 previously untreated superficial basal cell carcinoma tumor
Minimum tumor size 0.5 cm2 and maximum diameter of 2.0 cm

Exclusion Criteria:

Evidence of clinically significant, unstable medical conditions
Cannot have recent use of topical steroids or retinoids in the treatment area.",Aldara (imiquimod) cream 5%,ChEMBL:CHEMBL1282 | DrugBank:DB00724 | PubChem:57469,Imiquimod,CC(C)Cn1cnc2c(N)nc3ccccc3c21,D06BB10,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT00224289,NCT00224289_EG000,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 4,17,"Inclusion Criteria:

diagnosis of open angle glaucoma,
pseudoexfoliation glaucoma, pigmentary glaucoma or ocular hypertension in one or both eyes;
IOP above their target pressure as determined by a glaucoma specialist;
willingness to participate in the study.

Exclusion Criteria:

hypersensitivity to any of the components of the treatment medication;
previous use of topical prostaglandins;
documented ocular infection or intraocular inflammation within the past year;
previous filtering surgery or complicated cataract surgery;
active corneal disease;
presence of cystoid macular edema;
laser trabeculoplasty or any other ocular laser procedure within the past three months.","All participants will be taking Latanoprost; This study compares efficacy within age groups.

Latanoprost 0.005% : Latanoprost 0.005% ophthalmic solution QHS 8 weeks",ChEMBL:CHEMBL1051 | DrugBank:DB00654 | PubChem:5311221,Latanoprost,CC(C)OC(=O)CCC/C=C\C[C@@H]1[C@@H](CC[C@@H](O)CCc2ccccc2)[C@H](O)C[C@@H]1O,S01EE01 | S01EE51,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00227994,NCT00227994_EG000,No,All,Adult | Older Adult,Phase 4,40,"Inclusion Criteria:

Admitted to a rehabilitation hospital with primary diagnosis of ischemic stroke (cardiovascular accident)
Stroke was within 30 days of being admitted
Medically stable
Presence of memory and/or attentional impairments and evidence that these impairments were not present or were less severe prior to the stroke (assessed via interview with family)
Approval by individual's attending physician at the rehabilitation hospital

Exclusion Criteria:

Aphasia or cognitive (or behavioral) impairments severe enough to prevent valid neuropsychiatric assessment
Currently experiencing a major depressive episode (unless treated and in partial remission, assessed using the Primary Care Evaluation of Mental Disorders)
Current psychosis or mania
History of substance or alcohol abuse or dependence within three months of study entry
Currently taking a cholinomimetic drug
Medical condition with known sensitivity to donepezil (e.g., slower than normal heart rate, supraventricular cardiac conduction defects, severe asthma or obstructive pulmonary disease, active upper gastrointestinal bleed, or gastric/duodenal ulcer if not on acid-blocking agent)
Informed that taking donepezil is medically inadvisable
Current use of any anticholinergic medication (e.g., for bladder spasm)","Galantamine for 12 weeks

Galantamine: Participants assigned to receive galantamine will receive 4 mg twice a day for 4 weeks, 8 mg twice a day for the next 4 weeks, and 12 mg twice a day for the remainder of the study.",ChEMBL:CHEMBL659 | DrugBank:DB00674 | PubChem:9651,Galantamine,[H][C@]12C[C@@H](O)C=C[C@]13CCN(C)Cc1ccc(OC)c(c13)O2,N06DA04,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00234065,NCT00234065_EG000,No,All,Adult | Older Adult,Phase 4,1337,"Inclusion Criteria:

Patients with stable medical conditions for 182 days (26 weeks) after occurrence of cerebral infarction
Patients in whom the infarct-related foci was detected by X-ray CT scan or MRI
Patients aged 20 to 80 years (inclusive) at time of consent
Patients with none of the following cardiac diseases that may be associated with cardiogenic cerebral embolism: mitral stenosis, prosthetic heart valve, endocarditis, myocardial infarction within 6 weeks after occurrence, ventricular aneurysm, endocardial thrombosis, mitral valve prolapse (patients less than 45 years of age in whom no other cause was identified), atrial fibrillation, sick sinus syndrome, idiopathic cardiomyopathy, and patent foramen ovale
Patients without asymptomatic cerebral infarction
Patients who have neither undergone nor are scheduled to undergo percutaneous transluminal angioplasty or revascularization for the treatment of cerebral infarction
Patients without severe disturbances/impairments following occurrence of cerebral

Exclusion Criteria:

Patients with hemorrhage or bleeding tendency (hemophilia, capillary fragility, intracranial hemorrhage, hemorrhage in the digestive tract, hemorrhage in the urinary tract, hemoptysis, and hemorrhage in the vitreous body)
Pregnant, possibly pregnant, or nursing women
Patients with ischemic heart failure
Patients with peptic ulcer
Patients with severer blood disorders
Patients with severe hepatic or renal
Patients with malignant neoplasm or patients who have received any therapy for malignant neoplasm within 5 years prior to entering the study
Patients with a history of hypersensitivity to salicylic acid formulations or ingredients of cilostazol tablets
Patients with aspirin asthma (asthma attacks induced by nonsteroidal antiinflammatory analgesic agents) or a history of aspirin asthma
Patients who are being treated with ticlopidine hydrochloride
Patients who are participating in another study for an investigational drug
Patients who are otherwise judged inappropriate for inclusion in the study by the investigators","cilostazol, oral tablet, 100 mg cilostazol",ChEMBL:CHEMBL799 | DrugBank:DB01166 | PubChem:2754,Cilostazol,O=C1CCc2cc(OCCCCc3nnnn3C3CCCCC3)ccc2N1,B01AC23,0.0,1.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,1.0,1.0,1.0,1.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0
NCT00245583,NCT00245583_EG000,No,All,Adult | Older Adult,Phase 3,20,"Inclusion Criteria:

Subjects must have a current DSMV-IV-TRTM diagnosis of pathological gambling supported by the Structured Clinical Interview for Pathological Gambling (SCI-PG).
Subjects must have a severity score of ³ 4 (moderately ill) on the Clinical Global Impressions Scale - Severity (CGI-S) at Visit 1A (Day -28).
Subjects must have a severity score of ³5 on the South Oaks Gambling Screen (SOGS) at Visit 1B (Day -7).
Subjects must have a score of ³2 for item number 1 on the Gambling Symptom Assessment Scale (G-SAS) at Visit 1B (Day -7) and Visit 2 (Day 1).
Subjects must have a minimum score of >10 on the obsession subscale (questions 1-5) of the Pathological Gambling - Yale Brown Obsessive Compulsive Scale (PG-Y-BOC) at Visits 1B (Day -7) and 2 (Day 1).
Subjects must score ≤15 on the Young Mania Rating Scale (YMRS) at Visits 1B (Day -7) and 2 (Day 1).
Subjects must be between 18 and 70 years of age, inclusive.
Subjects must provide contact information for themselves to be used by the site in case of a missed appointment.
Subjects may be male or female and must be in generally good health as confirmed by medical history and physical examination, laboratory tests and vital signs.

Female subjects must be:

postmenopausal for at least one year, or
surgically sterile, or
practicing an effective method of birth control (e.g., oral contraceptives, contraceptive injections, intrauterine device, spermicide with barrier, contraceptive patch, contraceptive vaginal ring, male partner sterilization, or abstinence and agree to continue abstinence or to use an acceptable method of contraception, as listed above, should sexual activity commence) before entry and throughout the study; have a negative urine pregnancy test at Visits 1B (Day -7) and 2 (Day 1).
Subjects must be able to take oral medication, adhere to the medication regimens and be willing to return for regular visits.
Subjects must be able and willing to read written instructions and complete all scales and inventories required by the protocol.
Subjects must have signed an informed consent form indicating that they understand the purpose of and procedures required for the study and are willing to participate.

Exclusion Criteria:

Subjects with any current Axis I psychiatric disorder as defined by DSM-IV-TRä supported by the SCID-I/P, other than pathological gambling, that in the investigator's judgment might require intervention with either pharmacological or non-pharmacological therapy over the course of the study.
Subjects with a history of personality disorder (e.g., schizotypal or borderline) considered by the investigator to likely interfere with assessment or compliance with treatment.
Subjects who have a current or recent (within 3 months of Visit 2, Day 1) DSM-IV-TRTM diagnosis of substance abuse or dependence, with the exception of nicotine and caffeine abuse or dependence.
Subjects receiving formal psychotherapy for pathological gambling (with the exception of Gamblers Anonymous) within the 4 weeks prior to Visit 1B (Day -7).

Note: Formal psychotherapy is defined as behavioral therapy, cognitive therapy, cognitive-behavioral therapy, psychoanalysis, etc. for the treatment of a clinical diagnosis or for which a healthcare professional is billing for such therapy.

- Subjects who have begun to receive formal psychotherapy for a psychiatric disorder, other than pathological gambling, within 3 months prior to Visit 1B (Day -7).

Note: Subjects who have been engaged in formal psychotherapy for a condition other than pathological gambling for >3 months and plan to maintain therapy throughout the study will be considered on a case-by-case basis.

Subjects with a score of >24 on the Montgomery-Asberg Depression Rating Scale (MADRS) at Visit 1B (Day -7) and Visit 2 (Day 1).
Subjects who are expected to stay in a restricted environment.
Subjects who have taken a prohibited medication described in the Concomitant Therapy section of the protocol and who have not met the washout criteria specified in Attachment 15.
Subjects with a positive urine drug screening [benzodiazepines, phencyclidine, cocaine, amphetamines, tetrahydrocannabinol (THC), and opiates] at Visit 1B (Day -7).

Note: Subjects with a positive urine drug screen for THC may be retested in 7 days and enrolled if they a) continue to meet inclusion/exclusion criteria and b) have a negative urine drug screen upon retest.

Subjects who are pregnant or lactating.
Subjects who are members of the same household.
Subjects with a history of nephrolithiasis.

Subjects known to have clinically significant medical conditions, including but not limited to:

symptomatic coronary artery disease or peripheral vascular disease;
malignancy or history of malignancy within the past 5 years (except basal cell carcinoma);
renal disease and/or impaired renal function as defined by subjects with an estimated creatinine clearance of £60 mL/min;
diseases of the gastrointestinal system including active liver disease;
subjects with AST and/or ALT >2 times the upper limit of the normal range and/or an increased serum bilirubin > 2.0 mg/dL at Visit 1B (Day -7); Note: if these values are abnormal they can be re-tested prior to enrollment. If the repeat study is within the limits of the protocol the subject may be randomized.
pulmonary disorders including subjects with active tuberculosis;
endocrinological disorders;
neurological disorders including subjects with seizure disorders and subjects with progressive or degenerative neurological disorders (e.g., multiple sclerosis); or I. any disease or condition that compromises the function of those body systems that could result in altered absorption, excess accumulation, or impaired metabolism or excretion of topiramate.
Subjects who have previously been treated with topiramate for any reason and discontinued treatment due to an adverse event or a hypersensitivity reaction to topiramate.
Subjects with prior non-response to topiramate for the treatment of pathological gambling following an adequate trial.
Subjects who in the opinion of the investigator should not be enrolled in the study because of the precautions, warnings or contraindications outlined in the topiramate investigator brochure and/or package insert.
Employees of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the investigator or study center employees.","25mg to 300mg daily dose

Topiramate: minimum does of 50mg/day",ChEMBL:CHEMBL220492 | DrugBank:DB00273 | PubChem:5284627,Topiramate,[H][C@@]12OC(C)(C)O[C@]1([H])CO[C@@]1(COS(N)(=O)=O)OC(C)(C)O[C@]12[H],A08AA51 | N03AX11,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00245635,NCT00245635_EG000,No,All,Child,Phase 4,25,"Inclusion Criteria:

Male or female children and adolescents aged 16 and younger
BDD or its delusional variant present currently and for at least 6 months prior to the study
Ability to communicate meaningfully with the investigators and competent to provide written assent

Exclusion Criteria:

Presence of Schizophrenia or Bipolar Disorder
Recent suicide attempt or suicidal ideations that warrant hospitalizations
Previous allergic reaction to fluoxetine
History of a seizure disorder","Fixed/flexible dosing regimen of fluoxetine based on weight of subject and reaction to dosage, varying between 10mg and 80mg tablets once a day.

Fluoxetine: Tablets varying between 10mg and 80mg on a fixed/flexible dosing schedule based on the subjects' weight and side effects score.",ChEMBL:CHEMBL41 | DrugBank:DB00472 | PubChem:3386,Fluoxetine,CNCCC(Oc1ccc(C(F)(F)F)cc1)c1ccccc1,N06AB03 | N06CA03,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00251316,NCT00251316_EG000,No,All,Child | Adult | Older Adult,Phase 2,15,"INCLUSION CRITERIA

Patients older than 16 years with well-differentiated papillary or follicular thyroid cancer stage I or II, according to the NTCTCS classification at time of surgery
Patients younger than 45 years with any size of primary papillary or follicular tumor

Patients older than 45 years with:

primary papillary tumor less than 4 cm or
primary follicular tumor less than 1 cm

EXCLUSION CRITERIA

Patients with postsurgical thyroid remnant more than 5 g
Patients with distant metastases

Patients above 45 years of age having:

known cervical lymph nodes metastases
microscopic multifocal follicular cancer
microscopic extraglandular invasion of follicular cancer
gross extraglandular invasion of papillary or follicular cancer
Patients with confirmed histological subtypes of well-differentiated thyroid cancer such as Hurtle cell carcinoma, insular and tall cell variants of papillary cancer.
Pregnant or lactating women
Patients with renal impairment defined as repeat serum creatinine concentrations above 1.5 mg/dl on thyroid hormone
Patients on chronic lithium therapy for psychiatric illness
Patients with current unstable cardiovascular conditions
Patients with severe chronic medical conditions (liver failure, severe debilitation, dehydration, sodium depletion, any other cancer requiring therapy, etc)",Patients recently diagnosed with papillary or follicular thyroid cancer who have had their thyroid gland removed and whose cancer has not spread beyond the thyroid may be eligible for this study. Participants in this arm receive lithium capsules.,ChEMBL:CHEMBL1200826 | DrugBank:DB14509 | PubChem:11125,LITHIUM CARBONATE,O=C([O-])[O-].[Li+].[Li+],,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00251641,NCT00251641_EG001,No,All,Adult | Older Adult,Phase 3,211,"Inclusion Criteria:

Adult male and female subjects (>= 18 to 75 years of age) with a diagnosis of moderate to severe plaque-type psoriasis for at least 6 months prior to study screening (subjects with concurrent psoriatic arthritis may also be enrolled).
Subjects must be eligible for phototherapy or systemic therapy for their psoriasis and must have a Baseline Psoriasis Area and Severity Index (PASI) score of 12 or greater and have at least 10% of their total body surface area (BSA) involved at Baseline.
Subjects must agree to avoid prolonged sun exposure and avoid use of tanning booths or other ultraviolet light sources during the study.
Subjects must also meet the tuberculosis (TB) eligibility assessment and screening criteria as follows: Have no history of latent or active TB prior to screening; have no signs or symptoms suggestive of active TB upon medical history and/or physical examination; have had no recent close contact with a person with active TB or, if there has been such contact, will be referred to a physician specializing in TB to undergo additional evaluation and, if warranted, receive appropriate treatment for latent TB prior to or simultaneously with the first administration of study medication; within 1 month prior to the first administration of study medication, either have negative diagnostic TB test results (defined as 2 negative tuberculin skin tests) OR have a newly identified positive diagnostic TB test result (defined as at least 1 positive tuberculin skin tests) during screening in which active TB has been ruled out and for which appropriate treatment for latent TB has been initiated either prior to or simultaneously with the first administration of study medication.
Subjects must have had a chest x-ray (posterior-anterior and lateral) within 3 months prior to Screening with no evidence of malignancy, infection, fibrosis, or current or old active TB.
Specific parameters must also be met with regard to screening laboratory test results and liver enzymes in order to be eligible to participate in the study.

Exclusion Criteria:

Subjects who have non-plaque forms of psoriasis, current drug-induced psoriasis, are pregnant, nursing, or planning pregnancy;
Subjects previously treated with MTX or infliximab; subjects who are taking specific drugs within the specified time frame prior to Baseline as follows: any therapeutic agent targeted at reducing tumor necrosis factor (TNF) or any biologic, live virus or bacterial vaccinations within 3 months; any systemic medications or treatments that could affect psoriasis or PASI evaluations, or any systemic immunosuppressants or lithium within 4 weeks; any topical medications or treatments that could affect psoriasis or PASI evaluations within 2 weeks. The only allowed topical treatments for psoriasis are shampoos (containing tar or salicylic acid only) and topical moisturizers. Subjects should not use these topical agents during the morning prior to a study visit. Non-medicated shampoos may be used on the morning of a visit.
Subjects with poor health, including concomitant congestive heart failure (CHF); history of chronic or recurrent infectious disease, as specified; human immunodeficiency virus, hepatitis B, or hepatitis C; demyelinating disease or symptoms suggestive of multiple sclerosis or optic neuritis; systemic lupus erythematosus; or who have had serious infections (eg, hepatitis, pneumonia, or pyelonephritis], or who have been hospitalized or received IV antibiotics, or who had an opportunistic infection (eg, cytomegalovirus, Pneumocystis carinii, aspergillosis, histoplasmosis, or mycobacteria other than TB), or a transplanted organ within specified time frames; or other conditions as specified in the protocol.
Subjects who have used any investigational drugs within 4 weeks of Screening, who are participating in other clinical studies, staff or family members of study staff are excluded from participation in the study.",Adverse events reported through Week 26 for participants who did not switch treatment at Week 16 and adverse reported through Week 16 for those participants who switched treatment.,ChEMBL:CHEMBL34259 | DrugBank:DB00563 | PubChem:126941,Methotrexate,CN(Cc1cnc2nc(N)nc(N)c2n1)c1ccc(C(=O)N[C@@H](CCC(=O)O)C(=O)O)cc1,L01BA01 | L04AX03,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00255346,NCT00255346_EG000,No,All,Adult | Older Adult,Phase 2,68,"Inclusion Criteria:

Patients >/= 18 years old who meet the following eligibility criteria
Patients must have one of the following hematopoietic malignancies: C-kit positive (10% or more BM or PB MNC positive by flow) acute myeloid leukemia (AML excluding acute promyelocytic leukemia) or myelodysplastic syndrome (MDS) of the following types: Refractory-relapse AML-MDS including those who fail to achieve Complete Response (CR) after the first cycle of induction; Second or subsequent AML-MDS refractory-relapse; Newly diagnosed AML-MDS patients over 60 years of age with karyotype other than t(15:17), inv16, t(8:21), who do not want chemotherapy.
(Con't from # 2) Patients with MDS who do not want chemotherapy as initial treatment, or who are not eligible for the treatments of higher priority.
Agnogenic myeloid metaplasia - myelofibrosis (MMM)
Hypereosinophilic syndrome (HES)
Polycythemia vera (PV)
Mastocytosis
Serum bilirubin less than 2mg%, serum creatinine less than 2mg% unless abnormality is considered due to hematologic malignancy by investigator.
Eastern Cooperative Oncology Group (ECOG) Performance Status < 3
Patients must sign an informed consent indicating they are aware of the investigational nature of this study, in keeping with the policies of the hospital.
Women of pregnancy potential must practice an effective method of birth control during the course of the study, in a manner such that risk of failure is minimized. Prior to study enrollment, women of childbearing potential (WOCBP) (defined as not post-menopausal for 12 months or no previous surgical sterilization) must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy.
Continued from #11: In addition, men enrolled on this study should understand the risks to any sexual partner of childbearing potential and should practice an effective method of birth control.Women and men must continue birth control for the duration of the trial and at least 3 months after the last dose of study drug.
Inclusion of women and minorities: As per NIH policy, women and members of minorities will be included in this protocol as they are referred in the relevant populations. There are no exclusions of women or minorities based on the study objectives.
New York Heart Association (NYHA) Class < 3
Ph negative MPD including chronic myelomonocytic leukemia (CMML).

Exclusion Criteria:

Pregnant or breast-feeding women are excluded.
All WOCBP MUST have a negative pregnancy test prior to first receiving investigational product. If the pregnancy test is positive, the patient must not receive investigational product and must not be enrolled in the study.","Dasatinib 70 mg orally twice daily.

Dasatinib (BMS-354825): 70 mg orally twice daily",ChEMBL:CHEMBL1421 | DrugBank:DB01254 | PubChem:3062316,Dasatinib,Cc1nc(Nc2ncc(C(=O)Nc3c(C)cccc3Cl)s2)cc(N2CCN(CCO)CC2)n1,L01EA02 | L01XE06,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT00261495,NCT00261495_EG001,No,All,Adult | Older Adult,Phase 3,250,"Inclusion Criteria:

Adult patients with chronic noncancer pain severe enough to require continuous opioid therapy (a score of at least 5 in ""pain right now"" on a 11 point numeric rating scale) who have never received an opioid or are currently treated with a weak opioid, and who experience insufficient pain control.

Exclusion Criteria:

Patients who have been treated with strong opioids (including hydromorphone and oxycodone) within the last 4 weeks prior to study inclusion or who will probably undergo any treatment (e.g. neurological techniques, surgery) within the next 6 months, which may abruptly alter degree or nature of pain experienced
patients with a history of disease(s), current illness, or therapy which would preclude them from participation in the study
and patients who are pregnant or nursing.","Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)",ChEMBL:CHEMBL656 | DrugBank:DB00497 | PubChem:5284603,Oxycodone,COc1ccc2c3c1O[C@H]1C(=O)CC[C@@]4(O)[C@@H](C2)N(C)CC[C@]314,N02AA05 | N02AA55 | N02AA56 | N02AJ17 | N02AJ18 | N02AJ19,0.0,0.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT00262873,NCT00262873_EG000,No,All,Adult | Older Adult,Phase 2,8,"DISEASE CHARACTERISTICS:

Diagnosis of myelodysplastic syndromes (MDS)

Requires treatment or transfusion support for MDS, as indicated by 1 of the following:

Demonstrates transfusion or epoetin alfa dependence

Transfusion dependence is defined as requiring ≥ 2 units of packed RBCs within an 8-week period prior to study entry

Hemoglobin < 11g/dL on 2 separate occasions 2 weeks apart

No iron, cyanocobalamin (vitamin B_12), or folic acid deficiency or other causes of anemia

Must have 1 of the following FAB subtypes:

Refractory anemia
Refractory anemia with ringed sideroblasts
Refractory anemia with excess blasts
Secondary MDS (if ≥ 3 years since active primary cancer)
No chronic myelomonocytic leukemia
Not refractory to platelet transfusion support (i.e., inability to maintain platelet count > 20,000/mm^3 with transfusion)
No current acute myelogenous leukemia (e.g., > 30% blasts)

PATIENT CHARACTERISTICS:

Performance status

Karnofsky 50-100%

Life expectancy

At least 6 months

Hematopoietic

See Disease Characteristics

Hepatic

Bilirubin ≤ 2 mg/dL
AST and ALT < 2 times upper limit of normal

Renal

Creatinine clearance ≥ 30 mL/min

Cardiovascular

No significant cardiovascular condition that would preclude study participation
No uncontrolled hypertension

Pulmonary

No significant pulmonary condition that would preclude study participation

Immunologic

No serious concurrent infection

Active infections must be adequately treated with antibiotics prior to study entry
No hypersensitivity to bortezomib, boron, or mannitol

Other

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for up to 4 weeks after completion of study treatment
No peripheral neuropathy ≥ grade 2
No uncontrolled seizure activity, as defined by no activity within the past year on stable anticonvulsant medications
No other malignancy within the past 3 years except adequately treated basal cell skin cancer or carcinoma in situ of the cervix
No endocrine, neurologic, or other systemic disease that would preclude study entry

PRIOR CONCURRENT THERAPY:

Biologic therapy

See Disease Characteristics
No prior allogeneic bone marrow transplantation
Concurrent transfusion support allowed
Concurrent epoetin alfa or darbepoetin alfa allowed if initiated before start of study therapy, dose is stable for ≥ 4 weeks, and dose is stable during study participation
No concurrent platelet growth factor support
No concurrent thalidomide

Chemotherapy

No concurrent chemotherapy
No concurrent hydroxyurea

Endocrine therapy

Concurrent corticosteroids for chronic autoimmune or inflammatory condition allowed if initiated before start of study therapy and maintained on a stable or decreasing dose

Other

Recovered from all prior therapies
At least 4 weeks since prior MDS therapy, except epoetin alfa, darbepoetin alfa, filgrastim (G-CSF), pegfilgrastim (G-CSF), or transfusion support
At least 30 days since prior investigational agents
No prior bortezomib
No other concurrent investigational agents
No other concurrent therapy for MDS","Bortezomib was given at a dose of 1.3 mg per meter squared on day 1, 4, 8, and 11 on a 21 day cycle. Up to 12 cycles were allowed. Response assessments were made after the 3rd, 6th and 12 cycles of therapy.",ChEMBL:CHEMBL325041 | DrugBank:DB00188 | PubChem:387447,Bortezomib,CC(C)C[C@H](NC(=O)[C@H](Cc1ccccc1)NC(=O)c1cnccn1)B(O)O,L01XG01 | L01XX32,1.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT00267059,NCT00267059_EG000,No,All,Adult | Older Adult,Phase 2,44,"Inclusion Criteria:

Patients with B-cell CLL with indications for treatment by National Cancer Institute (NCI) Working Group Criteria, or Rai Stage III or IV or patients with CLL requiring treatment because of any of the following: disease related symptoms, progressive marrow failure (development or worsening of anemia and/or patients' thrombocytopenia) progressive splenomegaly, progressive lymphoadenopathy, progressive lymphocytosis
Patients who have received a minimum of one prior purine analog-based chemotherapy regimen. Prior treatment with corticosteroids, immunotherapy, monoclonal antibody or radiation therapy is permitted. All previous cancer therapy, including radiation, hormonal therapy and surgery must have been discontinued 2 weeks prior to treatment in this study. Any cytotoxic chemotherapy must be discontinued 4 weeks prior to treatment in this study.
Age more or equal to 18 years (CLL is not observed in patients less than 18 years of age).
Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) performance status 0-2.
Adequate renal function indicated by serum creatinine less or equal to 2 and adequate hepatic function indicated as total bilirubin less or equal to 2 times the upper limit of normal.
Understand and sign Informed Consent after the investigational nature, study design, risks and benefits of the study have been explained.
Females of childbearing potential (FCBP)must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days prior to and again within 24 hours of starting lenalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 4 weeks before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing.
Continued from #7. Men must agree to use a condom during sexual contact with a female of child bearing potential even if they have had a successful vasectomy. All patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure.
Continued from #8. A female of childbearing potential is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
Disease free of prior malignancies for 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma ""in situ"" of the cervix or breast. Patients with malignancies with indolent behavior such as prostate cancer treated with radiation can be enrolled in the study as long as they have a reasonable expectation to have been cured with treatment modality received.

Exclusion Criteria:

Known sensitivity to thalidomide or its derivatives
The development of erythema nodosum as characterized by a desquamating rash while taking thalidomide or similar drugs.
Prior use of lenalidomide
Concurrent use of other chemotherapy agents.
Known positivity for Human immunodeficiency virus (HIV) or infectious hepatitis type A, B or C.
Pregnant or lactating females.
A serious medical condition, laboratory abnormality or psychiatric illness that would pose the subject at unacceptable risk if he/she were to participate in the study or that would interfere with the ability of the patient to carry out the treatment program or confine the ability to interpret the data from the study.
Documented prolymphocytic leukemia (prolymphocytes more than 55% in the blood).
Active cardiovascular disease as defined by the New York Heart Association class 3 or 4.","10 mg/day, orally once a day for 28 days",ChEMBL:CHEMBL848 | DrugBank:DB00480 | PubChem:216326,Lenalidomide,Nc1cccc2c1CN(C1CCC(=O)NC1=O)C2=O,L04AX04,1.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT00274768,NCT00274768_EG000,No,All,Adult | Older Adult,Phase 2,26,"DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed diagnosis of adenocarcinoma of the breast

Evidence of metastatic involvement (stage IV disease)

Patients must have measurable disease

At least one measurable lesion as defined by the Response Evaluation Criteria in Solid Tumors (RECIST)
Treated brain metastases (surgery or radiation therapy) allowed if clinically stable
Patients with leptomeningeal disease are ineligible

Hormone receptor status:

Not specified

PATIENT CHARACTERISTICS:

Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Male or female
Menopausal status not specified
Absolute neutrophil count (ANC) ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3
Creatinine clearance > 50 mL/min
Fertile patients must use effective contraception
No history of another severe and/or life-threatening medical disease
No other active primary malignancy
Not pregnant or nursing
Negative pregnancy test
Patients with asymptomatic HIV infection are eligible
Liver dysfunction score ≤ 9
No pre-existing liver disease (i.e., cirrhosis or active viral hepatitis)
No active gastrointestinal malabsorption illness

No clinically significant cardiac disease, including the following:

Congestive heart failure, symptomatic coronary artery disease, and cardiac arrhythmias not well controlled with medication, or myocardial infarction within the past six months
No prior unanticipated severe reaction to fluoropyrimidine therapy, known hypersensitivity to fluorouracil, or known dihydropyrimidine dehydrogenase deficiency
No history of uncontrolled seizures or central nervous system disorders
No significant history of noncompliance to medical regimens
No clinically significant psychiatric disability that would preclude study compliance

PRIOR CONCURRENT THERAPY:

No previous capecitabine

Up to 3 prior cytotoxic regimens allowed for metastatic disease

Prior noncytotoxic therapy allowed (e.g., hormonal treatment or trastuzumab)
No other concurrent therapies intended to treat the primary condition including chemotherapy, biologic agents, or immunotherapy
No concurrent anti-estrogen therapy, radiation therapy, or investigational systemic therapy
No other concurrent investigational drugs

No concurrent use of the following drugs: warfarin for full anticoagulation, cimetidine, or azidothymidine (AZT)

Mini-dose warfarin for prophylaxis of central venous catheter thrombosis allowed
At least 4 weeks since prior sorivudine or brivudine
Concurrent use of bisphosphonates allowed if initiated before beginning study therapy
Concurrent use of megestrol acetate suspension as an appetite stimulant allowed","The starting dose of capecitabine was 3,000 mg (total daily dose) given in two divided daily doses for 14 days followed by 7 days of rest (1 cycle = 21 days). Missed doses were not substituted. Treatment was continued until unacceptable toxicity, disease progression, or withdrawal of consent.",ChEMBL:CHEMBL1773 | DrugBank:DB01101 | PubChem:42066809 | PubChem:60953,Capecitabine,CCCCCOC(=O)Nc1nc(=O)n([C@@H]2O[C@H](C)[C@@H](O)[C@H]2O)cc1F,L01BC06,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT00276614,NCT00276614_EG000,No,All,Adult | Older Adult,Phase 2,4,"Inclusion Criteria:

Histologically confirmed pure non-clear cell renal cell carcinoma (RCC)
Distant metastatic disease (Tx, Nx, M1)
Tumor expresses wild-type von Hippel-Lindau tumor suppressor gene/protein
Measurable disease on imaging scan (≥ 1 cm)
Brain metastases allowed provided they have been treated with surgery and/or radiation therapy and show no evidence of progression on cerebral CT or MRI scan 2 months following surgery and/or radiation therapy.
Life expectancy ≥ 3 months
Karnofsky performance status ≥ 60%
Negative pregnancy test
Fertile patients must use an acceptable method of contraception
No other major illnesses likely to limit survival
Platelet count ≥ 100,000/mm^3
Absolute neutrophil count ≥ 1, 000/mm^3
Hemoglobin ≥ 10 g/dL (transfusion allowed)
Creatinine clearance ≥ 30 mL/min OR creatinine ≤ 2 mg/dL
ALT or AST ≤ 2.5 times upper limit of normal
At least 4 weeks since prior radiotherapy and recovered
More than 30 days since any other prior investigational drugs

Exclusion Criteria:

active CNS metastases
pregnant or nursing
myocardial infarction within the past 6 months
New York Heart Association class III or IV heart failure
uncontrolled angina
severe uncontrolled ventricular arrhythmias
electrocardiographic evidence of acute ischemia or active conduction system abnormalities
Peripheral neuropathy ≤ grade 1
hypersensitivity to bortezomib, boron, or mannitol
history of a non-RCC malignancy within the past 5 years except basal cell carcinoma of the skin
serious medical or psychiatric illness that would preclude study participation
prior cytotoxic chemotherapy for this cancer
other concurrent investigational therapy
concurrent chemotherapy, immunotherapy, or hormonal therapy","Bortezomib 1.3 mg/m2 given on days 1, 4, 8, 11 of a 21 day cycle.",ChEMBL:CHEMBL325041 | DrugBank:DB00188 | PubChem:387447,Bortezomib,CC(C)C[C@H](NC(=O)[C@H](Cc1ccccc1)NC(=O)c1cnccn1)B(O)O,L01XG01 | L01XX32,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00281684,NCT00281684_EG001,No,All,Adult,Phase 2,36,"Inclusion criteria:

Female or male subjects aged 18 to 50. Women may be of child bearing potential or of non-child bearing potential. Women of child bearing potential must use an effective method of contraception (see below).
Females of non-child bearing potential are defined as:
Post-menopausal females, being amenorrhoeic for at least 2 years with an appropriate clinical profile, e.g., age appropriate, history of vasomotor symptoms. However, if indicated this should be confirmed by oestradiol and FSH levels consistent with menopause (according to local laboratory ranges).
Pre-menopausal females with a documented hysterectomy (medical report verification) and/or bilateral oophorectomy. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.
Subject is healthy. Healthy subjects are defined as individuals who are not taking any regular medication and are free from clinically significant illness or disease as determined by their medical history (including family history), physical examination, 12-lead ECG, Holter monitor, laboratory studies, and other tests specified in this protocol.
Subject is scheduled for outpatient surgical removal of up to four third molar teeth under local anesthesia. At least one third molar tooth must be a fully or partially impacted in the mandible requiring bone removal;
Subject agrees not to take analgesics other than protocol defined rescue analgesics during treatment (up to 24 hrs post dose)
Subject has the ability to read, comprehend, and record information required by protocol;
Subject is willing and able to provide signed and dated written informed consent prior to study participation.

Exclusion criteria:

Subject has a history or presence of significant organ disease or mental illness;
Subject has been exposed to analgesics other than aspirin (including prescription and over the counter NSAIDs or COX-2 inhibitors) within 24 hours prior to the start of surgery;
Subject is unable to refrain from alcohol, psychoactive drugs, and sedatives including sleeping preparations (e.g . benzodiazepines) within 24 hours prior to the start of surgery and for the duration of their participation in the study
Following screening (and 24 h Holter ECG) the subject has a significant abnormality that, in the opinion of the investigator makes them unsuitable for the study.
Subject with a known allergy to or judged by the investigator not to be a suitable candidate for ibuprofen or co-codamol therapy based on medical history, concomitant medications, and concurrent systemic disease as described in the product labeling, e.g., peptic ulcer disease, angioedema, bronchospastic reactivity (e.g., asthma), rhinitis and nasal polyps induced by aspirin or other NSAIDs;
The subject had a history of drug or alcohol abuse, or had a positive pre-study urine drug / alcohol breath screen. Abuse of alcohol is defined as an average weekly intake of greater than 21 units or an average daily intake of greater than three units for males and intake greater than 14 units per week or an average daily intake of greater than two units for females. One unit is equivalent to a half-pint (220 mL) of beer or one (25 mL) measure of spirits or one glass (125 mL) of wine.
Subject has participated, or is participating in, a clinical study in which they have been exposed to an investigational drug or device during the past 30 days;
Subject has donated blood (450 mL or more) within the previous month.
Male subjects only:
An unwillingness of male subjects to abstain from sexual intercourse with pregnant or lactating women from the time of the first dose of study medication until five half-lives following administration of the last dose of study medication.
An unwillingness of the male subject to use a condom/spermicide in addition to having their female partner use another form of contraception such as IUD, diaphragm with spermicide, oral contraceptives, injectable progesterone, subdermal implants or a tubal ligation if the woman could become pregnant from the time of the first dose of study medication until 84 days following administration of the last dose of study medication.
Female subjects of child bearing potential:
Female subjects who are pregnant, breast feeding, or have a positive serum pregnancy test or a positive urine pregnancy test either at screening or pre-dose on each dosing session.
An unwillingness of the female subject to use an appropriate form of contraception. Appropriate forms of contraception are defined as:
Abstinence - The lifestyle of the female should be such that there is complete abstinence from intercourse from at least the commencement of their last normal period prior to the first dose of study medication and to continue until the first normal period (defined as normal for the woman, both in terms of duration and quantity of menses) after treatment or 15 days after the last dose of medication, whichever is the longest.
One of the following methods is acceptable as the sole method of contraception if there is indisputable data that it is >99% effective otherwise it should be used with a barrier method (condom or occlusive cap {diaphragm or cervical/vault caps} used with spermicidal foam/gel/film/cream/suppository):
Established use of oral, injected or implanted hormonal methods of contraception from at least the commencement of their last normal period prior to the first dose of study medication. Subjects using hormonal contraception should use a barrier method in addition from the first dose of study medication until their next normal period following the end of the study.
Documented tubal ligation.
Documented placement of an intrauterine device (IUD) or intrauterine system (IUS).
Male partner sterilisation (vasectomy) prior to the female subject's entry into the study and is the sole partner for that female subject.",Eligible participants received a single dose of SB705498 400 mg capsules (2 x 200 mg capsules plus 2 placebo capsules) via oral route and were followed up to a maximum of 14 days.,DrugBank:DB11883 | PubChem:9910486,SB-705498,O=C(Nc1ccccc1Br)N[C@@H]1CCN(c2ccc(C(F)(F)F)cn2)C1,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00281684,NCT00281684_EG002,No,All,Adult,Phase 2,34,"Inclusion criteria:

Female or male subjects aged 18 to 50. Women may be of child bearing potential or of non-child bearing potential. Women of child bearing potential must use an effective method of contraception (see below).
Females of non-child bearing potential are defined as:
Post-menopausal females, being amenorrhoeic for at least 2 years with an appropriate clinical profile, e.g., age appropriate, history of vasomotor symptoms. However, if indicated this should be confirmed by oestradiol and FSH levels consistent with menopause (according to local laboratory ranges).
Pre-menopausal females with a documented hysterectomy (medical report verification) and/or bilateral oophorectomy. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.
Subject is healthy. Healthy subjects are defined as individuals who are not taking any regular medication and are free from clinically significant illness or disease as determined by their medical history (including family history), physical examination, 12-lead ECG, Holter monitor, laboratory studies, and other tests specified in this protocol.
Subject is scheduled for outpatient surgical removal of up to four third molar teeth under local anesthesia. At least one third molar tooth must be a fully or partially impacted in the mandible requiring bone removal;
Subject agrees not to take analgesics other than protocol defined rescue analgesics during treatment (up to 24 hrs post dose)
Subject has the ability to read, comprehend, and record information required by protocol;
Subject is willing and able to provide signed and dated written informed consent prior to study participation.

Exclusion criteria:

Subject has a history or presence of significant organ disease or mental illness;
Subject has been exposed to analgesics other than aspirin (including prescription and over the counter NSAIDs or COX-2 inhibitors) within 24 hours prior to the start of surgery;
Subject is unable to refrain from alcohol, psychoactive drugs, and sedatives including sleeping preparations (e.g . benzodiazepines) within 24 hours prior to the start of surgery and for the duration of their participation in the study
Following screening (and 24 h Holter ECG) the subject has a significant abnormality that, in the opinion of the investigator makes them unsuitable for the study.
Subject with a known allergy to or judged by the investigator not to be a suitable candidate for ibuprofen or co-codamol therapy based on medical history, concomitant medications, and concurrent systemic disease as described in the product labeling, e.g., peptic ulcer disease, angioedema, bronchospastic reactivity (e.g., asthma), rhinitis and nasal polyps induced by aspirin or other NSAIDs;
The subject had a history of drug or alcohol abuse, or had a positive pre-study urine drug / alcohol breath screen. Abuse of alcohol is defined as an average weekly intake of greater than 21 units or an average daily intake of greater than three units for males and intake greater than 14 units per week or an average daily intake of greater than two units for females. One unit is equivalent to a half-pint (220 mL) of beer or one (25 mL) measure of spirits or one glass (125 mL) of wine.
Subject has participated, or is participating in, a clinical study in which they have been exposed to an investigational drug or device during the past 30 days;
Subject has donated blood (450 mL or more) within the previous month.
Male subjects only:
An unwillingness of male subjects to abstain from sexual intercourse with pregnant or lactating women from the time of the first dose of study medication until five half-lives following administration of the last dose of study medication.
An unwillingness of the male subject to use a condom/spermicide in addition to having their female partner use another form of contraception such as IUD, diaphragm with spermicide, oral contraceptives, injectable progesterone, subdermal implants or a tubal ligation if the woman could become pregnant from the time of the first dose of study medication until 84 days following administration of the last dose of study medication.
Female subjects of child bearing potential:
Female subjects who are pregnant, breast feeding, or have a positive serum pregnancy test or a positive urine pregnancy test either at screening or pre-dose on each dosing session.
An unwillingness of the female subject to use an appropriate form of contraception. Appropriate forms of contraception are defined as:
Abstinence - The lifestyle of the female should be such that there is complete abstinence from intercourse from at least the commencement of their last normal period prior to the first dose of study medication and to continue until the first normal period (defined as normal for the woman, both in terms of duration and quantity of menses) after treatment or 15 days after the last dose of medication, whichever is the longest.
One of the following methods is acceptable as the sole method of contraception if there is indisputable data that it is >99% effective otherwise it should be used with a barrier method (condom or occlusive cap {diaphragm or cervical/vault caps} used with spermicidal foam/gel/film/cream/suppository):
Established use of oral, injected or implanted hormonal methods of contraception from at least the commencement of their last normal period prior to the first dose of study medication. Subjects using hormonal contraception should use a barrier method in addition from the first dose of study medication until their next normal period following the end of the study.
Documented tubal ligation.
Documented placement of an intrauterine device (IUD) or intrauterine system (IUS).
Male partner sterilisation (vasectomy) prior to the female subject's entry into the study and is the sole partner for that female subject.",Eligible participants received a single dose of SB705498 1000 mg capsules (2 x 200 mg capsules plus 2 x 300 mg capsules) via oral route and were followed up to a maximum of 14 days.,DrugBank:DB11883 | PubChem:9910486,SB-705498,O=C(Nc1ccccc1Br)N[C@@H]1CCN(c2ccc(C(F)(F)F)cn2)C1,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00286221,NCT00286221_EG000,No,All,Adult | Older Adult,Phase 2 | Phase 3,159,"Inclusion Criteria:

Adults undergoing intracranial surgery

Exclusion Criteria:

Patient refusal
Pregnancy
Aphasia
Respiratory failure
Allergy/intolerance to fentanyl
Opioids use
History of opioid-dependent pain,
Patient has been in an investigational drug trial (except chemotherapy) in the month preceding the day of enrollment
Mental or physical limitations that would prevent patient assessment or PCA use
Chronic painful conditions unrelated to the reason for surgery,
Clinically significant respiratory disease that required supplemental oxygen or ventilatory support such as use of mechanical ventilation or positive pressure ventilation
Patient is unable to initiate a bolus dose of IVPCA fentanyl","PCA fentanyl: PCA fentanyl 0.5 ug/kg with a dosing interval (""lockout"") of 15 minutes and a maximal permitted dosage of 4 demand doses per hour, according to their randomized preoperative assignment. The PCA pump (CADD-Solis Ambulatory Infusion Pump; Smiths Medical, Dublin, OH) had a preprogrammed dose limit of 50 ug fentanyl, and this was the maximal PCA dose permitted",ChEMBL:CHEMBL397976 | DrugBank:DB03088,PIDOLIC ACID,O=C1CC[C@@H](C(=O)O)N1,A12CC08,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00286221,NCT00286221_EG002,No,All,Adult | Older Adult,Phase 2 | Phase 3,159,"Inclusion Criteria:

Adults undergoing intracranial surgery

Exclusion Criteria:

Patient refusal
Pregnancy
Aphasia
Respiratory failure
Allergy/intolerance to fentanyl
Opioids use
History of opioid-dependent pain,
Patient has been in an investigational drug trial (except chemotherapy) in the month preceding the day of enrollment
Mental or physical limitations that would prevent patient assessment or PCA use
Chronic painful conditions unrelated to the reason for surgery,
Clinically significant respiratory disease that required supplemental oxygen or ventilatory support such as use of mechanical ventilation or positive pressure ventilation
Patient is unable to initiate a bolus dose of IVPCA fentanyl","PCA fentanyl: PCA fentanyl 0.5 ug/kg with a dosing interval (""lockout"") of 15 minutes and a maximal permitted dosage of 4 demand doses per hour, according to their randomized preoperative assignment. The PCA pump (CADD-Solis Ambulatory Infusion Pump; Smiths Medical, Dublin, OH) had a preprogrammed dose limit of 50 ug fentanyl, and this was the maximal PCA dose permitted",ChEMBL:CHEMBL397976 | DrugBank:DB03088,PIDOLIC ACID,O=C1CC[C@@H](C(=O)O)N1,A12CC08,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00287287,NCT00287287_EG000,No,All,Adult | Older Adult,Phase 2,25,"Inclusion Criteria:

Histological confirmation of follicular, papillary, insular, or Hürthle-cell thyroid carcinoma. Histologic slides and/or tissue blocks must be reviewed at the University of Kentucky Medical Center.
Patients must have an unresectable, distantly metastatic tumor, which does not concentrate radioactive iodine. Alternatively, follicular or papillary thyroid carcinoma patients with large distant tumor burdens which have not sufficiently responded to more than 800 mCi I-131 cumulative therapy and are progressive (criteria #4) may be appropriate for inclusion.
No systemic chemotherapy agents within 4 weeks of initiation of therapy.
Patients must have 3 consecutive radiographic evaluations demonstrating a cumulative 30% increase in tumor volume over a period of one year or less.
Patients must be over the age of 18 years with the ability to understand and willing to sign an informed consent.
Non-pregnant (if female). Women of childbearing potential (fertile females) must have a negative serum or urine pregnancy test within one day of starting study drug. In addition, sexually active fertile female subjects must agree to adequate contraceptive methods (oral, injectable, or implantable hormonal contraceptive; tubal ligation, intrauterine device, barrier contraceptive with spermicide; or vasectomized partner) while on study drug. Men must agree to use latex condoms when having sex with fertile women.
Karnofsky performance status ≥ 70.

Baseline laboratory studies:

absolute neutrophil count (ANC) > 1000/mm3
platelet count ≥ 100 K/mm3
creatinine ≤ 1.5 mg/dL, and
transaminase levels (AST/SGOT, ALT/SGPT) ≤ 2 x upper limit of normal (ULN) (or ≤ 5 x I:M if hepatic metastases are present)
Disease free of other prior malignancies for ≥ 5 years, with the exception of currently treated basal cell/squamous cell carcinoma of the skin or ""in-situ"" carcinoma of the cervix or breast.
Thyroid stimulating hormone (TSH, thyrotropin) levels must be suppressed with sufficient levothyroxine to be kept beneath the normal range of the assay.

Exclusion Criteria:

Patients may not have had prior REVLIMID® therapy.
No serious concomitant medical or psychiatric illness that might interfere with informed consent or conduct of the study, including active infections that are not controlled with medication.
Patients must not be pregnant or breastfeeding.
Use of any other experimental drug or therapy within 28 days of baseline.
Known hypersensitivity to thalidomide.
The development of erythema nodosum, characterized by a desquamating rash, while taking thalidomide or similar drugs.
Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
Concurrent use of other anti-cancer agents or treatments, with the exception of thyrotropin-suppression by levothyroxine.
All subjects with central nervous system involvement, with the exception of those subjects whose central nervous system metastases have been treated with either radiotherapy and/or surgery and remain asymptomatic with no evidence of active central nervous system disease (verified by computed tomography [CT] scan or magnetic resonance imaging [MRI]) for at least 6 months.
Known to be positive for HIV or infectious hepatitis, type A, B, or C.
Patients with medullary or anaplastic thyroid carcinomas are excluded. Patients whose disease is limited to bone metastases are excluded.",Treatment will be initated at 25 mg/day taken in the morning. Dose adjustments may be made to alleviate toxicities.,ChEMBL:CHEMBL848 | DrugBank:DB00480 | PubChem:216326,Lenalidomide,Nc1cccc2c1CN(C1CCC(=O)NC1=O)C2=O,L04AX04,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT00288574,NCT00288574_EG000,No,Female,Child | Adult,Phase 4,49,"Inclusion Criteria:

Meets DSM-IV criteria for anorexia nervosa (except the requirement for amenorrhea)
Successfully completed treatment at one of the study sites in an inpatient or day-program setting immediately prior to study entry (BMI remained at least 19 kg/m2 for two weeks)

Exclusion Criteria:

Currently taking any medications other than occasional lorazepam or zopiclone for anxiety or sleep disturbance
Previous serious adverse reactions to fluoxetine (e.g., allergy)
Currently at risk for suicide
Any medical condition requiring treatment with other psychotropic medication (except the occasional use of anti-anxiety medication)
Pregnant
Any serious medical illness besides the eating disorder
History of continuous illness (at a low weight with no periods of remission or return to normal functioning for more than 15 years)","fluoxetine up to 80 mg per day

Fluoxetine",ChEMBL:CHEMBL41 | DrugBank:DB00472 | PubChem:3386,Fluoxetine,CNCCC(Oc1ccc(C(F)(F)F)cc1)c1ccccc1,N06AB03 | N06CA03,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00289978,NCT00289978_EG000,No,All,Adult,Phase 3,429,"Inclusion Criteria:

Male and female patients between ages 18-55 with a diagnosis of multiple sclerosis
Patients with a relapsing-remitting disease course
Patients with EDSS score of 0-5.5

Exclusion Criteria:

Patients with other chronic disease of the immune system, malignancies, acute pulmonary disease, cardiac failure, etc.
Pregnant or nursing women

Other protocol-defined inclusion/exclusion criteria applied to this study.",Patients self-administered fingolimod 1.25 mg capsules orally once daily.,ChEMBL:CHEMBL314854 | DrugBank:DB08868 | PubChem:107970,Fingolimod,CCCCCCCCc1ccc(CCC(N)(CO)CO)cc1,L04AA27,0.0,0.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,1.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0
NCT00289978,NCT00289978_EG001,No,All,Adult,Phase 3,425,"Inclusion Criteria:

Male and female patients between ages 18-55 with a diagnosis of multiple sclerosis
Patients with a relapsing-remitting disease course
Patients with EDSS score of 0-5.5

Exclusion Criteria:

Patients with other chronic disease of the immune system, malignancies, acute pulmonary disease, cardiac failure, etc.
Pregnant or nursing women

Other protocol-defined inclusion/exclusion criteria applied to this study.",Patients self-administered fingolimod 0.5 mg capsules orally once daily.,ChEMBL:CHEMBL314854 | DrugBank:DB08868 | PubChem:107970,Fingolimod,CCCCCCCCc1ccc(CCC(N)(CO)CO)cc1,L04AA27,0.0,0.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,1.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0
NCT00300391,NCT00300391_EG000,No,All,Adult | Older Adult,Phase 3,16,"Inclusion Criteria:

All adult (>=18 years of age) mechanically ventilated patients admitted to the medical, surgical, trauma, or cardiothoracic ICUs of the UPMC main campus who are expected by the ICU clinical team to require >24 hours of mechanical ventilation

Exclusion Criteria:

Baseline QTc >480 milliseconds (ms); history of Parkinson's disease; pregnancy; history of schizophrenia or neurologic disease that would confound the delirium assessment; deafness or inability to understand English or Spanish; extubation prior to enrollment; previously enrolled in this study; patient, family, or attending physician refusal; death before enrollment; treatment with haloperidol within 2 days prior to ICU admission; and prisoners.","Once delirium was diagnosed, subjects were randomized to haloperidol 5 mg IV q 12h, which was continued until liberation from mechanical ventilation or 28 days, whichever was first.",ChEMBL:CHEMBL54 | DrugBank:DB00502 | PubChem:3559,Haloperidol,O=C(CCCN1CCC(O)(c2ccc(Cl)cc2)CC1)c1ccc(F)cc1,N05AD01,1.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,1.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0
NCT00300495,NCT00300495_EG000,No,All,Adult | Older Adult,Phase 3,19,"Inclusion Criteria:

Resectable lung nodule or mass

Exclusion Criteria:

Allergy to amiodarone
Currently taking amiodarone
Documented atrial fibrillation within past 12 months
Known pulmonary fibrosis
Known hepatic dysfunction
Thyroid disease
2nd or 3rd degree heart block
Severe SA node disease
Bradycardia-induced syncope
Pregnancy","Perioperative amiodarone

Amiodarone: Perioperative orally administered

Patients received 200 mg of amiodarone three times a day for one week prior to surgery and 200 mg twice a day for one week after the surgery",ChEMBL:CHEMBL633 | DrugBank:DB01118 | PubChem:2157,Amiodarone,CCCCc1oc2ccccc2c1C(=O)c1cc(I)c(OCCN(CC)CC)c(I)c1,C01BD01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00300742,NCT00300742_EG000,No,All,Adult | Older Adult,Phase 2,5,"Inclusion Criteria:

Males and females that have given written informed consent.
Good physical health as confirmed by a complete physical examination, vital signs including an EKG within normal limits, laboratory screening tests within acceptable parameters (see exclusion criteria), as well as a baseline psychiatric history
Diagnosis of alcohol dependence and binge eating disorder.
Subjects must have 3 or more binge days per week in the 2-week period prior to Screen.
Subjects may have uncomplicated and well-controlled Type II diabetes and/or hypertension that has been well controlled by diet and/or oral agent therapy for at least 3 months prior to screen.
Provide evidence of stable residence in the last month.
The pregnancy test for females at intake must be negative. The female patients must either be sterile, post menopausal, or practicing an acceptable form of contraception.
Literate in English and able to read, understand, and complete the ratings scales and questionnaires accurately, follow instructions, and make use of the behavioral treatment.
Subjects must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.

Exclusion Criteria:

Any current DSM-IV psychiatric diagnosis other than alcohol, nicotine dependence or binge eating disorder

Subjects who have begun to receive formal psychotherapy (cognitive-behavioral therapy, interpersonal therapy, dietary behavioral therapy*, or self-guided cognitive-behavioral) for binge-eating disorder or any other psychiatric disorder within 30 days prior to Screen. Subjects who have been engaged in formal psychotherapy for a longer period of time and plan to maintain therapy will be judged on a case-by-case basis.

Formal dietary behavioral therapy applies to therapy where the subject is diagnosed with an eating disorder and/or the health case provider is billing for costs of therapy (will be considered on a case-by-case basis if started within 30 days of Screen. Subjects engaged in dietary for obesity only (e.g., Jenny Craig, Weight Watchers, Overeater's Anonymous) should discontinue therapy prior to study entry (no washout applies).
Clinically significant laboratory screening test.
Clinically significant cardiovascular disease on a 12 lead EKG.
Symptomatic coronary artery disease or peripheral vascular disease.
Malignancy or history of malignancy within the past 5 years (except basal cell carcinoma).
Clinically significant neurological disease.
Clinically significant renal disease or impaired renal function as defined by subjects with an estimated creatinine clearance of less than 60 mL/min.
Severe withdrawal symptoms which in the physicians' opinion requires inpatient treatment or severe or life-threatening adverse reactions to medications either in the past or during this clinical trial.
Female patients who are pregnant, lactating, or not adhering to an acceptable form of contraception at any time during the study.
Members of the same household.
History of severe hypersensitivity to any medication or environmental allergens.
Subjects with prior non-response to topiramate for the treatment of binge-eating and or alcohol disorder following an adequate trial of this medication
Subjects who have been previously treated with topiramate for any reason and discontinued treatment due to an adverse event or due to a hypersensitivity reaction to topiramate.",Escalating dose of up to 300 mg/day of Topiramate,ChEMBL:CHEMBL220492 | DrugBank:DB00273 | PubChem:5284627,Topiramate,[H][C@@]12OC(C)(C)O[C@]1([H])CO[C@@]1(COS(N)(=O)=O)OC(C)(C)O[C@]12[H],A08AA51 | N03AX11,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00315341,NCT00315341_EG001,No,All,Adult | Older Adult,Phase 4,520,"Inclusion Criteria:

Were age 18 years or older,
Met DSM-IV-TR criteria for opioid dependence,
Were in good general health, or, in case of a medical/psychiatric condition requiring ongoing treatment, were under the care of a physician willing to continue participant's medical management and cooperate with study physicians,

For female participants, use of one of the following acceptable methods of birth control:

oral contraceptives
barrier (diaphragm or condom) with spermicide
IUD
intrauterine progesterone contraceptive system
levonorgestrel implant
medroxyprogesterone acetate contraceptive injection
contraceptive transdermal patch
hormonal vaginal contraceptive ring
surgical sterilization
complete abstinence from sexual intercourse
Able to read and verbalize understanding of the study and voluntarily sign study informed consent form.

Exclusion Criteria:

ALT or AST values > 5 times the upper limit of normal as per testing laboratory range criteria,
ALP values >3 times the upper limit of normal per testing laboratory criteria,
Any documented past or present history of ascites, presence of esophageal or gastric varices, hepatic encephalopathy or other signs of significant liver disease as indicated by a Model for Endstage Liver Disease score (Kamath et al., 2001) of ≥11,
Total bilirubin > 2.0 mg/dl (participants with documented Gilbert's syndrome were not excluded based on this criterion),
Prothrombin time more than 3 seconds prolonged,
Albumin level less than 2.5 g/dl,

Any cardiopathy or risk factor listed below without evidence of a normal ECG* with report performed within 6 months prior to first study medication dose,

Congestive heart failure
Left ventricular hypertrophy
Bradycardia
Hereditary QT prolongation
Uncorrected electrolyte imbalance
Concomitant medications that are known to have a risk of QT interval prolongation; refer to Appendix D for a list of medications.

Note: The list was not all-inclusive.

*An ECG was abnormal if one or more of the following occurred:

Significant ST segment abnormalities:

ST segment elevations in two or more continuous leads of > 0.1 mV
ST segment depression of greater than 1 mm that are flat or down-sloping at 80 msec after the J point ST segment abnormalities identified as ""non-specific"" are acceptable. If a potential participant's ECG indicated ST segment elevations or depression consistent with ischemia, the physician obtained a medical history of cardiac symptoms and referred the participant for evaluation.

Conduction abnormalities:

Mobitz II 2nd degree or 3rd degree heart block
Atrial fibrillation, atrial flutter, or any non-sinus tachyarrhythmia
Three or more consecutive ectopic ventricular complexes at a rate of > 100 per minute.
QTc greater than 450 msec in men and 480 msec in women

Repolarization abnormalities:

• Acute medical condition that would make participation, in the opinion of the study physician, medically hazardous (e.g., unstable pancreatic, cardiovascular or renal disease, significant anemia)

Known allergy or sensitivity to BUP, naloxone or MET or to any of the inactive ingredients in the study medications (including lactose, mannitol, cornstarch, povidone K30, citric acid, sodium citrate, FD&C Yellow No.6 color, magnesium stearate, Acesulfame K sweetener)
Known diagnosis of acute psychosis, severe depression or imminent suicide risk as determined via clinical interview by study physician or surrogates
DSM-IV diagnosis of dependence on alcohol requiring immediate medical attention.
DSM-IV diagnosis of dependence on benzodiazepines requiring immediate medical attention
DSM-IV diagnosis of dependence on other depressants, or stimulants requiring immediate medical attention
Participation in an investigational drug study within the past 30 days
Treatment with MET, BUP/NX, or BUP for more than 15 of the past 30 days (illicit use of these medications is allowed)
Pending legal action that could prohibit study participation
Unable or unwilling to comply with study requirements
Unable or unwilling to remain in the local area for duration of treatment
Poor venous access such that venipuncture could not be accomplished from a vein in an extremity during eligibility
Pregnant or lactating (females only)","For the MET group, all participants will receive a maximum of 30 mg for the first dose and a maximum of 40 mg on Day 1. It is recommended that participants receive a dose on day 2 that is 10 mg higher than their total day 1 dose, and a dose on day 3 that is 10 mg higher than their total day 2 dose, unless, in the clinical judgment of the physician, a slower induction is needed. Doses will be adjusted on Day 4 and thereafter according to clinical impression and depending upon the participant's clinical need with no specific upper limit. Investigators are encouraged to dose adequately to decrease craving and to obtain negative urine toxicology specimens.",ChEMBL:CHEMBL350719 | ChEMBL:CHEMBL651 | DrugBank:DB00333 | DrugBank:DB15198 | PubChem:4095 | PubChem:643985,Methadone,CCC(=O)C(CC(C)N(C)C)(c1ccccc1)c1ccccc1,N02AC52 | N07BC02,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,1.0,1.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT00320606,NCT00320606_EG000,No,All,Child | Adult,Phase 1,20,"Inclusion Criteria for Liver Recipients:

Received liver from living parent donor
Received transplant at least 4 years prior to study entry
Less than 18 years of age at time of transplant
Parent or guardian willing to provide informed consent

Inclusion Criteria for Liver Donors:

Willing to participate in this study

Exclusion Criteria for Liver Recipients:

Underwent transplant because of liver failure related to autoimmune disease
Underwent transplant of a second organ simultaneously with or after liver transplant OR liver retransplantation
Receiving immunosuppression with more than one drug
50% increase in dose of current immunosuppressive drug
HIV infection
Hepatitis B or C virus infection
Pregnancy or breastfeeding","Participants were gradually tapered off of their single immunosuppression (IS) drug (cyclosporine or tacrolimus), over a 36 week period by first reducing the drug dose and then the dosing frequency until the participant was completely withdrawn from all immunosuppression.",ChEMBL:CHEMBL484785 | DrugBank:DB05219 | PubChem:44591583,Crisaborole,N#Cc1ccc(Oc2ccc3c(c2)COB3O)cc1,D11AH06,1.0,0.0,0.0,1.0,0.0,1.0,1.0,1.0,1.0,1.0,1.0,1.0,1.0,1.0,1.0,1.0,1.0,0.0,1.0,0.0,1.0,1.0,1.0,0.0,1.0,1.0,0.0
NCT00322348,NCT00322348_EG000,No,Female,Adult | Older Adult,Phase 2,50,"Inclusion Criteria:

Pre-menopausal women aged 18 years or over with histologically/cytologically-confirmed oestrogen receptor positive (ER +ve) breast cancer
World Health Organization (WHO) performance status of 0, 1, or 2
Provided written informed consent

Exclusion Criteria:

Treatment with tamoxifen or other hormonal therapies as early breast cancer (EBC) adjuvant in the previous 24 weeks
Received radiotherapy within the past 4 weeks
History of systemic malignancy other than breast cancer within the previous 3 years
Estimated survival less than 24 weeks",ZOLADEX (goserelin acetate) 10.8 mg intramuscular depot for injection every 12 weeks,PubChem:16052011,Goserelin Acetate,CC(=O)O.CC(C)CC(NC(=O)C(COC(C)(C)C)NC(=O)C(Cc1ccc(O)cc1)NC(=O)C(CO)NC(=O)C(Cc1c[nH]c2ccccc12)NC(=O)C(Cc1cnc[nH]1)NC(=O)C1CCC(=O)N1)C(=O)NC(CCCN=C(N)N)C(=O)N1CCCC1C(=O)NNC(N)=O,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT00322348,NCT00322348_EG001,No,Female,Adult | Older Adult,Phase 2,48,"Inclusion Criteria:

Pre-menopausal women aged 18 years or over with histologically/cytologically-confirmed oestrogen receptor positive (ER +ve) breast cancer
World Health Organization (WHO) performance status of 0, 1, or 2
Provided written informed consent

Exclusion Criteria:

Treatment with tamoxifen or other hormonal therapies as early breast cancer (EBC) adjuvant in the previous 24 weeks
Received radiotherapy within the past 4 weeks
History of systemic malignancy other than breast cancer within the previous 3 years
Estimated survival less than 24 weeks",ZOLADEX (goserelin acetate) 3.6 mg intramuscular depot for injection every 4 weeks,PubChem:16052011,Goserelin Acetate,CC(=O)O.CC(C)CC(NC(=O)C(COC(C)(C)C)NC(=O)C(Cc1ccc(O)cc1)NC(=O)C(CO)NC(=O)C(Cc1c[nH]c2ccccc12)NC(=O)C(Cc1cnc[nH]1)NC(=O)C1CCC(=O)N1)C(=O)NC(CCCN=C(N)N)C(=O)N1CCCC1C(=O)NNC(N)=O,,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,1.0,1.0,0.0,0.0,1.0,0.0
NCT00325819,NCT00325819_EG000,Accepts Healthy Volunteers,All,Child,Phase 3,374,"Inclusion Criteria:

Child is a current Group Health enrollee.
Child will be seen at a Group Health clinic for a Well Child visit that is expected to include 2 or more vaccines after 6 wks and before 10 months of age.

Exclusion Criteria:

If child was born at less than 36 weeks of gestation, the child is not eligible until 4 months of age or older.
If the child's birth weight was less than 5.5 pounds (2500 grams), the child is not eligible until 4 months of age or older.","Children were randomized 1:1 to receive up to five doses of acetaminophen (10-15mg per kg) or placebo following routine vaccinations. Children were to receive a maximum of five doses of the study medication and all doses were to be administered within 24 hours of vaccination. Parents were encouraged to take the bottle of study medication to the vaccination visit, and to give the first dose at that visit, after the child's weight was assessed and within an hour before or after vaccination. Parents were instructed to give subsequent doses a minimum of four hours apart and to give the last dose of study medication no later than 24 hours after vaccination. Following the first dose, each subsequent dose was to be given no earlier than 4 hours following the previous dose. A maximum of five doses of study medication were to be given; the last dose no later than 24 hours after the study vaccination. Study drug was formulated to provide 160 mg of acetaminophen per 5 cc dose.",ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00328172,NCT00328172_EG004,No,All,Adult | Older Adult,Phase 2,65,"Inclusion criteria:

Male and female patients with a diagnosis of Type 2 diabetes treated only with diet and exercise (drug naïve) or with one or two oral hypoglycemic agents (as single treatment or in combination) other than rosiglitazone or pioglitazone -treatment. Antidiabetic therapy has to be stable for at least 10 weeks prior to screening.
Diagnosis of Type 2 diabetes with duration of at least 3 months

Glycosylated haemoglobin A1 (HbA1c) of:

7.5-10.0% at screening for drug naïve patients (no wash-out needed) 7.0-9.0% at screening for patients treated with only one oral antidiabetic agent (wash-out required) 6.5-8.0% at screening for patients treated with two oral antidiabetic agents (wash-out required)

HbA1c of 7.5%-10.0% at Visit 3 (beginning of the 2-week placebo run-in period).
Age >=21 and <=75 years.
BMI (Body Mass Index) >=25.0 and <=40 kg/m2.
Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and local legislation

Exclusion criteria:

Clinically relevant cardiovascular disease (e.g., myocardial infarction, stroke or transient ischemic attack within six months before enrollment)
Impaired hepatic function defined by serum levels of either alanine aminotransferase, aspartate aminotransferase or alkaline phosphatase above 3-fold upper limit of normal
Renal insufficiency or impaired renal function defined by serum creatinine above upper limit of normal at screening
Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or clinically relevant neurologic disorders (including cerebrovascular but with the exception of polyneuropathy) that would interfere with participation in the trial
Chronic or clinically relevant acute infections (e.g., Human immunodeficiency virus, Hepatitis)
History of relevant allergy/hypersensitivity that would interfere with trial participation (including allergy to investigational product or its excipients)
Treatment with rosiglitazone or pioglitazone within 6 months prior to screening
Treatment with insulin within 3 months prior to screening
Alcohol or drug abuse within the last 3 months that would interfere with trial participation)
Participation in another trial with an investigational drug within two months prior to administration or during the trial
Fasting plasma glucose >240 mg/dl (= 13.3 mmol/L) at Visit 2, 3 or 4 any visit and confirmed by a second measurement (not on the same day)

Pre-menopausal women (last menstruation <=1 year prior to signing informed consent) who:

are not surgically sterile,
or are nursing or pregnant;
or are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial. Acceptable methods of birth control include transdermal patch, intra-uterine devices, oral, implantable or injectable contraceptives and vasectomised partner. No exception will be made.
Intolerance of metformin",Patients randomized to receive treatment with metformin,ChEMBL:CHEMBL1431 | DrugBank:DB00331 | PubChem:4091,Metformin,CN(C)C(=N)NC(=N)N,A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00329407,NCT00329407_EG000,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 4,10,"Inclusion Criteria:

DSM-IV Diagnosis of Alcohol Dependence; Minimal drinking level of 14 drinks per week for women and 20 drinks per week for men over a consecutive 30 day period during the last 90 days
Intent to stop drinking
Male or female age 18-65
Able to maintain sobriety for 3 consecutive days without the use of detoxification medications
Able to provide informed consent and to comprehend study procedures.
If a woman, then is willing to use an effective means of birth control during throughout the study period. These include: a. barrier (diaphragm or condom) with spermicide b.intrauterine progesterone contraceptive system c. levonorgestrel implant d. medroxyprogesterone acetate contraceptive injection e. complete abstinence

Exclusion Criteria:

Dependent on or extensive abuse of drugs or substances other than ethanol, nicotine, or caffeine as assessed by urine toxicology (2 out of 3 Dependent on or extensive abuse of drugs or substances other than positive consecutive urines)
DSM IV Axis I diagnoses other than ethanol, caffeine, or nicotine dependence severe enough to require treatment with medication or to prevent compliance with the protocol.
Currently being treated with disulfiram (Antabuse), naltrexone (ReVia), or acamprosate
Currently being treated with any other psychoactive or other CNS medications or a carbonic anhydrase inhibitor (e.g. acetazolamide)
In need of medical detoxification from alcohol.
Prior history of kidney stones.
History of liver disease. ALT or AST 3 times higher than upper range of normal values.
BUN or serum creatinine outside the normal range
Major neurological disorder including seizures
Other major diseases including severe hypertension, renal disease, or cardiac disease.
Prior participation within 60 days in another clinical study.
If female, a positive serum HCG or breast feeding.
If female using oral contraceptives as a means of birth control.
History of allergic sensitivity to topiramate
Pending imprisonment
Cardiac pacemaker or metal surgical implant.
History of angle closure glaucoma.","In this open label non-placebo controlled trial all subjects received topiramate, the active medication.",ChEMBL:CHEMBL220492 | DrugBank:DB00273 | PubChem:5284627,Topiramate,[H][C@@]12OC(C)(C)O[C@]1([H])CO[C@@]1(COS(N)(=O)=O)OC(C)(C)O[C@]12[H],A08AA51 | N03AX11,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00336505,NCT00336505_EG001,No,All,Adult | Older Adult,Phase 3,291,"Inclusion Criteria:

Ambulatory male or female, 18 years of age or older
If female, non-lactating and at no risk or pregnancy (post-menopausal or must use adequate birth control)
Positive Chest X-ray consistent with diagnosis of bacterial pneumonia
Must be a suitable candidate for oral antibiotic therapy and must be able to swallow capsules intact
Recent history of respiratory illness consistent with the clinical signs and symptoms of bacterial CAP
Must be able to produce sputum

Exclusion Criteria:

Prior hospitalization within previous 4 weeks
Residence at a chronic care facility
Active tuberculosis (or other mycobacterial infection, empyema, lung abscess, pulmonary embolism, pulmonary edema, cystic fibrosis, tumor (primary or metastatic) involving the lung, bronchial obstruction, a history of post-obstructive pneumonia (chronic obstructive pulmonary disease [COPD] is not exclusionary), known or suspected Pneumocystis carinii pneumonia
Treatment with long-acting antimicrobial agents within the last 4 weeks, treatment with ceftriaxone, azithromycin or dirithromycin antibiotic within the last 7 days, or subjects who have received more than 24 hours of treatment with other antibiotics within 7 days prior to study drug administration
Any infection which requires the use of a concomitant antimicrobial agent
History of hypersensitivity or allergic reactions to macrolide, ketolide, quinolone, azalide or streptogramin antimicrobials
Treatment with another investigational drug within the last 4 weeks
Females who are pregnant or lactating
Subjects with known significant renal or hepatic impairment or disease
Subjects with a history of impaired renal function
Evidence of uncontrolled clinically significant cardiovascular, pulmonary, metabolic, gastrointestinal, neurological or endocrine disease, malignancy, or other abnormality (other than the disease being studied)
Subjects who would require parenteral antimicrobial therapy for the treatment of pneumonia
Any underlying disease or condition that would interfere with the completion of the study procedures and evaluations or absorption of the study drug
Currently receiving or are likely to require any of the following medications during the period between 2 weeks prior to Evaluation 1 and within 24 hours after the last dose of study drug: astemizol (Hismanal®) or pimozide (Orap®)
Currently receiving or are likely to require any of the following during the period from Evaluation 1 and within 24 hours after the last dose of study drug: theophylline or theophylline analogues (unless adequately monitored), carbamazepine, dexamethasone, phenobarbital, phenytoin, St. John's Wort, lamotrigine, troglitazone, warfarin and digitalis glycoside. Other barbiturates may be used with careful monitoring
Subjects who are currently receiving or who are likely to require any of the following medications during the period between Evaluation 1 and 4: other systemic antibiotic therapy, rifampin or rifabutin
Immunocompromised subjects, subjects receiving immunosuppressive agents, subjects with known human immunodeficiency virus (HIV) infections and history of acquired immune deficiency syndrome (AIDS) defining conditions or CD4+ T-lymphocyte count <200.
Subject with known or suspected central nervous system (CNS) disorder that predisposes them to seizures/lower seizure threshold (e.g., severe cerebral arteriosclerosis, epilepsy)
Previous treatment with cethromycin
Subjects with signs of septic shock (e.g., mental confusion, severe hypoxemia, severe hypotension, any other condition requiring intensive care unit [ICU] admission)","250 mg twice per day (BID) for 7 days, administered orally",ChEMBL:CHEMBL1741 | DrugBank:DB01211 | PubChem:84029,Clarithromycin,[H][C@]1(O[C@H]2[C@H](C)[C@@H](O[C@]3([H])O[C@H](C)C[C@H](N(C)C)[C@H]3O)[C@](C)(OC)C[C@@H](C)C(=O)[C@H](C)[C@@H](O)[C@](C)(O)[C@@H](CC)OC(=O)[C@@H]2C)C[C@@](C)(OC)[C@@H](O)[C@H](C)O1,A02BD04 | A02BD05 | A02BD06 | A02BD07 | A02BD09 | A02BD11 | A02BD12 | A02BD14 | J01FA09,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00336544,NCT00336544_EG001,No,All,Adult | Older Adult,Phase 3,257,"Inclusion Criteria:

Ambulatory male or female, 18 years of age or older
If female, non-lactating and at no risk or pregnancy (post-menopausal or must use adequate birth control)
Positive Chest X-ray consistent with diagnosis of bacterial pneumonia
Must be a suitable candidate for oral antibiotic therapy and must be able to swallow capsules intact
Recent history of respiratory illness consistent with the clinical signs and symptoms of bacterial CAP
Must be able to produce sputum

Exclusion Criteria:

Prior hospitalization within previous 4 weeks
Residence at a chronic care facility
Active tuberculosis (or other mycobacterial infection, empyema, lung abscess, pulmonary embolism, pulmonary edema, cystic fibrosis, tumor (primary or metastatic) involving the lung, bronchial obstruction, a history of post-obstructive pneumonia (Chronic Obstructive Pulmonary Disease [COPD] is not exclusionary), known or suspected Pneumocystis carinii pneumonia
Treatment with long-acting antimicrobial agents within the last 4 weeks, treatment with ceftriaxone, azithromycin or dirithromycin antibiotic within the last 7 days, or subjects who have received more than 24 hours of treatment with other antibiotics within 7 days prior to study drug administration
Any infection which requires the use of a concomitant antimicrobial agent
History of hypersensitivity or allergic reactions to macrolide, ketolide, quinolone, azalide or streptogramin antimicrobials
Treatment with another investigational drug within the last 4 weeks
Females who are pregnant or lactating
Subjects with known significant renal or hepatic impairment or disease
Subjects with a history of impaired renal function
Evidence of uncontrolled clinically significant cardiovascular, pulmonary, metabolic, gastrointestinal, neurological or endocrine disease, malignancy, or other abnormality (other than the disease being studied)
Subjects who would require parenteral antimicrobial therapy for the treatment of pneumonia
Any underlying disease or condition that would interfere with the completion of the study procedures and evaluations or absorption of the study drug
Currently receiving or are likely to require any of the following medications during the period between 2 weeks prior to Evaluation 1 and within 24 hours after the last dose of study drug: astemizol (Hismanal®) or pimozide (Orap®)
Currently receiving or are likely to require any of the following during the period from Evaluation 1 and within 24 hours after the last dose of study drug: theophylline or theophylline analogues (unless adequately monitored), carbamazepine, dexamethasone, phenobarbital, phenytoin, St. John's Wort, lamotrigine, troglitazone, warfarin and digitalis glycoside. Other barbiturates may be used with careful monitoring
Subjects who are currently receiving or who are likely to require any of the following medications during the period between Evaluation 1 and 4: other systemic antibiotic therapy, rifampin or rifabutin
Immunocompromised subjects, subjects receiving immunosuppressive agents, subjects with known human immunodeficiency virus (HIV) infections and history of acquired immune deficiency syndrome (AIDS) defining conditions or CD4+ T-lymphocyte count <200.
Subject with known or suspected central nervous system (CNS) disorder that predisposes them to seizures/lower seizure threshold (e.g., severe cerebral arteriosclerosis, epilepsy)
Previous treatment with cethromycin
Subjects with signs of septic shock (e.g., mental confusion, severe hypoxemia, severe hypotension, any other condition requiring intensive care unit [ICU] admission)","250 mg twice per day (BID) for 7 days, administered orally",ChEMBL:CHEMBL1741 | DrugBank:DB01211 | PubChem:84029,Clarithromycin,[H][C@]1(O[C@H]2[C@H](C)[C@@H](O[C@]3([H])O[C@H](C)C[C@H](N(C)C)[C@H]3O)[C@](C)(OC)C[C@@H](C)C(=O)[C@H](C)[C@@H](O)[C@](C)(O)[C@@H](CC)OC(=O)[C@@H]2C)C[C@@](C)(OC)[C@@H](O)[C@H](C)O1,A02BD04 | A02BD05 | A02BD06 | A02BD07 | A02BD09 | A02BD11 | A02BD12 | A02BD14 | J01FA09,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00345371,NCT00345371_EG000,No,All,Adult | Older Adult,Phase 2,69,"Inclusion Criteria:

Treatment seeking individuals as the time of the study
Must be able to proved written informed consent
Must have a body mass index greater than 18 kg/m(2)
Must meet DSM-IV criteria for methamphetamine dependence
Must currently be using methamphetamine as confirmed by a positive urine test over the past 14 days
If female of child bearing potential, must agree to use birth control

Exclusion Criteria:

Please contact the site for more information","Subjects will receive topiramate (in tablet form) up to 200 mg/day for 13 weeks.

Topiramate",ChEMBL:CHEMBL220492 | DrugBank:DB00273 | PubChem:5284627,Topiramate,[H][C@@]12OC(C)(C)O[C@]1([H])CO[C@@]1(COS(N)(=O)=O)OC(C)(C)O[C@]12[H],A08AA51 | N03AX11,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT00347438,NCT00347438_EG000,No,Female,Adult | Older Adult,Phase 2,16,"Inclusion Criteria:

Patients with locally advanced, histologically confirmed adenocarcinoma of the female breast. Women with ulcerated breast lesions may be enrolled. Patients with asymptomatic metastases to the bone are eligible.
Ability to provide written informed consent prior to study-specific screening procedures
TNM Stage:T3-4, N0-3 M0; Patients with asymptomatic bone metastases may be enrolled. Patients with large T2 tumors whose surgeons believe their results with breast conserving surgery will be improved by neoadjuvant therapy may be enrolled.
Age 18 years or older
Negative serum or urine pregnancy test within 7 days prior to starting therapy (female patients of childbearing potential).
Performance status 0-1
Required Initial Laboratory Data:
Granulocytes >=1,200/µl
Platelet count >=100,000/µl
Calculated Creatinine Clearance > 30 mL/min
Total bilirubin <= Upper Limit Normal
Alkaline Phosphatase <=Upper Limit Normal
SGPT, SGOT <=Upper Limit Normal
Normal chest x-ray

Exclusion Criteria:

HER2 positive breast cancer
Pregnant or lactating woman
Life expectancy < 3 months
Serious, uncontrolled, concurrent infection(s)
Any prior fluoropyrimidine therapy or other chemotherapy
Prior unanticipated severe reaction to fluoropyrimidine therapy, or known hyper-sensitivity to 5-fluorouracil or known DPD deficiency.
Patients who have received more than four weeks of tamoxifen therapy for this malignancy.
Treatment for other carcinomas within the last five years, except cured non- melanoma skin and treated in-situ cervical cancer.
Participation in any investigational drug study within 4 weeks preceding the start of study treatment.
Evidence of metastatic disease to sites other than the bone or with symptomatic bone lesions.
Other serious uncontrolled medical conditions that the investigator feels might compromise study participation.
Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome.
Known, existing uncontrolled coagulopathy or concurrent treatment with Coumadin and Phenytoin
Any of the following laboratory values:
Abnormal hematologic values (neutrophils < 1.0 x 109/L, platelet count < 100 x 109/L)
Impaired renal function (estimated creatinine clearance <30ml/min as calculated with Cockcroft-Gault equation)
Serum bilirubin > upper normal limit.
SGOT, SGPT > upper normal limit",Planned treatment consisted of 24 weeks of capecitabine at a dose of 1000 mg/m^2 twice daily.,ChEMBL:CHEMBL1773 | DrugBank:DB01101 | PubChem:42066809 | PubChem:60953,Capecitabine,CCCCCOC(=O)Nc1nc(=O)n([C@@H]2O[C@H](C)[C@@H](O)[C@H]2O)cc1F,L01BC06,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT00347776,NCT00347776_EG000,No,All,Adult | Older Adult,Phase 4,484,"Inclusion Criteria:

Presence of trichiasis:
no previous report of trichiasis surgery in at least one eye with trichiasis:
Agreement by at least one other family member accompanying the patient that, if the patient is randomized to the family-treatment arm, s/he also would be willing to receive antibiotic treatment
Age 18 or older

Exclusion Criteria:

other household members concurrently participating in the trial
Self-reported pregnancy
Documented allergy to tetracycline
Plans to move out of the region within 1 year.","Topical tetracycline

Antibiotic:Topical tetracycline",ChEMBL:CHEMBL1440 | DrugBank:DB00759 | PubChem:54675776,Tetracycline,[H][C@]12C[C@@]3([H])[C@H](N(C)C)C(O)=C(C(N)=O)C(=O)[C@@]3(O)C(O)=C1C(=O)c1c(O)cccc1[C@@]2(C)O,A01AB13 | A02BD02 | A02BD08 | D06AA04 | J01AA07 | J01AA20 | J01RA08 | S01AA09 | S02AA08 | S03AA02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00353522,NCT00353522_EG000,No,All,Adult | Older Adult,Phase 2,89,"Inclusion Criteria:

adult patients, 18-75 years of age;
CHD or CHD risk equivalent;
body weight <125kg at visit 1.

Exclusion Criteria:

recent (within 3 weeks of screening) clinically significant coronary events;
history of statin-associated myopathy, or intolerance to statin;
history of malignancy (except for curatively treated basal cell or squamous cell cancer of the skin) during the 3 years prior to screening;
exposure to RO4607381 in past 12 months.","Dalcetrapib 900mg po daily for 24 weeks

dalcetrapib: 900mg po daily for 24 weeks",ChEMBL:CHEMBL313006 | DrugBank:DB12181 | PubChem:6918540,Dalcetrapib,CCC(CC)CC1(C(=O)Nc2ccccc2SC(=O)C(C)C)CCCCC1,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00355368,NCT00355368_EG001,No,All,Adult | Older Adult,Phase 4,420,"Inclusion Criteria:

indication for emergency intubation in intensive care
availability of qualified study physician

Exclusion Criteria:

contraindication against succinylcholine or rocuronium
indication for awake fibreoptic intubation",0.6mg/kg,ChEMBL:CHEMBL1201244 | DrugBank:DB00728 | PubChem:441290,Rocuronium,[H][C@@]12CC[C@]3([H])[C@]([H])(CC[C@]4(C)[C@@H](OC(C)=O)[C@@H]([N+]5(CC=C)CCCC5)C[C@@]34[H])[C@@]1(C)C[C@H](N1CCOCC1)[C@@H](O)C2,M03AC09,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00358436,NCT00358436_EG000,No,All,Adult | Older Adult,Phase 3,600,"Inclusion Criteria:

Males and females aged ≥ 40 years with a clinical diagnosis of moderate to severe stable COPD

Exclusion Criteria:

History or current diagnosis of asthma, recent respiratory tract infection or acute COPD exacerbation, life expectancy of less than 1 year, known symptomatic prostatic hypertrophy, bladder neck obstruction or narrow-angle glaucoma",Aclidinium bromide 200 μg once-daily by inhalation,PubChem:11519741,Aclidinium Bromide,O=C(OC1C[N+]2(CCCOc3ccccc3)CCC1CC2)C(O)(c1cccs1)c1cccs1.[Br-],R03AL05,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0
NCT00360243,NCT00360243_EG000,No,Female,Adult,Phase 3,337,"Inclusion Criteria:

Women who are 18 years of age and older.
Premenopausal women having regular menstrual periods who have HSDD (decreased sexual desire), generalized acquired type, according to DSM IV-TR criteria.
Patient must meet minimum cut-off scores on questionnaires relating to sexual functioning and sexual distress.
Patients must be willing to try to have sexual activity (e.g., any act involving direct genital stimulation) at least once monthly.
Patients must be willing and able to use an electronic diary on a daily basis (e.g., have access to a working land line telephone for daily data transmissions).
At the Baseline Visit, patients must have complied with eDiary use adequately.
Patients must be in a stable, monogamous, heterosexual relationship that is secure and communicative, for at least 1 year prior to the Screen Visit. The partner is expected to be physically present at least 50% of each month.
Patients must have used a medically acceptable method of contraception for at least 3 months before the Baseline Visit (Visit 2) and continue to use that medically acceptable method of contraception during the trial.
In the investigators opinion, patients must be reliable, honest, compliant, and agree to co-operate with all trial evaluations as well as to be able to perform them.
Patients must be able and willing to give meaningful, written informed consent prior to participation in the trial, in accordance with regulatory requirements. Patients must have sufficient understanding to communicate effectively with the investigator, and be willing to discuss their sexual functioning with the investigative staff.
Patients must have a clinically acceptable Pap smear as read by a cytology facility (no evidence of malignancy or squamous intraepithelial lesions) within 6 months before the Screen Visit.

Exclusion Criteria:

Patients who have taken any medication noted in the protocols List of Prohibited Medications within 30 days before screening.
Patients whose sexual function was affected (enhanced or worsened) in the investigators opinion by any medication within 30 days before the Screen Visit and anytime prior to the Baseline Visit.
Patients with a history of drug dependence or abuse within the past one year.
Patients with a history of multiple severe reactions (i.e., allergic or oversensitivity to usual doses) to drugs that affect the brain.
Patients with a history of participation in a trial of another investigational medication within one month prior to the Screen Visit, or participation in any previous clinical trial of flibanserin.
Patients who meet accepted diagnostic criteria for sexual disorders that would interfere with improvement in HSDD (sexual aversion, substance-induced sexual problems, urge to live as a man, etc.
Patients who indicate that their sexual partner has inadequately treated sexual problems that could interfere with the patients response to treatment.
Patients who have entered the menopausal transition or menopause or have had a hysterectomy.
Patients with findings at the Screen Visit of infection, inflammation, undue tenderness, or shrinkage (atrophy) of the female organs.
Patients who are breast feeding or have breastfed within the last 6 months prior to the Baseline Visit.
Patients who are pregnant or have been pregnant within the last 6 months prior to the Baseline Visit.","25 mg twice daily for 24 weeks

flibanserin: Experimental: flibanserin 25 mg b.i.d",ChEMBL:CHEMBL231068 | DrugBank:DB04908 | PubChem:6918248,Flibanserin,O=c1[nH]c2ccccc2n1CCN1CCN(c2cccc(C(F)(F)F)c2)CC1,G02CX02,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT00360243,NCT00360243_EG001,No,Female,Adult,Phase 3,363,"Inclusion Criteria:

Women who are 18 years of age and older.
Premenopausal women having regular menstrual periods who have HSDD (decreased sexual desire), generalized acquired type, according to DSM IV-TR criteria.
Patient must meet minimum cut-off scores on questionnaires relating to sexual functioning and sexual distress.
Patients must be willing to try to have sexual activity (e.g., any act involving direct genital stimulation) at least once monthly.
Patients must be willing and able to use an electronic diary on a daily basis (e.g., have access to a working land line telephone for daily data transmissions).
At the Baseline Visit, patients must have complied with eDiary use adequately.
Patients must be in a stable, monogamous, heterosexual relationship that is secure and communicative, for at least 1 year prior to the Screen Visit. The partner is expected to be physically present at least 50% of each month.
Patients must have used a medically acceptable method of contraception for at least 3 months before the Baseline Visit (Visit 2) and continue to use that medically acceptable method of contraception during the trial.
In the investigators opinion, patients must be reliable, honest, compliant, and agree to co-operate with all trial evaluations as well as to be able to perform them.
Patients must be able and willing to give meaningful, written informed consent prior to participation in the trial, in accordance with regulatory requirements. Patients must have sufficient understanding to communicate effectively with the investigator, and be willing to discuss their sexual functioning with the investigative staff.
Patients must have a clinically acceptable Pap smear as read by a cytology facility (no evidence of malignancy or squamous intraepithelial lesions) within 6 months before the Screen Visit.

Exclusion Criteria:

Patients who have taken any medication noted in the protocols List of Prohibited Medications within 30 days before screening.
Patients whose sexual function was affected (enhanced or worsened) in the investigators opinion by any medication within 30 days before the Screen Visit and anytime prior to the Baseline Visit.
Patients with a history of drug dependence or abuse within the past one year.
Patients with a history of multiple severe reactions (i.e., allergic or oversensitivity to usual doses) to drugs that affect the brain.
Patients with a history of participation in a trial of another investigational medication within one month prior to the Screen Visit, or participation in any previous clinical trial of flibanserin.
Patients who meet accepted diagnostic criteria for sexual disorders that would interfere with improvement in HSDD (sexual aversion, substance-induced sexual problems, urge to live as a man, etc.
Patients who indicate that their sexual partner has inadequately treated sexual problems that could interfere with the patients response to treatment.
Patients who have entered the menopausal transition or menopause or have had a hysterectomy.
Patients with findings at the Screen Visit of infection, inflammation, undue tenderness, or shrinkage (atrophy) of the female organs.
Patients who are breast feeding or have breastfed within the last 6 months prior to the Baseline Visit.
Patients who are pregnant or have been pregnant within the last 6 months prior to the Baseline Visit.","50 mg taken once daily at bedtime for 24 weeks

flibanserin: Experimental: flibanserin 50mg qhs",ChEMBL:CHEMBL231068 | DrugBank:DB04908 | PubChem:6918248,Flibanserin,O=c1[nH]c2ccccc2n1CCN1CCN(c2cccc(C(F)(F)F)c2)CC1,G02CX02,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT00360243,NCT00360243_EG002,No,Female,Adult,Phase 3,336,"Inclusion Criteria:

Women who are 18 years of age and older.
Premenopausal women having regular menstrual periods who have HSDD (decreased sexual desire), generalized acquired type, according to DSM IV-TR criteria.
Patient must meet minimum cut-off scores on questionnaires relating to sexual functioning and sexual distress.
Patients must be willing to try to have sexual activity (e.g., any act involving direct genital stimulation) at least once monthly.
Patients must be willing and able to use an electronic diary on a daily basis (e.g., have access to a working land line telephone for daily data transmissions).
At the Baseline Visit, patients must have complied with eDiary use adequately.
Patients must be in a stable, monogamous, heterosexual relationship that is secure and communicative, for at least 1 year prior to the Screen Visit. The partner is expected to be physically present at least 50% of each month.
Patients must have used a medically acceptable method of contraception for at least 3 months before the Baseline Visit (Visit 2) and continue to use that medically acceptable method of contraception during the trial.
In the investigators opinion, patients must be reliable, honest, compliant, and agree to co-operate with all trial evaluations as well as to be able to perform them.
Patients must be able and willing to give meaningful, written informed consent prior to participation in the trial, in accordance with regulatory requirements. Patients must have sufficient understanding to communicate effectively with the investigator, and be willing to discuss their sexual functioning with the investigative staff.
Patients must have a clinically acceptable Pap smear as read by a cytology facility (no evidence of malignancy or squamous intraepithelial lesions) within 6 months before the Screen Visit.

Exclusion Criteria:

Patients who have taken any medication noted in the protocols List of Prohibited Medications within 30 days before screening.
Patients whose sexual function was affected (enhanced or worsened) in the investigators opinion by any medication within 30 days before the Screen Visit and anytime prior to the Baseline Visit.
Patients with a history of drug dependence or abuse within the past one year.
Patients with a history of multiple severe reactions (i.e., allergic or oversensitivity to usual doses) to drugs that affect the brain.
Patients with a history of participation in a trial of another investigational medication within one month prior to the Screen Visit, or participation in any previous clinical trial of flibanserin.
Patients who meet accepted diagnostic criteria for sexual disorders that would interfere with improvement in HSDD (sexual aversion, substance-induced sexual problems, urge to live as a man, etc.
Patients who indicate that their sexual partner has inadequately treated sexual problems that could interfere with the patients response to treatment.
Patients who have entered the menopausal transition or menopause or have had a hysterectomy.
Patients with findings at the Screen Visit of infection, inflammation, undue tenderness, or shrinkage (atrophy) of the female organs.
Patients who are breast feeding or have breastfed within the last 6 months prior to the Baseline Visit.
Patients who are pregnant or have been pregnant within the last 6 months prior to the Baseline Visit.","50 mg twice daily for 24 weeks

flibanserin: Experimental: flibanserin 50mg b.i.d.",ChEMBL:CHEMBL231068 | DrugBank:DB04908 | PubChem:6918248,Flibanserin,O=c1[nH]c2ccccc2n1CCN1CCN(c2cccc(C(F)(F)F)c2)CC1,G02CX02,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT00360529,NCT00360529_EG000,No,Female,Adult | Older Adult,Phase 3,295,"Inclusion Criteria:

Women who are 18 years of age and older.
Premenopausal women having regular menstrual periods who have HSDD (decreased sexual desire), generalized acquired type, according to DSM IV-TR criteria.
Patient must meet minimum cut-off scores on questionnaires relating to sexual functioning and sexual distress.
Patients must be willing to try to have sexual activity (e.g., any act involving direct genital stimulation) at least once monthly.
Patients must be willing and able to use an electronic diary (eDiary) on a daily basis (e.g., have access to a working land line telephone for daily data transmissions).
At the Baseline Visit, patients must have complied with eDiary use adequately.
Patients must be in a stable, monogamous, heterosexual relationship that is secure and communicative, for at least 1 year prior to the Screen Visit. The partner is expected to be physically present at least 50% of each month.
Patients must have used a medically acceptable method of contraception for at least 3 months before the Baseline Visit (Visit 2) and continue to use that medically acceptable method of contraception during the trial.
In the investigators opinion, patients must be reliable, honest, compliant, and agree to co-operate with all trial evaluations as well as to be able to perform them.
Patients must be able and willing to give meaningful, written informed consent prior to participation in the trial, in accordance with regulatory requirements. Patients must have sufficient understanding to communicate effectively with the investigator, and be willing to discuss their sexual functioning with the investigative staff.
Patients must have a clinically acceptable Pap smear as read by a cytology facility (no evidence of malignancy or squamous intraepithelial lesions) within 6 months before the Screen Visit.

Exclusion Criteria:

Patients who have taken any medication noted in the protocols List of Prohibited Medications within 30 days before screening.
Patients whose sexual function was affected (enhanced or worsened) in the investigators opinion by any medication within 30 days before the Screen Visit and anytime prior to the Baseline Visit.
Patients with a history of drug dependence or abuse within the past one year.
Patients with a history of multiple severe reactions (i.e., allergic or oversensitivity to usual doses) to drugs that affect the brain.
Patients with a history of participation in a trial of another investigational medication within one month prior to the Screen Visit, or participation in any previous clinical trial of flibanserin.
Patients who meet accepted diagnostic criteria for sexual disorders that would interfere with improvement in HSDD (sexual aversion, substance-induced sexual problems, urge to live as a man, etc.
Patients who indicate that their sexual partner has inadequately treated sexual problems that could interfere with the patients response to treatment.
Patients who have entered the menopausal transition or menopause or have had a hysterectomy.
Patients with findings at the Screen Visit of infection, inflammation, undue tenderness, or shrinkage (atrophy) of the female organs.
Patients who are breast feeding or have breastfed within the last 6 months prior to the Baseline Visit.
Patients who are pregnant or have been pregnant within the last 6 months prior to the Baseline Visit.
Patients with a history of Major Depressive Disorder within 6 months prior the Screen Visit, a score indicating depression on a depression scale, a history of suicide attempt, or current suicidal ideation evident at the Screen or Baseline Visit.
Patients with a history of any other psychiatric disorders that could impact sexual function, risks patients safety, or may impact compliance.

<truncated>",placebo at bedtime,ChEMBL:CHEMBL231068 | DrugBank:DB04908 | PubChem:6918248,Flibanserin,O=c1[nH]c2ccccc2n1CCN1CCN(c2cccc(C(F)(F)F)c2)CC1,G02CX02,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00360529,NCT00360529_EG001,No,Female,Adult | Older Adult,Phase 3,295,"Inclusion Criteria:

Women who are 18 years of age and older.
Premenopausal women having regular menstrual periods who have HSDD (decreased sexual desire), generalized acquired type, according to DSM IV-TR criteria.
Patient must meet minimum cut-off scores on questionnaires relating to sexual functioning and sexual distress.
Patients must be willing to try to have sexual activity (e.g., any act involving direct genital stimulation) at least once monthly.
Patients must be willing and able to use an electronic diary (eDiary) on a daily basis (e.g., have access to a working land line telephone for daily data transmissions).
At the Baseline Visit, patients must have complied with eDiary use adequately.
Patients must be in a stable, monogamous, heterosexual relationship that is secure and communicative, for at least 1 year prior to the Screen Visit. The partner is expected to be physically present at least 50% of each month.
Patients must have used a medically acceptable method of contraception for at least 3 months before the Baseline Visit (Visit 2) and continue to use that medically acceptable method of contraception during the trial.
In the investigators opinion, patients must be reliable, honest, compliant, and agree to co-operate with all trial evaluations as well as to be able to perform them.
Patients must be able and willing to give meaningful, written informed consent prior to participation in the trial, in accordance with regulatory requirements. Patients must have sufficient understanding to communicate effectively with the investigator, and be willing to discuss their sexual functioning with the investigative staff.
Patients must have a clinically acceptable Pap smear as read by a cytology facility (no evidence of malignancy or squamous intraepithelial lesions) within 6 months before the Screen Visit.

Exclusion Criteria:

Patients who have taken any medication noted in the protocols List of Prohibited Medications within 30 days before screening.
Patients whose sexual function was affected (enhanced or worsened) in the investigators opinion by any medication within 30 days before the Screen Visit and anytime prior to the Baseline Visit.
Patients with a history of drug dependence or abuse within the past one year.
Patients with a history of multiple severe reactions (i.e., allergic or oversensitivity to usual doses) to drugs that affect the brain.
Patients with a history of participation in a trial of another investigational medication within one month prior to the Screen Visit, or participation in any previous clinical trial of flibanserin.
Patients who meet accepted diagnostic criteria for sexual disorders that would interfere with improvement in HSDD (sexual aversion, substance-induced sexual problems, urge to live as a man, etc.
Patients who indicate that their sexual partner has inadequately treated sexual problems that could interfere with the patients response to treatment.
Patients who have entered the menopausal transition or menopause or have had a hysterectomy.
Patients with findings at the Screen Visit of infection, inflammation, undue tenderness, or shrinkage (atrophy) of the female organs.
Patients who are breast feeding or have breastfed within the last 6 months prior to the Baseline Visit.
Patients who are pregnant or have been pregnant within the last 6 months prior to the Baseline Visit.
Patients with a history of Major Depressive Disorder within 6 months prior the Screen Visit, a score indicating depression on a depression scale, a history of suicide attempt, or current suicidal ideation evident at the Screen or Baseline Visit.
Patients with a history of any other psychiatric disorders that could impact sexual function, risks patients safety, or may impact compliance.

<truncated>",Flibanserin 50 mg at bedtime,ChEMBL:CHEMBL231068 | DrugBank:DB04908 | PubChem:6918248,Flibanserin,O=c1[nH]c2ccccc2n1CCN1CCN(c2cccc(C(F)(F)F)c2)CC1,G02CX02,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00360555,NCT00360555_EG000,No,Female,Adult,Phase 3,396,"Inclusion Criteria:

Women who are 18 years of age and older.
Premenopausal women having regular menstrual periods who have HSDD (decreased sexual desire), generalized acquired type, according to DSM IV-TR criteria.
Patient must meet minimum cut-off scores on questionnaires relating to sexual functioning and sexual distress.
Patients must be willing to try to have sexual activity (e.g., any act involving direct genital stimulation) at least once monthly.
Patients must be willing and able to use an electronic diary on a daily basis (e.g., have access to a working land line telephone for daily data transmissions).
At the Baseline Visit, patients must have complied with eDiary use adequately.
Patients must be in a stable, monogamous, heterosexual relationship that is secure and communicative, for at least 1 year prior to the Screen Visit. The partner is expected to be physically present at least 50% of each month.
Patients must have used a medically acceptable method of contraception for at least 3 months before the Baseline Visit (Visit 2) and continue to use that medically acceptable method of contraception during the trial.
In the investigators opinion, patients must be reliable, honest, compliant, and agree to co-operate with all trial evaluations as well as to be able to perform them.
Patients must be able and willing to give meaningful, written informed consent prior to participation in the trial, in accordance with regulatory requirements. Patients must have sufficient understanding to communicate effectively with the investigator, and be willing to discuss their sexual functioning with the investigative staff.
Patients must have a clinically acceptable Pap smear as read by a cytology facility (no evidence of malignancy or squamous intraepithelial lesions) within 6 months before the Screen Visit.
A score of 15 or higher on the FSDS-R at the screen Visit.

Exclusion Criteria:

Patients who have taken any medication noted in the protocols List of Prohibited Medications within 30 days before screening.
Patients whose sexual function was affected (enhanced or worsened) in the investigators opinion by any medication within 30 days before the Screen Visit and anytime prior to the Baseline Visit.
Patients with a history of drug dependence or abuse within the past one year.
Patients with a history of multiple severe reactions (i.e., allergic or oversensitivity to usual doses) to drugs that affect the brain.
Patients with a history of participation in a trial of another investigational medication within one month prior to the Screen Visit, or participation in any previous clinical trial of flibanserin.
Patients who meet accepted diagnostic criteria for sexual disorders that would interfere with improvement in HSDD (sexual aversion, substance-induced sexual problems, urge to live as a man, etc.
Patients who indicate that their sexual partner has inadequately treated sexual problems that could interfere with the patients response to treatment.
Patients who have entered the menopausal transition or menopause or have had a hysterectomy.
Patients with findings at the Screen Visit of infection, inflammation, undue tenderness, or shrinkage (atrophy) of the female organs.
Patients who are breast feeding or have breastfed within the last 6 months prior to the Baseline Visit.
Patients who are pregnant or have been pregnant within the last 6 months prior to the Baseline Visit.
Patients with a history of Major Depressive Disorder within 6 months prior the Screen Visit, a score indicating depression on a depression scale, a history of suicide attempt, or current suicidal ideation evident at the Screen or Baseline Visit.
Patients with a history of any other psychiatric disorders that could impact sexual function, risks patients safety, or may impact compliance.
Patients who have started psychotherapy",flibanserin: 25 mg twice daily,ChEMBL:CHEMBL231068 | DrugBank:DB04908 | PubChem:6918248,Flibanserin,O=c1[nH]c2ccccc2n1CCN1CCN(c2cccc(C(F)(F)F)c2)CC1,G02CX02,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT00360555,NCT00360555_EG001,No,Female,Adult,Phase 3,392,"Inclusion Criteria:

Women who are 18 years of age and older.
Premenopausal women having regular menstrual periods who have HSDD (decreased sexual desire), generalized acquired type, according to DSM IV-TR criteria.
Patient must meet minimum cut-off scores on questionnaires relating to sexual functioning and sexual distress.
Patients must be willing to try to have sexual activity (e.g., any act involving direct genital stimulation) at least once monthly.
Patients must be willing and able to use an electronic diary on a daily basis (e.g., have access to a working land line telephone for daily data transmissions).
At the Baseline Visit, patients must have complied with eDiary use adequately.
Patients must be in a stable, monogamous, heterosexual relationship that is secure and communicative, for at least 1 year prior to the Screen Visit. The partner is expected to be physically present at least 50% of each month.
Patients must have used a medically acceptable method of contraception for at least 3 months before the Baseline Visit (Visit 2) and continue to use that medically acceptable method of contraception during the trial.
In the investigators opinion, patients must be reliable, honest, compliant, and agree to co-operate with all trial evaluations as well as to be able to perform them.
Patients must be able and willing to give meaningful, written informed consent prior to participation in the trial, in accordance with regulatory requirements. Patients must have sufficient understanding to communicate effectively with the investigator, and be willing to discuss their sexual functioning with the investigative staff.
Patients must have a clinically acceptable Pap smear as read by a cytology facility (no evidence of malignancy or squamous intraepithelial lesions) within 6 months before the Screen Visit.
A score of 15 or higher on the FSDS-R at the screen Visit.

Exclusion Criteria:

Patients who have taken any medication noted in the protocols List of Prohibited Medications within 30 days before screening.
Patients whose sexual function was affected (enhanced or worsened) in the investigators opinion by any medication within 30 days before the Screen Visit and anytime prior to the Baseline Visit.
Patients with a history of drug dependence or abuse within the past one year.
Patients with a history of multiple severe reactions (i.e., allergic or oversensitivity to usual doses) to drugs that affect the brain.
Patients with a history of participation in a trial of another investigational medication within one month prior to the Screen Visit, or participation in any previous clinical trial of flibanserin.
Patients who meet accepted diagnostic criteria for sexual disorders that would interfere with improvement in HSDD (sexual aversion, substance-induced sexual problems, urge to live as a man, etc.
Patients who indicate that their sexual partner has inadequately treated sexual problems that could interfere with the patients response to treatment.
Patients who have entered the menopausal transition or menopause or have had a hysterectomy.
Patients with findings at the Screen Visit of infection, inflammation, undue tenderness, or shrinkage (atrophy) of the female organs.
Patients who are breast feeding or have breastfed within the last 6 months prior to the Baseline Visit.
Patients who are pregnant or have been pregnant within the last 6 months prior to the Baseline Visit.
Patients with a history of Major Depressive Disorder within 6 months prior the Screen Visit, a score indicating depression on a depression scale, a history of suicide attempt, or current suicidal ideation evident at the Screen or Baseline Visit.
Patients with a history of any other psychiatric disorders that could impact sexual function, risks patients safety, or may impact compliance.
Patients who have started psychotherapy",flibanserin: 50 mg once at bedtime/twice daily,ChEMBL:CHEMBL231068 | DrugBank:DB04908 | PubChem:6918248,Flibanserin,O=c1[nH]c2ccccc2n1CCN1CCN(c2cccc(C(F)(F)F)c2)CC1,G02CX02,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT00360555,NCT00360555_EG003,No,Female,Adult,Phase 3,398,"Inclusion Criteria:

Women who are 18 years of age and older.
Premenopausal women having regular menstrual periods who have HSDD (decreased sexual desire), generalized acquired type, according to DSM IV-TR criteria.
Patient must meet minimum cut-off scores on questionnaires relating to sexual functioning and sexual distress.
Patients must be willing to try to have sexual activity (e.g., any act involving direct genital stimulation) at least once monthly.
Patients must be willing and able to use an electronic diary on a daily basis (e.g., have access to a working land line telephone for daily data transmissions).
At the Baseline Visit, patients must have complied with eDiary use adequately.
Patients must be in a stable, monogamous, heterosexual relationship that is secure and communicative, for at least 1 year prior to the Screen Visit. The partner is expected to be physically present at least 50% of each month.
Patients must have used a medically acceptable method of contraception for at least 3 months before the Baseline Visit (Visit 2) and continue to use that medically acceptable method of contraception during the trial.
In the investigators opinion, patients must be reliable, honest, compliant, and agree to co-operate with all trial evaluations as well as to be able to perform them.
Patients must be able and willing to give meaningful, written informed consent prior to participation in the trial, in accordance with regulatory requirements. Patients must have sufficient understanding to communicate effectively with the investigator, and be willing to discuss their sexual functioning with the investigative staff.
Patients must have a clinically acceptable Pap smear as read by a cytology facility (no evidence of malignancy or squamous intraepithelial lesions) within 6 months before the Screen Visit.
A score of 15 or higher on the FSDS-R at the screen Visit.

Exclusion Criteria:

Patients who have taken any medication noted in the protocols List of Prohibited Medications within 30 days before screening.
Patients whose sexual function was affected (enhanced or worsened) in the investigators opinion by any medication within 30 days before the Screen Visit and anytime prior to the Baseline Visit.
Patients with a history of drug dependence or abuse within the past one year.
Patients with a history of multiple severe reactions (i.e., allergic or oversensitivity to usual doses) to drugs that affect the brain.
Patients with a history of participation in a trial of another investigational medication within one month prior to the Screen Visit, or participation in any previous clinical trial of flibanserin.
Patients who meet accepted diagnostic criteria for sexual disorders that would interfere with improvement in HSDD (sexual aversion, substance-induced sexual problems, urge to live as a man, etc.
Patients who indicate that their sexual partner has inadequately treated sexual problems that could interfere with the patients response to treatment.
Patients who have entered the menopausal transition or menopause or have had a hysterectomy.
Patients with findings at the Screen Visit of infection, inflammation, undue tenderness, or shrinkage (atrophy) of the female organs.
Patients who are breast feeding or have breastfed within the last 6 months prior to the Baseline Visit.
Patients who are pregnant or have been pregnant within the last 6 months prior to the Baseline Visit.
Patients with a history of Major Depressive Disorder within 6 months prior the Screen Visit, a score indicating depression on a depression scale, a history of suicide attempt, or current suicidal ideation evident at the Screen or Baseline Visit.
Patients with a history of any other psychiatric disorders that could impact sexual function, risks patients safety, or may impact compliance.
Patients who have started psychotherapy",flibanserin: placebo,ChEMBL:CHEMBL231068 | DrugBank:DB04908 | PubChem:6918248,Flibanserin,O=c1[nH]c2ccccc2n1CCN1CCN(c2cccc(C(F)(F)F)c2)CC1,G02CX02,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT00360672,NCT00360672_EG000,No,All,Adult | Older Adult,Phase 2,27,"Inclusion Criteria:

Understand and voluntarily sign an informed consent form.
Age >/= 18 years at the time of signing the informed consent form. (Revlimid has not been tested in younger patients)
Able to adhere to the study visit schedule and other protocol requirements.
Diagnosis of relapsed/refractory AML (other than APL) or high-risk MDS (IPSS categories intermediate-2 and high) with chromosome 5 abnormality as a sole abnormality or with additional abnormalities. MDS patients with blast percentage of >/= 10% will be considered high-risk.
All non-hematological toxicity of previous cancer therapy should have resolved to </= grade1 (except alopecia or other toxicities not involving major organs).
Should not have received any prior treatment for AML or MDS within 2 weeks of starting Revlimid. Use of hydrea to control proliferative disease will be allowed prior to starting Revlimid and for 7 days during cycles 1 and 2 (Maximum daily dose of 7gm).
Eastern Cooperative Oncology Group (ECOG) performance status of </ =2 at study entry
Laboratory test results within these ranges: • Serum creatinine </= 1.5 mg/dL • Total bilirubin </=1.5 mg/dL • aspartate aminotransferase (AST or SGOT) and alanine aminotransferase (ALT or SGPT) </=2 * upper limit of normal (ULN) or </=5 * ULN if related to disease
Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 milli-International unit (mIU)/mL within 10 - 14 days prior to and again within 24 hours of prescribing Revlimid (prescriptions must be filled within 7 days) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 4 weeks before she starts taking Revlimid. FCBP must also agree to ongoing pregnancy testing.
(continued from above) Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy.
All study participants must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist®.
Disease free of prior malignancies for >/ = 2 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma ""insitu"" of the cervix or breast.

Exclusion Criteria:

Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking Revlimid).
Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
Use of any other experimental drug or experimental therapy within 28 days of baseline.
Known hypersensitivity to thalidomide.
The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
Any prior use of Revlimid.
Concurrent use of other anti-cancer agents or treatments. (Use of hydrea permitted as indicated in inclusion criterion 6)
Known positive for HIV or infectious hepatitis type B or C.
Heart rate less than or equal to 50.","Revlimid 25 mg/day, orally for 21 days with 7 days rest (28 day cycle).",ChEMBL:CHEMBL848 | DrugBank:DB00480 | PubChem:216326,Lenalidomide,Nc1cccc2c1CN(C1CCC(=O)NC1=O)C2=O,L04AX04,1.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00360685,NCT00360685_EG000,No,All,Child | Adult | Older Adult,Not Applicable,47,"Inclusion Criteria:

- Patient must be going through a T cell-replete allogeneic transplant

Exclusion Criteria:

- A contraindication to the use of tacrolimus, mycophenolate, or methotrexate",Tacrolimus (TAC) And Methotrexate (MTX),ChEMBL:CHEMBL34259 | DrugBank:DB00563 | PubChem:126941,Methotrexate,CN(Cc1cnc2nc(N)nc(N)c2n1)c1ccc(C(=O)N[C@@H](CCC(=O)O)C(=O)O)cc1,L01BA01 | L04AX03,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00360971,NCT00360971_EG001,No,All,Adult | Older Adult,Phase 3,11,"Inclusion Criteria:

Pathologically (histologically or cytologically) proven (from primary lesion and/or lymph nodes) diagnosis of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx;

Patients must have at least 2 mucosal sites of the oral cavity/oropharynx mucosa assessable by visual transoral inspection that will receive at least 66 Gy;

-2.1 Patients with tumors of the larynx or hypolarynx are eligible only if it is anticipated that the 2 index sites in the oral cavity/oropharynx mucosa will receive at least 66 Gy;

Patients must be able to be evaluated for the primary endpoint; therefore, patients must be able to eat at least soft solids and not require a feeding tube for nutrition or hydration at study entry.

Selected Stage III (excluding T1N1MO) or IVA-B (AJCC, 6th edition) at study entry, including no distant metastases, based upon the following minimum diagnostic workup:

4.1 History/physical examination, including documentation of tobacco/alcohol use and current medications (including opioids/dosing), within 8 weeks prior to registration;
4.2 Chest x-ray (or Chest CT scan) within 6 weeks prior to registration;
4.3 MRI or CT scan with contrast of tumor site within 6 weeks prior to registration;
4.4 Assessment of mucositis and xerostomia within 2 weeks prior to registration;
Zubrod Performance Status 0-1;
Age > 18;

Adequate bone marrow function, defined as follows:

7.1 Absolute neutrophil count (ANC) > 1,800 cells/mm3 based upon CBC/differential obtained within 2 weeks prior to registration on study
7.2 Platelets > 100,000 cells/mm3 based upon CBC/differential obtained within 2 weeks prior to registration on study
7.3 Hemoglobin > 8.0 g/dl based upon CBC/differential obtained within 2 weeks prior to registration on study (Note: The use of transfusion or other intervention to achieve Hgb > 8.0 g/dl is acceptable.)
Adequate hepatic function with bilirubin < 1.5 mg/dl, AST or ALT < 2 x ULN within 2 weeks prior to registration;

Adequate renal function with serum creatinine < 1.5 mg/dl and creatinine clearance (CC) ≥ 50 ml/min within 2 weeks prior to registration determined by 24-hour collection or estimated by Cockcroft-Gault formula:

CCr male = [(140 - age) x (wt in kg)]/[(Serum Cr mg/dl) x (72)] CCr female = 0.85 x (CrCl male)

Normal serum calcium or normal corrected serum calcium within 2 weeks prior to registration; formula for corrected calcium if albumin valued is below normal range: Corrected calcium (mg/dl) = (4 - [patient's albumin (g/dl)] x 0.8) + patient's measured calcium (mg/dl);
Serum pregnancy test for women of childbearing potential within 2 weeks prior to registration;
Women of childbearing potential and male participants must practice adequate contraception.
Patient agrees to refrain from using all products listed in Section 9.2, ""Non-permitted Supportive Therapy"";
Patient must sign study specific informed consent prior to study entry.

Exclusion Criteria:

Patients with a history of prior head and neck squamous cancer are ineligible;
Stage IVC (AJCC, 6th edition) [Any T, Any N, M1] or distant metastases at protocol study entry; T1N1M0 patients are excluded.
Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years;
Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable. See Sections 1 and 3.
Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields;
Initial surgical treatment, excluding diagnostic biopsy of the primary site or nodal sampling of neck disease; radical or modified neck dissection is not permitted.

Severe, active co-morbidity, defined as follows:

7.1 Symptomatic and/or uncontrolled cardiac disease, New York Heart Association Classification III or IV (see Appendix II);
7.2 Transmural myocardial infarction within the last 6 months;
7.3 Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration;
7.4 Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration.
7.5 Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects;
7.6 Patients known to be sero-positive for hepatitis B virus (HBV) or hepatitis C virus (HCV);
7.7 Patients known to be sero-positive for human immunodeficiency virus (HIV) or patients with Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with HIV or AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive.
7.8 A history of pancreatitis.
Collagen vascular disease, such as scleroderma, as this disease is thought to predispose patients to increased risk for radiation-associated toxicities;
Previous treatment with palifermin or other keratinocyte growth factors, such as velafermin or repifermin;
Prior allergic reaction or known sensitivity to any of the agents administered during dosing, including E. coli-derived products, such as Nutropin®, Neupogen®, Humulin®, Roferon®; Neumega®, Neulasta®), IntronA®, Betaseron®;
Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic.","Concurrent radiation therapy, cisplatin, and palifermin followed by neck dissection for indicated patients.",DrugBank:DB00515 | PubChem:5460033 | PubChem:5702198,Cisplatin,Cl[Pt]Cl.N.N,L01XA01,1.0,0.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,1.0,1.0,1.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0
NCT00363896,NCT00363896_EG000,No,All,Adult | Older Adult,Phase 3,627,"Inclusion Criteria:

Males and females aged ≥ 40 years with a clinical diagnosis of moderate to severe stable COPD

Exclusion Criteria:

History or current diagnosis of asthma, recent respiratory tract infection or acute COPD exacerbation, life expectancy of less than 1 year, known symptomatic prostatic hypertrophy, bladder neck obstruction or narrow-angle glaucoma",Aclidinium bromide 200 μg once-daily by inhalation,PubChem:11519741,Aclidinium Bromide,O=C(OC1C[N+]2(CCCOc3ccccc3)CCC1CC2)C(O)(c1cccs1)c1cccs1.[Br-],R03AL05,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT00366301,NCT00366301_EG001,No,All,Adult | Older Adult,Phase 4,126,"Inclusion Criteria:

Men and women aged 18 to 79
Type 2 diabetes, treated only by diet or oral drugs other than metformin
HbA1c greater than or equal to 7% and less than or equal to 10%
C-reactive protein greater than or equal to 2 mg/L

Exclusion Criteria:

Baseline use of metformin or insulin
Type 1 diabetes, history of ketoacidosis or positive anti-GAD antibody
History of congestive heart failure requiring drug therapy
Active liver disease
Kidney impairment
Recent initiation or change in dose of statins, fibric acid derivatives, angiotensin receptor blockers, nonsteroidal anti-inflammatory agents, or corticosteroids",Metformin pill,ChEMBL:CHEMBL1431 | DrugBank:DB00331 | PubChem:4091,Metformin,CN(C)C(=N)NC(=N)N,A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00367237,NCT00367237_EG001,No,All,Adult | Older Adult,Phase 3,54,"Inclusion Criteria:

The subject must meet ALL of the criteria listed below for entry into the study:
Subject must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent.
Subject aged 18 years or more, of either sex and any race

Diagnosis of Psoriatic Arthritis with peripheral polyarticular involvement. Patients will have at least one of the following:

Distal Interphalangeal Joints (DIP) involvement
polyarticular arthritis, absence of rheumatoid nodules and presence of psoriasis
arthritis mutilans
asymmetric peripheral arthritis
Negative rheumatoid factor
The disease should have been diagnosed at least 3 months prior to screening.

Active disease at the time of screening and prior to receiving the baseline study medication(s) as defined by:

5 or more swollen joints and
5 or more tender joints

and one out of the following three categories:

Erythrocyte Sedimentation Rate (ESR) >= 28 mm/h
C-reactive protein (CRP) >= 15 mg/l
Morning stiffness >= 45 min
Subjects must confirm that they are practicing adequate contraception: Female subjects of childbearing potential (includes women who are less than 1 year postmenopausal and women who become sexually active during the study) must agree to use a medically accepted method of contraception or be surgically sterilized prior to screening, while receiving protocol-specified medication, and for 6 months after stopping the medication. Acceptable methods of contraception include condoms (male and female) with or without a spermicidal agent, diaphragm or cervical cap with spermicide, medically prescribed intrauterine device (IUD), oral or injectable hormonal contraceptive, and surgical sterilization (e.g., hysterectomy or tubal ligation).
Female subjects of childbearing potential must have a negative pregnancy test at Screening.
Subjects must be eligible for anti-tumor necrosis factor (TNF) treatment according to applicable local guidelines. For all patients chest X-ray and skin test results must be available at baseline.
If using Nonsteroidal anti-inflammatory drugs (NSAIDs) or corticosteroids other than i.v., i.m. or i.a., the patient must be on a stable dose for four weeks prior screening (maximum dose up to 10mg/day of prednisone or its oral equivalent).

The screening laboratory tests must beet the following criteria:

Hemoglobin >= 10 g/dl providing the low hemoglobin level is not due to other diseases than anemia of chronic inflammation.
white blood cell (WBC) >= 3500 / μl
Neutrophils >= 1500 / μl
Platelets >= 100 000/ μl
Aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, and gamma-glutamyltransferase <= 1.5 x upper limit of normal
Total bilirubin <= 1 x upper limit of normal
Serum creatinine <= 1.5 mg/dl
Patient must be able to adhere to the study visit schedule and other protocol requirements and must have given informed consent prior to any screening procedures.

Exclusion Criteria:

The subject will be excluded from entry into the study if ANY of the criteria listed below are met:
Subject is a female who is pregnant, intends to become pregnant during the study (or within 6 months after study completion), or nursing.
Patients with other inflammatory diseases that might interfere with the evaluation of the psoriatic arthritis.
Previous treatment with Infliximab.
Subjects who have previously received MTX or have not discontinued their other DMARD therapy (i.e., sulfasalazine, hydroxychloroquine, leflunomide).
Patients with fibromyalgia syndrome.
Use of cyclosporine or tacrolimus within 4 weeks prior to screening. Use of IM, IV, or IA corticosteroids within 4 weeks prior to screening.
Treatment with any investigational drug within 3 months prior to screening.
Previous treatment with a monoclonal antibody or a fusion protein.
A history of known allergy to murine proteins.
History of infected joint prosthesis within the previous 5 years.
Chronic infections.
History of active tuberculosis requiring treatment within previous 3 years or history of opportunistic infections within 2 months, uncontrolled active infection or documented HIV infection. Also excluded are patients with evidence of latent tuberculosis and patients with old tuberculosis without documented adequate therapy, if they will not be treated according to local tuberculosis (TB) guidelines.
Subject has any clinically significant deviation from normal in the physical examination, chest X-ray, or electrocardiogram (ECG) that, in the investigator's judgment, may interfere with the study evaluation or affect subject safety.
Current signs or symptoms of other severe uncontrolled diseases, which in the investigators opinion would put the patient at an unacceptable risk.
History of lymphoproliferative disease, any current malignancies or history of malignancy within 5 years other than successfully treated basal cell carcinoma or squamous cell carcinoma of the skin.
Subject is part of the staff or a family member of the staff personnel directly involved with this study.
History of drug abuse.
Subjects who are participating in any other clinical study.",Oral methotrexate (MTX) 15 mg/week,ChEMBL:CHEMBL34259 | DrugBank:DB00563 | PubChem:126941,Methotrexate,CN(Cc1cnc2nc(N)nc(N)c2n1)c1ccc(C(=O)N[C@@H](CCC(=O)O)C(=O)O)cc1,L01BA01 | L04AX03,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00369967,NCT00369967_EG000,Accepts Healthy Volunteers,Female,Child | Adult,Not Applicable,48,"Inclusion Criteria: 1) female aged 15 through 21 presenting for contraception; 2) willing to use the NuvaRing as their contraceptive method; 3) English-speaking; 4) up to date on routine health maintenance screening (pap smear within 3 years of initiation of sexual intercourse and Gonorrhea/ Chlamydia testing yearly or with each new partner); and 5) able to read and understand the consent form.

Exclusion Criteria: 1) are pregnant; 2) have a contraindication to hormonal contraception; 3) are unwilling to use NuvaRing as their contraceptive method; 4) are currently using any hormonal contraceptive or have used one within past 2 months; 5) have used emergency contraception in the past 7 days; 6) have had unprotected intercourse in the past 10 days; 7) have untreated Gonorrhea or Chlamydia; or 8) are unable to give informed consent because of psychiatric or cognitive problems.",NuvaRing: Initiation of NuvaRing for contraception per package insert,PubChem:9960701,Nuvaring,C#CC1(O)CCC2C3CCC4=CC(=O)CCC4C3C(=C)CC21CC.C#CC1(O)CCC2C3CCc4cc(O)ccc4C3CCC21C,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00369967,NCT00369967_EG001,Accepts Healthy Volunteers,Female,Child | Adult,Not Applicable,48,"Inclusion Criteria: 1) female aged 15 through 21 presenting for contraception; 2) willing to use the NuvaRing as their contraceptive method; 3) English-speaking; 4) up to date on routine health maintenance screening (pap smear within 3 years of initiation of sexual intercourse and Gonorrhea/ Chlamydia testing yearly or with each new partner); and 5) able to read and understand the consent form.

Exclusion Criteria: 1) are pregnant; 2) have a contraindication to hormonal contraception; 3) are unwilling to use NuvaRing as their contraceptive method; 4) are currently using any hormonal contraceptive or have used one within past 2 months; 5) have used emergency contraception in the past 7 days; 6) have had unprotected intercourse in the past 10 days; 7) have untreated Gonorrhea or Chlamydia; or 8) are unable to give informed consent because of psychiatric or cognitive problems.",NuvaRing: Initiation of NuvaRing for contraception on day of enrollment,PubChem:9960701,Nuvaring,C#CC1(O)CCC2C3CCC4=CC(=O)CCC4C3C(=C)CC21CC.C#CC1(O)CCC2C3CCc4cc(O)ccc4C3CCC21C,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00373360,NCT00373360_EG000,No,All,Adult | Older Adult,Phase 4,10,"Inclusion Criteria:

Age 18 to 70 years
Diagnosis of Idiopathic or Familial Pulmonary Arterial Hypertension (PAH)or PAH associated with a collagen vascular disease or PAH associated with congenital systemic-to-pulmonary shunt repaired greater than 5 years prior to study entry or PAH associated with portal hypertension with mild or moderate hepatic dysfunction (Grade of A or B on the Child-Pugh Classification Scale)or PAH associated with drug or toxins or CTEPH
WHO Class II-III
Currently receiving intravenous epoprostenol therapy for at least three months and a stable dose for at least one month.
Have central intravenous catheter
Optimally treated with conventional pulmonary hypertension therapy and clinically stable for at least one month.
Mentally and physically capable of learning to administer Remodulin using an intravenous infusion pump.

Exclusion Criteria:

Nursing or pregnant woman
Have any other type of PAH due to conditions other than noted in the above inclusion criteria, including but not limited to PAH related to thrombotic or embolic disease
Have any other disease that is associated with pulmonary hypertension (e.g. sickle cell anemia, schistosomiasis)
Changes to chronic PAH therapy (i.e., new therapy added within last 30 days[including but not limited to oxygen, a different category of vasodilator, a diuretic, digoxin, bosentan, sildenafil] or PAH medication discontinued within 7 days of study entry.
Received any prostacyclin or prostacyclin analog except epoprostenol in the past 3 months.
Central venous line infection within the past 30 days.
Previous documented evidence of significant parenchymal lung disease
Evidence or history of left-sided heart disease
Musculoskeletal disorder or any other disease, which is thought to limit ambulation, or be connected to a machine that is not portable
Uncontrolled hypertension, chronic renal insufficiency, or active infection.
Use of investigational drug within past 30 days.",All subjects received active treatment with treprostinil sodium.,ChEMBL:CHEMBL1237119 | DrugBank:DB00374 | PubChem:6918140,Treprostinil,[H][C@@]12Cc3c(cccc3OCC(=O)O)C[C@]1([H])[C@@H](CC[C@@H](O)CCCCC)[C@H](O)C2,B01AC21,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0
NCT00377832,NCT00377832_EG001,Accepts Healthy Volunteers,Female,Adult,Not Applicable,13,"Inclusion Criteria:

Term pregnancy
Singleton pregnancy
Pregnancy with cephalic presentation
Pregnancy in active phase labor
Fetal tachycardia

Exclusion Criteria:

Acetaminophen allergy
Clinical chorioamnionitis
Maternal fever
Non-reassuring fetal status or fetal heart rate abnormalities requiring cesarean delivery
Previous cesarean delivery
Multifetal gestation
Breech presentation
Known fetal anomaly
Known contraindication to vaginal delivery","In labor, fever is identified, consent and randomization occurs, then acetaminophen is given.",ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00386009,NCT00386009_EG001,No,Male,Adult | Older Adult,Phase 2,99,"Inclusion Criteria:

Men 40 years of age or older with Lower Urinary Tract Symptoms (LUTS) with a total International Prostate Symptom Score (IPSS) greater than or equal to 13 at Visit 1.
Agree not to use any other approved or experimental medications for Benign Prostate Hyperplasia (BPH)-Lower Urinary Tract Symptoms, including alpha blockers, 5-alpha reductase inhibitors, PDE5 inhibitors, or herbal preparations at any time during the study.
Have not taken finasteride or dutasteride therapy for at least 4 months prior to Visit 2; have not taken any other LUTS therapy (including herbal preparations) or PDE5 inhibitors for at least 4 weeks prior to Visit 2.
Have had BPH-LUTS for greater than 6 months prior to Visit 1.

Exclusion Criteria:

Any pelvic surgical procedure on the urinary tract, including minimally invasive BPH-LUTS therapies and penile implant surgery.
History of urethral obstruction due to stricture, valves, sclerosis, or tumor.
Current neurologic disease or condition associated with neurogenic bladder (for example, Parkinson's disease, multiple sclerosis).
History of cardiac conditions including myocardial infarction, bypass surgery, angioplasty or stent placement for a specified time before starting the study.
History of angina requiring treatment with nitrates.
Prostate Specific Antigen (PSA) greater than 10 nanogram/milliliter (ng/ml) at Visit 1.",20 mg tadalafil tablet taken by mouth once a day for 12 weeks,ChEMBL:CHEMBL779 | DrugBank:DB00820 | PubChem:110635,Tadalafil,[H][C@]12Cc3c([nH]c4ccccc34)[C@@H](c3ccc4c(c3)OCO4)N1C(=O)CN(C)C2=O,C02KX52 | C02KX54 | G04BE08 | G04CA54 | G04CB51,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00387010,NCT00387010_EG000,No,All,Adult | Older Adult,Phase 3,218,"Inclusion Criteria:

The patient is willing to provide written informed consent to participate in this study.
The patient is 18 through 80 years of age.
Women must be surgically sterile, 2 years postmenopausal, or, if of childbearing potential, using a medically accepted method of birth control (i.e., barrier method with spermicide, steroidal contraceptive [oral, transdermal, implanted, and injected contraceptives must be used in conjunction with the barrier method], or intrauterine device [IUD]) and agree to continued use of this method for the duration of the study.
The patient has chronic pain of at least 3 months duration associated with any of the following conditions: cancer, diabetic peripheral neuropathy, postherpetic neuralgia, traumatic injury, complex regional pain syndrome, back pain, neck pain, fibromyalgia (patient has met diagnostic criteria), chronic pancreatitis, or osteoarthritis. Other chronic painful conditions may be evaluated for entry upon discussion with and written approval from the Cephalon medical expert.
The patient is currently using 1 of the following: at least 60 mg of oral morphine/day, or at least 25 mcg of transdermal fentanyl/hour, or at least 30 mg of oxycodone/day, or at least 8 mg of hydromorphone/day, or an equianalgesic dose of another opioid/day as a stable dose of around-the-clock (ATC) therapy for at least 7 days prior to enrollment in the study.
The patient reports an average pain intensity score, over the prior 24 hours, of 6 or less (0=no pain through 10=worst pain) for the chronic pain.
The patient experiences, on average, 1 to 4 BTP episodes per day while taking around-the-clock (ATC) opioid therapy, and on average, the duration of each breakthrough pain (BTP) episode is less than 3 hours.
The patient currently uses opioid therapy for alleviation of BTP episodes occurring at the location of the chronic pain, and achieves at least partial relief.
The patient must be willing and able to successfully self-administer the study drug, comply with study restrictions, and return to the clinic for scheduled study visits and a follow-up evaluation as specified in this protocol.

Exclusion Criteria:

The patient has uncontrolled or rapidly escalating pain as determined by the investigator (ie, the ATC therapy may be expected to change between the first and last treatments with study drug), or has pain uncontrolled by therapy that could adversely impact the safety of the patient or that could be compromised by treatment with study drug.
The patient has known or suspected hypersensitivities, allergies, or other contraindications to any ingredient in the study drug.
The patient has a recent history (within 5 years) or current evidence of alcohol or other substance abuse.
The patient has cardiopulmonary disease that, in the opinion of the investigator, would significantly increase the risk of treatment with potent synthetic opioids.
The patient has medical or psychiatric disease that, in the opinion of the investigator, would compromise collected data.
The patient's primary painful condition is headache, including migraine.
The patient is expected to have surgery during the study, and it is anticipated that the surgery will alleviate the patient's pain.
The patient has had therapy before study drug treatment that, in the opinion of the investigator, could alter pain or response to pain medication.
The patient is pregnant or lactating.
The patient has participated in a previous study with fentanyl buccal tablets.
The patient has participated in a study involving an investigational drug in the previous 30 days.
The patient has received a monoamine oxidase inhibitor (MAOI) within 14 days before the first treatment with study drug.
The patient has any other medical condition or is receiving concomitant medication/therapy (e.g., regional nerve block) that, in the opinion of the investigator, would compromise the patient's safety or compliance with the study protocol, or compromise collected data.
The patient is involved in active litigation in regard to chronic pain currently being treated.
The patient has a positive urine drug screen (UDS) for an illicit substance or a medication not legitimately prescribed to the patient.","Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.",ChEMBL:CHEMBL596 | DrugBank:DB00813 | PubChem:3345,Fentanyl,CCC(=O)N(c1ccccc1)C1CCN(CCc2ccccc2)CC1,N01AH01 | N01AH51 | N02AB03,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00391898,NCT00391898_EG001,No,All,Adult | Older Adult,Phase 4,49,"Inclusion Criteria:

Male and female patients ages ≥ 30 and ≤ 80 years old.
A clinical diagnosis of idiopathic Parkinson's disease.
Taking a stable dose of levodopa/carbidopa (≥ 300 and ≤ 600mg) for a period of at least 1 month prior to study entry.

Must be using any of the following levodopa/carbidopa standard formulation levodopa/carbidopa 100/25mg dose in any intake of the day.

1 full tablet, and/or
1½ tablets The patient can also be using, for a period of at least 1 month prior to study entry, 1 tablet of the controlled release formulation of levodopa/carbidopa 100/25 mg (marketed in Spain as Sinemet Plus retard) or 1 tablet the controlled release formulation of levodopa/carbidopa 200/50 mg (marketed in Spain as Sinemet retard) in each intake, at different doses.
Must have early end-of-dose wearing-off defined by >= 2 or <=7 positive responses to the QUICK questionnaire.
Must have a minimum UPDRS part II (ADL) score of 9.
Patients without dyskinesia or with mild dyskinesia.
Female patients must be either post-menopausal or using one or more acceptable methods of contraception.
Must be capable of satisfying the requirements of the protocol and must be willing and able to give informed consent according to legal requirements.

Exclusion Criteria:

Previous or current use of entacapone.
History, signs, or symptoms suggesting the diagnosis of secondary or atypical parkinsonism.
Unstable Parkinson's disease patients.
Patients who experience severe dyskinesia.

The following levodopa/carbidopa doses and strengths are not permitted:

Patients taking ½ tablet of standard formulation levodopa/carbidopa 100/25
Patients taking standard formulation levodopa/carbidopa 100/10 or 250/25
Patients taking fewer than 3 or more than 6 daily intakes of standard formulation levodopa/carbidopa 100/25 (fewer than 300mg or more than 600mg of levodopa)
Patients with hallucinations or psychiatric diseases related to levodopa or dopamine agonists intake. Patients with major depression.
Female patients who are pregnant, trying to become pregnant or nursing (lactating) an infant.
Concomitant treatment with MAO-inhibitors (except selegiline up to 10mg/day), rotigotine or neuroleptics, within 60 days prior to the screening visit.
Patients with a previous history of Neuroleptic Malignant Syndrome (NMS) and/or non-traumatic rhabdomyolysis.
Participated in another trial of an investigational drug/device within the last 30 days prior to study entry.
Patients who have a history of poor compliance or are in the Investigator's judgment unlikely to comply with medical regimens or study requirements.",Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa was available in 2 oral dosage forms: One or one and one-half 100/25 mg encapsulated tablets.,PubChem:104778 | PubChem:441193,Nacom,CC(Cc1ccc(O)c(O)c1)(NN)C(=O)O.NC(Cc1ccc(O)c(O)c1)C(=O)O,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00392951,NCT00392951_EG000,No,All,Child | Adult,Phase 1 | Phase 2,30,"Inclusion Criteria:

Age > 12 months and < 30 years at the time of study entry
Diagnosis of autoimmune cytopenias requiring treatment with medications
At least one of the following: Autoimmune Neutropenia, Autoimmune Hemolytic Anemia, and/or Autoimmune Thrombocytopenia
Must be proven autoimmune by either a documented autoantibody (positive direct anti globulin test, positive anti-neutrophil, and/or anti-platelet antibody) and/or a documented clinical response to immunosuppression
Autoimmune Cytopenias can be idiopathic (Idiopathic Thrombocytopenic Purpura (ITP), Autoimmune Hemolytic Anemia (AIHA), Autoimmune Neutropenia (AIN), or Evans syndrome) or secondary to one of following conditions: Lupus, Rheumatoid Arthritis (RA), ALPS (Autoimmune Lymphoproliferative Syndrome), or Inflammatory bowel disease (IBD)
Patients must have chronic disease diagnosed by either a documented cytopenia syndrome (Lupus, ALPS, RA, or IBD), or by having Evans syndrome defined as idiopathic destruction of multiple blood cell types, and/or by having disease >6 months
Patients must be refractory to or unable to tolerate standard front-line therapies for autoimmune cytopenias (corticosteroids and/or IVIG)
Patients may be taking second-line agents for autoimmune cytopenias (mycophenolate mofetil, cyclosporine, tacrolimus, mercaptopurine, and/or methotrexate) at time of study entry; however, attempts should be made to wean these agents. Patients may not stay on a combination of sirolimus and a calcineurin inhibitor for greater than 4 weeks
Informed consent/assent must be obtained prior to initiating treatment
Patient must be able to consume oral medication in the form of tablets or solution

Exclusion Criteria:

Pregnancy or breast feeding
Uncontrolled infection
Known allergy to Sirolimus or its components
Patients with a documented malignancy on therapy or not in remission
Patients who do not meet organ function requirements listed in protocol
Patients with a documented history of severe combined immunodeficiency or human immunodeficiency virus infection (HIV)","Sirolimus treatment

sirolimus: Tablet or liquid; taken once or twice daily; dosage is based on establishing a serum trough of 5-15 ng/ml by high-performance liquid chromatography (initial loading dose of 3 mg/m2 then 2.5 mg/m2 with adjustment based on serum trough)",ChEMBL:CHEMBL413 | DrugBank:DB00877 | PubChem:134760597 | PubChem:138404388 | PubChem:21944094 | PubChem:5284616,Sirolimus,COC1CC2CCC(C)C(O)(O2)C(=O)C(=O)N2CCCCC2C(=O)OC(C(C)CC2CCC(O)C(OC)C2)CC(=O)C(C)C=C(C)C(O)C(OC)C(=O)C(C)CC(C)C=CC=CC=C1C,L01EG04 | L04AA10 | S01XA23,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00394095,NCT00394095_EG000,No,All,Child | Adult,Phase 4,17,"Inclusion Criteria:

Male or female patients, ages 10-18 years.
Female patients of menarche must be using a medically accepted means of contraception (e.g. oral contraceptives, Depo-Provera, abstinence).
Each patient's authorized legal guardian must understand the nature of the study and must provide written informed consent. Each patient must also give assent to study participation.
Patients must have a diagnosis of Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV-TR) bipolar disorder, type I and currently display an acute manic or mixed episode as determined by K-SADS (Geller et al 2000).
Patients must have a baseline (day 0) Young Mania Rating Scale score of at least 16.
Subjects should be fluent in English.

Exclusion Criteria:

Female patients who are either pregnant or lactating.
Clinically significant or unstable hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, immunologic, hematologic or other systemic medical conditions.
Any history of current or past diabetes that has been treated with pharmacological intervention.
Neurological disorders including epilepsy, stroke, or severe head trauma.
Clinically significant laboratory abnormalities (> 3 times upper limit of normal), on any of the following tests: CBC with differential, electrolytes, BUN, creatinine, hepatic transaminases, lipid profile, fasting glucose, urinalysis, or thyroid indices. Clinically abnormal ECG.
Manic or mixed episode due to a general medical condition or substance-induced mania (DSM-IV-TR).
Mental retardation (IQ <70).
History of hypersensitivity to or intolerance of olanzapine or topiramate.
Prior history of olanzapine or topiramate non-response or allergic reaction.
DSM-IV substance (except nicotine or caffeine) dependence within the past 3 months.
Judged clinically to be at suicidal risk (defined as having active suicidal ideation, intent or plan, or a serious suicide attempt within 30 days, or a baseline Children's Depression Rating Scale suicide score of >3).
Treatment with an injectable depot neuroleptic within less than one dosing interval between depot neuroleptic injections and day 0.
Treatment with concurrent mood stabilizers or anticonvulsants, benzodiazepines (except as described below), psychostimulants, guanethidine, or guanadrel, or antidepressants.
Schizophrenia or other psychotic disorders (including schizophreniform disorder, schizoaffective disorder, delusional disorder, brief psychotic disorder, shared psychotic disorder, psychotic disorder due to a general medical condition, substance-induced psychotic disorder, psychotic disorder not otherwise specified) as defined in the DSM-IV.
Major depressive disorder, dysthymic disorder, depressive disorder not otherwise specified.","Experimental Group Receiving oral Topiramate, 300-400mg/day for 12 weeks",ChEMBL:CHEMBL220492 | DrugBank:DB00273 | PubChem:5284627,Topiramate,[H][C@@]12OC(C)(C)O[C@]1([H])CO[C@@]1(COS(N)(=O)=O)OC(C)(C)O[C@]12[H],A08AA51 | N03AX11,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00397839,NCT00397839_EG001,No,Male,Adult | Older Adult,Phase 3,86,"Inclusion criteria:

Ambulatory men at least 30 years old at screening, who are diagnosed with primary, idiopathic or hypogonadal osteoporosis according to the following criteria: Femoral neck (FN) BMD T-score < -2.0 and LS BMD T-score < -1.0 OR LS BMD T-score < -2.0 and FN BMD T-score < -1.0 and BMD T-score > 4.0 at any site
Subjects who, in the opinion of the investigator, are willing and able to comply with the protocol requirements
Subjects who have signed an informed consent

Exclusion criteria:

Significant medical conditions or laboratory abnormalities, which in the opinion of the investigator may preclude the patient's ability to complete the study
Malignant disease diagnosed within the previous 5 years (except resected basal cell cancer)
Disease/disorder known to influence bone metabolism or cause of secondary osteoporosis e.g., chronic gastrointestinal or liver disease, renal disease, chronic alcoholism, malabsorption syndrome
Hypersensitivity to any component of ibandronate
Inability to stand or sit in an upright position for at least 60 minutes
Inability to swallow a tablet without breaking it
Vitamin D deficiency (serum 25-OH vitamin D <20ng/mL (equivalent to 50nmol/L) at screening
Any prevalent osteoporotic vertebral fracture identified by total spine x-ray (Total spine x-ray consists of lateral and PA films of the thoracic & lumbar spine)
Subjects who are receiving testosterone supplementation for < 2 years (if applicable) (Patients who are identified with clinical signs of hypogonadism at screening and are started on testosterone supplementation will be excluded from participation.)
Contraindications to calcium or vitamin D therapy
Administration of any investigational drug within 30 days preceding the first dose of the study drug
Previous treatment with an oral bisphosphonate within the last six months, OR more than one month of cumulative treatment within the last year, OR more than three months of cumulative treatment within the last two years AND/OR treatment with intravenous bisphosphonate within one year.
Treatment with PTH or similar anabolic agent for osteoporosis within the last two years

Treatment with other drugs affecting bone metabolism within the last six months prior to Screening including:

Chronic systemic glucocorticoid treatment except for topical treatment at a frequency of up to twice per week
Calcineurin inhibitors [e.g., cyclosporine, tacrolimus] or methotrexate
Testosterone therapy (unless stabilized on medications > 2 years)
Calcitonin
Fluoride (dose greater than 10mg/day) or strontium for osteoporosis within the last 12 months, or past treatment for more than a total of 2 years
Selective estrogen receptor modulators (SERMS) such as raloxifene, toremifene, tamoxifen, arzoxifene and lasofoxifene
Anabolic steroids and other androgens, such as dehydroepiandrosterone (DHEA) or its sulphated form (DHEAs)
Active vitamin D analogs/metabolites such as1,25-dihydroxy vitamin D (calcitriol) or 1-alpha-hydroxy vitamin D3 (1 - alpha hydroxycholecalciferol)
Gonadotropin releasing antagonists (lupron)
ALT > twice upper limit of normal range of central laboratory
Hypercalcemia or uncorrected hypocalcemia: Serum total Ca 2+ > 10.5mg/dl or < 8.0 mg/dL (equivalent to 2.6 and 2.0 mmol/L)
GFR < 30 ml/min as determined by estimated creatinine clearance (CLcr) calculated by the Cockcroft-Gault equation:

CLcr = (140-age) * ABW X 0.85 72*Scr where : CLcr - estimated creatinine clearance Age - in years ABW - actual body weight at screening (kg) Scr - serum creatinine at screening (mg/dL)

History of major upper GI disease defined by:

Significant upper GI bleeding within the last year requiring hospitalization or transfusion
Recurrent peptic ulcer disease documented by radiographic or endoscopic means
Dyspepsia or gastroesophageal reflux that is uncontrolled by medication
Abnormalities of the esophagus that delay esophageal emptying, such as stricture, achalasia, or dysmotility
Active gastric/duodenal ulcers
Dyspepsia controlled by daily medication OR prior history of non-recurrent peptic ulcer disease are not considered exclusionary
WBC < 2500/µL
Serum albumin < 3.0g/dL
History of hyperthyroidism, hyperparathyroidism or osteomalacia within one year of study entry
Fewer than three (3) vertebrae in the range L1-L4 evaluable by DXA. Conditions which interfere with the BMD measurement include prevalent fracture, sequelae of orthopedic procedures (e.g., spinal fusion, metal implants, etc.), severe scoliosis and severe degenerative changes (e.g., osteophytes, sclerosis)
Bilateral hip replacement
Any restrictions, defined by site requirements for hrMRI procedure (for subset of hrMRI subjects)",Ibandronate orally at a dose of 150 mg once a month for 12 months,ChEMBL:CHEMBL997 | DrugBank:DB00710 | PubChem:60852,Ibandronate,CCCCCN(C)CCC(O)(P(=O)(O)O)P(=O)(O)O,M05BA06 | M05BB09,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT00397878,NCT00397878_EG000,No,All,Adult | Older Adult,Phase 2,10,"Inclusion Criteria:

Patients must have histologically or cytologically confirmed adenocarcinoma of the colon or rectum that is metastatic
Patients must have measurable disease, defined (per RECIST criteria) as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 20 mm with conventional techniques or >= 10 mm with spiral CT scan
Patients must have received one and only one prior chemotherapy regimen for metastatic colorectal cancer; patients may have received biologic therapy (e.g., bevacizumab) in combination with chemotherapy as part of their prior chemotherapy
ECOG performance status 0-2
Absolute neutrophil count (ANC) >= 1,500/mcL
Platelets >= 100,000/mcL
Hemoglobin >= 9 g/dL
Total bilirubin =< 1.5 x institutional ULN
AST(SGOT)/ALT(SGPT) =< 3.0 x institutional ULN
Creatinine within normal institutional limits OR estimated CrCl (Cockcroft-Gault) or 24 hr urine collection of >= 50 mL/min
The effects of AZD0530 on the developing human fetus at the recommended therapeutic dose are unknown; however, AZD0530 has been shown to cause gross fetal malformations and to negatively impact embryo fetal survival in rats; for this reason and because many tyrosine kinase inhibitors are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and up to 30 days following removal from the study; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately; women of child-bearing potential will have serum beta-Hcg levels drawn up to 7 days prior to receiving study treatment
Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with AZD0530, breastfeeding should be discontinued if the mother is treated with AZD0530
Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to study registration or those who have not recovered from treatment related adverse events > grade 1 (except for neuropathy [ies] which may be =< grade 2) due to agents administered more than 4 weeks earlier
Use of specifically prohibited CYP3A4-active agents or substances are not permitted during protocol treatment, and patients who must continue treatment with these agents are not eligible; prohibited drugs should be discontinued seven (7) days or 5 half-lives (whichever is the longer time period) prior to the administration of the first dose of AZD0530 and for 7 days or 5 half-lives (which ever is the longer time period) following discontinuation of AZD0530
Patients may not be receiving any other investigational agents
Patients with greater than +1 proteinuria on two consecutive readings taken no less than 24 hours apart are ineligible
Patients with QTc prolongation (defined as a QTc interval greater than or equal to 480 msecs) are ineligible
Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection (requiring parenteral antibiotics at the time of registration), cardiac disease NYHA class III or IV, unstable angina pectoris, unstable cardiac arrhythmia or tachycardia (heart rate >= 100 beats per minute), poorly controlled hypertension (systolic blood pressure >= 140 mmHg or diastolic blood pressure >= 90 mmHg)
Patients with any condition (e.g., gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease) that impairs their ability to swallow AZD0530 tablets are excluded
Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
Pregnant women are excluded from this study because AZD0530 has the potential for teratogenic or abortifacient effects as shown by the gross fetal malformation and effects on embryofetal survival seen in reproductive toxicity studies in the rat
Patients with a history of another primary malignancy within the last 5 years, with the exception of non-melanoma skin cancer, and carcinoma in situ of uterine cervix
Patient who are known to be HIV-positive are ineligible because of the potential for pharmacokinetic interactions with AZD0530 and antiretroviral therapy (HAART)",Oral AZD0530 175 mg once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.,ChEMBL:CHEMBL217092 | DrugBank:DB11805 | PubChem:10302451,Saracatinib,CN1CCN(CCOc2cc(OC3CCOCC3)c3c(Nc4c(Cl)ccc5c4OCO5)ncnc3c2)CC1,,1.0,1.0,0.0,0.0,1.0,1.0,1.0,1.0,1.0,1.0,1.0,0.0,1.0,1.0,1.0,1.0,1.0,0.0,1.0,1.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT00399360,NCT00399360_EG002,No,All,Adult | Older Adult,Not Applicable,13,"Inclusion Criteria:

Age ≥ 18 and ≤ 65 years of age
HIV positive, on a stable combination antiretroviral regimen for > 6 months, including but not limited to either 2 nucleoside reverse transcriptase inhibitors (NRTI) and a non-nucleoside reverse transcriptase inhibitors (NNRTI) or protease inhibitor (PI), or a triple NRTI regimen
Ability and motivation to modify behavior and make lifestyle changes
NCEP-Adult Treatment Panel III defined metabolic syndrome, as defined by 3 out of 5 of the following: 1) Waist circumference greater than 102 cm (40 in) in men and 88 cm (35 in) in women, 2) Triglycerides ≥ 150 mg/dL or current anti-lipolytic drug treatment, 3) high-density lipoprotein less than 40mg/dL in men and 50 mg/dL in women, 4) Blood pressure ≥ 130/85 mmHg or current antihypertensive drug treatment, 5) Fasting glucose ≥ 100 mg/dL

Exclusion Criteria:

Any new serious opportunistic infection within the past 6 weeks
History of unstable angina, aortic stenosis, uncontrolled hypertension, severe neuropathy, arthritis or other contraindication to exercise
Current therapy with insulin or other diabetic agent, fasting blood sugar > 126
Requiring parenteral nutrition or parenteral glucocorticoid therapy or oral glucocorticoid therapy
Estrogen, progestational derivative, or ketoconazole use within 3 months
New antiretroviral regimen in the past 6 months
Serum creatinine > 1.5 mg/dL (males) and 1.4 mg/dL (females), serum glutamic pyruvic transaminase-liver function (SGPT), > 2.5 upper limit of normal (ULN), Lactate > 2.0 ULN, hemoglobin < 10.0 mg/dL
Current substance and/or alcohol abuse
Known hypersensitivity to Metformin
Congestive heart failure requiring pharmacologic treatment
Use of cimetidine or planned use during the study period
Hypertrophic obstructive cardiomyopathy
Pregnant or actively seeking pregnancy, breastfeeding
Testosterone use for non-physiologic purposes, or physiologic testosterone replacement for < 3 months.
Presence of active AIDS including cancers
Current viral, bacterial or other infections (excluding HIV)
Weight loss in the past 3 months of greater than 10 pounds
Nitrates or other medications that can alter endothelial function
Contraindication to beta blocker or nitroglycerin use
Patients with previous allergic reactions to iodine-containing contrast media or to iodine","Participants did not participate in lifestyle modification and took metformin 500mg twice daily for 3 months, this was increased to 850mg twice daily at the 3 month visit for the duration of the study.",ChEMBL:CHEMBL1431 | DrugBank:DB00331 | PubChem:4091,Metformin,CN(C)C(=N)NC(=N)N,A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00400439,NCT00400439_EG000,No,All,Adult | Older Adult,Phase 2,77,"Inclusion Criteria:

patients who have completed treatment on study NC19453.

Exclusion Criteria:

any significant lymph node abnormalities at the end of study NC19453.",dalcetrapib (RO4607381): 900mg po daily for 24 weeks,ChEMBL:CHEMBL313006 | DrugBank:DB12181 | PubChem:6918540,Dalcetrapib,CCC(CC)CC1(C(=O)Nc2ccccc2SC(=O)C(C)C)CCCCC1,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00406848,NCT00406848_EG000,No,All,Older Adult,Phase 4,249,"Inclusion Criteria:

Are male or female outpatients at least 65 years of age who meet the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition Text Revision (DSM-IV-TR) diagnostic criteria for Major Depressive Disorder (MDD)
Have a Mini Mental Score Exam (MMSE) score of at least 20 at Visit 1
Have a degree of understanding such that the patient can communicate intelligibly with the investigator and study coordinator

Exclusion Criteria:

Patients judged clinically to be at serious suicidal risk in the opinion of the investigator
Have any prior history of bipolar disorder, panic disorder, psychosis, schizophrenia, or obsessive-compulsive disorder
Have any current (within the past 12 months) DSM-IV-TR primary Axis I diagnosis other than MDD
Have moderate to severe dementia
Have a serious medical illness, including any cardiovascular (CV), hepatic, renal, respiratory, hematologic, endocrinologic, or neurologic disease, or clinically significant laboratory abnormality that is not stabilized or is anticipated to require hospitalization within 6 months, in the opinion of the investigator","Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.",PubChem:60834,Duloxetine Hydrochloride,CNCCC(Oc1cccc2ccccc12)c1cccs1.Cl,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT00408681,NCT00408681_EG000,No,All,Adult | Older Adult,Not Applicable,20,"Inclusion Criteria:

Patient with a diagnosis of severe intestinal GVHD that is not improving at any time after initial treatment with glucocorticoids for at least 7 days are eligible for enrollment; measures indicating severity of GVHD will include: a) persistent diarrhea with average daily stool volumes > 500 mL per day; or b) persistent hemorrhage that is detectable by visual inspection of the stool
Patients with denuded mucosa caused by GVHD are eligible for enrollment, regardless of prior treatment for acute GVHD; denuded mucosa is defined as loss (i.e., erosion or sloughing) of the epithelium in: a) at least one-third of the surface area in a 30 cm colonic segment (i.e., rectosigmoid, descending or transverse colon); or b) at least one fifth of the surface area of the second portion of the duodenum, as estimated by endoscopic evaluation; denuded mucosa must be documented by images of the duodenum and colon and by histologic evaluation of the colon
All subjects must provide written informed consent with the use of forms approved by the Fred Hutchinson Cancer Research Center (FHCRC) Institutional Review Board (IRB)

Exclusion Criteria:

Significant renal dysfunction (estimated creatinine clearance < 30 mL/min)
Persistent or recurrent malignancy
Secondary malignancy
Patients who had autologous or syngeneic marrow transplantation
Presence of any cause of intestinal symptoms or ulceration other than GVHD
Patients with any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol will be excluded",Patients received oral lithium carbonate once or twice daily. Treatment continued for up to 8 weeks in the absence of disease progression or unacceptable toxicity.,ChEMBL:CHEMBL1200826 | DrugBank:DB14509 | PubChem:11125,LITHIUM CARBONATE,O=C([O-])[O-].[Li+].[Li+],,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT00412425,NCT00412425_EG000,No,All,Adult | Older Adult,Phase 1 | Phase 2,15,"Inclusion Criteria:

They have non-resectable stage III or IV metastatic melanoma with measurable disease and have agreed to be treated with biochemotherapy.
They have Zubrod performance status of 0-1
They have normal blood counts with a white blood count (WBC) count >/= 3,500/mm^3, ANC >/= 1,500/mm^3 and a platelet count >/= 100,000/mm^3 and have serum creatinine <1.5 mg/dl, and serum bilirubin level < 1.5 mg/dl, and no evidence of significant cardiac or pulmonary dysfunction.
They have no significant intercurrent illness such as a serious infection, significant psychiatric illness, hypercalcemia (calcium >11 mg), gastro-intestinal (GI) bleeding or evidence of brain metastasis.
They have not been exposed to prior interferon, interleukin-2 or previous chemotherapy including regional perfusion. Prior radiation therapy for metastatic melanoma is permitted provided the patient has unirradiated metastatic sites for response evaluation and has fully recovered from its toxicity.
They must have been off corticosteroids for at least 2 weeks.

Exclusion Criteria:

They are younger than 18 years or more than 65 years of age and those with an expected survival of less than 8 weeks or a Zubrod performance status of 2, 3 or 4.
They have received previous treatment with any prior systemic chemotherapy for unresectable metastasis including and not limited to the following drugs: cisplatin, vinblastine, Dacarbazine (DTIC), interferon and interleukin-2
They have active central nervous system involvement by melanoma either as brain metastasis, spinal cord compression, or meningeal carcinomatosis"".
They have significant cardiac illness such as symptomatic coronary artery disease or previous history of myocardial infarction, impaired left ventricular function or serious cardiac arrhythmias requiring therapy.
They have significant impairment of pulmonary function on account of chronic bronchitis or chronic obstructive pulmonary disease (COPD).
They have symptomatic effusions on account of pleural, pericardial or peritoneal metastasis of melanoma.
They have history of a second malignant tumor (except for other skin cancers and in situ carcinoma of the cervix) within the past 5 years and uncertainty about the histologic nature of the metastatic lesions.
They are on corticosteroids or any other type of immunosuppressive agent (e.g., methotrexate, chloroquine, azathioprine, cyclophosphamide).
They are pregnant or breast feeding. Patients of childbearing potential must agree to use an effective method of contraception.
They have known hypersensitivity to any of the study drugs or to other selective 5-HT3(subscript).
They have ongoing emesis due to any organic etiology including but not limited to central nervous system or gastrointestinal metastasis.
They have grade 2 or higher nausea due to administration of drugs including but not limited to narcotics.",3 Days Palonosetron 0.25 mg intravenous (IV),ChEMBL:CHEMBL1189679 | DrugBank:DB00377 | PubChem:6337614,Palonosetron,[H][C@]12CCCc3cccc(c31)C(=O)N([C@@H]1CN3CCC1CC3)C2,A04AA05 | A04AA55,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00412425,NCT00412425_EG001,No,All,Adult | Older Adult,Phase 1 | Phase 2,15,"Inclusion Criteria:

They have non-resectable stage III or IV metastatic melanoma with measurable disease and have agreed to be treated with biochemotherapy.
They have Zubrod performance status of 0-1
They have normal blood counts with a white blood count (WBC) count >/= 3,500/mm^3, ANC >/= 1,500/mm^3 and a platelet count >/= 100,000/mm^3 and have serum creatinine <1.5 mg/dl, and serum bilirubin level < 1.5 mg/dl, and no evidence of significant cardiac or pulmonary dysfunction.
They have no significant intercurrent illness such as a serious infection, significant psychiatric illness, hypercalcemia (calcium >11 mg), gastro-intestinal (GI) bleeding or evidence of brain metastasis.
They have not been exposed to prior interferon, interleukin-2 or previous chemotherapy including regional perfusion. Prior radiation therapy for metastatic melanoma is permitted provided the patient has unirradiated metastatic sites for response evaluation and has fully recovered from its toxicity.
They must have been off corticosteroids for at least 2 weeks.

Exclusion Criteria:

They are younger than 18 years or more than 65 years of age and those with an expected survival of less than 8 weeks or a Zubrod performance status of 2, 3 or 4.
They have received previous treatment with any prior systemic chemotherapy for unresectable metastasis including and not limited to the following drugs: cisplatin, vinblastine, Dacarbazine (DTIC), interferon and interleukin-2
They have active central nervous system involvement by melanoma either as brain metastasis, spinal cord compression, or meningeal carcinomatosis"".
They have significant cardiac illness such as symptomatic coronary artery disease or previous history of myocardial infarction, impaired left ventricular function or serious cardiac arrhythmias requiring therapy.
They have significant impairment of pulmonary function on account of chronic bronchitis or chronic obstructive pulmonary disease (COPD).
They have symptomatic effusions on account of pleural, pericardial or peritoneal metastasis of melanoma.
They have history of a second malignant tumor (except for other skin cancers and in situ carcinoma of the cervix) within the past 5 years and uncertainty about the histologic nature of the metastatic lesions.
They are on corticosteroids or any other type of immunosuppressive agent (e.g., methotrexate, chloroquine, azathioprine, cyclophosphamide).
They are pregnant or breast feeding. Patients of childbearing potential must agree to use an effective method of contraception.
They have known hypersensitivity to any of the study drugs or to other selective 5-HT3(subscript).
They have ongoing emesis due to any organic etiology including but not limited to central nervous system or gastrointestinal metastasis.
They have grade 2 or higher nausea due to administration of drugs including but not limited to narcotics.",2 Days Palonosetron 0.25 mg IV,ChEMBL:CHEMBL1189679 | DrugBank:DB00377 | PubChem:6337614,Palonosetron,[H][C@]12CCCc3cccc(c31)C(=O)N([C@@H]1CN3CCC1CC3)C2,A04AA05 | A04AA55,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00418028,NCT00418028_EG000,No,Female,Adult | Older Adult,Phase 2 | Phase 3,95,"Inclusion Criteria

Patients diagnosed with metastatic breast cancer
Patients that either have received previous treatment with anthracyclines and/or taxanes or not (either as advance or in metastatic disease).
The patient is ambulatory with a functional ECOG < 2 status (see Appendix 2).
Patient presents, at least one lesion measurable according to RECIST criteria (see Appendix 3)
Patients with a life expectancy of at least 3 months.
Patients that agree to and are able to fulfill the requirements of the whole protocol through the whole study.

Exclusion criteria:

Patients that have previously shown unexpected severe reactions to therapy with fluoropyrimidines or with a known sensitivity to 5-fluorouracile.
Patients previously treated with capecitabine.
Patients with organ transplants.

Other diseases or severe affections:

Patients with previous convulsions, central nervous system diseases or psychiatric diseases, including dementia, that the investigator might consider clinically significant and which adversely affect therapeutic compliance.
Patients with severe intellectual impairment, unable to carry out basic daily routines and established depression.
Clinical significant cardiac disease (e. g. . congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmia not fully controlled with medication) or myocardial infarction within the last 12 months.
Severe renal impairment (baseline creatinine clearance < 30 ml/min)
Patients with signs of metastasis in the CNS. Patients with a history of uncontrolled convulsions, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant precluding informed consent or interfering with compliance for oral drug intake should be excluded.
Patients with an active infection.
Patients with a history of other neoplasias during the previous five years, except for basal cell skin cancer or cervical cancer in situ, both cured.

Patients showing the following laboratory values:

Neutrophil count < 555 x 109/l
Platelet count< 100 x 109/l
Serum creatinine > 1,5 x upper normality limit
seric bilirubin > 2,0 x upper normality limit
ALAT, ASAT > 2,5 x upper normality limit or > 5 x upper normality limit in case of liver metastases
Alkaline phosphatase > 2,5 x upper normality limit > 5 x upper normality limit in case of liver metastases o > 10 x upper normality limit in case of bone metastases.
Patients under radiotherapy four weeks prior to the initiation of the study treatment, or under previous radiotherapy on the marker lesions be measured during the study (new marker lesions that appear in previously irradiated areas are accepted) or patients who are receiving programmed radiotherapy.
Patients under major surgery within 4 weeks prior to study treatment or who have not completely recovered from the effects of major surgery.
Patients who lack upper gastrointestinal tract physical integrity or with malabsorption syndrome.
Patients who have received more than two cycles of chemotherapy for the metastatic disease.
Patients Her2 + per FISH ó +++ Immunohistochemistry","Capecitabine will be administered orally at a dose of 1250 mg/m2 twice-daily (in the morning and in the evening, the equivalent of a total daily dose of 2500 mg/m2) for 14 days, in 3 week cycles with a resting period of 7 days,until disease progression or severe toxicity. Dose adjustments were made in patients with grade 3 or greater diarrhea or hand and food syndrome.

drug: capecitabine: 800 mg/m2 twice a day orally continuous administration until disease progression or severe toxicity. Dose adjustments were made in patients with grade 3 or greater diarrhea or hand and food syndrome.",ChEMBL:CHEMBL1773 | DrugBank:DB01101 | PubChem:42066809 | PubChem:60953,Capecitabine,CCCCCOC(=O)Nc1nc(=O)n([C@@H]2O[C@H](C)[C@@H](O)[C@H]2O)cc1F,L01BC06,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT00418028,NCT00418028_EG001,No,Female,Adult | Older Adult,Phase 2 | Phase 3,97,"Inclusion Criteria

Patients diagnosed with metastatic breast cancer
Patients that either have received previous treatment with anthracyclines and/or taxanes or not (either as advance or in metastatic disease).
The patient is ambulatory with a functional ECOG < 2 status (see Appendix 2).
Patient presents, at least one lesion measurable according to RECIST criteria (see Appendix 3)
Patients with a life expectancy of at least 3 months.
Patients that agree to and are able to fulfill the requirements of the whole protocol through the whole study.

Exclusion criteria:

Patients that have previously shown unexpected severe reactions to therapy with fluoropyrimidines or with a known sensitivity to 5-fluorouracile.
Patients previously treated with capecitabine.
Patients with organ transplants.

Other diseases or severe affections:

Patients with previous convulsions, central nervous system diseases or psychiatric diseases, including dementia, that the investigator might consider clinically significant and which adversely affect therapeutic compliance.
Patients with severe intellectual impairment, unable to carry out basic daily routines and established depression.
Clinical significant cardiac disease (e. g. . congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmia not fully controlled with medication) or myocardial infarction within the last 12 months.
Severe renal impairment (baseline creatinine clearance < 30 ml/min)
Patients with signs of metastasis in the CNS. Patients with a history of uncontrolled convulsions, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant precluding informed consent or interfering with compliance for oral drug intake should be excluded.
Patients with an active infection.
Patients with a history of other neoplasias during the previous five years, except for basal cell skin cancer or cervical cancer in situ, both cured.

Patients showing the following laboratory values:

Neutrophil count < 555 x 109/l
Platelet count< 100 x 109/l
Serum creatinine > 1,5 x upper normality limit
seric bilirubin > 2,0 x upper normality limit
ALAT, ASAT > 2,5 x upper normality limit or > 5 x upper normality limit in case of liver metastases
Alkaline phosphatase > 2,5 x upper normality limit > 5 x upper normality limit in case of liver metastases o > 10 x upper normality limit in case of bone metastases.
Patients under radiotherapy four weeks prior to the initiation of the study treatment, or under previous radiotherapy on the marker lesions be measured during the study (new marker lesions that appear in previously irradiated areas are accepted) or patients who are receiving programmed radiotherapy.
Patients under major surgery within 4 weeks prior to study treatment or who have not completely recovered from the effects of major surgery.
Patients who lack upper gastrointestinal tract physical integrity or with malabsorption syndrome.
Patients who have received more than two cycles of chemotherapy for the metastatic disease.
Patients Her2 + per FISH ó +++ Immunohistochemistry","Capecitabine 800 mg/m2 orally twice-daily (in the morning and in the evening the equivalent of one dose of 1600 mg/m2) for 21 days, in 3 week cycles without resting period, until disease progression or severe toxicity. Dose adjustments were made in patients with grade 3 or greater diarrhea or hand and food syndrome.

capecitabine: 1250 mg/m2 twice a day orally x 14 days every 3 weeks until disease progression or severe toxicity. Dose adjustments were made in patients with grade 3 or greater diarrhea or hand and food syndrome.",ChEMBL:CHEMBL1773 | DrugBank:DB01101 | PubChem:42066809 | PubChem:60953,Capecitabine,CCCCCOC(=O)Nc1nc(=O)n([C@@H]2O[C@H](C)[C@@H](O)[C@H]2O)cc1F,L01BC06,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT00420017,NCT00420017_EG000,No,All,Adult | Older Adult,Phase 4,40,"Inclusion Criteria:

Males or females over the age of 40
Scheduled to undergo esophagectomy

Exclusion Criteria:

History of atrial fibrillation
Prior severe side effects from amiodarone
Elevated liver enzymes >3 times the upper limit of normal (UNL)
Corrected QT interval > 450 ms
Receiving class Ia or class III antiarrhythmics",Intravenous amiodarone,ChEMBL:CHEMBL633 | DrugBank:DB01118 | PubChem:2157,Amiodarone,CCCCc1oc2ccccc2c1C(=O)c1cc(I)c(OCCN(CC)CC)c(I)c1,C01BD01,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00420628,NCT00420628_EG000,No,All,Child,Phase 4,72,"Inclusion Criteria:

Child, 0 to 6 years of age, any sex and race
Subject must have a clinical diagnosis of lid inflammation (e.g. Chalazion/Hordeolum) in at least one eye. If both eyes are diagnosed with lid inflammation, both eyes will be treated
In good health (no current or past relevant medical history), based on the judgment of the investigator
Parent/guardian is able and willing to follow instructions and provide informed consent

Exclusion Criteria:

Known hypersensitivity to corticosteroids, loteprednol etabonate, or any component of the study medication
Known hypersensitivity to aminoglycosides, tobramycin, or any component of the study medication
Use of concurrent ocular therapy with non-steroidal anti-inflammatory agent (NSAID), mast cell stabilizer, antihistamine, or decongestant within 48 hours before and during the study
Use of oral or topical ophthalmic corticosteroids (other than study medication) within 48 hours before and during the study
Use of systemic antibiotics within 72 hours before and during the 14 day study medication treatment duration
Use of topical ophthalmic antibiotics (other than the study medication) within 72 hours before and during the study
History of ocular surgery, including laser procedures, within the past six months
Anticipation that surgical intervention for lid inflammation will be required prior to completion of the study
Subjects with suspected vernal conjunctivitis, glaucoma of any kind, viral or bacterial conjunctivitis, preseptal cellulitis requiring systemic antibiotics, dacryocystitis, uveitis, or any other disease conditions that could interfere with the safety and efficacy evaluations of the study medication
History of any severe/serious ocular pathology or medical condition that could result in the subject's inability to complete the study
Participation in an ophthalmic drug or device research study within 30 days prior to entry in this study
Unlikely to comply with the protocol instructions for any reason",0.5% loteprednol etabonate with 0.3% tobramycin opthalmic suspension administered into affected eye(s) for 14 days,PubChem:9811635,Loteprednol etabonate/tobramycin,CCOC(=O)OC1(C(=O)OCCl)CCC2C3CCC4=CC(=O)C=CC4(C)C3C(O)CC21C.NCC1OC(OC2C(N)CC(N)C(OC3OC(CO)C(O)C(N)C3O)C2O)C(N)CC1O,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00422734,NCT00422734_EG001,No,Male,Adult | Older Adult,Phase 3,264,"Inclusion Criteria:

Male

History of erectile dysfunction (ED) for at least 3 months duration
Anticipate having the same female partner willing to participate throughout the study
At least 18 years of age at Visit 1 and agree to make at least 4 sexual attempts during the early phase of the study
Adequate partner sexual function as determined by a Female Sexual Function Index
Willing to record responses to efficacy questionnaires, sexual quality of life questionnaires and other instruments used in the study

Exclusion Criteria:

May not participate in the study if you have taken tadalafil previously.
History of cardiac conditions including angina requiring treatment with nitrates, heart disease of coronary conditions including myocardial infarction, bypass surgery, angioplasty or stent placement for specified time before starting the study.
Have sexual partner not willing to complete the scales.
Use of nitrates.",5 mg tadalafil tablet taken by mouth once a day for 12 weeks,ChEMBL:CHEMBL779 | DrugBank:DB00820 | PubChem:110635,Tadalafil,[H][C@]12Cc3c([nH]c4ccccc34)[C@@H](c3ccc4c(c3)OCO4)N1C(=O)CN(C)C2=O,C02KX52 | C02KX54 | G04BE08 | G04CA54 | G04CB51,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT00437125,NCT00437125_EG000,No,All,Adult | Older Adult,Phase 4,151,"Inclusion Criteria:

Are outpatients, male or female, 30 through 75 years of age
Meet diagnostic criteria for major depression episode and a clinical diagnosis of idiopathic Parkinson's disease
Have a clinician-rated 17-item Hamilton Depression Rating Scale (HAMD17) total score greater than or equal to 15, a Beck Depression Inventory (BDI) total score greater than or equal to 13 and a Clinical Global Impression of Severity (CGI-S) score greater than or equal to 3 at both Visit 1 and Visit 2
Have satisfactory cognitive function
Have been held on stable dosage of antiparkinsonian medications for at least 4 weeks immediately prior to Visit 1

Exclusion Criteria:

Any current primary psychiatric diagnosis other than Major depressive episode, and any personality disorder that could interfere with the compliance with the study protocol
Atypical or secondary parkinsonism due to drugs or diseases with features of Parkinson's disease
Motor conditions for which it is to be expected to change the antiparkinsonian treatment during the course of the study
Clinically significant laboratory abnormalities or serious, unstable medical illness
Lack of response of current episode to two or more adequate courses of antidepressant therapy","Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks",PubChem:60834,Duloxetine Hydrochloride,CNCCC(Oc1cccc2ccccc12)c1cccs1.Cl,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00438100,NCT00438100_EG000,No,Female,Adult | Older Adult,Phase 2,71,"Inclusion Criteria:

Biopsy-diagnosed breast cancer with metastasis in multiple organs
Performance Status (World Health Organization :WHO) 0-2

Functions below are maintained in major organs:

Leukocyte count: 4,000/mm3 to 12,000/mm3
Neutrophil count: >2,000/mm3 or more
Platelet count: <100,000/mm3 or more
Hemoglobin: >9.5 g/dL
Total bilirubin: >1.5 mg/dL
AST(GOT): within twice a normal upper value in an institution
AST(GPT): within twice a normal upper value in an institution
BUN: < 25 mg/dL
Creatinine: within a normal upper value in the institution
24 hours creatinine clearance: >50 mL/min (using the Cockcroft-Gault formula)
Women's Ccr = Body weight x (140-Age)/(72 x Serum creatinine) x 0.85
Written informed consent will be obtained for patients for entering this study

Exclusion Criteria:

Patients with synchronous multiple cancers
Complicated with infection
Fever from suspected infection
Metastasis to the central nerve system
A history of ischemic cardiac diseases
Active gastrointestinal ulcer
Severe nerve disorder
Women who are potentially pregnant, pregnant, or breast-feeding
Severe drug allergy
Severe suppression of the bone marrow
Severe renal disorder
Being treated with other pyrimidine fluoride antineoplastic agents (including any combination therapy)
Being treated with flucytosine
Complicated with the infection onset which a study doctor assesses to be inappropriate for this study","Capecitabine (Xeloda): 1600 mg/m2 orally bid daily for day 1 through day 21 followed by 7-day washout; repeat this as a course.

Capecitabine: 1600 mg/m2 orally bid daily for day 1 through day 21 followed by 7-day washout; repeat this as a course.",ChEMBL:CHEMBL1773 | DrugBank:DB01101 | PubChem:42066809 | PubChem:60953,Capecitabine,CCCCCOC(=O)Nc1nc(=O)n([C@@H]2O[C@H](C)[C@@H](O)[C@H]2O)cc1F,L01BC06,1.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT00438464,NCT00438464_EG000,No,Male,Adult | Older Adult,Phase 2,204,"Criteria:

Histologically confirmed adenocarcinoma of the prostate
Clinical stage T1c or T2 (stage II)
Gleason score of 6 or 7 on initial biopsy
Prostate-specific antigen (PSA) level less than 10 ng/mL within the past 3 months
Candidate for and scheduled to undergo prostatectomy
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2 OR Karnofsky PS 70-100%
Fertile patients must use effective contraception
No active malignancy at any other site
No history of allergic reactions attributed to compounds of similar chemical or biological composition to finasteride
No uncontrolled intercurrent illness including, but not limited to, any of the following: Ongoing or active infection; Symptomatic congestive heart failure; Unstable angina pectoris; Cardiac arrhythmia
No psychiatric illness or social situation that would preclude study compliance
More than 6 months since prior hormonal agents, including dutasteride or finasteride
More than 6 months since prior chemotherapy
More than 1 month since prior participation in another investigational study
No prior radiotherapy for the primary tumor
No concurrent dehydroepiandrosterone, phytoestrogen supplements, antiandrogen therapy, dutasteride, or other finasteride
No concurrent anticoagulation, except for the use of daily acetylsalicylic acid (81 mg to 325 mg)","Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.",ChEMBL:CHEMBL710 | DrugBank:DB01216 | PubChem:57363,Finasteride,[H][C@@]12CC[C@@]3([H])NC(=O)C=C[C@]3(C)[C@@]1([H])CC[C@]1(C)[C@@H](C(=O)NC(C)(C)C)CC[C@@]21[H],D11AX10 | G04CA51 | G04CA55 | G04CB01 | G04CB51,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00441558,NCT00441558_EG000,No,Female,Adult,Phase 3,1723,"Inclusion Criteria:

Women with a primary diagnosis of HSDD who have completed a previous study of Flibanserin.
Patients must have used a medically acceptable method of contraception for at least 2 months before the start of the study and continue to use that method for the duration of the study.
Patients must be reliable, compliant, and agree to cooperate with all study evaluations.
Patients must be able and willing to give meaningful, written informed consent prior to the start of the study and be willing to discuss their sexual functioning with the study staff.

Exclusion Criteria:

A history of Major Depressive Disorder within 6 months prior to the start of the study, current suicidal thoughts, or any history of a suicide attempt.
Participation in another clinical trial within 1 month prior to the start of the study, except for Flibanserin.
Patients with pelvic inflammatory disease, urinary tract infection, vaginal infection/vaginitis, cervicitis, interstitial cystitis, vulvodynia, or significant vaginal atrophy.
Patients who are pregnant or have been pregnant within 1 month prior to study start.
Patients experiencing major life stress (including loss of income, death of a family member, major illness, etc.) or relationship trouble that could interfere with sexual activity, except distress about HSDD.
Clinically significant ECG or lab abnormalities at study start.
Patients taking prohibited medications that were excluded in their previous trial which contribute to sexual dysfunction or safety-related interactions.","Flibanserin: flexible dosing of either 50 or 100mg every evening, or 25 or 50mg twice daily.",ChEMBL:CHEMBL231068 | DrugBank:DB04908 | PubChem:6918248,Flibanserin,O=c1[nH]c2ccccc2n1CCN1CCN(c2cccc(C(F)(F)F)c2)CC1,G02CX02,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT00442338,NCT00442338_EG001,No,All,Child | Adult | Older Adult,Phase 3,30,"Inclusion Criteria:

Adult participants with acute asthma attacks

Exclusion Criteria:

Participant has any known or suspected, acute or chronic cause for their pulmonary symptoms other than asthma (e.g., COPD, chronic heart failure, etc.).
Participant has a smoking habit (15 cigarettes per day) within a month prior to screening period, and/or has a smoking history (20 cigarettes per day) of more than 15 years.
Participant has a disease of the cardiovascular, hepatic, renal, hematologic systems, or other severe disease.",Montelukast 14 mg Intravenous Administration,PubChem:23663996,Montelukast Sodium,CC(C)(O)c1ccccc1CCC(SCC1(CC(=O)[O-])CC1)c1cccc(C=Cc2ccc3ccc(Cl)cc3n2)c1.[Na+],,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00442559,NCT00442559_EG000,No,All,Child,Phase 4,100,"Inclusion Criteria:

Between 2 and 14 years old
Diagnosed with asthma, classified as mild persistent asthma according to Global Initiative Asthma Guidelines (GINA)
Diagnosed with comorbid allergic rhinitis

Exclusion Criteria:

Patients with suspected sinus infection
Prior treatment with high dose inhaled corticosteroid requiring a dose higher than beclomethasone dipropionate 400 ug per day, or equivalent, other medications used in severe cases","Participants were treated for 12 months after randomization: Participants 2 to 5 years of age took one 4 mg chewable tablet and 6 to 14 years of age took one 5 mg chewable tablet daily in the evening. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.",PubChem:23663996,Montelukast Sodium,CC(C)(O)c1ccccc1CCC(SCC1(CC(=O)[O-])CC1)c1cccc(C=Cc2ccc3ccc(Cl)cc3n2)c1.[Na+],,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT00443430,NCT00443430_EG000,No,All,Child,Phase 4,43,"Inclusion Criteria:

Diagnosis of active poly-JIA as determined by International League of Associations for Rheumatology (ILAR) criteria
Onset of signs and symptoms of poly-JIA for 12 months or less prior to study screening
Willing to use acceptable forms of contraception for the duration of the study and for 3 months after the study
Parent or guardian willing to provide informed consent
Able to attend all study visits

Exclusion Criteria:

Received or currently receiving disease-modifying antirheumatic drugs (DMARDs), biologic, or prednisone for any duration for treatment of poly-JIA, with the following exceptions:

Methotrexate duration must be less than or equal to 6 weeks at a dose of less than or equal to 0.5 mg/kg/week (40 mg max),
Steroid use has been less than or equal to 4 weeks and the subject is off of steroids for at least 1 week prior to enrollment
Received intramuscular or soft-tissue injections of corticosteroids for treatment of poly-JIA before receiving the first dose of study medication. Up to 2 joint injections with intra-articular steroids (IAS) will be allowed up to 7 days after the baseline visit.
History of or active cancer of any type
Active gastrointestinal disease (e.g., inflammatory bowel disease)
Chronic or acute kidney or liver disorder
Significant blood clotting defect
AST (SGOT), ALT (SGPT), or BUN levels more than two times the upper level of normal, creatinine levels more than 1.5 mg/dl, or any other laboratory abnormality considered to be clinically significant within 28 days prior to baseline
Chronic condition (e.g., diabetes, epilepsy) that is either not stable or poorly controlled and may interfere with study participation
Received any investigational medication within 30 days prior to the first dose of study medication or scheduled to receive an investigational drug (other than the study medications) during the course of the study
Chronic or active infection or any major episode of infection requiring hospitalization or treatment with intravenous antibiotics within 30 days prior to study screening
HIV infected
Known past or current hepatitis infection
Received a live virus vaccine within 1 month prior to baseline
Purified protein derivative (PPD) positive (positive tuberculosis [TB] test)
Pregnancy
Any medical condition that would make study participation difficult or inadvisable in the opinion of the investigator
History of or current psychiatric illness that would interfere with study participation
History of alcohol or drug abuse within the 6 months prior to study entry that would interfere with study participation
Inability to comply with study requirements for any reason","Methotrexate 0.5 mg/kg given by subcutaneous injection once per week, plus placebo etanercept and placebo prednisolone",ChEMBL:CHEMBL34259 | DrugBank:DB00563 | PubChem:126941,Methotrexate,CN(Cc1cnc2nc(N)nc(N)c2n1)c1ccc(C(=O)N[C@@H](CCC(=O)O)C(=O)O)cc1,L01BA01 | L04AX03,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00446641,NCT00446641_EG000,No,All,Adult | Older Adult,Phase 4,125,"Inclusion Criteria:

Symptomatic cerebral infarction documented on MRI or CT
More than 35 years of age
Patients taking aspirin 100mg a day for 2 weeks or more before randomization

Exclusion Criteria:

Patients taking any antiplatelets other than aspirin within 2 weeks before randomization
Patients taking any anticoagulants within 2 weeks before randomization
Patients taking thrombolytic therapy within 2 weeks before randomization
Patients taking any NSAIDs within 2 weeks before randomization
Patients who need to take NSAIDs regularly (e.g. rheumatic arthritis).
Bleeding diathesis
Chronic liver disease (ALT > 100 or AST > 100) or chronic renal disease (creatinine > 3.0mg/dl)
Anemia (hemoglobin < 10mg/dl) or thrombocytopenia (platelet count less than 100,000/mm3)
Pregnant or lactating patients
Patients scheduled for angioplasty or revascularization procedures within 4 weeks
Patients scheduled for any surgery or invasive procedures within 4 weeks
Patients having acute coronary syndrome",Cilostazol 100mg twice per day,ChEMBL:CHEMBL799 | DrugBank:DB01166 | PubChem:2754,Cilostazol,O=C1CCc2cc(OCCCCc3nnnn3C3CCCCC3)ccc2N1,B01AC23,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00467350,NCT00467350_EG000,Accepts Healthy Volunteers,All,Child,Not Applicable,40,"Inclusion Criteria:

Constipated children who have one of the following three conditions:

Fecal impaction (lower quadrant mass or dilated rectum with hard stool),
Functional fecal retention (large diameter stools as determined by caregiver <twice/week and retentive behaviors, or
Excessive stool in colon on abdominal radiograph as determined by attending radiologist or treating physician

Exclusion Criteria:

Ill appearing patients (signs of acute surgical abdomen, abnormal vital signs, or overall ill appearing as determined by treating physician)
Patients whose evaluation in the ED includes more than plain radiographs or urinalysis
Patients who receive analgesia for the abdominal pain in the ED (except acetaminophen or ibuprofen)
Non-English speaking patients and families
Patients with milk allergy
Patients with molasses allergy
Patients who are pregnant
Patients with a chronic medical conditions which may be associated with constipation (including patients with cystic fibrosis, cerebral palsy, hypothyroidism, spinal anomalies, and known gastrointestinal anatomic abnormalities) or a history of prior abdominal or rectal surgery
Patients who are admitted to an in-patient unit",milk and molasses enema: enema 10 cc/kg per rectum (max 500 cc)then PEG 3350 0.8 gram/kg for maintenance,ChEMBL:CHEMBL389621 | DrugBank:DB00741 | PubChem:5754,Hydrocortisone,[H][C@@]12CC[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)CC[C@@]21C,A01AC03 | A07EA02 | C05AA01 | D07AA02 | D07BA04 | D07CA01 | D07XA01 | H02AB09 | R01AD60 | S01BA02 | S01BB01 | S01CA03 | S01CB03 | S02BA01 | S02CA03 | S03CA04,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00470392,NCT00470392_EG000,No,All,Adult | Older Adult,Not Applicable,7,"Inclusion Criteria:

The presence of plaque-type psoriasis in areas of the trunk, buttocks, or extremities that are amenable to biopsy and evaluable disease in at least 2 cm target treatment sites separated by 1 cm
Age 18-80, both genders, all ethnicities
No contraindications to phototherapy or biopsy procedures
No topical steroid, tar, phototherapy, Vitamin D, or retinoid therapy to target lesions for at least 1 week prior to the study
No systemic psoriasis therapy for at least four weeks prior to the study
Able to give informed consent under IRB approval procedures

Exclusion Criteria:

Photosensitivity disorders
Active untreated diseases or medication usage which may interfere with UVB, wound healing, or immune function
Hypersensitivity to local anesthetic
Inability to provide informed consent
Pregnancy and /or lactating","Each study subject served as his/her own control. For this arm of the study, topical vehicle was applied to one plaque for 5 days. Imiquimod (5% topical cream) was applied to two psoriasis plaques for 5 days. Skin biopsies were taken from half of each of the 3 plaques at specific time points after completion of topical pre-treatment. The other half of the plaques were exposed to UVB light (via Excimer laser). Biopsies were subsequently taken at a specified time point.",ChEMBL:CHEMBL1282 | DrugBank:DB00724 | PubChem:57469,Imiquimod,CC(C)Cn1cnc2c(N)nc3ccccc3c21,D06BB10,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT00473876,NCT00473876_EG000,No,All,Adult | Older Adult,Phase 4,39,"Inclusion Criteria:

Patients aged 25-80 yrs with compensated CHF in NYHA functional I-III with evidence of insulin resistance [fasting insulin resistance index values of > 2.7 are said to have insulin resistance].
Documented Left ventricular systolic dysfunction or LV ejection fraction < 35%

Exclusion Criteria:

Elderly patients (aged >80 yrs);
Patients with decompensated CHF (NYHA functional class IV and /or signs of decompensated CHF);
Renal dysfunction (serum creatinine > 160 mmol/L);
Patients who are unable to exercise including patients that will be excluded for reasons of safety or potential effects on exercise performance. Therefore, patients with angina or other cardiac or pulmonary symptoms potentially limiting exercise performance will be excluded.
Systolic blood pressure >190 mmHg at rest or >250 mmHg with exercise or diastolic blood pressure >95 mmHg at rest or >105 mmHg with exercise will also be a reason for exclusion;
Patients with underlying disease likely to limit life span and/or increase risk of interventions will be excluded i.e., cancer; cardiovascular disease .i.e., uncontrolled hypertension: SBP>180 mmHg or DBP, recent stroke, any severe chronic disease (including renal and hepatic disease).",Receiving Metformin for 4 months with a target dose of 1000mg twice a day,ChEMBL:CHEMBL1431 | DrugBank:DB00331 | PubChem:4091,Metformin,CN(C)C(=N)NC(=N)N,A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00476151,NCT00476151_EG001,No,All,Adult | Older Adult,Phase 2,114,"Inclusion Criteria:

Adult patients with chronic pain due to diabetic peripheral neuropathy (DPN) of at least 6 months duration are eligible if they have an average daily pain score of > 4 during the baseline week.

Exclusion Criteria:

Clinically significant intercurrent illness (e.g., endocrine, cardiac, hepatic, renal, neurologic, hematologic, skeletal) that the investigator determines could interfere with the efficacy or safety assessments in this study",active topical cream applied twice daily for 4 weeks,DrugBank:DB05492,Epicept NP-1,Cc1ccc(NCCCN)c([N+](=O)[O-])c1,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00489424,NCT00489424_EG001,No,Female,Adult | Older Adult,Phase 4,264,"Inclusion Criteria:

Postmenopausal women greater than or equal to 45 and less than or equal to 79 years of age at randomization
Women who are clinically indicated for treatment with Bisphosphonates for osteopenia or osteoporosis with a documented central (spine or hip) Bone Mineral Density T Score less than or equal to 1.5

Exclusion Criteria:

Any prior treatment with intravenous Bisphosphonates
Oral treatment with Bisphosphonates for more than 8 weeks or within 6 months prior to the screening visit
Patients who are taking, and are unwilling or unable to stop taking, certain medications
Patients who require anticoagulant therapy
Patients with a known hypersensitivity to ibuprofen, ACET, bisphosphonates, statins or with allergies manifested by attacks of asthma, urticaria or acute rhinitis following
Proteinuria (protein detected on a urine dipstick) greater than or equal to 2+ at screening
Protocol specific laboratory values that fall out of range for this study
Ongoing infection (oral body temperature greater than or equal to 37.5C (99.5°F),chronic febrile disease or fever of unknown origin at screening or randomization
Active dental infection, unhealed dental extraction or planned oral surgery within 3 months after randomization
History of iritis, uveitis or chronic conjunctivitis
History of hypoparathyroidism, hyperparathyroidism or Paget's Disease
Partial or total removal of parathyroid or thyroid gland
History of malignancy of any organ system, treated or untreated, within the past 1 year whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin
Treatment with an investigational drug within the previous 30 days of screening
Patients with any medical or psychiatric condition which, in the opinion of the Principal Investigator, would preclude the participant from adhering to the protocol or completing the trial per protocol, or any patient who the Principal Investigator thinks should not participate in the study for any reason, including current drug or alcohol abuse

Other protocol-defined inclusion/exclusion criteria may apply","2 capsules of acetaminophen 325 mg and 2 capsules of placebo (matching fluvastatin) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of acetaminophen 325 mg 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).",ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00491244,NCT00491244_EG000,No,All,Adult | Older Adult,Phase 4,189,"Inclusion Criteria:

Age 18-65 years old
Creatinine clearance (Ccr) < 15 ml/min/1.73 m2
Anti-HCV (Abbott HCV EIA 3.0, Abbott Diagnostic, Chicago, IL) positive > 6 months
Detectable serum quantitative HCV-RNA (Cobas Taqman HCV test, version 2, Roche Diagnostics) with a dynamic range of 25-391000000 IU/ml

Exclusion Criteria:

Receiving interferon-based therapy for chronic hepatitis C
Severe anemia (hemoglobin < 10 g/dL) or hemoglobinopathy
Neutropenia (neutrophil count, <1,500/mm3)
Thrombocytopenia (platelet <90,000/ mm3)
Co-infection with HBV or HIV
Chronic alcohol abuse (daily consumption > 20 g/day)
Autoimmune liver disease
Decompensated liver disease (Child classification B or C)
Neoplastic disease
An organ transplant
Immunosuppressive therapy
Poorly controlled autoimmune diseases, pulmonary diseases, cardiac diseases, psychiatric diseases, neurological diseases, diabetes mellitus
Evidence of drug abuse
Unwilling to have contraception","Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 24 to 48 weeks (genotype 1: 48 weeks, genotype 2: 24 weeks)",ChEMBL:CHEMBL1643 | DrugBank:DB00811 | PubChem:37542,Ribavirin,NC(=O)c1ncn([C@@H]2O[C@H](CO)[C@@H](O)[C@H]2O)n1,J05AP01,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT00500318,NCT00500318_EG000,No,All,Adult | Older Adult,Phase 3,86,"Inclusion Criteria:

A diagnosis of stable moderate to severe COPD (GOLD 2006); post-levalbuterol FEV1 >=30% and < 80% predicted and FEV1/FVC<70% predicted
Current or former cigarette smoker
Functional Residual Capacity (FRC) measured by body plethysmography >= 120% of predicted value
Baseline Dyspnea Index (BDI) focal score ≤ 7 at Visit 4

Exclusion Criteria:

History of presence of asthma, allergic rhinitis, or atopy
Hospitalization for acute COPD exacerbation in the 3 months prior to study entry
Respiratory tract infection (including the upper respiratory tract) or COPD exacerbation in the 6 weeks prior to study entry
Clinically significant respiratory conditions other than COPD
Chronic use of oxygen therapy >= 15 hours a day","Aclidinium bromide, 200 micrograms, oral inhalation once per day.",PubChem:11519741,Aclidinium Bromide,O=C(OC1C[N+]2(CCCOc3ccccc3)CCC1CC2)C(O)(c1cccs1)c1cccs1.[Br-],R03AL05,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT00504023,NCT00504023_EG000,No,Female,Adult | Older Adult,Not Applicable,8,"Inclusion Criteria:

All patients presenting to the Gynecology outpatient service at a participating institution who meet eligibility requirements may be included in this clinical trial. The eligibility requirements are as follows:

Age ≥18.
Ability to give informed consent.
Patients must have biopsy proven recurrent extramammary Paget's disease confirmed at the participating site.

Exclusion Criteria:

Patients with known hypersensitivity to imiquimod.
Pregnant and nursing women are not eligible
Patients with underlying adenocarcinoma on biopsy of lesion confirmed at the participating site.","This is a pilot study of the use of a topical immunomodulatory agent, imiquimod, for the treatment of recurrent Extramammary Paget's disease (EMPD).",ChEMBL:CHEMBL1282 | DrugBank:DB00724 | PubChem:57469,Imiquimod,CC(C)Cn1cnc2c(N)nc3ccccc3c21,D06BB10,0.0,0.0,0.0,0.0,0.0,1.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT00527592,NCT00527592_EG001,No,All,Adult | Older Adult,Phase 4,54,"Inclusion Criteria:

18 years of age or older.
Clinical diagnosis of ocular hypertension, primary open-angle, pigment dispersion, or exfoliation glaucoma in both eyes.
Best corrected visual acuity of 20/200 Snellen or better in each eye.
Intraocular pressure within protocol-specified range.
Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

Any abnormality preventing reliable applanation tonometry in the study eye(s).
Any eye conditions or procedures as specified in protocol.
Progressive retinal or optic nerve disease from any cause.
Use of contact lenses in the study eye(s).
Other protocol-defined exclusion criteria may apply.","One drop in the study eye, single dose",ChEMBL:CHEMBL1051 | DrugBank:DB00654 | PubChem:5311221,Latanoprost,CC(C)OC(=O)CCC/C=C\C[C@@H]1[C@@H](CC[C@@H](O)CCc2ccccc2)[C@H](O)C[C@@H]1O,S01EE01 | S01EE51,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00528957,NCT00528957_EG000,No,All,Child,Phase 3,48,"Major Inclusion Criteria:

Documented laboratory diagnosis of HIV-1 infection
Plasma HIV-1 RNA < 400 copies/mL
Currently on a stable stavudine or zidovudine -containing antiretroviral therapy regimen for at least 12 weeks
Naive to tenofovir DF

Key Inclusion Criteria for the First 96-Week Extension

Completed 48 weeks of treatment in Arm 1 or Arm 2 of the study
<18 years of age (at the start of the extension)
Participants initially randomized to Arm 2 will be given the option to replace stavudine or zidovudine with tenofovir DF in the 96-week extension at the investigator's discretion, if the investigator determines that tenofovir DF is safe and beneficial for the participant.

Key Inclusion Criteria for the Second and Third 96-Week Extension and Fourth Open-Ended Extension

Completed of treatment with study drug in the first extension phase
<18 years of age at the start of the extension. This inclusion criterion is not applicable in those regions where tenofovir DF is not commercially available for treatment of HIV-1 infection in adults.

Key Exclusion Criteria:

Participants receiving ongoing therapy with any of the following
Nephrotoxic agents
Systemic chemotherapeutic agents
Systemic corticosteroids
Interleukin 2 (IL 2) and other immunomodulating agents
Investigational agents
Pregnant or lactating participants
Evidence of a gastrointestinal malabsorption syndrome or chronic nausea or vomiting which may confer an inability to receive an orally administered medication
Current alcohol or substance abuse judged by the investigator to potentially interfere with participant compliance
Malignancy other than cutaneous Kaposi's sarcoma (KS) or basal cell carcinoma.
Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic therapy within 15 days prior to screening
Prior history of significant renal disease (ie, nephrotic syndrome, renal dysgenesis, polycystic kidney disease, congenital nephrosis)
Prior history of significant bone disease (ie, osteomalacia, chronic osteomyelitis, osteogenesis imperfecta, osteochondroses, multiple bone fractures)

Note: Other protocol defined Inclusion/ Exclusion criteria may apply.",Participants in this group received TDF during the randomized phase (48 weeks),PubChem:5486830 | PubChem:6398764,Tenofovir Disoproxil Fumarate,CC(C)OC(=O)OCOP(=O)(COC(C)Cn1cnc2c(N)ncnc21)OCOC(=O)OC(C)C.O=C(O)C=CC(=O)O,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT00535873,NCT00535873_EG000,No,All,Older Adult,Phase 2,60,"Inclusion Criteria:

Patients with untreated CLL or small lymphocytic lymphoma (SLL) with indication to treatment according to NCI Working Group guidelines.Patients that have received single agent rituximab will be allowed to participate in this study.
Age 65 or older
Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) performance status of 0-2.
Adequate renal function indicated by serum creatinine less or equal to 2 and adequate hepatic function indicated as total bilirubin less or equal to upper level of normal and as alanine aminotransferase (ALT) less or equal 2 upper limit of normal (ULN).
Able to understand and sign Informed Consent after the investigational nature, study design, risks and benefits have been explained.
Able to adhere to the study visit schedule and other protocol requirements.
Disease free of prior malignancies for 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma ""in situ"" of the cervix or breast. Patients with malignancies with indolent behavior such as prostate cancer treated with radiation can be enrolled in the study as long as they have a reasonable expectation to have been cured with treatment modality received.
Females of childbearing potential (FCBP). A female of childbearing potential is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months). Must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10-14 days prior to and again within 24 hours of starting lenalidomide and must either commit to continued abstinence
Continued from above. from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 4 weeks before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing.
Men must agree to use a condom during sexual contact with a female of child bearing potential even if they have had a successful vasectomy.
All patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure.
All patients must be able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to Acetylsalicylic Acid (ASA) may use warfarin or low molecular weight heparin.

Exclusion Criteria:

Known sensitivity to thalidomide or its derivatives.
Documented prolymphocytic leukemia (prolymphocytes more than 55% in the blood).
Known positivity for HIV or active hepatitis (B or C).
A serious medical condition, laboratory abnormality or psychiatric illness that would interfere with the ability of the patient to participate in this program according to the judgement of the Principal Investigator.
Active cardiovascular disease as defined by the New York Heart Association Class 3 or 4.
History of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
Concurrent use of other chemotherapy agents.
Pregnant or breast feeding females. Lactating females must agree not to breast feed while taking lenalidomide.
No known history of tuberculosis or recent exposure to tuberculosis.","Lenalidomide starting dose of 5 mg (capsules) by mouth daily for 28 days, one cycle.",ChEMBL:CHEMBL848 | DrugBank:DB00480 | PubChem:216326,Lenalidomide,Nc1cccc2c1CN(C1CCC(=O)NC1=O)C2=O,L04AX04,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,1.0,1.0,1.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,1.0,0.0,0.0
NCT00536484,NCT00536484_EG001,No,All,Adult | Older Adult,Phase 3,438,"Inclusion Criteria:

Overactive bladder symptoms for greater than or equal to 3 months.
Mean urinary frequency of greater than or equal to 8 micturitions per 24 hours in bladder diary.
Mean number of Urgency episodes greater than or equal to 3 per 24 hours in bladder diary.

Exclusion Criteria:

Contraindication to fesoterodine (antimuscarinics).
Known etiology of OAB (e.g., neurogenic, local urinary tract pathology).
Previous history of acute urinary retention requiring catheterization or severe voiding difficulties in the judgment of the investigator, prior to baseline.
Unable to follow the study procedures, including completion of self-administered bladder diary and patient reported outcome questionnaires.",All randomized participants were treated with fesoterodine 4mg once daily for the first 2 weeks of treatment. The dose remained at 4 mg once daily or increased to 8 mg once daily for the next 10 weeks based on discussion between investigator and participant.,ChEMBL:CHEMBL1201764 | DrugBank:DB06702 | PubChem:6918558,Fesoterodine,CC(C)C(=O)Oc1ccc(CO)cc1[C@H](CCN(C(C)C)C(C)C)c1ccccc1,G04BD11,0.0,0.0,0.0,0.0,0.0,1.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT00537199,NCT00537199_EG000,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 3,1,"Inclusion Criteria:

High risk of oral cancer as defined by a twenty-pack/year cigarette smoking history or equivalent and is either a current smoker or has quit smoking within the last 24 months. Twenty-pack/year equivalent is defined as ½ pack/day for 40 years, or one pack/day for 20 years, or 2 packs/day for 10 years, or 4 packs/day for 5 years. AND/OR;
Ten-year history of twenty orally-consumed alcohol units/week and is either a current drinker or has quit drinking within the last 24 months. Twenty orally-consumed alcohol units/week is defined as the equivalent of twenty - 1 ounce shots of whisky or spirits/week (20 ounces = 600 mL), or twenty - 3 ounce glasses of wine/week (60 ounces = 1800 mL), or twenty - 12 ounce glasses of beer/week (240 ounces = 7200 mL);
Male or female, at least 45 years of age;
Written informed consent.
Females of childbearing potential may be enrolled following a negative urine pregnancy test performed at the SE visit. Abstinence will be considered an acceptable form of birth control.

Exclusion Criteria:

History of oral cancer, surgery or biopsy for suspected oral neoplasm;
History of recent oral surgery, periodontal treatment, or oral trauma (<14 days) or current orthodonture (e.g., braces);
Known hypersensitivity to study drug or its analogs;
Active and uncontrolled infection or any other severe concurrent disease that in the judgment of the investigator would make the patient inappropriate for entry into this study;
Psychiatric disorders which would interfere with informed consent or follow-up;
Use of any investigational agent within previous 30 days;
Female that is lactating or demonstrating positive pregnancy test;
Patients in whom betel nut use/abuse has been reported within the past 5 years;
Patients currently taking medication containing prohibited dyes.","Visual oral exam, followed by OraTest Rinse Staining Procedure",ChEMBL:CHEMBL1445 | DrugBank:DB01185 | PubChem:6446,Fluoxymesterone,[H][C@@]12CC[C@](C)(O)[C@@]1(C)C[C@H](O)[C@@]1(F)[C@@]2([H])CCC2=CC(=O)CC[C@@]21C,G03BA01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00538980,NCT00538980_EG000,No,All,Adult | Older Adult,Phase 2,10,"Inclusion Criteria:

Patients must be >= 18 years old
Performance Status (ECOG) 0-3
Previous therapies limited to interferon-alpha, hydroxyurea, anagrelide, and imatinib
Patients may have documented resistance or intolerance to interferon-alpha, imatinib, hydroxyurea, or anagrelide, but must have been demonstrated to be phlebotomy dependent requiring 6 or more phlebotomies per year to maintain the target HCT.
Patients may have newly diagnosed PV.
Patients may have had inadequate phlebotomy control on hydroxyurea or imatinib.

Adequate Organ Function

Total bilirubin < 2.0 times the institutional Upper Limit of Normal (ULN)
Hepatic enzymes (AST, ALT ) ≤ 2.5 times the institutional ULN
Serum Na, K+, Mg2+, Phosphate and Ca2+³ Lower Limit of Normal (LLN)
Serum Creatinine < 1.5 time the institutional ULN
Hemoglobin, Neutrophil count, Platelets, PT, PTT all Grade 0-1
Ability to take oral medication: dasatinib tablets may be swallowed whole, or may be ingested as a solution. Dasatinib tablets can be dissolved in juice, and can then be administered through a nasogastric tube.

Women of childbearing potential (WOCBP) must have:

A negative serum or urine pregnancy test within 72 hours prior to the start of study drug administration
Persons of reproductive potential must agree to use an adequate method of contraception throughout treatment and for at least 4 weeks after study drug is stopped.
Signed written informed consent including HIPAA according to institutional guidelines

Exclusion Criteria:

Patients receiving busulfan within six weeks of Study Day 1.
Patients receiving treatment with interferon-alpha within 4 weeks of Study Day 1.
Patients receiving treatment with imatinib within 14 days of Study, Day 1.
Patients with Grade 3 or 4 cardiac problems as defined by the New York Heart Association Criteria.
Patients with a history of non-compliance to medical regimens or who are considered potentially unreliable.
A malignancy [other than the one treated in this study], which required radiotherapy or systemic treatment within the past 5 years.

Concurrent medical condition which may increase the risk of toxicity, including:

Pleural or pericardial effusion of any grade
Clinically-significant coagulation or platelet function disorder (e.g. known von Willebrand's disease)

Cardiac Symptoms, consider the following:

Uncontrolled angina, congestive heart failure or MI within (6 months)
Diagnosed congenital long QT syndrome
Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de pointes)
Prolonged QTc interval on pre-entry electrocardiogram (> 450 msec)
Subjects with hypokalemia or hypomagnesemia if it cannot be corrected

History of significant bleeding disorder unrelated to cancer, including:

Diagnosed congenital bleeding disorders (e.g., von Willebrand's disease)
Diagnosed acquired bleeding disorder within one year (e.g., acquired anti-factor VIII antibodies)
Ongoing or recent (≤ 3 months) significant gastrointestinal bleeding

Concomitant Medications, consider the following prohibitions:

Drugs that are generally expected to have a risk of causing Torsades de Pointes including: (Patients must discontinue drug 7 days prior to starting dasatinib)
The concomitant use of H2 blockers or proton pump inhibitors with dasatinib is not recommended. The use of antacids should be considered in place of H2 blockers or proton pump inhibitors in patients receiving dasatinib therapy.
Patient agrees to discontinue St. Johns Wort while receiving dasatinib therapy
Patient agrees that IV bisphosphonates will be withheld for the first 8 weeks of dasatinib therapy due to risk of hypocalcemia.
Patient may not be receiving any prohibited CYP3A4 inhibitors

Women:

Unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 4 weeks after cessation of study drug, or
Have a positive pregnancy test at baseline, or
Are pregnant or breastfeeding","Patients will receive a once-daily oral administration of dasatinib at a dose of 100 mg QD (two 50 mg tablets taken together each day) for the duration of the study with the modifications as indicated. If the platelet count remains above 600,000/microL or the spleen remains enlarged in the absence of leukopenia or other side effects, the dose of dasatinib may be escalated to 120 mg QD (two 50 mg tablets plus one 20 mg tablet taken together each day).

Dasatinib: Patients will receive a once-daily oral administration of dasatinib at a dose of 100 mg QD (two 50 mg tablets taken together each day) for the duration of the study with the modifications as indicated. If the platelet count remains above 600,000/microL or the spleen remains enlarged in the absence of leukopenia or other side effects, the dose of dasatinib may be escalated to 120 mg QD (two 50 mg tablets plus one 20 mg tablet taken together each day).",ChEMBL:CHEMBL1421 | DrugBank:DB01254 | PubChem:3062316,Dasatinib,Cc1nc(Nc2ncc(C(=O)Nc3c(C)cccc3Cl)s2)cc(N2CCN(CCO)CC2)n1,L01EA02 | L01XE06,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT00539526,NCT00539526_EG002,No,All,Adult | Older Adult,Phase 4,38,"Inclusion Criteria:

Diagnosis of open-angle glaucoma (pseudoexfoliative or pigmentary glaucomas are allowed) or ocular hypertension

Exclusion Criteria:

Known contraindication to latanoprost, bimatoprost or travoprost
Uncontrolled systemic disease
Active ocular disease other than glaucoma or ocular hypertension
Pregnant or lactating women or women of childbearing potential NOT utilizing a medically acceptable form of birth control",latanoprost 0.005%,ChEMBL:CHEMBL1051 | DrugBank:DB00654 | PubChem:5311221,Latanoprost,CC(C)OC(=O)CCC/C=C\C[C@@H]1[C@@H](CC[C@@H](O)CCc2ccccc2)[C@H](O)C[C@@H]1O,S01EE01 | S01EE51,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00540124,NCT00540124_EG001,No,Male,Adult | Older Adult,Phase 2,51,"Inclusion Criteria:

Have Benign Prostatic Hyperplasia - Lower Urinary Tract Symptoms (BPH-LUTS) for at least 6 months prior to Visit 1.
Agree not to use any other approved or experimental treatments for erectile dysfunction or BPH-LUTS during the study.
Have not taken Finasteride therapy for at least 3 months prior to Visit 2.
Have not taken Dutasteride therapy for at least 6 months prior to Visit 2.
Have an International Prostate Symptom Score (IPSS) total score greater than or equal to 13 at Visit 2.

Exclusion Criteria:

Prostate Specific Antigen (PSA) greater than 10.0 nanograms per milliliter (ng/mL) at Visit 1.
Bladder Post Void Residual (PVR) greater than or equal to 300 mL by ultrasound at Visit 1.
History of pelvic surgery, prostatectomy, radiotherapy, penile implant surgery, lower urinary tract malignancy or trauma.
Urinary tract infection or inflammation or current antibiotic therapy for urinary tract infection at Visit 1.
Glycosylated hemoglobin (HbA1c) greater than 9% at Visit 1.",5 mg by mouth once a day,ChEMBL:CHEMBL779 | DrugBank:DB00820 | PubChem:110635,Tadalafil,[H][C@]12Cc3c([nH]c4ccccc34)[C@@H](c3ccc4c(c3)OCO4)N1C(=O)CN(C)C2=O,C02KX52 | C02KX54 | G04BE08 | G04CA54 | G04CB51,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00540449,NCT00540449_EG001,No,All,Adult | Older Adult,Phase 3,344,"Inclusion Criteria:

Patient with documented HIV-1 infection
Patient has never been treated with a therapeutic HIV vaccine or an ARV drug prior to screening
Patient's HIV-1 plasma viral load at screening is > 5,000 HIV-1 RNA copies/mL (assayed by RNA PCR standard specimen procedure)
Patient's virus is sensitive to TDF and FTC
Patient agrees not to start ART (antiretroviral treatment) before the baseline visit

Exclusion Criteria:

Previous use of ANY ARV drug for ANY length of time
Any documented evidence of NNRTI resistance associated mutations in patient's HIV
Category C AIDS defining illness, except: stable Kaposi Sarcoma, wasting syndrome if not progressive
Pneumocystis carinii pneumonia (PCP) that is considered not cured
Active TB
Allergy or hypersensitivity to study or background ARTs
Specific grade 3 or 4 toxicity
Kidney impairment: calculated creatinine clearance <50 ml/min",600 mg once daily for 96 weeks.,ChEMBL:CHEMBL223228 | DrugBank:DB00625 | PubChem:64139,Efavirenz,O=C1Nc2ccc(Cl)cc2[C@@](C#CC2CC2)(C(F)(F)F)O1,J05AG03 | J05AR06 | J05AR11,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0
NCT00541242,NCT00541242_EG001,No,All,Adult | Older Adult,Phase 4,586,"Inclusion Criteria:

Ocular hypertension or chronic glaucoma
Patient requires IOP-lowering therapy in both eyes

Exclusion Criteria:

Uncontrolled medical conditions
Hypersensitivity to study medications",Latanoprost 0.005% eye drops,ChEMBL:CHEMBL1051 | DrugBank:DB00654 | PubChem:5311221,Latanoprost,CC(C)OC(=O)CCC/C=C\C[C@@H]1[C@@H](CC[C@@H](O)CCc2ccccc2)[C@H](O)C[C@@H]1O,S01EE01 | S01EE51,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00543309,NCT00543309_EG001,No,All,Child | Adult | Older Adult,Phase 2,36,"Inclusion Criteria:

Patients undergoing an elective, primary Fontan operation at Children's Hospital Boston.

Exclusion Criteria:

Revision surgery for failing Fontan circulation.
Preoperative serum creatinine > 1.5 mg/dL or chronic dialysis.
The attending surgeon, cardiac anesthesiologist, or cardiac intensivist has a compelling indication to initiate either nesiritide or milrinone outside of the confines of the study.","Patients assigned to the milrinone group will receive a bolus of 50 mcg/kg followed by an infusion of 0.5 mcg/kg/min, administered for at least 12 hours after CICU admission and up to five days unless prespecified lack of efficacy criteria are met.

milrinone: Milrinone 50 mcg/kg bolus on CPB, the infusion of 0.5 mcg/kg/min. Infusion rate may be adjusted",ChEMBL:CHEMBL189 | DrugBank:DB00235 | PubChem:4197,Milrinone,Cc1[nH]c(=O)c(C#N)cc1-c1ccncc1,C01CE02,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00544713,NCT00544713_EG001,Accepts Healthy Volunteers,All,Adult | Older Adult,Not Applicable,114,"Inclusion Criteria:

Candidate for bilateral LASIK surgery for myopia correction in the range of -1.00 to -8.00 diopters

Exclusion Criteria:

Dry eye signs and symptoms
Preoperative soft or rigid contact lens wear within last 7 or 30 days, respectively
Pregnancy or planning pregnancy
Uncontrolled systemic disease
Use of systemic medications affecting dry eye",Carboxymethylcellulose based artificial tear,PubChem:24748,7H,CC(=O)O.O=CC(O)C(O)C(O)C(O)CO,,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00545051,NCT00545051_EG000,No,Female,Adult | Older Adult,Phase 4,70,"Inclusion Criteria:

post-menopausal women, 50-85 years of age;
any inflammatory rheumatoid disease including polymyalgia rheumatica;
receiving treatment with 5-15 mg/day of prednisolone.

Exclusion Criteria:

previous treatment with an iv bisphosphonate at any time;
previous treatment with an oral bisphosphonate within the last 6 months, >1 month of treatment within last year, or >3 months of treatment within last 2 years;
treatment with parathyroid hormone in last 2 years;
inability to stand or sit in an upright position for at least 60 minutes;
inability to swallow a tablet whole;
history of major gastrointestinal disease.",Participants received 150 mg ibandronate tablet orally once a month for 12 months. Participants also received 1000 mg calcium and 800 IU Vitamin D per day.,ChEMBL:CHEMBL997 | DrugBank:DB00710 | PubChem:60852,Ibandronate,CCCCCN(C)CCC(O)(P(=O)(O)O)P(=O)(O)O,M05BA06 | M05BB09,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00545363,NCT00545363_EG001,No,Female,Adult | Older Adult,Phase 4,357,"Inclusion Criteria:

ambulatory, post-menopausal women with osteoporosis;
eligible for bisphosphonate treatment;
naïve to bisphosphonate therapy, or lapsed users (last bisphosphonate intake greater than or equal to [>=] 6 months ago).

Exclusion Criteria:

inability to stand or sit upright for at least 60 minutes;
inability to swallow a tablet whole;
hypersensitivity to bisphosphonates;
treatment with drugs, or presence of active disease, known to influence bone metabolism;
history of upper gastrointestinal disease.","Postmenopausal women received ibandronate 150 mg QM orally for 6 months. Participants were supported by PRP, carried out by supplying alarm devices, specifically designed to support the participant's regular drug intake.",ChEMBL:CHEMBL997 | DrugBank:DB00710 | PubChem:60852,Ibandronate,CCCCCN(C)CCC(O)(P(=O)(O)O)P(=O)(O)O,M05BA06 | M05BB09,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00545779,NCT00545779_EG000,No,Female,Child | Adult | Older Adult,Phase 3,640,"Inclusion Criteria:

post-menopausal women;
>=3 months daily or weekly alendronate or risedronate for treatment or prevention of post-menopausal osteoporosis.

Exclusion Criteria:

inability to stand or sit in an upright position for at least 60 minutes;
hypersensitivity to bisphosphonates;
treatment with other drugs affecting bone metabolism;
abnormalities of the oesophagus, which delay oesophageal emptying.",Participants completed Candidate Identification Questionnaire (CIQ) in Part A and received Ibandronate 150 milligram (mg) tablet orally once-monthly up to 6 months in Part B of the study.,ChEMBL:CHEMBL997 | DrugBank:DB00710 | PubChem:60852,Ibandronate,CCCCCN(C)CCC(O)(P(=O)(O)O)P(=O)(O)O,M05BA06 | M05BB09,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00546637,NCT00546637_EG000,No,Male,Adult | Older Adult,Phase 3,471,"Inclusion Criteria:

Men aged 40 years and above.
On a stable and well-tolerated dose of an alpha-blocker prescribed for LUTS for at least 6 weeks prior to screening (Visit 1).
Persistent symptoms of OAB with urinary frequency >=8 times/24 hours and micturition-related urgency episodes >=3 episode/24 hours.

Exclusion Criteria:

Contraindication to fesoterodine (antimuscarinics).
Previous history of acute urinary retention requiring catheterization or severe voiding difficulties in the judgment of the investigator, prior to baseline.
Unable to follow the study procedures, including completion of self-administered bladder diary and patient reported outcome questionnaires.","Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.",ChEMBL:CHEMBL1201764 | DrugBank:DB06702 | PubChem:6918558,Fesoterodine,CC(C)C(=O)Oc1ccc(CO)cc1[C@H](CCN(C(C)C)C(C)C)c1ccccc1,G04BD11,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00546728,NCT00546728_EG001,No,All,Adult | Older Adult,Phase 4,50,"Inclusion Criteria:

Greater than or equal to 18 years old
Impaired glucose tolerance: 2-hr oral glucose tolerance test (OGTT) plasma glucose >140 mg/dL OR impaired fasting glucose: fasting glucose > or = 100 mg/dL OR elevated glycosylated hemoglobin: Hemoglobin A1c > or = 5.7%
Abdominal obesity: waist circumference >102 cm (men) and >88 cm (women)
Stable cardiovascular medication regimen (or other medications known to affect endothelial function) at least 1 month prior to enrollment and throughout the study

Exclusion Criteria:

Type 2 diabetes
Current use of glycemic control medications within one month of randomization
Fasting glucose >126 mg/dL
Current use of weight loss medication
Previous weight loss surgery
History of severe gastrointestinal disease
Standard clinical contraindications to exenatide or metformin therapy
Unstable angina
Heart failure
Stroke or coronary artery bypass graft within 3 months of screening
Women who are currently pregnant or planning to become pregnant
Breastfeeding women
Clinically significant liver disease
Creatinine > 1.5 mg/dL
Hepatic function greater than 3 times upper limit of normal
Patients who are mentally incompetent and cannot sign a Patient Informed Consent","Three months of Metformin therapy. Metformin was initiated at 500 mcg, twice a day for one month and then up titrated to 1000 mcg, twice a day for the remaining two months.",ChEMBL:CHEMBL1431 | DrugBank:DB00331 | PubChem:4091,Metformin,CN(C)C(=N)NC(=N)N,A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00552422,NCT00552422_EG000,No,All,Adult | Older Adult,Not Applicable,6,"Inclusion Criteria:

gastroparesis or gastroesophageal reflux that is refractory to standard therapy.
signed informed consent

Exclusion Criteria:

serious cardiac arrhythmias
clinically significant bradycardia, sinus node dysfunction, or heart block.
prolonged QTc
clinically significant electrolyte disorders.
gastrointestinal hemorrhage or obstruction.
prolactinoma
pregnant or breast feeding female
known allergy to domperidone.",Participants ranged from 18-65 years of age. Gender composition was 60$% female and 40% male.,ChEMBL:CHEMBL219916 | DrugBank:DB01184 | PubChem:153420471 | PubChem:3151,Domperidone,O=c1[nH]c2ccccc2n1CCCN1CCC(n2c(=O)[nH]c3cc(Cl)ccc32)CC1,A03FA03,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00552669,NCT00552669_EG000,No,All,Adult | Older Adult,Phase 4,100,"Inclusion Criteria:

Indication of revascularization
De novo lesions
Native vessels
Suitable for stent placement

Exclusion Criteria:

Acute myocardial infarction within the last 24 hours
In stent restenosis
Previous percutaneous coronary intervention within the last 6 months",Oral sirolimus plus bare metal stent implantation,ChEMBL:CHEMBL413 | DrugBank:DB00877 | PubChem:134760597 | PubChem:138404388 | PubChem:21944094 | PubChem:5284616,Sirolimus,COC1CC2CCC(C)C(O)(O2)C(=O)C(=O)N2CCCCC2C(=O)OC(C(C)CC2CCC(O)C(OC)C2)CC(=O)C(C)C=C(C)C(O)C(OC)C(=O)C(C)CC(C)C=CC=CC=C1C,L01EG04 | L04AA10 | S01XA23,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00555061,NCT00555061_EG000,No,All,Child,Phase 4,86,"Inclusion criteria:

Subject Age: The subject is ≥2 months to ≤24 months of age at study entry
Subject Diagnosis: The subject has a diagnosis of secondarily-infected traumatic lesion (SITL), secondarily-infected dermatoses (SID), or primary impetigo (bullous or non-bullous) that is suitable for treatment with topical antibacterial therapy:

The subject has a small laceration, sutured wound or abrasion, which has a secondary bacterial infection. The infected portion of the laceration or sutured wound should not exceed 10cm in length with surrounding erythema not extending more than 2cm from the edge of the wound. Abrasions should not exceed 2% of the total body surface area with surrounding erythema not extending more than 2cm from the edge of the abrasion.

The subject has a diagnosis of inflammatory skin disease (i.e., dermatosis), such as atopic dermatitis or contact dermatitis, which has a secondary bacterial infection. The infected portion of the lesion(s) should not exceed 2% of the total body surface area.

Impetigo: The subject has a lesion or group of £10 discrete localized lesions on otherwise healthy skin, characterized by red spots or blisters without crusts which later progress to lesions which ooze and form yellow or honey-colored crusts surrounded by an erythematous margin.

Subject SIRS Score: The subject has a total SIRS score of at least 8 (Appendix 1 Skin Infection Rating Scale)
Protocol Compliance: The parent/legal guardian is willing to comply with the protocol
Informed Consent: The parent/legal guardian has given written informed, dated consent for the subject to participate in the study
French Subjects: In France, a subject will be eligible for inclusion in this study if either affiliated to or a beneficiary of a social security category

Exclusion criteria:

The subject has demonstrated a previous hypersensitivity reaction to pleuromutilin or any component of the ointment (refer to the Investigator Brochure for composition of Retapamulin ointment, 1%)
The subject was considered to be premature at birth (<37 weeks gestation)
The subject has a secondarily-infected animal/human bite, or a puncture wound
The subject has an abscess
The subject has a chronic ulcerative lesion that is unlikely to have Staphylococcus aureus or Streptococcus pyogenes as the causative agent
The subject has systemic signs and symptoms of infection (such as fever; defined as a temperature equivalent to a rectal temperature greater than 101°F or 38.3°C)
The subject has a bacterial skin infection which, due to area, depth or severity, in the opinion of the investigator, cannot be appropriately treated by a topical antibiotic
The subject has more than one type of infected lesion as defined in the protocol
The subject requires surgical intervention for treatment of the infection prior to enrollment in the study, or is likely to require such intervention during the course of the study
The subject has applied any topical therapeutic agent (including glucocorticoid steroids, antibacterials or antifungals) directly to the infected wound/lesion, within 24 hours prior to study entry
The subject has received one or more days of treatment with a systemic antibacterial within 72 hours of study entry
The subject is receiving systemic corticosteroids at a dose of >0.125mg/kg per day of prednisone (or the equivalent)
The subject has a known, pre-existing, serious underlying disease that could be imminently life-threatening
The subject has participated in any study using an investigational drug during the previous 30 days prior to entering the study
The subject has been previously enrolled in this study or in any other study involving Retapamulin","Retapamulin ointment, 1%, administered twice daily for 5 consecutive days",ChEMBL:CHEMBL1534 | DrugBank:DB00140 | PubChem:493570,Riboflavin,Cc1cc2nc3c(=O)[nH]c(=O)nc-3n(C[C@H](O)[C@H](O)[C@H](O)CO)c2cc1C,A11HA04 | S01XA26,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00562718,NCT00562718_EG000,No,Female,Adult | Older Adult,Phase 2,39,"DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed invasive adenocarcinoma of the breast, meeting 1 of the following high-risk criteria:

T3 or T4 primary tumor
4 or more involved axillary lymph nodes (N2 nodal stage)

Completed surgical excision

No immediate reconstruction with autologous flap reconstruction

Patients having tissue expanders or implants placed prior to radiation may be enrolled at the physician's discretion

No residual breast cancer

Microscopically positive margins are allowed if a re-excision is not felt to be clinically justified

Candidate for radiotherapy

Must not require bilateral radiotherapy
No metastatic (stage IV) breast cancer by AJCC staging criteria
Hormone receptor status not specified
No CNS disorders

PATIENT CHARACTERISTICS:

Life expectancy ≥ 6 months
Karnofsky performance status 70-100%
Menopausal status not specified
Ambulatory
Hemoglobin > 9 g/dL
Platelet count > 100,000/mm³
ANC > 1,500/mm³
Serum AST, ALT, and alkaline phosphatase ≤ 2 times upper limit of normal (ULN)
Total bilirubin normal
Creatinine clearance > 50 mL/min
Negative pregnancy test
Not pregnant or nursing
Fertile patients must use effective contraception during study and for 30 days after the last study drug administration
No serious, uncontrolled, concurrent infection(s)
No diabetes with current or history of delayed wound healing or skin ulcers
No autoimmune connective tissue disorder
No prior unanticipated severe reaction to fluoropyrimidine therapy, known sensitivity to 5-fluorouracil, or known dihydropyrimidine dehydrogenase (DPD) deficiency
No other carcinomas within the last five years except cured non-melanoma skin cancer and in-situ cervical cancer
No clinically significant cardiac disease (e.g., congestive heart failure, symptomatic coronary artery disease, or cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 12 months

No other serious uncontrolled medical conditions that the investigator feels might compromise study participation, including any of the following:

Uncontrolled seizures
Psychiatric disability judged by the investigator to be clinically significant
Physically intact upper gastrointestinal tract
No malabsorption syndrome
No uncompensated coagulopathy
No patients whose breast size or body contour puts them at increased risk for skin desquamation from standard radiotherapy
Able to read and speak English

PRIOR CONCURRENT THERAPY:

Fully recovered from surgery and chemotherapy with completely healed surgical wounds

At least 4 weeks since completion of prior chemotherapy regimen, excluding trastuzumab (Herceptin®)

Concurrent trastuzumab allowed at the physician's discretion
More than 4 weeks since prior participation in any investigational drug study
At least 4 weeks since prior and no concurrent sorivudine or brivudine
More than 2 weeks since prior major surgery
No prior capecitabine
No prior radiotherapy to the chest or ipsilateral lymphatics
No concurrent hormonal therapy during course of chemotherapy or radiation therapy
No concurrent allopurinol or cimetidine
Concurrent coumadin is allowed","Eligible patients had undergone surgery and chemotherapy for high risk breast cancer, defined as either a T3 or T4 primary tumor, or N2 by either clinical or pathological criteria.

capecitabine

adjuvant therapy

radiation therapy",ChEMBL:CHEMBL1773 | DrugBank:DB01101 | PubChem:42066809 | PubChem:60953,Capecitabine,CCCCCOC(=O)Nc1nc(=O)n([C@@H]2O[C@H](C)[C@@H](O)[C@H]2O)cc1F,L01BC06,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00564486,NCT00564486_EG002,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 3,43,"Inclusion Criteria:

Provide written Informed Consent prior to participation in the Study
Is scheduled to undergo abdominal laparoscopic surgery under general anesthesia (laparoscopic bariatric procedures, including gastric bypass or gastric banding, laparoscopic exploratory procedures in which no visceral dissection is performed, and laparoscopic procedures with minimal visceral dissection, such as laparoscopic sterilization,are excluded)
If Subject is a female of childbearing potential, have a negative pregnancy test within 21 days of surgery
Be at least 18, but not more than 80 years of age
Have a Body Mass Index (BMI) ≥ 19 and ≤ 40 lb/in2
Have an American Society of Anesthesiologist (ASA) risk class of I, II, or III
Have the ability to read and understand the Study procedures and the use of the pain scales and have the ability to communicate meaningfully with the Study Investigator and staff
Be free of other physical, mental, or medical conditions which, in the opinion of the Investigator, makes Study participation inadvisable

Exclusion Criteria:

Used opioids or tramadol daily for greater than 7 days prior to Study Medication administration (Subjects who, in the Investigator's opinion have or are developing opioid tolerance are to be excluded)
Has been treated with Chapparal, Comfrey, Germander, Gin Bu Huan, Kava, Pennyroyal, Skullcap, St. John's Wort, or Valerian within 14 days prior to surgery
Has significant medical disease(s), laboratory abnormalities or condition(s) that in the Investigator's judgment could compromise the Subject's welfare, ability to communicate with the Study staff, complete Study activities, or would otherwise contraindicate Study participation
Has known hypersensitivity to opioids, acetaminophen, or the inactive ingredients (excipients) of the Study Medication
Has known or suspected history of alcohol or drug abuse or dependence within the previous 2 years
Has impaired liver function, e.g., aspartate aminotransferase (AST)/Alanine transaminase (ALT)/bilirubin greater than or equal to 3.0 times the upper limit of normal, active hepatic disease, evidence of clinically significant liver disease, or other condition (e.g., alcoholism, cirrhosis, or hepatitis) that may suggest the potential for an increased susceptibility to hepatic toxicity with Study Medication exposure
Has been treated with monoamine oxidase inhibitors (MAOIs) within 7 days prior to surgery
Has participated in another clinical Study (investigational or marketed product) within 30 days of surgery

Post Operative Exclusion Criteria

The Subject must not meet any of the following criteria prior to randomization to Study Medication:

Had any other surgery than the planned laparoscopic surgery or had intra operative or post operative complications which in the view of the Investigator would make Study participation inadvisable
Has taken non steroidal anti-inflammatory drugs (NSAIDs), steroids or MAOIs during the day after surgery. Exceptions: The use of low-dose aspirin, e.g, 81 mg/day, for cardioprophylaxis, and limited use of topical or inhaled steroids are acceptable.
Had any neuraxial (spinal or epidural) opioid injected perioperatively
Had a local anesthetic injection (including into surgical wound at closure) or continuous infusion by any route
Had an epidural, regional, or percutaneous (intrawound) catheter with continuous local anesthetic infusion used for postoperative analgesic management
Had a fever (greater than 38.6 ºC or 101.5 ºF) requiring treatment

Post Operative Day 1 Randomization Criterion On the morning of the first post operative day (POD1), the Subject must have a categorical pain intensity score at rest of moderate or severe and a score ≥ 40 mm and ≤ 70 mm at rest on a 100 mm Visual Analogue Scale (VAS)",IV Acetaminophen 650 mg dosed every every 4 hours for 24 hours (6 doses total).,ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT00564876,NCT00564876_EG000,No,All,Adult | Older Adult,Phase 2,2,"Inclusion Criteria:

Suspected or histological/cytological diagnosis of Non-Small Cell Lung Cancer (NSCLC), Stage IB (≥4 cm per CT) or Stage IIA or IIB, amenable to surgical resection
Must be deemed a surgical candidate
Tumors ≥2 cm in maximum diameter without radiographic, bronchoscopic or pathologic evidence of nodal metastases are eligible for biopsy
Fresh tissue biopsy material must be available for genomics analysis prior to initiating dasatinib therapy
Age ≥18 years
Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
No prior chemotherapy, immunotherapy, radiation therapy or biologic/targeted therapy for any malignancy

Adequate Organ Function:

Total bilirubin <institutional upper limit normal (ULN)
Hepatic enzymes (AST, ALT) ≤2.5x institutional ULN
Serum creatinine <1.5x institutional ULN
Hemoglobin ≥9 gm/dL
Neutrophil count (ANC or AGC) ≥1500 per μL
Platelets ≥100,000 per μL
Prothrombin time (PT)/a partial thromboplastin time (PTT) ≤1.5x control
No other serious medical or psychiatric illness
Ability to take oral medication (dasatinib must be swallowed whole)
Women of childbearing potential (WOCBP) must have a negative serum pregnancy test preferably within 72 hours and no later than 7 days, prior to the start of study drug administration
Both sexually active males and females of reproductive potential must agree to use an adequate method of contraception throughout treatment and for at least 4 weeks after study drug is stopped
Signed written informed consent including Health Insurance Portability and Accountability Act (HIPAA) according to institutional guidelines

Exclusion Criteria:

Previous or concomitant malignancy in the past 2 years other than curatively treated carcinoma in situ of the cervix, basal cell or squamous cell carcinoma of the skin
Prior dasatinib therapy
Evidence of pleural or pericardial effusion of any grade

Cardiac Symptoms:

Uncontrolled angina, congestive heart failure (CHF), or myocardial infarction (MI) within 6 months
Diagnosed congenital long QT syndrome
Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de Pointes)
Prolonged QT corrected (QTc) interval on pre-entry EKG (>450 msec)
Uncontrolled hypertension defined as >160/90 on a regimen of antihypertensive therapy
Subjects with hypokalemia or hypomagnesaemia if it cannot be corrected
History of diagnosed congenital acquired bleeding disorders (e.g., von Willebrand's disease)
Ongoing or recent (≤3 months) significant (≥grade 3) gastrointestinal bleeding

Concomitant Medications:

Drugs that are generally accepted to have a risk of causing Torsades de Pointes including: (Patients must discontinue drug 7 days prior to starting dasatinib)

**quinidine, procainamide, disopyramide, amiodarone, sotalol, ibutilide, dofetilide, erythromycin, clarithromycin, chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide, cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone, halofantrine, levomethadyl, pentamidine, sparfloxacin, lidoflazine

Current therapeutic dose heparin or coumadin therapy
St. John's Wort and all herbal supplements must be stopped while on dasatinib
IV bisphosphonates will be withheld for 2 weeks prior and 6 weeks after dasatinib administration due to risk of hypocalcaemia
Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious) illness
Pregnant or breastfeeding
Active or uncontrolled infection requiring intravenous antibiotics
Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of dasatinib (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)
Patients who have received investigational drugs ≤4 weeks prior to starting study drug and/or who have not recovered from side effects of such therapy",Neoadjuvant dasatinib is to be administered as an oral dose of 70 mg PO twice daily on a continuous basis for 3 weeks prior to surgery. Patients will begin adjuvant dasatinib (70 mg PO twice daily) between 4-6 weeks after standard adjuvant therapy is complete or 4-8 weeks after surgery for those patients that do not receive adjuvant chemotherapy. Adjuvant dasatinib will be given on a continuous basis for up to 3 months after adjuvant chemotherapy or after surgery if no adjuvant chemotherapy is given.,ChEMBL:CHEMBL1421 | DrugBank:DB01254 | PubChem:3062316,Dasatinib,Cc1nc(Nc2ncc(C(=O)Nc3c(C)cccc3Cl)s2)cc(N2CCN(CCO)CC2)n1,L01EA02 | L01XE06,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00567229,NCT00567229_EG000,No,All,Adult | Older Adult,Phase 2,3,"DISEASE CHARACTERISTICS:

Histologically confirmed CD20+ multiple myeloma

CD20+ disease defined as co-expression of CD20 on ≥ 25% of the clonal plasma cell population as defined by immunohistochemical or flow cytometric staining of a bone marrow or plasmacytoma specimen obtained at study entry

For flow cytometry, this is determined by calculating the frequency of CD20+ CD138+ double-positive cells within the total CD138+ plasma cell population
For immunohistochemistry, this is determined by dual staining for CD20 and the involved clonal light chain (kappa or lambda), with a determination of the percent double-positive (≤ 25% or ≥ 25%)
Symptomatic multiple myeloma that has relapsed or progressed after at least 1 prior anti-myeloma therapeutic regimen

PATIENT CHARACTERISTICS:

ECOG performance status 0-2
Life expectancy > 16 weeks (4 months)
ANC ≥ 1,500/μL (unless low ANC due to multiple myeloma)
Platelets ≥ 100,000/μL (unless low platelets are due to multiple myeloma)
Serum bilirubin ≤ 2.0 mg/dL
AST, ALT, and alkaline phosphatase < 3 times upper limit of normal
Serum creatinine ≤ 2.5 mg/dL
Able to understand the investigational nature of lenalidomide and rituximab combination therapy and to give informed consent
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective double-method contraception at least 28 days before, during, and for at least 28 days after completion or discontinuation of study treatment
Able to take acetylsalicylic acid (ASA) (325 mg) daily as prophylactic anticoagulation (patients intolerant to ASA may use warfarin or low molecular weight heparin)
Prior malignancies with a disease free interval of ≥ 5 years allowed
No history of thromboembolic disease within the past 6 months, regardless of anticoagulation
No myocardial infarction within the past 6 months
No New York Hospital Association class III or IV heart failure
No uncontrolled angina
No severe uncontrolled ventricular arrhythmias
No active hepatitis B or C infection
No HIV 1or 2 positivity
No acute ischemia or active conduction system abnormalities as evidenced by ECG
No history of hypersensitivity reactions to lenalidomide, thalidomide, or rituximab
No other medical condition or laboratory evaluation that, in the treating physician's or principal investigators' opinion, makes the patient unsuitable to participate in this clinical trial
No concurrent active malignancy other than nonmelanoma skin cancers or carcinoma-in-situ of the cervix

PRIOR CONCURRENT THERAPY:

At least 3 weeks since prior therapy, including radiotherapy
Prior lenalidomide or thalidomide allowed
No prior rituximab","This study will employ a Simon optimal two-stage design. Patients will receive lenalidomide 25 mg daily for days 1-21 of each 28 day cycle. Rituximab 375 mg/m2 will be given weekly for 4 weeks beginning 1 week after the start of lenalidomide therapy (weeks 2-5), and then once 8 weeks later (week 13). Patients with stable disease or better after 4 cycles (week 16, in the absence of delays for toxicity) will be able to continue on therapy on the same lenalidomide schedule and with rituximab 375 mg/m2 given once every 8 weeks.",ChEMBL:CHEMBL848 | DrugBank:DB00480 | PubChem:216326,Lenalidomide,Nc1cccc2c1CN(C1CCC(=O)NC1=O)C2=O,L04AX04,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT00569868,NCT00569868_EG000,Accepts Healthy Volunteers,All,Adult | Older Adult,Not Applicable,11,"Inclusion Criteria:

Patients with myeloma who had relapsed after one prior treatment and who have demonstrated resistance to their last treatment, who are candidate to receive Velcade and had normal PT and PTT, will be evaluated for inclusion in the present study.

Exclusion Criteria:

Previous history of venous thromboembolism, myocardial infarction, stroke, TIA
Hypercoagulable state (deficit ATIII, Factor V Leiden, deficit protein S, deficit protein C, prothrombin gene mutation), antiphospholipid syndrome.
Von Willebrand disease, inherited platelet abnormalities.
Familiar history of hypercoagulable state.
Anticoagulant therapy, aspirin, non-steroidal anti-inflammatory drugs, beta blockers, tricyclic antidepressant, hormone replacement therapy, BCPs, and all other agents able to interfere with platelet function in the previous two weeks.
Non-secretory MM, unless the patient has measurable lesions on CT, MRI and/or PET.","Velcade IV, 1.3 mg/m2, days 1,4,8, and 11: Treatment on this study will last 2 cycles. Each cycle consists of 3 weeks, or 21 days, then followed every three months for approximately 2 years.",ChEMBL:CHEMBL325041 | DrugBank:DB00188 | PubChem:387447,Bortezomib,CC(C)C[C@H](NC(=O)[C@H](Cc1ccccc1)NC(=O)c1cnccn1)B(O)O,L01XG01 | L01XX32,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00570063,NCT00570063_EG000,No,All,Adult | Older Adult,Phase 2,24,"Inclusion Criteria:

Have a current diagnosis of schizophrenia.
Increase in symptoms over the past 2-4 weeks.
Willing to remain inpatients for the duration of the trial.

Exclusion Criteria:

Evidence or history of clinically significant medical problems.
Females of childbearing potential.
A primary psychiatric diagnosis other than schizophrenia.
A diagnosis of substance abuse or dependence in the last 6 months.","Participants received single dose of PF-02545920 15 mg tablet, orally twice daily (approximately 12 hours apart) from Day 1 to Day 21 and were followed up to Day 31.",ChEMBL:CHEMBL562318 | DrugBank:DB08387 | PubChem:11581936,Mardepodect,Cn1cc(-c2ccncc2)c(-c2ccc(OCc3ccc4ccccc4n3)cc2)n1,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT00572117,NCT00572117_EG000,No,All,Adult | Older Adult,Phase 4,5,"Inclusion Criteria:

Age 18+
Written informed consent.
Meet DSM-IV criteria (by SCID) for alcohol dependence.
Meet DSM-IV criteria (by SCID) for bipolar disorder I or II disorder.
≥ 8 heavy drinking days (defined as ≥ 5 standard drinks per day for men, ≥ 4 standard drinks per day for women) in the prior 4 weeks.
During the baseline visit, patients must be on a stable dose of accepted maintenance treatment for bipolar disorder for the past 4 weeks. If the subject is on more than one agent, at least one agent must be adequately dosed.
Antidepressant treatment is permitted if the dose has been stable for the past 4 weeks.

Exclusion Criteria:

Pregnant women or women of child bearing potential who are not using a medically accepted means of contraception (condom, diaphragm, spermicide, intrauterine device, tubal ligation, or partner with vasectomy). Because of the risk of the lowering of oral contraceptive blood levels with topiramate, women whose sole means of contraception is oral contraceptives or hormonal implants will be asked to use an additional barrier method of birth control during treatment with the study drug.
Women who are lactating.
Age under 18.
Patients who do not have ≥ 8 heavy drinking days in the 4 weeks prior to the baseline visit.
Important alcohol withdrawal symptoms (Clinical Institute Withdrawal Assessment for Alcohol-Revised, CIWA-Ar, score > 15)
Urine toxicological screen positive for amphetamines or cocaine.
Meets DSM-IV criteria for current substance dependence for drugs other than cannabis or nicotine.
Currently meets full DSM-IV criteria for manic, hypomanic, or mixed episode.
Serious suicide or homicide risk, as assessed by evaluating clinician.
Unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease or uncontrolled seizure disorder.
History of nephrolithiasis, or treatment with any drug associated with nephrolithiasis.
Current treatment with zonisamide.
Current treatment with any carbonic anhydrase inhibitors, including acetazolamide, dorzolamide, and methazolamide.
Current treatment with any drug known to decrease drinking.
Subjects who have begun a new psychosocial treatment within 12 weeks of study enrollment. Subjects receiving psychosocial treatment that has been stable for at least 12 weeks prior to study entry, however, will be permitted to enroll in the study.
Any psychotic disorder, including schizoaffective disorder (current or past).
Clinical or laboratory evidence of untreated hypothyroidism.
Patients with a diagnosis or history of glaucoma
Patients requiring excluded medications (see table below for details).
Psychotic features in the current episode or a history of a psychotic disorder, as assessed by SCID.
Past intolerance to topiramate.
Any use of topiramate in the past 12 months.
Any investigational psychotropic drug within the last 3 months.","Half the participants will receive topiramate and half will receive placebo. Neither participants nor study staff will know who is receiving which pills until the end of the study. The pills will be slowly increased over 5 weeks from 25 mg a day to 150 mg twice a day in an effort to minimize side effects that might enable participants and raters to guess whether they are on active drug or placebo. Subjects will continue on 150 mg twice a for Weeks 6-12 of the study.

Topiramate: Medication will be slowly increased over 5 weeks from 25 mg a day to 150 mg twice a day in an effort to minimize side effects that might enable participants and raters to guess whether they are on active drug or placebo. Subjects will continue on 150 mg twice a for Weeks 6-12 of the study.",ChEMBL:CHEMBL220492 | DrugBank:DB00273 | PubChem:5284627,Topiramate,[H][C@@]12OC(C)(C)O[C@]1([H])CO[C@@]1(COS(N)(=O)=O)OC(C)(C)O[C@]12[H],A08AA51 | N03AX11,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00572117,NCT00572117_EG001,No,All,Adult | Older Adult,Phase 4,7,"Inclusion Criteria:

Age 18+
Written informed consent.
Meet DSM-IV criteria (by SCID) for alcohol dependence.
Meet DSM-IV criteria (by SCID) for bipolar disorder I or II disorder.
≥ 8 heavy drinking days (defined as ≥ 5 standard drinks per day for men, ≥ 4 standard drinks per day for women) in the prior 4 weeks.
During the baseline visit, patients must be on a stable dose of accepted maintenance treatment for bipolar disorder for the past 4 weeks. If the subject is on more than one agent, at least one agent must be adequately dosed.
Antidepressant treatment is permitted if the dose has been stable for the past 4 weeks.

Exclusion Criteria:

Pregnant women or women of child bearing potential who are not using a medically accepted means of contraception (condom, diaphragm, spermicide, intrauterine device, tubal ligation, or partner with vasectomy). Because of the risk of the lowering of oral contraceptive blood levels with topiramate, women whose sole means of contraception is oral contraceptives or hormonal implants will be asked to use an additional barrier method of birth control during treatment with the study drug.
Women who are lactating.
Age under 18.
Patients who do not have ≥ 8 heavy drinking days in the 4 weeks prior to the baseline visit.
Important alcohol withdrawal symptoms (Clinical Institute Withdrawal Assessment for Alcohol-Revised, CIWA-Ar, score > 15)
Urine toxicological screen positive for amphetamines or cocaine.
Meets DSM-IV criteria for current substance dependence for drugs other than cannabis or nicotine.
Currently meets full DSM-IV criteria for manic, hypomanic, or mixed episode.
Serious suicide or homicide risk, as assessed by evaluating clinician.
Unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease or uncontrolled seizure disorder.
History of nephrolithiasis, or treatment with any drug associated with nephrolithiasis.
Current treatment with zonisamide.
Current treatment with any carbonic anhydrase inhibitors, including acetazolamide, dorzolamide, and methazolamide.
Current treatment with any drug known to decrease drinking.
Subjects who have begun a new psychosocial treatment within 12 weeks of study enrollment. Subjects receiving psychosocial treatment that has been stable for at least 12 weeks prior to study entry, however, will be permitted to enroll in the study.
Any psychotic disorder, including schizoaffective disorder (current or past).
Clinical or laboratory evidence of untreated hypothyroidism.
Patients with a diagnosis or history of glaucoma
Patients requiring excluded medications (see table below for details).
Psychotic features in the current episode or a history of a psychotic disorder, as assessed by SCID.
Past intolerance to topiramate.
Any use of topiramate in the past 12 months.
Any investigational psychotropic drug within the last 3 months.","Half the participants will receive topiramate and half will receive placebo. Neither participants nor study staff will know who is receiving which pills until the end of the study. Subjects will receive placebo pills identical to the active pills (pills that contain the study drug, topiramate) for the 12 treatment weeks of the study and will have the pills discontinued over the next four weeks of the study. All subjects will be re-evaluated at 26 and 52 weeks.

Topiramate: Medication will be slowly increased over 5 weeks from 25 mg a day to 150 mg twice a day in an effort to minimize side effects that might enable participants and raters to guess whether they are on active drug or placebo. Subjects will continue on 150 mg twice a for Weeks 6-12 of the study.",ChEMBL:CHEMBL220492 | DrugBank:DB00273 | PubChem:5284627,Topiramate,[H][C@@]12OC(C)(C)O[C@]1([H])CO[C@@]1(COS(N)(=O)=O)OC(C)(C)O[C@]12[H],A08AA51 | N03AX11,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00573937,NCT00573937_EG000,No,All,Adult | Older Adult,Phase 2,1,"Inclusion Criteria:

Must have a telephone
Age: patient must be 18 years or older and less than 70 years of age
Life expectancy of 3 months or greater
No prior use of step-3 opioids (step 2 opioids are allowed)
Provision of informed consent
Score of 26 or greater on Mini-Mental Status Exam (MMSE) (to be done by investigator if there is question about mental status)
Nonmalignant pain will be excluded; however, if the patient has both malignant and nonmalignant pain, entry into the trial will be determined by the predominant site of pain
Moderate to severe cancer related pain that requires the use of step-3 opioids
Normal renal function
There will be no exclusionary criteria based on Karnofsky score
Must live no more than 1 hour away from clinic
Patient must have pain severity of 5-7/10 on a 0-10 pain scale

Exclusion Criteria:

Nursing home patients
Obvious cognitive dysfunction
Intractable nausea or vomiting
A true allergy or intolerance to opioids
Unstable renal function
Undergoing therapeutic procedures likely to influence pain during the study period
Gastrointestinal pathology or surgery that influences absorption of morphine or methadone
Must not have had treatment with radiotherapy, chemotherapy or radionuclides in the last 30 days
History of drug seeking behavior
Respiratory compromise
Treatment with bisphosphonates within the last month
Use of MAO inhibitors
Drugs that interfere with CYP34A or CYP2D6
Drugs that interfere with morphine metabolism
Retroviral therapies
Active radiation or antineoplastic therapies
Hepatic dysfunction
As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)
Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study
Study will exclude women who are pregnant and/or nursing
Women who are of child bearing potential must have a negative urine pregnancy test
Patients with a recent substance abuse history will be excluded
Patients with major depression will be excluded","Oral methadone 2.5 mg every 8 hours, and oral methadone 2.5 mg every 4 hours as needed for breakthrough pain.",ChEMBL:CHEMBL350719 | ChEMBL:CHEMBL651 | DrugBank:DB00333 | DrugBank:DB15198 | PubChem:4095 | PubChem:643985,Methadone,CCC(=O)C(CC(C)N(C)C)(c1ccccc1)c1ccccc1,N02AC52 | N07BC02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00574119,NCT00574119_EG000,No,All,Adult | Older Adult,Phase 4,16,"Inclusion Criteria:

18 years or older
Nonischemic dilated cardiomyopathy
Left ventricular ejection fraction 35% or less
Stable heart failure symptoms
Able to undergo both positron emission tomography and magnetic resonance imaging with gadolinium
Able to tolerate treatment with spironolactone

Exclusion Criteria:

Serum potassium >5.0
Serum creatinine >2.5
Contraindications to magnetic resonance imaging such as internal cardioverter-defibrillator.","patients with heart failure due to nonischemic dilated cardiomyopathy will be studied by 11C acetate positron emission tomography and magnetic resonance imaging using vasodilator and gadolinium to judge myocardial blood flow, before and after 6 months' treatment with spironolactone.

spironolactone: spironolactone 50 mg daily for 6 months",ChEMBL:CHEMBL1393 | DrugBank:DB00421 | PubChem:5833,Spironolactone,[H][C@]12CC[C@]3(C)[C@]4(CCC(=O)O4)CC[C@@]3([H])[C@]1([H])[C@]([H])(SC(C)=O)CC1=CC(=O)CC[C@@]12C,C03DA01,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT00576823,NCT00576823_EG000,No,All,Child,Phase 3,12,"Inclusion Criteria:

Children and adolescents of either gender 2 - 16 years of age with a detrusor Leak Point Pressure (LPP) of 40 cm water or greater and with newly diagnosed or progressive hydronephrosis either Society of Fetal Urology (SFU) grade 1, 2 or 3 due to neuropathic bladder dysfunction.

Exclusion Criteria:

Hydronephrosis of non-neuropathic etiology.
Urological surgery in the last 4 months prior to the study.
Urethral dilatation in the last 3 months prior to the baseline urodynamic assessment.
α-blocker therapy in the last 4 weeks prior to the baseline urodynamic assessment.
Detrusor injections of botulinum toxin in the last 6 months.
Urological diseases/conditions other than functional bladder obstruction of neuropathic etiology, that can lead to upper urinary tract dilatation (e.g., bladder anomalies, ureterocele).
History of intolerance to α-blocker therapy.
Orthostatic hypotension.
History of risk factors for Torsade de pointes (e.g., family history of Long QT Syndrome).

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.","Alfuzosin solution, daily dose divided in 3 doses given at breakfast, lunch and dinner to children 2-7 years of age.",ChEMBL:CHEMBL709 | DrugBank:DB00346 | PubChem:2092,Alfuzosin,COc1cc2nc(N(C)CCCNC(=O)C3CCCO3)nc(N)c2cc1OC,G04CA01 | G04CA51,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,1.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT00584402,NCT00584402_EG000,No,All,Adult | Older Adult,Not Applicable,8,"Inclusion Criteria:

Patients with primary hepatocellular carcinoma (HCC) or secondary (metastatic) carcinoma of the liver who have been referred for ultrasound-guided radiofrequency ablation (RFA) treatment
Recent (within 90 days) CT or MRI scan with report of one or more tumors ≤ 1.5 cm in diameter
Patient is stable and is to be managed conservatively (i.e. non-surgically)
18 years of age or older
Ability and willingness to provide written informed consent

Exclusion Criteria:

Known or suspected cardiac shunt(s)
Known sensitivity to octafluoropropane
Pregnant or breastfeeding","Contrast-enhanced sonography

perflutren lipid microspheres : IV in 0.1 cc doses, as needed, to enhance lesion conspicuity",ChEMBL:CHEMBL1663 | DrugBank:DB00556 | PubChem:6432,Perflutren,FC(F)(F)C(F)(F)C(F)(F)F,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00585247,NCT00585247_EG000,No,All,Child | Adult | Older Adult,Not Applicable,27,"Inclusion Criteria:

Diagnosis of Port Wine Stain birthmark
Male and female subjects of any age who are in good health.
Fitzpatrick skin type I-VI

Exclusion Criteria:

Pregnant or lactating
History of cutaneous photosensitivity
History of hypersensitivity to imiquimod 5% cream or any of its components
History of photodermatoses","Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks

Imiquimod: Combining Topical Imiquimod 5% Cream With a Pulsed Dye Laser to Treat Port Wine Stain Birthmarks

Healthy individuals with PWS (n = 24) were treated with PDL and then randomized to apply post treatment Imiquimod 5% cream for 8 weeks for 57 PWS sites (multiple sites per patient)",ChEMBL:CHEMBL1282 | DrugBank:DB00724 | PubChem:57469,Imiquimod,CC(C)Cn1cnc2c(N)nc3ccccc3c21,D06BB10,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00587483,NCT00587483_EG001,No,All,Adult | Older Adult,Not Applicable,342,"Inclusion Criteria:

Patients undergoing cardiac surgery that was expected to include cross-clamping of the aorta

Exclusion Criteria:

Women wishing to become pregnant within 6 months of surgery
Allergy to amiodarone
History of organ dysfunction due to previous amiodarone use
Patients who require more than mild systemic hypothermia (<32 degrees C) during cardiopulmonary bypass
Patients who require more than one bypass run or more than one period of aortic cross-clamping",Subjects randomized to receive Amiodarone 300 mg IV(followed by 150 mg IV if needed) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.,ChEMBL:CHEMBL633 | DrugBank:DB01118 | PubChem:2157,Amiodarone,CCCCc1oc2ccccc2c1C(=O)c1cc(I)c(OCCN(CC)CC)c(I)c1,C01BD01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00590018,NCT00590018_EG000,No,All,Child,Phase 2,9,"Inclusion Criteria:

Age < 1 month
Postoperative
Inotrope score > 20 x > 4 hrs [epinephrine: (mcg/kg/min) x 100 + norepinephrine: (mcg/kg/min) x 100 + phenylephrine: (mcg/kg/min) x 100 + vasopressin: (units/kg/hr) x 100 + milrinone: (mcg/kg/min) x 15 + dopamine: (mcg/kg/min) x 1 + dobutamine: (mcg/kg/min) x 1 + calcium chloride: (mg/kg/hr) x 1]

Exclusion Criteria:

Age > 1 month
Documented sepsis
Preoperative use of steroids > 1 wk",Subjects in this arm will receive a 5 day tapering course of hydrocortisone. Hydrocortisone: Hydrocortisone taper (100mg/m2/day --> 25mg/m2/day) over 5 days intravenously.,ChEMBL:CHEMBL389621 | DrugBank:DB00741 | PubChem:5754,Hydrocortisone,[H][C@@]12CC[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)CC[C@@]21C,A01AC03 | A07EA02 | C05AA01 | D07AA02 | D07BA04 | D07CA01 | D07XA01 | H02AB09 | R01AD60 | S01BA02 | S01BB01 | S01CA03 | S01CB03 | S02BA01 | S02CA03 | S03CA04,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00602537,NCT00602537_EG001,No,All,Adult | Older Adult,Phase 4,140,"Inclusion Criteria:

Meets DSM-IV criteria for Axis I bipolar II disorder
Meets DSM-IV criteria for Axis I major depressive episode
Score of 16 on 17-item HAM-D rating scale
Not taking monoamine oxidase inhibitors (MAOI) for more than 2 weeks prior to study entry
Willing to use an effective form of birth control throughout the study

Exclusion Criteria:

History of mania
Current primary Axis I diagnosis other than bipolar II disorder
Alcohol or drug dependence within 3 months prior to study entry
Contraindication to treatment with venlafaxine or lithium
Unstable medical condition (e.g., thyroid disease, hypertension, or angina pectoris)
Pregnant or breastfeeding
Experiencing suicidal thoughts
Requires hospitalization
Requires concurrent neuroleptic or MS therapy
Requires concurrent AD therapy
Current psychotic features
Inadequate trial of therapy at the time of initial screening visit
History of intolerance to either venlafaxine or lithium
Unlikely to participate in a 36-week trial
Presence of apparent secondary gain",Lithium Carbonate: 300 to 2400 mg,ChEMBL:CHEMBL1200826 | DrugBank:DB14509 | PubChem:11125,LITHIUM CARBONATE,O=C([O-])[O-].[Li+].[Li+],,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00603018,NCT00603018_EG000,Accepts Healthy Volunteers,Female,Adult,Not Applicable,23,"Inclusion Criteria:

Recovered from Anorexia Nervosa
Not taking medication for emotional problems
Regular menstrual cycle

Exclusion Criteria:

Women who are pregnant or nursing
Psychoactive medications in the past 30 days
Neurological disorders.","Recovered anorexia

Fluoxetine: 8 weeks of fluoxetine(2.5mg,5mg,10mg,20mg,30mg,40mg,40mg,40mg)each week per day.",ChEMBL:CHEMBL41 | DrugBank:DB00472 | PubChem:3386,Fluoxetine,CNCCC(Oc1ccc(C(F)(F)F)cc1)c1ccccc1,N06AB03 | N06CA03,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00604019,NCT00604019_EG000,No,All,Adult | Older Adult,Phase 3,252,"Inclusion Criteria:

Patients are transferred to our medical intensive care unit from the emergency room (ER), general medical floors, and from outside hospitals.
Patients were eligible if they were greater than 18 years of age
Presented with a diagnosis of SIRS plus a suspected or documented source of infection.

Exclusion Criteria:

Patients were not eligible if they were found to have hypovolemic and/or hemorrhagic etiologies of their vasodilatory shock or another etiology of their SIRS.",Patients that get DA infusion,DrugBank:DB00988 | PubChem:681,Dopamine,NCCc1ccc(O)c(O)c1,C01CA04,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00605176,NCT00605176_EG000,No,All,Adult | Older Adult,Phase 3,160,"Inclusion Criteria:

In good general health
Have 5 to 20 AKs on the face or balding scalp
Negative urine pregnancy test (for women who are able to become pregnant)
Willing to make frequent visits to the study center during treatment and follow-up periods.

Exclusion Criteria:

Women who are pregnant, lactating or planning to become pregnant during the study.
Have had a medical event within 90 days of the first visit (such as; stroke, heart attack).
Have any skin condition in the treatment area that may be made worse by treatment with imiquimod (e.g., rosacea, psoriasis, atopic dermatitis, eczema).
Have received specific treatments/medications in the treatment area(s) within the designated time period prior to study treatment initiation.","250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.",ChEMBL:CHEMBL1282 | DrugBank:DB00724 | PubChem:57469,Imiquimod,CC(C)Cn1cnc2c(N)nc3ccccc3c21,D06BB10,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00605176,NCT00605176_EG001,No,All,Adult | Older Adult,Phase 3,160,"Inclusion Criteria:

In good general health
Have 5 to 20 AKs on the face or balding scalp
Negative urine pregnancy test (for women who are able to become pregnant)
Willing to make frequent visits to the study center during treatment and follow-up periods.

Exclusion Criteria:

Women who are pregnant, lactating or planning to become pregnant during the study.
Have had a medical event within 90 days of the first visit (such as; stroke, heart attack).
Have any skin condition in the treatment area that may be made worse by treatment with imiquimod (e.g., rosacea, psoriasis, atopic dermatitis, eczema).
Have received specific treatments/medications in the treatment area(s) within the designated time period prior to study treatment initiation.","250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.",ChEMBL:CHEMBL1282 | DrugBank:DB00724 | PubChem:57469,Imiquimod,CC(C)Cn1cnc2c(N)nc3ccccc3c21,D06BB10,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00606801,NCT00606801_EG000,No,All,Adult,Not Applicable,34,"Inclusion Criteria:

Male and females, between the ages 21 and 50
Fulfill criteria for past cocaine dependence
No cocaine use for the past 30 days
No other current dependence or abuse of other drugs or alcohol
No current medical problems and normal ECG
Not pregnant,nor breast feeding,
Using acceptable birth control methods.

Exclusion Criteria:

Current major psychiatric illness including mood, psychotic or anxiety disorders
History of major medical illnesses; including asthma or chronic obstructive lung disease, history or current gastrointestinal ulcer, hepatic or renal impairment and cardiac rhythm disturbances
Use of other medications including,drugs that slow heart rate
Known allergy to galantamine",Galantamine 8 mg/day given for 10 days.,ChEMBL:CHEMBL659 | DrugBank:DB00674 | PubChem:9651,Galantamine,[H][C@]12C[C@@H](O)C=C[C@]13CCN(C)Cc1ccc(OC)c(c13)O2,N06DA04,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00607594,NCT00607594_EG000,No,All,Adult | Older Adult,Phase 2,21,"Inclusion Criteria:

Histologically or cytologically confirmed adenocarcinoma of the stomach or gastroesophageal junction (GEJ)

Tumors of the GEJ must be sub-specified as type I, II, or III using the Siewert classification

Metastatic or locally advanced disease

Patients with local/regional disease only, must have unresectable disease
Measurable disease, defined as ≥ 1 lesion that can be accurately measured in ≥ 1 dimension (longest diameter to be recorded) as ≥ 20 mm by conventional techniques or as ≥ 10 mm by spiral computed tomography (CT) scan
No known brain metastases
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2 OR Karnofsky PS 60-100%
Life expectancy > 3 months
Platelet count ≥ 100,000/mm³
Leukocytes ≥ 3,000/mm³
Absolute neutrophil count ≥ 1,500/mm³
Hemoglobin > 9 g/dL
Total bilirubin normal
Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 2.5 times upper limit of normal
Creatinine normal OR creatinine clearance ≥ 60 mL/min
Urine protein creatinine ratio < 1.0 OR urine protein < 1,000 mg by 24-hour urine collection

Exclusion Criteria:

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception

No condition that potentially impairs the ability to swallow or absorb AZD0530, including any of the following:

Gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation
Active peptic ulcer disease
Short gut syndrome
Malabsorption syndrome of any type
Total or partial bowel obstruction
Inability to tolerate oral medications
No history of allergic reactions attributed to compounds of similar chemical or biologic composition to AZD0530
No QTc prolongation (defined as a QTc interval ≥ 460 msec) or other significant electrocardiogram (ECG) abnormalities
No poorly controlled hypertension (i.e., systolic blood pressure [BP] ≥ 140 mm Hg or diastolic BP ≥ 90 mm Hg)
No history of ischemic heart disease, including myocardial infarction

No concurrent cardiac dysfunction including, but not limited to, any of the following:

Symptomatic congestive heart failure
Unstable angina pectoris
Cardiac arrhythmia
No other concurrent uncontrolled illness, including ongoing or active infection or psychiatric illness/social situations, that would limit compliance with study requirements

Prior chemotherapy allowed provided it was administered as part of initial curative intent therapy (i.e., neoadjuvant therapy, adjuvant therapy and/or concurrently with radiotherapy) in combination with surgery

At least 4 weeks since prior chemotherapy
At least 4 weeks since prior and no more than 1 line of palliative chemotherapy for advanced disease
At least 4 weeks since prior radiotherapy and recovered
At least 4 weeks since prior major surgery and recovered
No cytochrome 450 3A4 (CYP3A4) active agents or substances for ≥ 7 days before, during, and for ≥ 7 days after completion of study treatment
No other concurrent investigational agents
No other concurrent anticancer therapy
No concurrent combination antiretroviral therapy for human immunodeficiency virus (HIV)-positive patients","Patients receive saracatinib PO QD in the absence of disease progression or unacceptable toxicity.

saracatinib

laboratory biomarker analysis: Correlative studies",ChEMBL:CHEMBL217092 | DrugBank:DB11805 | PubChem:10302451,Saracatinib,CN1CCN(CCOc2cc(OC3CCOCC3)c3c(Nc4c(Cl)ccc5c4OCO5)ncnc3c2)CC1,,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,1.0,1.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0
NCT00612313,NCT00612313_EG000,No,All,Child,Not Applicable,69,"Inclusion Criteria:

Primary diagnosis of nonpsychotic MDD (single or recurrent) for at least 4 weeks before study entry
In good general medical health
Normal intelligence

Exclusion Criteria:

Lifetime history of any psychotic disorder, including psychotic depression
Lifetime history of bipolar I and II disorders
Alcohol or substance dependence within the 6 months before study entry
Anorexia nervosa or bulimia within the 6 months before study entry
Pregnant or breastfeeding females, or sexually active females not using medically acceptable means of birth control (e.g., IUD, birth control pills, barrier devices)
Chronic medical illness (medically unstable and requires regular medication that may interfere with treatment interventions)
Concurrent medication(s) with psychotropic effects (e.g., anticonvulsants, steroids, etc.) other than stable ADHD medication
First degree relatives with bipolar I disorder
Severe suicidal ideation or previous history of serious suicide attempt within this episode
Prior failure to respond to an adequate treatment with fluoxetine (defined as at least 40 mg/day for 4 weeks)
Non-English speaking","Participants received antidepressant treatment with fluoxetine for 30 weeks

Fluoxetine: Participants took 10 to 40 mg per day of fluoxetine for 30 weeks.

N=69",ChEMBL:CHEMBL41 | DrugBank:DB00472 | PubChem:3386,Fluoxetine,CNCCC(Oc1ccc(C(F)(F)F)cc1)c1ccccc1,N06AB03 | N06CA03,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00612508,NCT00612508_EG001,Accepts Healthy Volunteers,Female,Adult,Not Applicable,7,"Inclusion Criteria:

Female
18-35 years
In general good health
With regular menses (every 28-32 days)
Seeking contraception and willing to use a hormonal method for at least 6 months

Exclusion Criteria:

Current or recent (within the past 8 weeks) vaginitis or pelvic inflammatory disease
History of recurrent vaginitis (> 2 episodes in one year, any type)
Pregnancy
Recent use of hormonal contraceptives
Depot medroxyprogesterone: 6 months
Progestin implants: 3 months
Oral contraceptives: 3 months
Hormone impregnated IUD: 3 months
Contraindications to use of oral contraceptive pills or vaginal ring
History of deep vein thrombosis
Known coagulopathy or thrombophilia
Unexplained vaginal bleeding
Uncontrolled hypertension
Diabetes with vascular changes
Present or history of hepatic disease or liver tumors
Migraines with neurologic changes
Myocardial infection
Pulmonary embolus
Stroke
Breast cancer
Hypersensitivity or allergy to hormonal contraception
Heavy Smoking ( ≥ 15 cigarettes per day)",intravaginal contraception,PubChem:9960701,Nuvaring,C#CC1(O)CCC2C3CCC4=CC(=O)CCC4C3C(=C)CC21CC.C#CC1(O)CCC2C3CCc4cc(O)ccc4C3CCC21C,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00616018,NCT00616018_EG000,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 4,27,"Inclusion Criteria:

age 21 years or older
provide written informed consent
consume, on average, less than 1 alcoholic beverage daily for the previous 3 months and would be considered non-drinkers

Exclusion Criteria:

History of ingesting more than 4 grams of acetaminophen per day for any of the 4 days preceding study enrollment
Currently taking isoniazid
Consumption of any alcoholic beverage during the run-in period
A detectable serum acetaminophen at baseline
Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels greater than 50 IU/L at the start of the run-in period or at baseline
Platelet count less than 125,000/cc at baseline
Positive pregnancy test at baseline (female participants only)
Currently adheres to a fasting type diet as determined by self report
Currently has anorexia nervosa as determined by self report
Subject appears clinically intoxicated, psychiatrically impaired or unable to give informed consent for any reason
Known hypersensitivity to acetaminophen",all subjects receive 4 g/day of acetaminophen for 10 consecutive days in this open-label study,ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00617240,NCT00617240_EG000,No,All,Child,Phase 2,5,"Inclusion Criteria:

Subjects will be between the ages of 10 and 17, male or female, any race or ethnicity
Any SPMI pediatric diagnosis that meets DSM-IV criteria and frequently is treated with a SGA- typically but not limited to psychotic, mood, pervasive developmental, oppositional defiant, and conduct disorders
SGA-naïve or less than 2 weeks exposure to any SGA, except ziprasidone
Legal guardian able and willing to give written informed consent
If competent, subject able and willing to assent for their own participation

Exclusion Criteria:

Previous trial of metformin
Recommendation for treatment with clozapine or ziprasidone
Current use of insulin or any oral hypoglycemic agent
Current use of a medication known to mitigate weight gain - amantidine, histamine (H2) antagonists (cimetidine, ranitidine, nizatidine), topiramate, orlistat, sibutramine, stimulants (dextroamphetamine, methylphenidate)
Any current or past diagnosis of an eating disorder
Diabetes mellitus
Current active thyroid (TSH >18 microIU/ml; T4 total >18 mcg/dl), hepatic (2 LFTs >4x upper limits of normal), renal (serum Creatinine >1.4 mg/dL in females and serum Creatinine >1.5 mg/dL in males), cardiac, gastrointestinal, or adrenal disease
Current substance abuse/dependence within past 2 weeks; a positive urine tox screen at baseline in the absence of meeting criteria for abuse/dependence will not preclude enrollment.
Pregnancy or breast feeding",metformin in doses from 250mg to 2000mg/day for 26 weeks,ChEMBL:CHEMBL1431 | DrugBank:DB00331 | PubChem:4091,Metformin,CN(C)C(=N)NC(=N)N,A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00620191,NCT00620191_EG001,No,All,Adult | Older Adult,Phase 2,40,"Inclusion criteria:

Age range: 55 years to 90 years. The main rationale for this inclusion criteria is to follow the standard set by the Alzheimer's Disease Cooperative Study (ADCS).
Memory complaint expressed by the participant and recognized by the informant. The memory complaint must represent a change from previous functioning based on information provided by both subject and informant.
Fluent in English or Spanish.
Mini-Mental State Examination (MMSE) equal or more than 20.
Subjects must fulfill criteria for amnestic mild cognitive impairment (MCI). Guidelines for the diagnosis of MCI: Subjects must score below a predetermined cut-off score on the logical memory II delayed paragraph recall sub-test of the Wechsler Memory Scale Revised (WMS-R) or the selective reminding test (SRT).
Global Clinical Dementia Rating (CDR) score must be 0.5 at screening.
Subjects without a known history of diabetes or diabetes that has never been treated with medications. If diabetes is diagnosed during screening or they have a history of diabetes not treated in the last 12 months they will be excluded if their Hemoglobin A1c (HbA1c) is > 6.5. In addition, a diagnosis of diabetes can be made if the HbA1c is 6.5% or more.
Overweight or obese by National Heart, Lung, and Blood Institute (NHLBI) criteria (Body Mass Index (BMI) of more or equal of 25 kg/ m2).
No contraindications to metformin treatment.
Hachinski score less or equal to 4.
Hamilton score less or equal to 12 on the 17 item scale.
General cognition and functional performance such that a diagnosis of dementia cannot be made at the time of screening based on DSM-IV criteria.
Vision and hearing must be sufficient for compliance with testing procedures.

Exclusion criteria:

Individuals with dementia
MMSE < 20
Subjects with neurologic diseases associated to neurologic deficits.
Subjects with current psychiatric diagnoses such as depression, bipolar disorder or schizophrenia.
Subjects with uncontrolled hypertension (systolic blood pressure more than 160 mmHg or diastolic blood pressure more than 95 mmHg.
Subjects with a history of active cancer or cancer within last five years, with the exception of squamous or basal cell carcinoma of the skin.
Subjects who for any reason may not complete the study as judged by the study physician.
Subjects with a known history of diabetes treated with medications.
Subjects with a new or old diagnosis of diabetes, never treated, with a HbA1c of more than 6.5 .
Contraindications to metformin: Contraindications to metformin use include a creatinine of > 1.5, liver disease by history or by elevated transaminases, congestive heart failure, and alcohol abuse.
Use of cholinesterase inhibitors.

Exclusion criteria for brain imaging study:

Presence of diabetes, even if the HbA1c is less or equal to 6.5.
Inability to lie down for any reason.
Presence of any metallic implant.
Claustrophobia.
Any contraindication to magnetic resonance imaging (MRI) or fluorodeoxyglucose (FDG) positron emission tomography (PET).","metformin 1000 mg twice a day

metformin: metformin 1000 mg twice a day titrated from 500 mg once a day",ChEMBL:CHEMBL1431 | DrugBank:DB00331 | PubChem:4091,Metformin,CN(C)C(=N)NC(=N)N,A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00620373,NCT00620373_EG000,Accepts Healthy Volunteers,Female,Adult | Older Adult,Not Applicable,969,"Inclusion Criteria:

Past prior screening mammography (SM) interpreted as negative or benign (This screening must have been performed at Mayo Clinic Rochester, Minnesota).
Past prior SM interpreted as heterogeneously dense or extremely dense (This screening must have been performed at Mayo Clinic Rochester, Minnesota).
Women younger than 50 years who had not undergone prior mammography, as most of these women have dense breasts.

Subjects had to have at least one of the following risk factors:

Known mutation in breast cancer susceptibility gene 1 (BRCA1) or breast cancer susceptibility gene 2 (BRCA2)
History of chest, mediastinal, or axillary irradiation
Personal history of breast cancer
History of prior biopsy showing atypical ductal hyperplasia, atypical lobular hyperplasia, lobular carcinoma in situ, or atypical papilloma
Gail or Claus model lifetime risk greater than or equal to 20%
Gail model 5 year risk greater or equal to 2.5%
Gail model 5 year risk greater or equal to 1.6%
One first-degree relative with history of breast cancer
Two second-degree relatives with history of breast cancer

Exclusion Criteria:

They are unable to understand and sign the consent form
They are pregnant or lactating
They are physically unable to sit upright and still for 40 minutes.
They have self-reported signs or symptoms of breast cancer (palpable mass, bloody nipple discharge, axillary mass etc.).
They have had needle biopsy within 3 months, or breast surgery within 1 year prior to the study.
They are currently taking tamoxifen, evista (raloxifene), or an aromatase inhibitor for adjuvant therapy or chemoprevention.",Participants underwent conventional mammography and molecular breast imaging after a 740-millibecquerel (mBQ)(20-mCi) Technetium (99mTc) sestamibi injection.,PubChem:22617237,Technetium (99mTc) sestamibi,[C-]#[N+]CC(C)(C)OC.[C-]#[N+]CC(C)(C)OC.[C-]#[N+]CC(C)(C)OC.[C-]#[N+]CC(C)(C)OC.[C-]#[N+]CC(C)(C)OC.[C-]#[N+]CC(C)(C)OC.[Tc],,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00621309,NCT00621309_EG000,Accepts Healthy Volunteers,All,Adult,Phase 1,29,"Inclusion Criteria:

Adults from all ethnicities will be encouraged to participate, with our recruitment efforts we expect similar profile as that of the greater Seattle area.

Exclusion Criteria:

Exclusion criteria address a mix of medical and practical issues and include:

Medical history of gastrointestinal, hepatic, or renal disorders
Pregnancy or lactation
Known allergies/intolerances to any foods used in the feeding trial
Weight loss or gain greater than 4.5 kg within the past year
Major changes in eating habits within the past year (e.g. adoption of a faddish diet)
Antibiotic use within the past 3 months
Body weight greater than 150% of desirable
Exercise patterns that require or result in major changes in diet
Current use of prescription medication (including oral contraceptives)
Current use of over-the-counter medications and herbal supplements
Regular exposure to passive smoke
Occupational exposure to smoke or organic solvents
Food dislikes that would preclude participation in the feeding trial
Alcohol intake of greater than 2 drinks/day (2 drinks=720 mL beer, 240 mL wine, or 9 mL spirits). Additionally, before the trial, participants will have a blood draw to be sent to the UW Medical Center Lab for liver and kidney functions profile and pregnancy test for women. Those with abnormal test results will be excluded as well as pregnant women.","Randomized, crossover trial. 1: Rifampicin (300 mg/d) given alone for 7 days; 2: daily combination with 450 μmol SFN (Broccoli Sprout extract); 3: SFN alone. 29 participants consented. The powdered broccoli extract imparted a bitter taste to the cheese soup used as vehicle. We had all potential participants try the soup before committing to participate. 3 participants who initially did not object to the taste did dropout and did not finish any of the study arms due to dislike or intolerance of the extract. Two of these participants became nauseated, one also had vomiting but it was determined that the subject was suffering from the flu and thus the response was deemed by our attending physician not to be solely treatment related. Three additional participants did not complete all their study periods (one developed apparent lactose intolerance to the soup, one did not routinely comply with study activities, and one relocated out of state after the second study period).",ChEMBL:CHEMBL374478 | DrugBank:DB01045 | PubChem:135398735 | PubChem:135403807 | PubChem:135441414 | PubChem:135449527 | PubChem:135476790 | PubChem:135512673 | PubChem:135550179 | PubChem:135876149 | PubChem:135900090 | PubChem:135921123 | PubChem:135921134 | PubChem:135925261 | PubChem:135925741 | PubChem:135932822 | PubChem:136122621 | PubChem:136136478 | PubChem:136246612 | PubChem:136601293 | PubChem:136619758 | PubChem:136709103 | PubChem:137016821 | PubChem:137086834 | PubChem:137225336 | PubChem:137270779 | PubChem:137286743 | PubChem:137287990 | PubChem:154825551 | PubChem:163059759,RIFAMPIN,COC1C=COC2(C)Oc3c(C)c(O)c4c(O)c(c(C=NN5CCN(C)CC5)c(O)c4c3C2=O)NC(=O)C(C)=CC=CC(C)C(O)C(C)C(O)C(C)C(OC(C)=O)C1C,J04AB02 | J04AM02 | J04AM05 | J04AM06 | J04AM07 | J04BA50 | J04BA51,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00625365,NCT00625365_EG000,No,All,Adult | Older Adult,Phase 4,1053,"Inclusion criteria

Patients who, in the investigator's opinion, require DEFINITY® echocardiography due to suboptimal, unenhanced images.

Exclusion criteria

Known hypersensitivity to perflutren, DEFINITY®, or other echo contrast agent.
Prior SAE associated with perflutren, DEFINITY®, or administration of other echo contrast agent.",Patients who had undergone unenhanced echocardiography yielding suboptimal images and who were determined by the Principal Investigator to require DEFINITY-enhanced echocardiography,ChEMBL:CHEMBL1663 | DrugBank:DB00556 | PubChem:6432,Perflutren,FC(F)(F)C(F)(F)C(F)(F)F,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00628095,NCT00628095_EG000,No,All,Adult | Older Adult,Phase 2,53,"Inclusion Criteria:

Active rheumatoid arthritis
Incomplete response to methotrexate

Exclusion Criteria:

Must not be on biologic therapies
No recent infections","CE-224,535 500 milligram (mg) tablet orally twice daily for 12 weeks.",PubChem:11547499,"2-(4-Chloro-3-(3-(1-hydroxycycloheptyl)propanoyl)phenyl)-4-((2R)-2-hydroxy-3-methoxy-propyl)-1,2,4-triazine-3,5-dione",COCC(O)Cn1c(=O)cnn(-c2ccc(Cl)c(C(=O)NCC3(O)CCCCCC3)c2)c1=O,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0
NCT00633945,NCT00633945_EG000,No,All,Adult | Older Adult,Not Applicable,5,"Inclusion Criteria:

Subjects must understand and voluntarily sign Informed Consent and HIPAA forms.
Males and females over the age of 18 at the time of signing informed consent form.
Able to adhere to the study visit schedule and other protocol requirements
Subjects must have biopsy proven Cutaneous Lupus Erythematosus (CLE) either in the form of Discoid Lupus Erythematosus (DLE) or Subacute Lupus Erythematosus (SCLE), with or without systemic involvement.
Subjects must have grade II erythema in at least three skin locations as defined by the Cutaneous Lupus Activity and Severity Index (CLASI).
Subjects must have failed standard treatment with hydroxychloroquine (Plaquenil) for up to three months.
Female subjects who are not pregnant.
Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days prior to and again within 24 hours of starting lenalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional method AT THE SAME TIME, at least 28 days before starting to take lenalidomide (Revlimid®). FCBP must also agree to ongoing pregnancy testing. Males must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy. All subjects must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure.
If pregnancy or a positive pregnancy test is noted in a study subject or in the partner of a male study subject during study participation, the study drug must be discontinued immediately.

Exclusion Criteria:

Any serious medical condition, laboratory abnormality or psychiatric illness that would prevent the subject from signing the informed consent form.
Female subjects who are pregnant, plan to be pregnant during the study, or who are breastfeeding.
Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk for study participation, or confounds the ability to interpret data from the study.
Use of any other experimental drug or therapy within 28 days of baseline.
Known hypersensitivity to thalidomide.
The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
Prior history of deep vein thrombosis (DVT).
Prior history of pulmonary embolus (PE).
Known positive for HIV viral DNA by qPCR.
Positive hepatitis B surface antigen, or hepatitis C.
Platelet count < 50,000/mcL.
Absolute neutrophil count < 750/mcL
Lymphopenia < 500/mcL.
Have current signs or symptoms of severe progressive or uncontrolled renal disease (creatinine ≥1.5 x ULN).
If female, unwillingness to use one highly effective method and one additional method of birth control.
If male, unwillingness to use a latex condom during intercourse with females of childbearing potential.
Continued therapy with thalidomide.",Lenalidomide treated patients,ChEMBL:CHEMBL848 | DrugBank:DB00480 | PubChem:216326,Lenalidomide,Nc1cccc2c1CN(C1CCC(=O)NC1=O)C2=O,L04AX04,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00636805,NCT00636805_EG000,No,All,Adult | Older Adult,Phase 2,63,"Inclusion Criteria:

In order to be included in the study, patients must meet all of the following criteria:

Patients must have histologically confirmed diagnosis of primary malignant glioma (glioblastoma multiforme, gliosarcoma or anaplastic astrocytoma, or anaplastic oligodendroglioma) who are either chemotherapy naïve or non-naïve and scheduled to receive Irinotecan/Bevacizumab chemotherapy.
Patients with recurrent disease whose diagnostic pathology confirmed malignant glioma (glioblastoma multiforme, gliosarcoma or anaplastic astrocytoma, or anaplastic oligodendroglioma) will not need re-biopsy.
Age > or = 18 years.
Patient is scheduled to receive Irinotecan/Bevacizumab chemotherapy every 2 weeks for one complete 6-week cycle.
An interval of at least 6 weeks between prior surgical resection and study enrollment.
An interval of at least 4 weeks between prior radiotherapy and enrollment on this protocol unless there is unequivocal evidence of tumor progression after radiotherapy or chemotherapy.
The lab values following the prior chemotherapy must return within normal limits prior to study enrollment.
Karnofsky > 60%.
Hematocrit > 29%, absolute neutrophil count (ANC) > 1,500 cells/*l, platelets > 125,000 cells/*l.
Serum creatinine < 1.5 mg/dl, serum glutamic-oxaloacetic transaminase (SGOT) and bilirubin < 1.5 times upper limit of normal.
Patients on corticosteroids must be on a stable dose for 1 week prior to entry, and the dose should not be escalated over entry dose level, if clinically possible.
Signed consent form approved by the Institutional Review Board prior to patient entry.
No evidence of hemorrhage on the baseline MRI or CT scan.
If sexually active, patients will take contraceptive measures for the duration of the treatments.

Exclusion Criteria:

Patients are excluded from this study if they meet any of the following criteria:

Inability or unwillingness to understand or cooperate with study procedures.
Received any intravenous drug with potential anti-emetic effect within 24 hours prior to the start of study-designated chemotherapeutic agent or be scheduled to receive any drug of this type (with the exception of administration of the palonosetron/dexamethasone infusion solution) at any time during the trial, including the following:
5 HT3 receptor antagonists;
Dopamine receptor antagonists (metoclopramide);
Phenothiazine anti-emetics (prochlorperazine, thiethylperazine and perphenazine);
Diphenhydramine, scopolamine, chlorpheniramine maleate, trimethobenzamide. Diphenhydramine will be allowed if given for prophylactic treatment of hypersensitivity reactions associated with the administration of taxanes;
Haloperidol, droperidol, tetrahydrocannabinol, or nabilone; and
Any systemic corticosteroid (hydrocortisone, methylprednisolone, prednisone). Topical or inhaled preparations are allowed;
Previous participation in any clinical trial involving palonosetron (RS-25259 of Syntex).
Any vomiting, retching or NCI Common Toxicity Criteria version 3.0 grade 2-4 nausea (see Appendix 8.6) in the 24 hours preceding chemotherapy.
Ongoing vomiting from any organic etiology.
Will receive radiotherapy of upper abdomen or cranium within one week prior to or during the study.
Received palonosetron within 14 days prior to study enrollment (AloxiTM).
Evidence of central nervous system (CNS) hemorrhage on baseline MRI on CT scan.
Co -medication that may interfere with study results; e.g. immuno-suppressive agents other than corticosteroids.
Prophylactic medication for the prevention of nausea and vomiting 24 hours prior to the start of chemotherapy through 120 hours after the initiation of chemotherapy on Study Day 1 (Study Day 6) is prohibited, with the exception of the study drug. Corticosteroids will be allowed for treatment of cerebral swelling. Diphenhydramine will be allowed only if given for prophylactic treatment of hypersensitivity reactions associated with the administration of taxanes, as per the package insert for these agents. Rescue medication for treatment of nausea and vomiting is permitted after chemotherapy at the discretion of the investigator. The agent, dose, and time of administration will be recorded in the patient diary.","Patient receives IV Aloxi

Palonosetron (Aloxi) and Dexamethasone: single i.v. , dose of palonosetron 0.25 mg, and 10mg dexamethasone infused over 15 min, administered 30 min before the first dose Irinotecan and Bevacizumab chemotherapy.",ChEMBL:CHEMBL1189679 | DrugBank:DB00377 | PubChem:6337614,Palonosetron,[H][C@]12CCCc3cccc(c31)C(=O)N([C@@H]1CN3CCC1CC3)C2,A04AA05 | A04AA55,0.0,0.0,0.0,0.0,0.0,1.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,1.0,1.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT00637780,NCT00637780_EG000,No,All,Child,Phase 4,2,"Inclusion Criteria:

Patients with a diagnosis of oligoarticular, polyarticular, psoriatic or enthesitis-related JIA as determined by ILAR criteria. Patients who have been continuously treated with generic sulfasalazine delayed release formulation and have tolerated the product for at least 3 months prior to study enrolment and who are switched to Azulfidine-EN at least 8 days prior to Day 0 are eligible.
Patients must be at least 6 years of age and has not reached his/her 18th birthday prior to the Baseline Visit (Day 0).
Onset of JIA must have occurred prior to the patient's 16th birthday.
Patients must weigh at least 20 kg.
Patients must be on sulfasalazine 500 mg delayed release tablets and the total daily dose must be within the specified range of 30-60 mg/kg/day with a maximum daily dose of 3 g/day

Exclusion Criteria:

Patient currently with systemic features of systemic JIA.
Hypersensitivity to sulfasalazine , its metabolites, sulfonamides or salicylates.
History of sensitivity to heparin or heparin-induced thrombocytopenia.
Inability to swallow whole (uncrushed) sulfasalazine 500 mg delayed release tablets as required by protocol","All participants received sulfasalazine 30-50 milligrams (mg)/kilograms (kg)/day, divided into twice daily (BID) doses, for 6 days. On Day 7, the morning dose was administered at the site in presence of site staff. Sulfasalazine was administered orally in the form of 500-mg tablets.",ChEMBL:CHEMBL421 | DrugBank:DB00795 | PubChem:5339,Sulfasalazine,O=C(O)c1cc(/N=N/c2ccc(S(=O)(=O)Nc3ccccn3)cc2)ccc1O,A07EC01 | G01AE10,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00638937,NCT00638937_EG000,No,All,Adult | Older Adult,Phase 2,37,"Inclusion Criteria:

Recurrent/metastatic/locally advanced unresectable, histologically or cytologically confirmed NSCLC
Measurable disease defined (RECIST) as at least 1 lesion measured in at least 1 dimension (longest diameter) as >20mm with conventional techniques or >10mm with spiral CT scan

Previously treated with firstline platinum-based systemic chemotherapy for advanced disease AND had at least disease stabilization as best response to firstline therapy

<=1 line of prior therapy
Not have had prior treatment with EGFR Tyrosine kinase inhibitor
Completed chemotherapy/surgery/radiotherapy 4 weeks before study entry and must have recovered from toxic effects of prior therapy
Had >40% of their bone marrow radiated and must have either measurable disease outside field/documented progression post radiation therapy
Life expectancy >3 months
ECOG performance status =<2 OR Karnofsky >=60%
Leukocytes >=3x10^9/L
Absolute neutrophil count >=1.5x10^9/L
Platelet count >=10x10^9/L
Hemoglobin >9g/dL (may be transfused to meet this)
Total bilirubin =<1.5 times institutional ULN (IULN)
AST/ALT =<2.5xIULN (=<5 times ULN in the presence of liver metastases)
Creatinine =<1.5xIULN OR creatinine clearance >=50 mL/min/1.73m^2
Urine protein creatinine ratio =<1.0 OR urine protein >1.0, 24 hour urine for protein should be <1000mg
Women of childbearing potential/men must use adequate contraception (hormonal/barrier method of birth control; abstinence) prior to study entry, for duration of study participation, and for 8 weeks following cessation of study therapy
Ability to understand/willingness to sign written informed consent

Exclusion Criteria:

Chemotherapy/radiotherapy within 4 weeks (6 weeks for nitrosoureas/mitomycin C) prior to study entry/not recovered from AEs due to agents administered > than 4 weeks earlier
No CYP3A4-active agents permitted during protocol treatment. Patients requiring treatment with these agents are not eligible; prohibited drugs should be discontinued 7 days before first dose of AZD0530 and for 7 days after discontinuation of AZD0530
Cannot receive other investigational agents
History of allergic reactions attributed to compounds of similar chemical/biologic composition to AZD0530
QTc prolongation (i.e.QTc interval >=460 msec)/other significant ECG abnormalities
Poorly controlled hypertension (i.e.systolic BP of 140 mmHg or higher, diastolic BP of 90mm Hg or higher)
Any condition impairing ability to swallow AZD0530 tablets
Treated brain metastases which are clinically and radiologically stable are permitted; patients requiring steroids/with neurological symptoms should be excluded because of poor prognosis/often develop progressive neurologic dysfunction
Intercurrent cardiac dysfunction including but not limited to symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia are excluded as are those with ischemic heart disease history including myocardial infarction
Uncontrolled intercurrent illness including but not limited to ongoing/active infection or psychiatric illness/social situations that would limit compliance with study requirements
Pregnant women excluded because AZD0530 has potential teratogenic/abortifacient effects; because unknown but potential risks for AEs in nursing infants secondary to treatment of mother with AZD0530, breastfeeding should be discontinued if mother is treated with AZD0530
HIV-positive patients on combination antiretroviral therapy are ineligible because potential for PK interactions with AZD0530; these patients have increased risk of lethal infections when treated with marrow-suppressive therapy; appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated","Patients receive saracatinib PO QD on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression

saracatinib: Given PO

laboratory biomarker analysis: Correlative studies",ChEMBL:CHEMBL217092 | DrugBank:DB11805 | PubChem:10302451,Saracatinib,CN1CCN(CCOc2cc(OC3CCOCC3)c3c(Nc4c(Cl)ccc5c4OCO5)ncnc3c2)CC1,,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0
NCT00642369,NCT00642369_EG001,No,All,Adult | Older Adult,Not Applicable,60,"Inclusion Criteria:

For inclusion in the study patients must fulfill all of the following criteria:

Provision of written informed consent by patient or his/her legal guardian
Hospitalized for a diagnosis of Schizophrenia paranoid subtype by Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition (DSM-IV)
Positive and Negative Syndrome Scale (PANSS) total score≥60
Female patients of childbearing potential must be using a reliable method of contraception and have a negative urine human chronic gonadotropin (HCG) test at enrolment
Able to understand and comply with the requirements of the study

Exclusion Criteria:

Any of the following is regarded as a criterion for exclusion from the study:

Pregnancy or lactation
Any DSM-IV Axis I disorder not defined in the inclusion criteria
Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others
Known intolerance or lack of response to quetiapine fumarate or/and haloperidol, as judged by the investigator
Use of any of the following cytochrome P450 3A4 inhibitors in the 14 days preceding enrolment including but not limited to: ketoconazole, itraconazole, fluconazole, erythromycin, clarithromycin, troleandomycin, indinavir, nelfinavir, ritonavir, fluvoxamine and saquinavir
Use of any of the following cytochrome P450 3A4 inducers in the 14 days preceding enrolment including but not limited to: phenytoin, carbamazepine, barbiturates, rifampin, St. John's Wort, and glucocorticoids
Administration of a depot antipsychotic injection within one dosing interval (for the depot) before randomisation
Substance or alcohol dependence at enrolment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by DSM-IV criteria
Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IV criteria within 4 weeks prior to enrolment
Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment
Unstable or inadequately treated medical illness (e.g. congestive heart failure, angina pectoris, hypertension) as judged by the investigator
Organic changes was founded by brain CT
Involvement in the planning and conduct of the study
Previous enrolment or randomisation of treatment in the present study.
Participation in another drug trial within 4 weeks prior enrolment into this study or longer in accordance with local requirements
A patient with Diabetes Mellitus (DM) fulfilling one of the following criteria: unstable DM defined as enrolment glycosylated hemoglobin (HbA1c) >8.5%; admitted to hospital for treatment of DM or DM related illness in past 12 weeks; not under physician care for DM Physician responsible for patient's DM care has not indicated that patient's DM is controlled; Physician responsible for patient's DM care has not approved patient's participation in the study; has not been on the same dose of oral hypoglycaemic drug(s) and/or diet for the 4 weeks prior to randomisation; for thiazolidinediones (glitazones) this period should not be less than 8 Weeks; taking insulin whose daily dose on one occasion in the past 4 weeks has been more than 10% above or below their mean dose in the preceding 4 weeks. Note: If a diabetic patient meets one of these criteria, the patient is to be excluded even if the treating physician believes that the patient is stable and can participate in the study.
An absolute neutrophil count (ANC) of 1.5 x 109/L
Sleep disorder such as Apnea Hypopneas Syndrome, periodic leg movement syndrome and narcolepsy
The work time is rotate and/or often flies across the time zone
Use of clozapine within 28 days prior to randomization",haloperidol treatment (6-40mg/day) in 28 days,ChEMBL:CHEMBL54 | DrugBank:DB00502 | PubChem:3559,Haloperidol,O=C(CCCN1CCC(O)(c2ccc(Cl)cc2)CC1)c1ccc(F)cc1,N05AD01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00647699,NCT00647699_EG001,No,All,Child | Adult | Older Adult,Phase 3,74,"Inclusion Criteria:

Diagnosis of keratoconus
Documented progression over previous 24 months
Decreased BSCVA
Must complete all study visits

Exclusion Criteria:

Prior corneal surgery or Intacs
History of delayed wound healing",riboflavin ophthalmic solution without UVA irradiation,ChEMBL:CHEMBL1534 | DrugBank:DB00140 | PubChem:493570,Riboflavin,Cc1cc2nc3c(=O)[nH]c(=O)nc-3n(C[C@H](O)[C@H](O)[C@H](O)CO)c2cc1C,A11HA04 | S01XA26,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00650806,NCT00650806_EG001,No,All,Adult | Older Adult,Phase 2,98,"Inclusion Criteria:

BMI >=30 kg/m2 and <50 kg/m2 or a BMI >=27 kg/m2 and <50 kg/m2 in the presence of controlled hypertension and/or treated or untreated dyslipidemia
Must have a stable weight, i.e., increasing or decreasing not more than 5% in the 3 months before screening
Serum creatinine <=1.5 mg/dL for men and <=1.4 mg/dL for women at screening
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels within 2 times the upper limit of normal (ULN) and bilirubin within the normal range, unless the findings are consistent with Gilbert's disease
fasting plasma glucose PG <7.0 mmol/L (126 mg/dL) at screening

Exclusion Criteria:

A history of hereditary glucose-galactose malabsorption or primary renal glycosuria
An established diagnosis of diabetes mellitus or treatment with glucose lowering drugs at screening
A history of reactive hypoglycemia or of symptomatology possibly due to hypoglycemia
Fasting triglyceride level >6.78 mmol/L (600 mg/dL) at screening
History of obesity with a known cause (e.g., Cushing's disease)",Each patient received 50 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.,DrugBank:DB08907 | PubChem:24812758,Canagliflozin,[H][C@@]1(c2ccc(C)c(Cc3ccc(-c4ccc(F)cc4)s3)c2)O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O,A10BD16 | A10BK02,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00650806,NCT00650806_EG002,No,All,Adult | Older Adult,Phase 2,93,"Inclusion Criteria:

BMI >=30 kg/m2 and <50 kg/m2 or a BMI >=27 kg/m2 and <50 kg/m2 in the presence of controlled hypertension and/or treated or untreated dyslipidemia
Must have a stable weight, i.e., increasing or decreasing not more than 5% in the 3 months before screening
Serum creatinine <=1.5 mg/dL for men and <=1.4 mg/dL for women at screening
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels within 2 times the upper limit of normal (ULN) and bilirubin within the normal range, unless the findings are consistent with Gilbert's disease
fasting plasma glucose PG <7.0 mmol/L (126 mg/dL) at screening

Exclusion Criteria:

A history of hereditary glucose-galactose malabsorption or primary renal glycosuria
An established diagnosis of diabetes mellitus or treatment with glucose lowering drugs at screening
A history of reactive hypoglycemia or of symptomatology possibly due to hypoglycemia
Fasting triglyceride level >6.78 mmol/L (600 mg/dL) at screening
History of obesity with a known cause (e.g., Cushing's disease)",Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.,DrugBank:DB08907 | PubChem:24812758,Canagliflozin,[H][C@@]1(c2ccc(C)c(Cc3ccc(-c4ccc(F)cc4)s3)c2)O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O,A10BD16 | A10BK02,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00650806,NCT00650806_EG003,No,All,Adult | Older Adult,Phase 2,96,"Inclusion Criteria:

BMI >=30 kg/m2 and <50 kg/m2 or a BMI >=27 kg/m2 and <50 kg/m2 in the presence of controlled hypertension and/or treated or untreated dyslipidemia
Must have a stable weight, i.e., increasing or decreasing not more than 5% in the 3 months before screening
Serum creatinine <=1.5 mg/dL for men and <=1.4 mg/dL for women at screening
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels within 2 times the upper limit of normal (ULN) and bilirubin within the normal range, unless the findings are consistent with Gilbert's disease
fasting plasma glucose PG <7.0 mmol/L (126 mg/dL) at screening

Exclusion Criteria:

A history of hereditary glucose-galactose malabsorption or primary renal glycosuria
An established diagnosis of diabetes mellitus or treatment with glucose lowering drugs at screening
A history of reactive hypoglycemia or of symptomatology possibly due to hypoglycemia
Fasting triglyceride level >6.78 mmol/L (600 mg/dL) at screening
History of obesity with a known cause (e.g., Cushing's disease)",Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily for 12 weeks.,DrugBank:DB08907 | PubChem:24812758,Canagliflozin,[H][C@@]1(c2ccc(C)c(Cc3ccc(-c4ccc(F)cc4)s3)c2)O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O,A10BD16 | A10BK02,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00655083,NCT00655083_EG000,No,All,Child,Phase 1,12,"Inclusion Criteria:

Subjects will be eligible for inclusion in the study if they meet all of the following criteria:

Infants with a history consistent with a diagnosis of colic or other functional gastrointestinal disorders
Age >6 weeks and < 24 weeks
At least 44 weeks post-conceptual age at enrolment
Normal growth
Informed consent by parents (one or both) or legal guardian
Caregiver available to be trained in collection and storage of used diapers
Caregiver available to record feeding episodes and defecations on the diary

Exclusion Criteria:

Subjects will be excluded from the study if they meet any of the following criteria:

Clinical evidence of major cardiovascular, respiratory, renal, hepatic, endocrine, metabolic, gastrointestinal (excluding infantile colic and other functional gastrointestinal disorders, unless associated to symptoms which are likely to interfere with drug absorption, e.g. frequent vomiting), haematological, severe dermatological or neurological pathology or other diseases;
Previous major surgery or blood loss
Intake of antimuscarinic drugs, simethicone, or dimethicone 24 hours before study treatment administration.",Nepadutant 0.1 mg/kg,ChEMBL:CHEMBL1908318 | DrugBank:DB12538 | PubChem:166639582 | PubChem:44208970 | PubChem:9876321,Nepadutant,CC(=O)NC1C(NC(=O)CC2NC(=O)C(CC(C)C)NC(=O)C3CNC(=O)CC(NC2=O)C(=O)NC(Cc2c[nH]c4ccccc24)C(=O)NC(Cc2ccccc2)C(=O)N3)OC(CO)C(O)C1O,,0.0,0.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT00655083,NCT00655083_EG001,No,All,Child,Phase 1,8,"Inclusion Criteria:

Subjects will be eligible for inclusion in the study if they meet all of the following criteria:

Infants with a history consistent with a diagnosis of colic or other functional gastrointestinal disorders
Age >6 weeks and < 24 weeks
At least 44 weeks post-conceptual age at enrolment
Normal growth
Informed consent by parents (one or both) or legal guardian
Caregiver available to be trained in collection and storage of used diapers
Caregiver available to record feeding episodes and defecations on the diary

Exclusion Criteria:

Subjects will be excluded from the study if they meet any of the following criteria:

Clinical evidence of major cardiovascular, respiratory, renal, hepatic, endocrine, metabolic, gastrointestinal (excluding infantile colic and other functional gastrointestinal disorders, unless associated to symptoms which are likely to interfere with drug absorption, e.g. frequent vomiting), haematological, severe dermatological or neurological pathology or other diseases;
Previous major surgery or blood loss
Intake of antimuscarinic drugs, simethicone, or dimethicone 24 hours before study treatment administration.",Nepadutant 0.5 mg/kg,ChEMBL:CHEMBL1908318 | DrugBank:DB12538 | PubChem:166639582 | PubChem:44208970 | PubChem:9876321,Nepadutant,CC(=O)NC1C(NC(=O)CC2NC(=O)C(CC(C)C)NC(=O)C3CNC(=O)CC(NC2=O)C(=O)NC(Cc2c[nH]c4ccccc24)C(=O)NC(Cc2ccccc2)C(=O)N3)OC(CO)C(O)C1O,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT00655473,NCT00655473_EG000,No,All,Adult | Older Adult,Phase 2,64,"Inclusion Criteria:

adult patients, 18-75 years of age;
CHD, including patients with other CHD risk factors;
treated appropriately for dyslipidemia;
clinically stable.

Exclusion Criteria:

previous exposure to any cholesteryl ester transfer protein (CETP) inhibitor or vaccine;
recent (within 3 months) clinically significant coronary events, transient ischemic attacks or cerebrovascular accident;
severe anemia;
uncontrolled hypertension;
poorly controlled diabetes.",Dalcetrapib (RO4607381): 600mg po daily for 24 months,ChEMBL:CHEMBL313006 | DrugBank:DB12181 | PubChem:6918540,Dalcetrapib,CCC(CC)CC1(C(=O)Nc2ccccc2SC(=O)C(C)C)CCCCC1,,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00655538,NCT00655538_EG000,No,All,Adult | Older Adult,Phase 2,236,"Inclusion Criteria:

adult patients, 18-75 years of age;
CHD or CHD risk equivalent;
appropriately treated for accepted LDL-C level.

Exclusion Criteria:

treatment with drugs raising HDL-C (eg niacin, fibrates);
uncontrolled hypertension;
recent (within 3 months) clinically significant coronary events, transient ischemic attacks or cerebrovascular accident;
severe anemia;
poorly controlled diabetes.",dalcetrapib: 600mg po daily for 36 weeks,ChEMBL:CHEMBL313006 | DrugBank:DB12181 | PubChem:6918540,Dalcetrapib,CCC(CC)CC1(C(=O)Nc2ccccc2SC(=O)C(C)C)CCCCC1,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00657618,NCT00657618_EG000,No,All,Child | Adult | Older Adult,Phase 1 | Phase 2,74,"Inclusion Criteria:

DoD healthcare beneficiary of any age and gender.
Clinicoepidemiologic or parasitologic diagnosis (microscopy, PCR or culture) of Leishmania infection.
Able to provide informed consent or assent (children).
All participants (both male and female) must agree to take precautions not to become pregnant or father a child for at least 2 months after receiving SSG.

Exclusion Criteria:

Pregnancy. Females of childbearing potential must have negative urine human chorionic gonadotropin hormone (HCG) within 96 hours start of infusion period.
History of hypersensitivity to pentavalent antimonials.

Any of the following on screening examination:

QTc interval greater or equal to 0.5 sec
Severe cardiac disease (disabling valvular heart disease, myopathy, or arrhythmias)
History of recurrent pancreatitis
Liver failure or active hepatitis with transaminases > 3x upper limit of normal
Renal failure or creatinine > 2.5 mg/dL
Thrombocytopenia (platelets <100,000/mm^3)
White blood cell count < 2000 / mm^3
Hematocrit < 30 %","All consented subjects who meet all inclusion and no exclusion criteria will enter this open label protocol and be treated with Sodium Stibogluconate (SSG).

Sodium Stibogluconate (SSG): 100 mg/ml/vial. Treatment for laboratory-confirmed leishmaniasis with SSG 20mg/kg/d intravenously (IV) for 10 days or 20 days; visceral leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days as a second line of therapy for those failing or intolerant of Ambisome; and mucosal leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days.",DrugBank:DB05630 | PubChem:16683012,Sodium stibogluconate,O.O.O.O.O.O.O.O.O.[H][C@]1([C@H](O)CO)O[Sb]2([O-])(O[Sb]34(O)O[C@@H](C(=O)[O-])[C@@]([H])(O3)[C@@]([H])([C@H](O)CO)O4)O[C@@H](C(=O)[O-])[C@@]1([H])O2.[Na+].[Na+].[Na+],P01CB02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00658411,NCT00658411_EG000,No,All,Adult | Older Adult,Not Applicable,5,"Inclusion Criteria:

18 years of age or older
Histologically confirmed acute myeloid leukemia, acute lymphoblastic leukemia, or myelodysplastic syndrome
Planned allogeneic stem cell transplantation with myeloablative conditioning regimen; the planned date of transplantation must be at least 4 weeks from time of enrollment
Severe iron overload as defined by BOTH: Ferritin greater than 1000ng/ml (at the time of donor availability) and Liver iron content estimated greater than or equal to 5mg/g dry weight by MRI (at the time of donor availability)
Patients with a history of prior autologous transplantation will be eligible for this study

Exclusion Criteria:

Contraindication to magnetic resonance imaging (MRI)
Creatinine >2.0mg/dl or creatinine clearance <50ml/min
Active uncontrolled bacterial or fungal infection
History of mucormycosis
Pre-existing clinically apparent retinal neuropathy. If patients have clinically apparent visual loss at the time of screening, they will be excluded if either they have known retinal neuropathy or if this cannot be excluded by further testing
Pre-existing clinically apparent sensorineural hearing loss. If patients have auditory loss at the time of screening, they will be excluded if either they have known sensorineural hearing loss, or if this cannot be excluded by further testing
Pregnancy or inability or unwillingness to use contraception during the time of the study
Lactating patients
Inability to provide informed consent",All patients received a maximum dose of 50mg/kg/d of deferoxamine as chelation therapy for at least 2 weeks prior to receiving myeloablative transplant.,ChEMBL:CHEMBL556 | DrugBank:DB00746 | PubChem:2973,Deferoxamine,CC(=O)N(O)CCCCCNC(=O)CCC(=O)N(O)CCCCCNC(=O)CCC(=O)N(O)CCCCCN,V03AC01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT00659230,NCT00659230_EG001,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 2,45,"Inclusion Criteria:

Signed informed consent
Patient understands the risks and benefits and agrees to visit frequency and procedures
Male or female
Any race or ethnic origin
Served in OIF/OEF or Afghanistan conflicts or other Southwest Asia conditions
Currently Active Duty, National Guard, Reservist, Veteran, and/or Retired Military
Diagnosis of PTSD (by MINI (Mini International Neuropsychiatric Interview) and CAPS-DX (Clinician Administered PTSD scale- Diagnostic Form) using Rule of Fours and total CAPS-DX score of 45)
No substance use disorders in the previous 2 weeks and no substance dependence disorders in the past 4 weeks (except for nicotine and caffeine)
Free of psychotropic medication for 2 weeks prior to randomization
Physical and laboratory panel are within normal limits or not clinically significant
Women of childbearing potential must be using medically-approved methods of birth control
≥19 to 65 years of age

Exclusion Criteria:

Lifetime history of bipolar I, schizophrenia, schizoaffective or cognitive disorders
Actively considering plans of suicide or homicide
Psychotic symptoms that in the investigator's opinion impair the patient's ability to give informed consent or make it unsafe for patient to be maintained without a neuroleptic
Unstable general medical conditions or a contraindication to the use of nepicastat
Women planning to become pregnant or breastfeed during the study
Current or pending incarceration
Terminal Illness","Arm 2

Nepicastat: 100-800mg",DrugBank:DB12979 | PubChem:9796181,Nepicastat,NCc1c[nH]c(=S)n1[C@H]1CCc2c(F)cc(F)cc2C1,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT00659360,NCT00659360_EG000,No,All,Adult | Older Adult,Phase 2,17,"Inclusion Criteria:

Leukocytes >= 3,000/mcL

Histologically or cytologically confirmed soft tissue sarcoma including, but not limited to any of:

Malignant fibrous histiocytoma
Fibrosarcoma - non infantile
Leiomyosarcoma - not uterine
Liposarcoma
Non-rhabdomyosarcoma soft tissue sarcoma
Rhabdomyosarcoma, not otherwise specified
Carcinosarcoma of the uterus
Dermatofibrosarcoma
Endometrial stromal sarcoma
Leiomyosarcoma - uterus

Recurrent or locally advanced or metastatic disease

No more than two prior lines of chemotherapy for metastatic disease (not including adjuvant chemotherapy)

Measurable disease, defined as >= 1 unidimensionally measurable lesion >= 20 mm by conventional techniques or >= 10 mm by spiral CT scan

Target measurable lesion must not have been in previous radiation portal, unless progression of this lesion after radiotherapy has been documented
ECOG performance status (PS) 0-2 or Karnofsky PS 60-100%
Life expectancy > 12 weeks
Recovered from all prior therapy
Platelet count >= 100,000/mcL
Hemoglobin > 9 g/dL
Total bilirubin =< 1.25 times upper limit of normal (ULN)
AST and ALT =< 3 times ULN
Creatinine =< 1.5 times ULN OR creatinine clearance >= 50 mL/min
Urine protein:creatinine ratio =< 1.0 OR 24-hour urine protein < 1,000 mg
ANC >1,500/mcL
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for 8 weeks after completion of study therapy
No history of allergic reactions attributed to compounds of similar chemical or biological composition to AZD0530
No QTc prolongation (defined as a QTc interval >= to 460 msecs) or other significant ECG abnormalities
No poorly controlled hypertension (i.e., systolic blood pressure (BP) >= 140 mm Hg, or diastolic BP >= 90 mm Hg)

No condition that impairs a patient's ability to swallow AZD0530 tablets, including any of the following:

Gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation
Prior surgical procedures affecting absorption
Active peptic ulcer disease

Exclusion Criteria:

At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C)

No intercurrent cardiac dysfunction including, but not limited to, any of the following:

Symptomatic congestive heart failure
Unstable angina pectoris
Cardiac arrhythmia
No history of ischemic heart disease, including myocardial infarction
No uncontrolled intercurrent illness including, but not limited to ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements
More than 4 weeks since prior radiotherapy
More than 7 days since prior and no concurrent prohibited CYP3A4-active agents or substances
No other concurrent investigational agents or commercial agents or therapies
No concurrent combination antiretroviral therapy for HIV-positive patients
No known brain metastases","Patients receive oral AZD0530 once daily in the absence of disease progression or unacceptable toxicity.

saracatinib: Given orally",ChEMBL:CHEMBL217092 | DrugBank:DB11805 | PubChem:10302451,Saracatinib,CN1CCN(CCOc2cc(OC3CCOCC3)c3c(Nc4c(Cl)ccc5c4OCO5)ncnc3c2)CC1,,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT00660348,NCT00660348_EG000,No,All,Adult | Older Adult,Not Applicable,1,"DISEASE CHARACTERISTICS:

Inclusion criteria:

Histologically confirmed adenocarcinoma of the pancreas

Mixed adenocarcinoma tumors allowed provided the predominant invasive component of the tumor is adenocarcinoma
Locally advanced, unresectable, or metastatic disease
Patients must be within two months of diagnosis or have started chemotherapy within 60 days of study
Average pain score ≥ 4/10 over a 7-day period on a verbal numerical rating scale

Exclusion criteria:

Known brain metastases
Tumor with clinically significant obstruction of the spinal canal

PATIENT CHARACTERISTICS:

Inclusion criteria:

Karnofsky performance status 60-100%
ANC ≥ 1,500 cells/mm³
Hematocrit ≥ 28%
WBC ≥ 3,500 cells/mm³
Platelets ≥ 90,000/mm³
Serum creatinine ≤ 2.0 mg/dL
Bilirubin ≤ 2.5 mg/dL
AST/ALT ≤ 5 times upper limit of normal (ULN)
Alkaline phosphatase ≤ 5 times ULN
INR ≤ 1.5
Not pregnant or nursing
Negative pregnancy test
Mini-mental status exam score ≥ 22

Exclusion criteria:

Uncontrolled medical conditions that could potentially increase the risk of toxicities or complications of this therapy, including any of the following:

Gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation
Active peptic ulcer disease
Active infections
Insensitive to opioid medication for cancer pain
Insufficient tissue or decubitus ulcer near device implantation site
Current history of substance abuse

PRIOR CONCURRENT THERAPY:

Minor procedures (i.e., dental work or skin biopsy), tumor biopsies, and biliary stent placement are allowed
No prior surgical procedures affecting absorption
Prior or other concurrent pain medications are allowed
Concurrent chemotherapy or radiotherapy allowed at the discretion of the treating physician","morphine given traditionally (IV, pill, patch)

morphine sulfate: This is morphine given in the traditional methods.",PubChem:16051935,Morphine Sulfate,CN1CCC23c4c5ccc(O)c4OC2C(O)C=CC3C1C5.CN1CCC23c4c5ccc(O)c4OC2C(O)C=CC3C1C5.O=S(=O)(O)O,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00661492,NCT00661492_EG001,No,Male,Adult | Older Adult,Phase 2,39,"Inclusion Criteria:

Histologically confirmed adenocarcinoma of the prostate. Note: Patients may have either measurable or non-measurable disease.
Radiographic evidence of regional or distant metastases
Current evidence of progression (by PSA and/or imaging studies) despite standard hormonal therapy.
Progression by PSA will be defined as: A rising PSA defined as: at least 2 rises in PSA over a reference value (PSA #1). The first rising PSA (PSA #2) must be taken at least 1 week after PSA #1. A third PSA (PSA #3) is required to be greater than PSA #2; if not, a fourth PSA (PSA #4) is required to be greater than PSA #2. Progression for nonmeasurable disease will be defined as 2 or more new bone lesions; for measurable disease, progression will be defined by standard RECIST criteria.
For patients who have been on antiandrogen therapy (ie, bicalutamide, flutamide, etc.), patients must have discontinued anti-androgen therapy for at least 6 weeks (4 weeks for flutamide) without evidence of an antiandrogen withdrawal response. A washout period will not be required for patients who did not respond to an antiandrogen prescribed as second line hormonal therapy. For patients whose progression is documented by PSA, the last required PSA must be after the required anti-androgen washout period (4-6 weeks as appropriate).
One prior docetaxel-containing regimen. Patients must have received at least 2 doses in an every 3-week schedule or 6 doses on a weekly schedule of docetaxel. Patients may have discontinued therapy due to progression, intolerance, completion of planned therapy, or other reasons. Chemotherapy treatment with any second-line regimen will not be permitted. Patients who have been previously treated with a first-line docetaxel-based doublet regimen will be eligible for this study, (eg, patients treated on a prior first-line trial containing a docetaxel/carboplatin or other docetaxel-based doublet).
Serum testosterone levels (See protocol for specific details) (unless surgically castrate). Patients must continue androgen deprivation with an LHRH agonist if they have not undergone orchiectomy
ECOG performance status

Laboratory criteria for entry:

absolute neutrophil count
platelets
bilirubin
AST or ALT
Life expectancy greater than 3 months
Age greater than or equal to 18 years
Agree to use contraceptives while on study if sexually active, and for 2 months after the last dose of study drug.
Has signed a Patient Informed Consent Form
Has signed a Patient Authorization Form

Exclusion Criteria:

More than 1 prior chemotherapy regimen for metastatic disease
Prior history of uncontrolled congestive heart failure or left ventricular ejection fraction (LVEF) that is less than the institution's lower limit of normal on MUGA or echocardiogram
A second active malignancy (diagnosed within 5 years) except adequately treated non-melanoma skin cancer or other non-invasive or in-situ neoplasm
Significant active concurrent medical illness or infection
Treatment with chemotherapy for AIPC within the past 21 days
Prior treatment with Novantrone (mitoxantrone)
Prior therapy which specifically and directly targets the EGFR pathway
Prior severe infusion reaction to a monoclonal antibody
Recent myocardial infarction (within prior 6 months)
Prior treatment with radionuclides, with the exception of prior treatment with samarium, which will be allowed provided at least 8 weeks have passed since administration.
Is receiving concurrent immunotherapy, hormonal therapy, radiation therapy, or any other non-protocol therapy (excluding LHRH antagonist)
Is receiving concurrent investigational therapy or has received such therapy within the past 30 days
Has evidence of CNS involvement
Has a serious uncontrolled intercurrent medical or psychiatric illness, including serious infection.
Is unable to comply with requirements of study",Novantrone,ChEMBL:CHEMBL58 | DrugBank:DB01204 | PubChem:4212,Mitoxantrone,O=C1c2c(O)ccc(O)c2C(=O)c2c(NCCNCCO)ccc(NCCNCCO)c21,L01DB07,1.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,1.0,1.0,0.0,1.0,1.0,1.0,0.0,1.0,0.0,0.0,1.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0
NCT00661960,NCT00661960_EG002,Accepts Healthy Volunteers,All,Adult,Not Applicable,25,"Inclusion Criteria:

willing to sign consent form
no known GI pathology
no anticipated antiretroviral therapy adjustments or changes
males & females between the ages of 18 & 50 years
no active opportunistic infections (OI) or therapy for OI within 30 days of entry
can be on secondary prophylaxis with a history of AIDS defining illness
per standard of care requirements, all females of child-bearing potential must agree to use barrier methods to prevent pregnancy or be abstinent from activity while on study

Exclusion Criteria:

abnormal coagulation parameters (PT > or equal to 1.2 ULN)
thrombocytopenia (platelet count < 50,000 within 6 weeks)
contra-indications to upper endoscopy or conscious sedation
anemia (> or equal to grade 1)
aspirin, ibuprofen, warfarin or other agents that interfere with the coagulation cascade are prohibited within 1 week of endoscopy",HIV-Positive volunteers taking efavirenz or any other non-nucleoside reverse transcriptase inhibitors (NNRTI) in combination with two other nucleoside reverse transcriptase inhibitor (NRTI) medications,ChEMBL:CHEMBL223228 | DrugBank:DB00625 | PubChem:64139,Efavirenz,O=C1Nc2ccc(Cl)cc2[C@@](C#CC2CC2)(C(F)(F)F)O1,J05AG03 | J05AR06 | J05AR11,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00662532,NCT00662532_EG000,No,All,Adult | Older Adult,Phase 3,22,"Inclusion Criteria:

21 years of age and good general health
appropriately documented Informed Consent
willing to adhere to the study schedule, prohibitions and restrictions specified in the protocol
female subjects must meet the pregnancy and contraceptive requirements
must have oral health appropriate for study inclusion

Exclusion Criteria:

oral health inappropriate for study inclusion
females self-reporting pregnancy or lactation, or having a positive urine pregnancy result
reporting any of the following conditions:
allergy to a tetracycline-class drug
systemic medical conditions requiring antibiotic prophylaxis prior to invasive dental procedures
active systemic infectious disease such as hepatitis, human immunodeficiency virus (HIV) or tuberculosis
diagnosed with clinically significant or unstable organic disease, or compromised healing potential, heart murmurs, histories of rheumatic fever, valvular disease or prosthetic joint replacement
participation in a dental clinical trial or use of an investigational drug within 30 days of enrollment
employees of the Investigator or study center, with direct involvement in the proposed study or other studies, as well as family members of the employees or the Investigator
anyone who the investigator determines should not be included in the study for any reason that could compromise safety or the analysis of study results",1 mg microspheres of minocycline hydrochloride,PubChem:54685925,Minocycline hydrochloride,CN(C)c1ccc(O)c2c1CC1CC3C(N(C)C)C(=O)C(C(N)=O)=C(O)C3(O)C(=O)C1=C2O.Cl,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0
NCT00665652,NCT00665652_EG000,No,All,Adult | Older Adult,Phase 2,8,"Inclusion Criteria:

Clinically proven MGUS associated neuropathy with a Total Neuropathy Score (TNS) ≥5 (determined by exam, history and confirmatory EDX testing in association with MGUS (IgM,IgG,IgA))
Disease duration less than or equal to 8 years
Able to take Plavix 75mg/day or aspirin 325 mg daily as prophylactic anticoagulation. (patients currently taking warfarin with a stable INR may stay on current dose)

Exclusion Criteria:

Patients previously treated with thalidomide
Patients previously treated with lenalidomide
Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs
Known positive for HIV or infectious hepatitis, type A, B or C
Medical history of deep venous thrombosis or hyper-coagulable state
Gastrointestinal abnormalities including: inability to take oral medication, requirement for intravenous alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease
Patients with dementia, other serious neurological diseases, uncompensated medical illness, substance abuse and debilitating psychiatric illness.
A serious uncontrolled medical disorder or active infection that would impair the patient's ability to receive study treatment. Significant cardiac disease, including uncontrolled high blood pressure, unstable angina, congestive heart failure, myocardial infarction within the previous 6 months or serious cardiac arrhythmias will be excluded.
Medical conditions associated with neuropathy such as active thyroid disease, diabetes mellitus, and lupus, nutritional deficiencies, malignancy, human immunodeficiency virus infection, alcohol dependence, amyloidosis, or connective tissue diseases and Guillain-Barre Syndrome. Medications or toxic exposures known to cause neuropathy, or a family history of neuropathy will also be grounds for exclusion.
Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide).
Subjects who are allergic to aspirin or Plavix (clopidogrel)",Lenalidomide: Subjects will receive lenalidomide 25 mg per day for days 1-21 followed by 7 days rest (28-day cycle) for 12 cycles.,ChEMBL:CHEMBL848 | DrugBank:DB00480 | PubChem:216326,Lenalidomide,Nc1cccc2c1CN(C1CCC(=O)NC1=O)C2=O,L04AX04,1.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00666757,NCT00666757_EG002,No,All,Adult | Older Adult,Phase 4,57,"Inclusion criteria:

At least 18 years of age
Have major depression and are currently in a severe depressive episode
Have a degree of understanding such that patient can communicate with the investigator and study staff
All females must test negative for pregnancy
Females of childbearing potential must use reliable method of birth control during the study and for 1 month after taking the last dose of study drug

Exclusion criteria:

Have not responded to duloxetine for depression in the past
Have a history of bipolar disorder, a psychotic disorder (such as schizophrenia), a cognitive disorder (such as moderate or severe dementia), or obsessive-compulsive disorder (OCD)
Are at significant risk for suicide
Have not responded to 2 or more adequate trials of antidepressant medications during the current depressive episode
Have a serious, unstable medical condition
Have a current or recent history of substance abuse or dependence
Have had electroconvulsive therapy (ECT), transcranial magnetic stimulation (rTMS), or vagus nerve stimulation (VNS) in the past year
Have started psychotherapy within 6 weeks prior to study entry
Have a serious medical illness or clinically significant laboratory abnormality that is not stabilized or is anticipated, in the judgment of the investigator, to require hospitalization or use of an excluded medication during the course of the study",20-80 mg orally daily for 12 weeks,ChEMBL:CHEMBL41 | DrugBank:DB00472 | PubChem:3386,Fluoxetine,CNCCC(Oc1ccc(C(F)(F)F)cc1)c1ccccc1,N06AB03 | N06CA03,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT00667095,NCT00667095_EG001,No,Female,Adult | Older Adult,Phase 3,10,"Inclusion Criteria:

Female patient aged 18 years or older
No evidence of stress urinary incontinence on physical examination or urodynamics
Patients who have failed prior drug therapy for overactive bladder or detrusor hyperreflexia
Patients with symptoms and signs of OAB, detrusor hyperreflexia, urinary urgency, urinary urge incontinence.
Patient who is mentally competent with the ability to understand and comply with the requirements of the study
Patient who agrees to be available for the follow-up evaluations as required by the protocol
Patient who has given signed informed consent

Exclusion Criteria:

Patient with Post-Void Residual Urine (PVRU) greater than 100 ml on repeated measures. (Patient with a single PVRU of >100 ml and followed by two consecutive PVRU measurements of <100 ml may be included in the study)
Patient with greater than vesicoureteral reflux grade 1, interstitial cystitis, genitourinary fistulae
Patient with pelvic organ prolapse stage III or IV, i.e. the most distal part of the prolapse protruding more than 1 cm beyond the hymen (>+1), at straining
Patient with un-investigated hematuria
Patient with lower tract genitourinary malignancies
Patient on current medication for stress urinary incontinence, such as alpha-adrenergic agonists or duloxetine, within three weeks prior to completing the baseline Bladder Diary (estrogen therapy on a stable dose for at least two months prior to study start is allowed)
Patient with ongoing complications of prior anti-incontinence surgery
Patient who is pregnant, lactating, or planning to become pregnant within the study period
Patient who has received pelvic radiation
Patient with any condition, which could lead to significant postoperative complications, including current infection and uncontrolled diabetes.
Patient who is morbidly obese (defined as BMI > 40 Kg/m2)
Patient who is bedridden, institutionalized or in such physical condition that she cannot move to the closest bathroom without assistance from another person
Patient with current or acute urinary tract infection, including cystitis or urethritis. (Patient with such infections should be treated with antibiotics, with subsequent urinalysis tests confirming the absence of such infection before study inclusion)
Patient with any condition that would preclude treatment due to contraindications and/or warnings in the study product's labeling
Patient on immunomodulatory therapy (suppressive or stimulatory)
Patient with known lidocaine hypersensitivity or hypersensitivity to any anesthetics to be used during the treatment session/surgical procedure
Patient with a concurrent use of another study product within two weeks prior to study start, or who concurrently participate in any other clinical study
Any disease that in the opinion of the Investigator would make the patient unsuitable for the study
Patient with a life expectancy of less than 12 months","Dimethyl Sulfoxide (DMSO) 50% w/w aqueous solution, 50 cubic centimeters

DMSO Instillation: DMSO 50% w/w aqueous solution; 50 cubic centimeters instilled into the bladder via ureteral catheter and retained up to 30 minutes then spontaneously voided.",ChEMBL:CHEMBL504 | DrugBank:DB01093 | PubChem:679,DIMETHYL SULFOXIDE,CS(C)=O,G04BX13 | M02AX03,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00668395,NCT00668395_EG001,Accepts Healthy Volunteers,All,Adult,Not Applicable,73,"Inclusion Criteria:

Male and female subjects between 18 and 49 years old.
HIV negative. All potential subjects will be HIV tested at screening visit.
Healthy individuals without any significant medical condition.
Adherence to the study dietary restrictions.
Nonsmoker or individuals willing to refrain from smoking or use of tobacco or marijuana for at lest one month prior to and until the completion of the study. The entire study lasts for 30 days.
Ability to commit the time requested for this study.

Exclusion Criteria:

History or current HIV infection.
Life style that places you at a higher risk for contracting HIV (e.g. drug abuse, excessive alcohol drinking, and having multiple sexual partners).
Does not consent to HIV testing.
Underweight (weigh less than 52 kg or 114 lb) or overweight (body mass index (BMI) greater than 32).
History or current alcohol or drug abuse (more than 3 alcoholic drinks per day on a regular basis).
History of intolerance or allergic reaction (e.g. rash) to efavirenz, midazolam, tolbutamide, caffeine, or omeprazole.
History or current significant health conditions such as heart, liver, or kidney.
History or current psychiatric illness such as depression, anxiety, or nervousness.
History or current gastrointestinal disorders such as persistent diarrhea or malabsorption that would interfere with the absorption of orally administered drugs.
Individuals having a serious infection within the last month.
Donation of blood within the past two months.
Blood hemoglobin less than 12.5 mg/dl.
Individuals who are regularly taking prescriptions, over-the-counter, herbal or dietary supplements, alternative medications, or hormonal agents (i.e. oral contraceptives, intera-uterine device with hormones).
Females with a positive pregnancy test.
Breastfeeding.
Females of child-bearing potential who are unable or unwilling to either practice abstinence or use two non-hormonal forms of birth control (e.g. condom, contraceptive foams) up until the study completion, which will take a total of 30 days.
Participation in a research study or use of an investigational drug in the last two months.
An employee or student under supervision of any of the investigators of this study.
Individuals who cannot state a good understanding of this study including risks and requirements; are unable to follow the rules of this study.
Individuals with a gene type (DNA) that does not match one of the available genetic slot categories.",Intermediate metabolizer,ChEMBL:CHEMBL223228 | DrugBank:DB00625 | PubChem:64139,Efavirenz,O=C1Nc2ccc(Cl)cc2[C@@](C#CC2CC2)(C(F)(F)F)O1,J05AG03 | J05AR06 | J05AR11,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00668395,NCT00668395_EG002,Accepts Healthy Volunteers,All,Adult,Not Applicable,73,"Inclusion Criteria:

Male and female subjects between 18 and 49 years old.
HIV negative. All potential subjects will be HIV tested at screening visit.
Healthy individuals without any significant medical condition.
Adherence to the study dietary restrictions.
Nonsmoker or individuals willing to refrain from smoking or use of tobacco or marijuana for at lest one month prior to and until the completion of the study. The entire study lasts for 30 days.
Ability to commit the time requested for this study.

Exclusion Criteria:

History or current HIV infection.
Life style that places you at a higher risk for contracting HIV (e.g. drug abuse, excessive alcohol drinking, and having multiple sexual partners).
Does not consent to HIV testing.
Underweight (weigh less than 52 kg or 114 lb) or overweight (body mass index (BMI) greater than 32).
History or current alcohol or drug abuse (more than 3 alcoholic drinks per day on a regular basis).
History of intolerance or allergic reaction (e.g. rash) to efavirenz, midazolam, tolbutamide, caffeine, or omeprazole.
History or current significant health conditions such as heart, liver, or kidney.
History or current psychiatric illness such as depression, anxiety, or nervousness.
History or current gastrointestinal disorders such as persistent diarrhea or malabsorption that would interfere with the absorption of orally administered drugs.
Individuals having a serious infection within the last month.
Donation of blood within the past two months.
Blood hemoglobin less than 12.5 mg/dl.
Individuals who are regularly taking prescriptions, over-the-counter, herbal or dietary supplements, alternative medications, or hormonal agents (i.e. oral contraceptives, intera-uterine device with hormones).
Females with a positive pregnancy test.
Breastfeeding.
Females of child-bearing potential who are unable or unwilling to either practice abstinence or use two non-hormonal forms of birth control (e.g. condom, contraceptive foams) up until the study completion, which will take a total of 30 days.
Participation in a research study or use of an investigational drug in the last two months.
An employee or student under supervision of any of the investigators of this study.
Individuals who cannot state a good understanding of this study including risks and requirements; are unable to follow the rules of this study.
Individuals with a gene type (DNA) that does not match one of the available genetic slot categories.",Slow metabolizer,ChEMBL:CHEMBL223228 | DrugBank:DB00625 | PubChem:64139,Efavirenz,O=C1Nc2ccc(Cl)cc2[C@@](C#CC2CC2)(C(F)(F)F)O1,J05AG03 | J05AR06 | J05AR11,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00669019,NCT00669019_EG000,No,All,Adult | Older Adult,Phase 2,23,"Inclusion Criteria:

Histologically or cytologically confirmed metastatic melanoma

Stage IV or unresectable stage III disease
Measurable disease, defined as ≥ 1 lesion that can be accurately measured in ≥ 1 dimension (longest diameter to be recorded) as ≥ 20 mm by conventional techniques or as ≥ 10 mm by spiral computed tomography (CT) scan
No known brain metastases
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2 OR Karnofsky PS 60-100%
Life expectancy > 12 weeks
White blood cell (WBC) ≥ 3,000/mcL
Absolute neutrophil count (ANC) ≥ 1,500/mcL
Platelet count ≥ 100,000/mcL
Hemoglobin ≥ 9 g/dL
Total bilirubin normal
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times upper limit of normal
Creatinine normal OR creatinine clearance ≥ 60 mL/min
Proteinuria ≤ 1+ by dipstick OR 24-hour urine protein ≤ 1 g
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception prior to study until completion of study treatment
No history of allergic reactions attributed to compounds of similar chemical or biologic composition to AZD0530
No QTc prolongation (defined as a QTc interval ≥ 480 msecs) or other significant electrocardiogram (ECG) abnormalities
No poorly controlled hypertension (e.g., systolic blood pressure [BP] of ≥ 140 mm Hg or diastolic BP of ≥ 90 mm Hg)
No condition (e.g., gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation), prior surgical procedures affecting absorption, or active peptic ulcer disease that impairs the ability to swallow AZD0530 tablets

No intercurrent cardiac dysfunction including, but not limited to, any of the following:

Symptomatic congestive heart failure
Unstable angina pectoris
Cardiac arrhythmia
No recent history of ischemic heart disease including myocardial infarction
No uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements
No other malignancy within the past 5 years, except definitively treated, localized, nonmelanoma skin cancer or low-grade cervical neoplasm
At least 4 weeks since prior and no more than one prior treatment regimen for advanced disease
No prior kinase inhibitor with activity against Src kinases for metastatic melanoma
More than 4 weeks since prior luteinizing hormone-releasing hormone agonists
No concurrent combination antiretroviral therapy for human immunodeficiency virus (HIV)-positive patients

No concurrent prohibited cytochrome P450 3A4 (CYP3A4)-active agents or substances

Prohibited drugs should be discontinued 7 days prior to the administration of the first dose of AZD0530 and for 7 days following discontinuation of AZD0530
No other concurrent investigational agents or commercial therapies",Patients receive saracatinib 175 mg oral once daily in the absence of disease progression or unacceptable toxicity.,ChEMBL:CHEMBL217092 | DrugBank:DB11805 | PubChem:10302451,Saracatinib,CN1CCN(CCOc2cc(OC3CCOCC3)c3c(Nc4c(Cl)ccc5c4OCO5)ncnc3c2)CC1,,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00669279,NCT00669279_EG000,No,All,Adult | Older Adult,Phase 4,41,"Inclusion Criteria:

At least 18 years of age
Hypertension (untreated or treated with no more then one anti-hypertensive drug)

Exclusion Criteria:

Secondary forms of hypertension (including sleep apnea)
Patients currently treated with two or more antihypertensive drugs
Patients taking antihypertensive drugs with properly measured clinic systolic blood pressure greater then 170mmHg
Isolated systolic hypertension
Other diseases requiring treatment with blood pressure lowering medications
Heart rate less then 55 beats/min (in the absence of beta-blocker therapy)
Known cardiovascular disease including history of angina pectoris, heart failure, presence of a cardiac pacemaker, history of myocardial infarction or revascularization procedure, or cerebrovascular disease (including stroke and TIA)
Known diabetes mellitus (Type 1 or 2)
Renal insufficiency defined as a serum creatinine greater then 1.5mg/dL in males and 1.4mg/dL in females
Primary renal disease
Pregnancy or lactation
History of Raynaud's syndrome
Alcoholism and recreational drug use (due to compliance concerns)","Controlled-release carvedilol 20 mg - Forced titration occurred in carvedilol to 40 mg at week one, and to 80 mg at week two.",PubChem:11954344,Carvedilol Phosphate,COc1ccccc1OCCNCC(O)COc1cccc2[nH]c3ccccc3c12.COc1ccccc1OCCNCC(O)COc1cccc2[nH]c3ccccc3c12.O.O=P(O)(O)O.O=P(O)(O)O,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00670306,NCT00670306_EG000,No,Male,Adult | Older Adult,Phase 3,528,"Inclusion Criteria:

Benign Prostatic Hyperplasia, based on medical history
Voiding symptoms
Uroflow (max) 5-15mL/sec

Exclusion Criteria:

Urgent need for prostate surgery
History of allergic reaction to peptide
Major organ dysfunction
Prior surgical treatment of the prostate or bladder
Current or recent treatment with sexual hormone drugs or 5 α reductase inhibitors or botulinum toxin type a (Botox) within the last 6 months prior to trial medication at Week 0 or with α blockers or saw palmetto within the last 6 weeks prior to trial medication at Week 0
Urologic disorders including neurogenic bladder dysfunction due to diabetes mellitus or documented neurologic disorder, urethral stricture disease or history of pelvic radiation therapy
History of acute obstructive, infectious, or neurological disorders of the genitourinary tract within the last 3 months","Drug: Cetrorelix 52 mg week 0, and 26 mg week 2, intra muscular-2 doses in 2 weeks and follow up to week 26.",PubChem:92135817,Dicetrorelix pamoate,CC(=O)NC(Cc1ccc2ccccc2c1)C(=O)NC(Cc1ccc(Cl)cc1)C(=O)NC(Cc1cccnc1)C(=O)NC(CO)C(=O)NC(Cc1ccc(O)cc1)C(=O)NC(CCCNC(N)=O)C(=O)NC(CC(C)C)C(=O)NC(CCCN=C(N)N)C(=O)N1CCCC1C(=O)NC(C)C(N)=O.CC(=O)NC(Cc1ccc2ccccc2c1)C(=O)NC(Cc1ccc(Cl)cc1)C(=O)NC(Cc1cccnc1)C(=O)NC(CO)C(=O)NC(Cc1ccc(O)cc1)C(=O)NC(CCCNC(N)=O)C(=O)NC(CC(C)C)C(=O)NC(CCCN=C(N)N)C(=O)N1CCCC1C(=O)NC(C)C(N)=O.O=C(O)c1cc2ccccc2c(Cc2c(O)c(C(=O)O)cc3ccccc23)c1O,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT00670449,NCT00670449_EG000,No,All,Adult,Phase 2,46,"Inclusion Criteria:

Patients who completed 6 months of treatment with the study drug and the Month 6 visit in the core study NCT00537082.
Females of childbearing potential who have a negative pregnancy test in the core study NCT00537082.

Exclusion Criteria:

Patients who permanently discontinued study drug treatment prior to the Month 6 visit in the core study NCT00537082.

Other protocol-defined inclusion/exclusion criteria applied to the study.",Patients who received fingolimod 1.25 mg orally once daily in the core study continued on the same dose in this extension study.,ChEMBL:CHEMBL314854 | DrugBank:DB08868 | PubChem:107970,Fingolimod,CCCCCCCCc1ccc(CCC(N)(CO)CO)cc1,L04AA27,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,1.0,1.0,1.0,1.0,1.0,0.0,1.0,0.0,1.0,0.0,1.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT00670449,NCT00670449_EG001,No,All,Adult,Phase 2,47,"Inclusion Criteria:

Patients who completed 6 months of treatment with the study drug and the Month 6 visit in the core study NCT00537082.
Females of childbearing potential who have a negative pregnancy test in the core study NCT00537082.

Exclusion Criteria:

Patients who permanently discontinued study drug treatment prior to the Month 6 visit in the core study NCT00537082.

Other protocol-defined inclusion/exclusion criteria applied to the study.",Patients who received fingolimod 0.5 orally once daily in the core study continued on the same dose in this extension study.,ChEMBL:CHEMBL314854 | DrugBank:DB08868 | PubChem:107970,Fingolimod,CCCCCCCCc1ccc(CCC(N)(CO)CO)cc1,L04AA27,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,1.0,1.0,1.0,1.0,1.0,1.0,1.0,0.0,1.0,0.0,1.0,1.0,1.0,0.0,0.0,1.0,0.0
NCT00670449,NCT00670449_EG002,No,All,Adult,Phase 2,23,"Inclusion Criteria:

Patients who completed 6 months of treatment with the study drug and the Month 6 visit in the core study NCT00537082.
Females of childbearing potential who have a negative pregnancy test in the core study NCT00537082.

Exclusion Criteria:

Patients who permanently discontinued study drug treatment prior to the Month 6 visit in the core study NCT00537082.

Other protocol-defined inclusion/exclusion criteria applied to the study.",Patients who were randomized to placebo in the core study were re-randomized to either fingolimod 0.5 or 1.25 mg (1:1) orally once daily in this extension study.,ChEMBL:CHEMBL314854 | DrugBank:DB08868 | PubChem:107970,Fingolimod,CCCCCCCCc1ccc(CCC(N)(CO)CO)cc1,L04AA27,1.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT00670449,NCT00670449_EG003,No,All,Adult,Phase 2,27,"Inclusion Criteria:

Patients who completed 6 months of treatment with the study drug and the Month 6 visit in the core study NCT00537082.
Females of childbearing potential who have a negative pregnancy test in the core study NCT00537082.

Exclusion Criteria:

Patients who permanently discontinued study drug treatment prior to the Month 6 visit in the core study NCT00537082.

Other protocol-defined inclusion/exclusion criteria applied to the study.",Patients who were randomized to placebo in the core study were re-randomized to either fingolimod 0.5 or 1.25 mg (1:1) orally once daily in this extension study.,ChEMBL:CHEMBL314854 | DrugBank:DB08868 | PubChem:107970,Fingolimod,CCCCCCCCc1ccc(CCC(N)(CO)CO)cc1,L04AA27,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,1.0,1.0,1.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT00672620,NCT00672620_EG001,No,All,Adult | Older Adult,Phase 3,149,"Inclusion Criteria:

Suffers from a major depressive episode as the primary diagnosis according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria.
The reported duration of the current major depressive episode is at least 3 months.

Exclusion Criteria:

Has 1 or more the following:

Any current psychiatric disorder other than major depressive disorder as defined in the DSM-IV-TR.
Current or past history of: manic or hypomanic episode, schizophrenia, or any other psychotic disorder, including major depression with psychotic features, mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in the DSM-IV-TR.
Any substance disorder (except nicotine and caffeine) within the previous 6 months as defined in the DSM-IV-TR.
Presence or history of a clinically significant neurological disorder (including epilepsy).
Neurodegenerative disorder (Alzheimer disease, Parkinson disease, multiple sclerosis, Huntington disease, etc).
Any Axis II disorder that might compromise the study.
Has a significant risk of suicide according to the investigator's opinion or has a score ≥5 on item 10 (suicidal thoughts) of the Montgomery Åsberg Depression Rating Scale (MADRS) or has made a suicide attempt in the previous 6 months.
The current depressive symptoms of the patient are considered by the investigator to have been resistant to 2 adequate antidepressant treatments of at least 6 weeks duration each.
Has received electroconvulsive therapy within 6 months prior to Screening.
Is currently receiving formal cognitive or behavioral therapy, systematic psychotherapy, or plans to initiate such therapy during the study.","Vortioxetine 2.5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.",ChEMBL:CHEMBL2104993 | DrugBank:DB09068 | PubChem:9966051,Vortioxetine,Cc1ccc(Sc2ccccc2N2CCNCC2)c(C)c1,N06AX26,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT00672620,NCT00672620_EG002,No,All,Adult | Older Adult,Phase 3,153,"Inclusion Criteria:

Suffers from a major depressive episode as the primary diagnosis according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria.
The reported duration of the current major depressive episode is at least 3 months.

Exclusion Criteria:

Has 1 or more the following:

Any current psychiatric disorder other than major depressive disorder as defined in the DSM-IV-TR.
Current or past history of: manic or hypomanic episode, schizophrenia, or any other psychotic disorder, including major depression with psychotic features, mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in the DSM-IV-TR.
Any substance disorder (except nicotine and caffeine) within the previous 6 months as defined in the DSM-IV-TR.
Presence or history of a clinically significant neurological disorder (including epilepsy).
Neurodegenerative disorder (Alzheimer disease, Parkinson disease, multiple sclerosis, Huntington disease, etc).
Any Axis II disorder that might compromise the study.
Has a significant risk of suicide according to the investigator's opinion or has a score ≥5 on item 10 (suicidal thoughts) of the Montgomery Åsberg Depression Rating Scale (MADRS) or has made a suicide attempt in the previous 6 months.
The current depressive symptoms of the patient are considered by the investigator to have been resistant to 2 adequate antidepressant treatments of at least 6 weeks duration each.
Has received electroconvulsive therapy within 6 months prior to Screening.
Is currently receiving formal cognitive or behavioral therapy, systematic psychotherapy, or plans to initiate such therapy during the study.","Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks, then placebo-matching capsules, orally, once daily, for 1 week following the treatment period.",ChEMBL:CHEMBL2104993 | DrugBank:DB09068 | PubChem:9966051,Vortioxetine,Cc1ccc(Sc2ccccc2N2CCNCC2)c(C)c1,N06AX26,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT00672958,NCT00672958_EG001,No,All,Adult | Older Adult,Phase 3,299,"Inclusion Criteria:

Suffers from a major depressive episode (MDE) as the primary diagnosis according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria.
The reported duration of the current MDE is at least 3 months.
Has a Montgomery Åsberg Depression Rating Scale total score greater than or equal to 30.
Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.

Exclusion Criteria:

Has received any investigational compound less than 30 days before Screening or 5 half-lives prior to Screening, whichever is longer.
Has received Lu AA21004 in a previous clinical study.

Has 1 or more the following:

Any current psychiatric disorder other than major depressive disorder as defined in the DSM-IV-TR (as assessed by the Mini International Neuropsychiatric Interview)
Current or past history of: manic or hypomanic episode, schizophrenia, or any other psychotic disorder, including major depression with psychotic features, mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in the DSM-IV-TR.
Any substance disorder (except nicotine and caffeine) within the previous 6 months as defined in the DSM-IV-TR.
Presence or history of a clinically significant neurological disorder (including epilepsy).
Neurodegenerative disorder (Alzheimer disease, Parkinson disease, multiple sclerosis, Huntington disease, etc).
Any Axis II disorder that might compromise the study.

Is required to take or intends to continue taking any disallowed medication, any prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including:

Narcotic analgesics
Nonsteroidal anti-inflammatory drugs
Rifampin
Macrolide antibiotics
Hormones (only thyroid hormone replacement, contraceptives [oral, patch], estrogen and progesterone replacement therapy are allowed in chronic use)
Hypoglycemic agents (chronic use is allowed)
Insulin (chronic use is allowed)
Systemic steroids
Quinidine
Antineoplastics
Antiobesity agents
Has a significant risk of suicide according to the investigator's opinion or has a score greater than or equal to 5 on item 10 (suicidal thoughts) of the Montgomery Åsberg Depression Rating Scale or has made a suicide attempt in the previous 6 months.
The current depressive symptoms are considered by the investigator to have been resistant to 2 adequate antidepressant treatments of at least 6 weeks duration each.
Has received electroconvulsive therapy within 6 months prior to Screening.
Is currently receiving formal cognitive or behavioral therapy, systematic psychotherapy, or plans to initiate such therapy during the study.
Has a clinically significant unstable illness, for example, hepatic impairment or renal insufficiency, or a cardiovascular, pulmonary, gastrointestinal, endocrine, neurological, rheumatologic, immunologic, infectious, skin and subcutaneous tissue disorders, or metabolic disturbance.
Has an alanine aminotransferase, aspartate aminotransferase or total bilirubin level greater than 1.5 times the upper limits of normal.
Has a serum creatinine greater than 1.5 times the upper limits of normal.
Has a previous history of cancer that had been in remission for less than 5 years prior to the first dose of study medication. This criterion does not include basal cell or Stage I squamous cell carcinoma of the skin.
Has clinically significant abnormal vital signs as determined by the investigator.
Has an abnormal electrocardiogram determined by the central reader and confirmed as clinically significant by the investigator.
Has 1 or more laboratory values outside the normal range, based on the blood or urine samples taken at the Screening Visit, that are considered by the investigator to be clinically significant.
Has a thyroid stimulating hormone value outside the normal range at Screening Visit that is determined to be clinically significant by the investigator.
Has a disease or takes medication that, in the opinion of the investigator, could interfere with the assessments of safety, tolerability, or efficacy.
Has previously enrolled in this study.","Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 6 weeks.",ChEMBL:CHEMBL2104993 | DrugBank:DB09068 | PubChem:9966051,Vortioxetine,Cc1ccc(Sc2ccccc2N2CCNCC2)c(C)c1,N06AX26,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00673712,NCT00673712_EG001,No,All,Adult | Older Adult,Phase 4,647,"Inclusion Criteria:

Men and women, >18 years of age;
Scheduled for elective cardiac surgical procedure, including coronary revasculari-zation or valve surgery;
Provision of informed consent

Exclusion Criteria:

Patients with a prior allergic reaction or dependency to morphine, Demerol, Di-laudid, Fentanyl, Marcaine (bupivacaine), lidocaine or Naropin (ropivacaine);
Cardiac transplant patients
Inability to perform follow-up assessments;
Pre-existing infection (pneumonia or surgical site)
Repeat of primary surgery","Opioid based analgesia including Patient controlled analgesia plus IM, Oral narcotics and other analgesics

Opioid based analgesia: Opioid Analgesic agents delivered by:

PCA on demand mode IV injections PRN IM injections PRN Oral PRN",ChEMBL:CHEMBL397976 | DrugBank:DB03088,PIDOLIC ACID,O=C1CC[C@@H](C(=O)O)N1,A12CC08,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00674570,NCT00674570_EG000,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 4,111,"Inclusion Criteria:

Veterans and civilians with an age range of 18 to 65 years
Participants must be physically healthy volunteers

Exclusion Criteria:

Individuals who fall outside the age range
Individuals with medical conditions that would interfere with participation
Other criteria","Hydrocortisone

Hydrocortisone: 25 mg/oral one hour prior to extinction task",ChEMBL:CHEMBL389621 | DrugBank:DB00741 | PubChem:5754,Hydrocortisone,[H][C@@]12CC[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)CC[C@@]21C,A01AC03 | A07EA02 | C05AA01 | D07AA02 | D07BA04 | D07CA01 | D07XA01 | H02AB09 | R01AD60 | S01BA02 | S01BB01 | S01CA03 | S01CB03 | S02BA01 | S02CA03 | S03CA04,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00674661,NCT00674661_EG001,No,All,Child | Adult | Older Adult,Phase 3,63,"Inclusion Criteria:

Diagnosis of ectasia after refractive surgery
Documented ectasia on Pentacam or topography map
BSCVA worse than 20/20
Must complete all study visits

Exclusion Criteria:

History of delayed wound healing
History of corneal melt or corneal dystrophy",riboflavin opthalmic solution without UVA irradiation,ChEMBL:CHEMBL1534 | DrugBank:DB00140 | PubChem:493570,Riboflavin,Cc1cc2nc3c(=O)[nH]c(=O)nc-3n(C[C@H](O)[C@H](O)[C@H](O)CO)c2cc1C,A11HA04 | S01XA26,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00674739,NCT00674739_EG001,No,All,Child | Adult | Older Adult,Phase 3,195,"Inclusion Criteria:

In good general health
Diagnosis of external genital / perianal warts with at least 2 warts and no more than 30 warts
Negative pregnancy test (for women who are able to become pregnant)

Exclusion Criteria:

Women who are pregnant, lactating or planning to become pregnant during the study
Evidence of clinically significant or unstable disease (such as stroke, heart attack)
Have any of the following conditions: HIV infection; current or history of high risk HPV infection (e.g., HPV 16, 18, etc.); outbreak of herpes genitalia in the wart areas; internal warts requiring or undergoing treatment; dermatological disease (e.g., psoriasis) or skin condition in the wart areas
Have received specific treatments in the treatment area(s) within the designated time period prior to study treatment initiation.",3.75% imiquimod cream applied once daily to wart areas for up to 8 weeks,ChEMBL:CHEMBL1282 | DrugBank:DB00724 | PubChem:57469,Imiquimod,CC(C)Cn1cnc2c(N)nc3ccccc3c21,D06BB10,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT00675441,NCT00675441_EG000,No,All,Adult | Older Adult,Phase 2,5,"Inclusion Criteria:

Patients with chronic GVHD following allogeneic HSCT of any source (bone marrow, peripheral blood or cord blood stem cells), from any donor type (related, unrelated, mismatched) and with any type of malignancy.
Patients must have failed a trial of steroids and calcineurin inhibitors. Steroids must have been given at an initial dose of 1 mg/kg/d of methylprednisolone (MP) or equivalent in combination with tacrolimus or cyclosporine. Steroid refractoriness or resistance will be defined as: 1- Lack of any response after 1 month of treatment with MP, including 15 days of at least 0.5 mg/kg/d, 2- Worsening of existing GVHD or new organ involvement at any time following one week of initiation of MP at 1 mg/kg/day, 3- Reflare or worsening of GVHD at any time during steroid taper.
Patients may have received steroids and calcineurin inhibitors (i.e. cyclosporine or tacrolimus) for chronic GVHD. Patients who have previously been treated for chronic GVHD with any other drug or treatment may be enrolled, provided the other drug or treatment was completed >/= 30 days before registration for study entry.
Eastern Cooperative Oncology Group (ECOG) performance status </= 2.
White Blood Count (WBC) >/= 2,500/mm^3, Absolute neutrophil count (ANC)>/= 1,000/mm^3, platelet count >/= 50,000/mm^3
Left ventricular ejection fraction >/= 40%. No uncontrolled arrythmias or symptomatic heart disease. forced expiratory volume at one second (FEV1), forced vital capacity (FVC) and diffusion capacity of lung for carbon monoxide (DLCO) >/= 40%.
Serum creatinine <2.0 mg/dL. Serum bilirubin <3 * upper limit of normal (ULN), aspartate aminotransferase (AST)/ serum glutamic-oxaloacetic transminase (SGOT) and Alanine transaminase (ALT)/ serum glutamic pyruvic transaminase (SGPT) < or = 5 * ULN. No evidence of chronic active hepatitis or cirrhosis.
No uncontrolled infections.
No evidence of malignancy (patients must be in complete remission from their malignancy)
Patients must be able to provide written informed consent, and be 18 years or older at the time of signing consent.
Patient must be able to return to clinic for follow up at least every 2 weeks for the first 2 months and at least monthly thereafter.
Women of childbearing potential must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL 10 - 14 days prior to therapy and repeated within 24 hours of starting study drug and must either commit to continued abstinence from heterosexual intercourse or agree to use 2 contraceptive methods. These birth control methods must be used for at least 4 weeks before, during and after lenalidomide therapy. Men must agree not to father a child and agrees to use a condom if his partner is of child bearing potential.
Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation. (patients intolerant to ASA may use low molecular weight heparin).

Exclusion Criteria:

Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
Pregnant or lactating females.
Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
Use of any other experimental drug or therapy within 28 days of baseline.
Known hypersensitivity to thalidomide.
The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
Any prior use of Lenalidomide.
Use of prior immunosuppressants other than steroids and calcineurin inhibitors (i.e. cyclosporine or tacrolimus).
Known positive for HIV or infectious hepatitis, type A, B or C","Lenalidomide 10 mg (capsule) by mouth on days 1-21 of a 28-day cycle, for a total of 6 cycles.",ChEMBL:CHEMBL848 | DrugBank:DB00480 | PubChem:216326,Lenalidomide,Nc1cccc2c1CN(C1CCC(=O)NC1=O)C2=O,L04AX04,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00678080,NCT00678080_EG000,Accepts Healthy Volunteers,Female,Adult,Not Applicable,25,"Inclusion Criteria:

The onset of T2DM for less than 10 years prior to the onset of pregnancy by patient history
Treatment with diet or oral hypoglycemic agents prior to pregnancy.
Pregnancies less than 20 weeks of pregnancy. This gestational age was chosen to include those women who initiated prenatal care in the second trimester, but still have the ability to improve their hemoglobin A1C (primary outcome) with medical therapy prior to delivery.
Newly diagnosed diabetes in the first 20 weeks of pregnancy. These women likely have had diabetes prior to the onset of pregnancy. They do not qualify for the diagnosis of gestational diabetes which is typically made after 20 weeks of pregnancy. Diagnosis will be made based on an elevated fasting blood glucose greater than 105 mg/dL, a 50 gram glucola result greater than 200 mg/dL or an abnormal 3 hour glucola test prior to 20 weeks of pregnancy. An abnormal 3-hour glucola test is defined as 2 out of 4 abnormal values.
Hemoglobin A1C <9%

Exclusion Criteria:

Gestational age greater than 20 weeks
Multiple gestations (twins or more gestations)
Type 1 diabetes by patient history
Known fetal chromosomal or structural defects
Contraindications to the use of metformin including renal disease, liver disease, prior myocardial infarction or sepsis.
Those with a hemoglobin A1C greater than 9%.
On insulin at the start of pregnancy","Metformin therapy

Metformin: Metformin 500 mg orally daily increased as needed to maintain glycemic control until a maximum of 2500 daily",ChEMBL:CHEMBL1431 | DrugBank:DB00331 | PubChem:4091,Metformin,CN(C)C(=N)NC(=N)N,A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00679627,NCT00679627_EG001,No,All,Adult | Older Adult,Phase 3,1024,"Inclusion Criteria:

Outpatients
diagnosed with mild to moderately-severe, probable or possible AD, established in accordance with the criteria defined by the National Institute of Neurological and Communicative Disorders and Stroke and Alzheimer's Disease Related Disorders Association or the Diagnostic and Statistical Manual, Fourth Edition
living with or have regular and frequent visits from a responsible caregiver.

Exclusion Criteria:

Neurodegenerative disorders other than AD, such as Parkinson's Disease, Frontotemporal Dementia or Huntington's disease
Any of specified conditions which may contribute to dementia
any of specified coexisting diseases, including significant cardiovascular disease.","During the titration period (Days 1 to 84), participants received galantamine controlled-release oral capsules 8 mg/day for the first 4 weeks, followed by 16 mg/day for the next 4 weeks, then 24 mg/day for the next 4 weeks (based on tolerability). During the long-term maintenance period (Months 4 to 24), participants received galantamine at the dosage achieved at Day 84 of the titration period and continued until the completion of the Month 24 visit. A one-time dose titration to 16 or 24 mg/day was allowed, based on the investigator's judgment and participant tolerability.",ChEMBL:CHEMBL659 | DrugBank:DB00674 | PubChem:9651,Galantamine,[H][C@]12C[C@@H](O)C=C[C@]13CCN(C)Cc1ccc(OC)c(c13)O2,N06DA04,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00682448,NCT00682448_EG000,No,All,Adult | Older Adult,Phase 4,12,"Inclusion Criteria:

Diagnosis of: Schizophrenia, Schizoaffective Disorder, Bipolar I or II or major depression with psychotic features who will be started on or who have just started taking Olanzapine (Zyprexa).

Exclusion Criteria:

Patients with either a history of diabetes mellitus or a baseline FBG>126 or two random blood sugars of > 200 or during a OGTT glucose level of > 200 two hours after a glucose load of 50 grams. (All American Diabetes Association criteria for diabetes mellitus).
Baseline liver function tests (SGOT, SGPT, AP) greater than 3X normal.
Chronic alcoholism
MDRD less than 60 ml/1.73 m2. Modification of Diet in Renal Disease (MDRD) Equation estimates the glomerular filtration rate as a measure of kidney function. This equation takes into account the plasma creatinine, age, race and gender, and is a more accurate estimation of glomerular filtration rate than serum creatinine alone.
Patients with unstable medical problems, including cardiovascular instability or significant congestive heart failure (as determined by study investigators).
Prolonged QTc greater than 430 ms on baseline EKG.
History of lactic acidosis.
History of hypoglycemia.
Current treatment with metformin or other antidiabetic agents.
Treatment with any antihyperlipidemic medication within 3 months of randomization.
Treatment with olanzapine or clozapine within 3 months of randomization.
Concurrent treatment with ziprasidone, risperidone, quetiapine or aripiprazole or any other neuroleptic medication.
Concurrent use of OTC chromium, gymnema or cimetidine will be prohibited. Patient may discontinue these medications up to one day prior to randomization.
Current treatment with corticosteroids.","Olanzapine plus metformin: olanzapine plus metformin 500 mg titrated up to but no greater than 2,000 mg based upon fasting blood glucose during study visits over six months.

Metformin: Drug: Metformin 500 mg po daily titrated up to but no greater than 2000 mg based upon fasting blood glucose during study visits over six months.",ChEMBL:CHEMBL1431 | DrugBank:DB00331 | PubChem:4091,Metformin,CN(C)C(=N)NC(=N)N,A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT00682890,NCT00682890_EG001,Accepts Healthy Volunteers,Female,Adult,Phase 4,28,"Inclusion Criteria:

Ages 18-45, , 8 menstrual cycles annually, elevated serum free testosterone, normal thyroid function test and serum prolactin, exclusion of late onset adrenal hyperplasia

Exclusion Criteria:

Diabetes mellitus, pulmonary, cardiac, renal, hepatic, cholestatic, neurologic, psychiatric, infectious, malignant diseases,history of breast cancer, history of Deep Vein Thrombosis, pregnancy and lactation.",metformin 2000 mg and birth control pill daily,ChEMBL:CHEMBL1431 | DrugBank:DB00331 | PubChem:4091,Metformin,CN(C)C(=N)NC(=N)N,A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00684177,NCT00684177_EG000,No,All,Child | Adult | Older Adult,Phase 3,342,"Inclusion criteria:

subject is aged 2 months or older
subject has secondarily-infected traumatic lesion (laceration, sutured wound or abrasion)
negative urine pregnancy test
subject has total skin infection rating scale score of at least 8, including pus/exudate score of at least 3
subject and/or parent/legal guardian is willing and able to comply with protocol
subject or parent/legal guardian has given written informed consent or assent as applicable

Exclusion criteria:

previous hypersensitivity to pleuromutilin
secondarily-infected animal/human bite or puncture wound
subject has an abscess
chronic ulcerative lesion
underlying skin disease
systemic signs and symptoms of infection
infection not appropriately treated with topical antibiotic
infection requires surgical intervention prior to or during study
subject received systemic antibacterial or steroid, or topical therapeutic agent within 24 hours of entry into study
serious underlying disease
subject pregnant, breast feeding or planning a pregnancy, or unacceptable method of contraception
other investigational drug within 30 days of study entry
subject previously enrolled in this study","Topical retapamulin ointment, 1% twice daily for 5 days",ChEMBL:CHEMBL1534 | DrugBank:DB00140 | PubChem:493570,Riboflavin,Cc1cc2nc3c(=O)[nH]c(=O)nc-3n(C[C@H](O)[C@H](O)[C@H](O)CO)c2cc1C,A11HA04 | S01XA26,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00685178,NCT00685178_EG001,No,All,Adult,Phase 2,45,"Inclusion Criteria:

18 - 55 years old
active opioid and cocaine dependence
seeking treatment for cocaine and opioid dependence
eligible for methadone maintenance per state and federal regulations
able and willing to provide a urine sample thrice a week
willing to answer questionnaires on a weekly basis
willing to provide breath samples for presence of alcohol thrice weekly
fluent in the English language

Exclusion Criteria:

allergy to sulfonamide drugs
diabetes, respiratory insufficiency, renal tubular acidosis, renal insufficiency, heart failure, liver insufficiency, chronic diarrhea, other chronic diseases predisposing to a risk of acidosis
history of nephrolithiasis
HIV positive individuals who meet AIDS criteria by CDC criteria or are taking antiretroviral medications
serious psychiatric illness (psychosis, dementia)
glaucoma or family history of glaucoma
prostate hyperplasia, shy bladder, irritable bladder, difficulty providing urine samples on demand
female participants: being pregnant, lactating, or unwilling to use an effective method of contraception
use of antiepileptic agents
benzodiazepine dependence
latex allergy","Topiramate and random reinforcement irrespective of cocaine use

topiramate: topiramate powder 0mg - 150 mg with lactate in blind capsules. Two capsules dispensed daily. One capsule ingested under supervision at the methadone window. One capsule to be ingested at home at bedtime. Participant is expected to return the empty blister pack on the following day.",ChEMBL:CHEMBL220492 | DrugBank:DB00273 | PubChem:5284627,Topiramate,[H][C@@]12OC(C)(C)O[C@]1([H])CO[C@@]1(COS(N)(=O)=O)OC(C)(C)O[C@]12[H],A08AA51 | N03AX11,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00685295,NCT00685295_EG000,No,All,Adult,Phase 1 | Phase 2,60,"INCLUSION:

18-60 years of age
Present to ED with a chief complaint of extremity injury
Negative pregnancy test (urine or blood)
Clinician judges subject to need extremity radiography to rule out a fracture
Subjects must indicate that their pain is of sufficient severity to warrant treatment with a pain medication stronger than acetaminophen or aspirin.
Subject's treating ED provider is aware of, and approves, participation (i.e. participation cannot be allowed to impair provision of standard patient care).

EXCLUSION:

Treating provider judges that IV analgesia is required
Allergy to acetaminophen or to any opiate/opioid
Currently taking phenothiazines or CNS depressants (including alcohol), or if subject has taken MAO inhibitors or SSRIs within the past two weeks
Already taken or been administered opioid analgesia for their current injury
Chronic opioid therapy or if the subject (or their medical records) indicate a history of opioid abuse
Breastfeeding mothers
If subject is planning to drive home after their ED visit, or if they are judged for any other reason to be non-candidates for opioid therapy.
hypersensitivity to lansoprazole
phenylketonuria","Subject receives placebo swallowed pill, and Fentora 100mcg rapidly dissolving transbuccal tablet",ChEMBL:CHEMBL596 | DrugBank:DB00813 | PubChem:3345,Fentanyl,CCC(=O)N(c1ccccc1)C1CCN(CCc2ccccc2)CC1,N01AH01 | N01AH51 | N02AB03,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00690794,NCT00690794_EG001,No,All,Adult | Older Adult,Phase 3,363,"Inclusion Criteria:

18 years or older.
Ocular Surface Disease Index (OSDI) score and corneal fluorescein staining score as specified in protocol.
Diagnosis of open-angle glaucoma or ocular hypertension in at least one eye.
Intraocular pressure (IOP) controlled with latanoprost 0.005% (XALATAN®) for at least one continuous month prior to Visit 1.
Willing and able to discontinue use of any topical ocular medication other than the study medication for the duration of the study, including artificial tears.
Best corrected visual acuity of -0.6 logarithm of the Minimum Angle of Resolution (logMAR) or better in each eye.
Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

Any medical condition (systemic or ophthalmic) that may preclude safe administration of the test article.
Use of contact lenses within 30 days of Visit 1.
Use of contact lenses during the study.
Participation in an investigational drug or device study within 30 days of entering this study.
Other protocol-defined exclusion criteria may apply.",One drop self-administered in the study eye(s) once daily for 90 days,ChEMBL:CHEMBL1051 | DrugBank:DB00654 | PubChem:5311221,Latanoprost,CC(C)OC(=O)CCC/C=C\C[C@@H]1[C@@H](CC[C@@H](O)CCc2ccccc2)[C@H](O)C[C@@H]1O,S01EE01 | S01EE51,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00691002,NCT00691002_EG002,No,All,Adult | Older Adult,Phase 3,362,"Inclusion Criteria:

Clinical diagnosis of psoriasis vulgaris involving the face
Clinical signs of psoriasis vulgaris on the trunk and/or the limbs, or earlier diagnosed with psoriasis vulgaris on the trunk and/or the limbs
An extent of psoriatic involvement of the face of at least 10 cm2 (the sum of all facial lesions)
Treatment areas (the face and the intertriginous areas) amenable to topical treatment with a maximum of 100 g of ointment per week
Disease severity graded as mild, moderate, severe or very severe according to the investigator's global assessment of disease severity of the face

Exclusion Criteria:

Systemic treatments with all other therapies than biologicals, with a potential effect on psoriasis vulgaris (e.g., corticosteroids, vitamin D analogues, retinoids, immunosuppressants) within the 4-week period prior to randomisation
Systemic use of biological treatments, whether marketed or not, directed against or with a potential effect on psoriasis vulgaris (e.g., alefacept, efalizumab, etanercept, infliximab, adalimumab) within 3 months prior to randomisation
PUVA therapy or Grenz ray therapy within the 4-week period prior to randomisation
UVB therapy within the 2-week period prior to randomisation
Topical treatment of the face and the intertriginous areas within the 2-week period prior to randomisation (use of emollients is allowed on treatment areas during this 2-week period, but not during the double-blind phase of the study)
Topical treatment with very potent WHO group IV corticosteroids within the 2-week period prior to randomisation
Initiation of or expected changes in concomitant medication that may affect psoriasis vulgaris (e.g., beta blockers, anti-malaria drugs, lithium and ACE inhibitors) during the study
Current diagnosis of erythrodermic, exfoliative, guttate or pustular psoriasis
Patients with any of the following conditions present on the treatment area: viral (e.g., herpes or varicella) lesions of the skin, fungal and bacterial skin infections, parasitic infections, skin manifestations in relation to syphilis or tuberculosis, rosacea, perioral dermatitis, acne vulgaris, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, acne rosacea, ulcers and wounds
Other inflammatory skin diseases (e.g., seborrhoiec dermatitis, contact dermatitis and cutaneous mycosis) that may confound the evaluation of psorisis vulgaris on the face or on the intertriginous areas
Planned exposure to sun, UVA or UVB that may affect the psoriasis vulgaris during the study
Known or suspected severe renal insufficiency or severe hepatic disorders
Known or suspected disorders of calcium metabolism associated with hypercalcaemia",Once daily application Hydrocortisone 10 mg/g in the ointment vehicle,ChEMBL:CHEMBL389621 | DrugBank:DB00741 | PubChem:5754,Hydrocortisone,[H][C@@]12CC[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)CC[C@@]21C,A01AC03 | A07EA02 | C05AA01 | D07AA02 | D07BA04 | D07CA01 | D07XA01 | H02AB09 | R01AD60 | S01BA02 | S01BB01 | S01CA03 | S01CB03 | S02BA01 | S02CA03 | S03CA04,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT00695188,NCT00695188_EG000,No,All,Adult | Older Adult,Phase 4,10,"Inclusion Criteria:

MTX-naive
Age > 18 years
DAS-28 > 3.2
American College of Rheumatology-criteria for RA
Chest-X-ray
Informed consent
Prednisolon < 10 mg a day

Exclusion Criteria:

Pregnancy
Lactation
Renal and hepatic impairment
Malignant diseases (last 5 years)
Contraindications
Human Immunodeficiency Virus (HIV), Hepatitis B and C","Escalating dose (Start with 15 mg MTX/week, escalating dose until 25 mg/week, administered orally)",ChEMBL:CHEMBL34259 | DrugBank:DB00563 | PubChem:126941,Methotrexate,CN(Cc1cnc2nc(N)nc(N)c2n1)c1ccc(C(=O)N[C@@H](CCC(=O)O)C(=O)O)cc1,L01BA01 | L04AX03,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00695188,NCT00695188_EG001,No,All,Adult | Older Adult,Phase 4,9,"Inclusion Criteria:

MTX-naive
Age > 18 years
DAS-28 > 3.2
American College of Rheumatology-criteria for RA
Chest-X-ray
Informed consent
Prednisolon < 10 mg a day

Exclusion Criteria:

Pregnancy
Lactation
Renal and hepatic impairment
Malignant diseases (last 5 years)
Contraindications
Human Immunodeficiency Virus (HIV), Hepatitis B and C","Start with 25 mg MTX per week, administered orally",ChEMBL:CHEMBL34259 | DrugBank:DB00563 | PubChem:126941,Methotrexate,CN(Cc1cnc2nc(N)nc(N)c2n1)c1ccc(C(=O)N[C@@H](CCC(=O)O)C(=O)O)cc1,L01BA01 | L04AX03,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00695435,NCT00695435_EG001,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 1,21,"Inclusion:

Visual Acuity (VA) of 0.6 logMAR or better
Tear meniscus height of ≥ 0.3mm at Visit 1.
No concomitant topical ocular medications, including artificial tears, during the study period

Exclusion

ocular hypertension, iritis or uveitis, glaucoma
ocular surgery, intraocular surgery or ocular laser procedures in either eye within the past six months
epithelial herpes simplex (dendritic keratitis); Vaccinia, active or recent varicella viral disease of the cornea and/or conjunctiva; ocular Rosacea; Mycobacterial infection of the eye; and / or fungal disease of the eye
lacrimal duct obstruction, dry eye, ocular allergies.
contact lens within 7 days of Visit 1.
ocular medications within 14 days of Visit 1.",TOBREX® Ophthalmic Solution,ChEMBL:CHEMBL1747 | DrugBank:DB00684 | PubChem:36294,Tobramycin,NC[C@H]1O[C@H](O[C@H]2[C@H](O)[C@@H](O[C@H]3O[C@H](CO)[C@@H](O)[C@H](N)[C@H]3O)[C@H](N)C[C@@H]2N)[C@H](N)C[C@@H]1O,J01GB01 | S01AA12,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00695435,NCT00695435_EG002,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 1,21,"Inclusion:

Visual Acuity (VA) of 0.6 logMAR or better
Tear meniscus height of ≥ 0.3mm at Visit 1.
No concomitant topical ocular medications, including artificial tears, during the study period

Exclusion

ocular hypertension, iritis or uveitis, glaucoma
ocular surgery, intraocular surgery or ocular laser procedures in either eye within the past six months
epithelial herpes simplex (dendritic keratitis); Vaccinia, active or recent varicella viral disease of the cornea and/or conjunctiva; ocular Rosacea; Mycobacterial infection of the eye; and / or fungal disease of the eye
lacrimal duct obstruction, dry eye, ocular allergies.
contact lens within 7 days of Visit 1.
ocular medications within 14 days of Visit 1.",TOBRADEX® Ophthalmic Suspension,ChEMBL:CHEMBL1747 | DrugBank:DB00684 | PubChem:36294,Tobramycin,NC[C@H]1O[C@H](O[C@H]2[C@H](O)[C@@H](O[C@H]3O[C@H](CO)[C@@H](O)[C@H](N)[C@H]3O)[C@H](N)C[C@@H]2N)[C@H](N)C[C@@H]1O,J01GB01 | S01AA12,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00696761,NCT00696761_EG000,No,Male,Adult | Older Adult,Phase 4,41,"Inclusion Criteria:

Ambulatory males (≥50 years) suffering from LUTS suggestive of BPH
Patients satisfying all of the following:
Moderate to severe LUTS :
international prostate symptom score (IPSS)≥ 8
An enlarged prostate (≥25 mL)
Decreased peak flow rate : Qmax ≤15 mL/s (volume voided ≥ 120 mL)

Exclusion Criteria:

Post voided residual urine ≥ 200 mL
Patients performing catheterization
Urinary tract infection patients
Patients taking 5 alpha reductase inhibitor
Known hypersensitivity to alfuzosin
History of postural hypotension or syncope
Hypertension patients treated with other alpha1-blockers
Patients newly taking anticholinergic medication within 1 month
Hepatic insufficiency (Aspartate transaminase /alanine aminotransferase ≥ 2 times of normal range)
Renal insufficiency (s-Cr ≥ 2mg/dL)
Unstable angina pectoris
Uninvestigated hematuria
Serum Prostate specific antigen ≥ 4 ng/mL (biopsy proven no cancer patients can be included)
Interstitial cystitis patients
Severe concomitant condition threatening life.
Patient who is unable to make voiding diary
Bladder or prostate cancer patients
Patients receiving prostate or bladder surgery","BOOI<20, BCI≥ 100)

alfuzosin : 10mg, once daily, 12months",ChEMBL:CHEMBL709 | DrugBank:DB00346 | PubChem:2092,Alfuzosin,COc1cc2nc(N(C)CCCNC(=O)C3CCCO3)nc(N)c2cc1OC,G04CA01 | G04CA51,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT00696761,NCT00696761_EG001,No,Male,Adult | Older Adult,Phase 4,54,"Inclusion Criteria:

Ambulatory males (≥50 years) suffering from LUTS suggestive of BPH
Patients satisfying all of the following:
Moderate to severe LUTS :
international prostate symptom score (IPSS)≥ 8
An enlarged prostate (≥25 mL)
Decreased peak flow rate : Qmax ≤15 mL/s (volume voided ≥ 120 mL)

Exclusion Criteria:

Post voided residual urine ≥ 200 mL
Patients performing catheterization
Urinary tract infection patients
Patients taking 5 alpha reductase inhibitor
Known hypersensitivity to alfuzosin
History of postural hypotension or syncope
Hypertension patients treated with other alpha1-blockers
Patients newly taking anticholinergic medication within 1 month
Hepatic insufficiency (Aspartate transaminase /alanine aminotransferase ≥ 2 times of normal range)
Renal insufficiency (s-Cr ≥ 2mg/dL)
Unstable angina pectoris
Uninvestigated hematuria
Serum Prostate specific antigen ≥ 4 ng/mL (biopsy proven no cancer patients can be included)
Interstitial cystitis patients
Severe concomitant condition threatening life.
Patient who is unable to make voiding diary
Bladder or prostate cancer patients
Patients receiving prostate or bladder surgery","BOOI<20, BCI<100

alfuzosin : 10mg, once daily, 12 months",ChEMBL:CHEMBL709 | DrugBank:DB00346 | PubChem:2092,Alfuzosin,COc1cc2nc(N(C)CCCNC(=O)C3CCCO3)nc(N)c2cc1OC,G04CA01 | G04CA51,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT00696761,NCT00696761_EG002,No,Male,Adult | Older Adult,Phase 4,61,"Inclusion Criteria:

Ambulatory males (≥50 years) suffering from LUTS suggestive of BPH
Patients satisfying all of the following:
Moderate to severe LUTS :
international prostate symptom score (IPSS)≥ 8
An enlarged prostate (≥25 mL)
Decreased peak flow rate : Qmax ≤15 mL/s (volume voided ≥ 120 mL)

Exclusion Criteria:

Post voided residual urine ≥ 200 mL
Patients performing catheterization
Urinary tract infection patients
Patients taking 5 alpha reductase inhibitor
Known hypersensitivity to alfuzosin
History of postural hypotension or syncope
Hypertension patients treated with other alpha1-blockers
Patients newly taking anticholinergic medication within 1 month
Hepatic insufficiency (Aspartate transaminase /alanine aminotransferase ≥ 2 times of normal range)
Renal insufficiency (s-Cr ≥ 2mg/dL)
Unstable angina pectoris
Uninvestigated hematuria
Serum Prostate specific antigen ≥ 4 ng/mL (biopsy proven no cancer patients can be included)
Interstitial cystitis patients
Severe concomitant condition threatening life.
Patient who is unable to make voiding diary
Bladder or prostate cancer patients
Patients receiving prostate or bladder surgery","BOOI≥ 20, BCI≥ 100

alfuzosin : 10mg, once daily, 12months",ChEMBL:CHEMBL709 | DrugBank:DB00346 | PubChem:2092,Alfuzosin,COc1cc2nc(N(C)CCCNC(=O)C3CCCO3)nc(N)c2cc1OC,G04CA01 | G04CA51,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT00696761,NCT00696761_EG003,No,Male,Adult | Older Adult,Phase 4,76,"Inclusion Criteria:

Ambulatory males (≥50 years) suffering from LUTS suggestive of BPH
Patients satisfying all of the following:
Moderate to severe LUTS :
international prostate symptom score (IPSS)≥ 8
An enlarged prostate (≥25 mL)
Decreased peak flow rate : Qmax ≤15 mL/s (volume voided ≥ 120 mL)

Exclusion Criteria:

Post voided residual urine ≥ 200 mL
Patients performing catheterization
Urinary tract infection patients
Patients taking 5 alpha reductase inhibitor
Known hypersensitivity to alfuzosin
History of postural hypotension or syncope
Hypertension patients treated with other alpha1-blockers
Patients newly taking anticholinergic medication within 1 month
Hepatic insufficiency (Aspartate transaminase /alanine aminotransferase ≥ 2 times of normal range)
Renal insufficiency (s-Cr ≥ 2mg/dL)
Unstable angina pectoris
Uninvestigated hematuria
Serum Prostate specific antigen ≥ 4 ng/mL (biopsy proven no cancer patients can be included)
Interstitial cystitis patients
Severe concomitant condition threatening life.
Patient who is unable to make voiding diary
Bladder or prostate cancer patients
Patients receiving prostate or bladder surgery","BOOI≥ 20, BCI<100

alfuzosin : 10mg, once daily, 12months",ChEMBL:CHEMBL709 | DrugBank:DB00346 | PubChem:2092,Alfuzosin,COc1cc2nc(N(C)CCCNC(=O)C3CCCO3)nc(N)c2cc1OC,G04CA01 | G04CA51,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT00697073,NCT00697073_EG000,No,All,Child | Adult,Phase 3,68,"Inclusion criteria:

Friedreich's ataxia patients completing core study SNT-III-002 (NCT00537680) and presenting at Week 24 (Visit 5) of that study
Body weight ≥ 25kg/55 lbs
Negative urine pregnancy test
Patients who in the opinion of the investigator are able to comply with the requirements of this study

Exclusion criteria:

Adverse events during the course of SNT-III-002(NCT00537680)which in the opinion of the investigator are attributable to idebenone and preclude further treatment with idebenone
Clinically significant abnormalities of clinical hematology or biochemistry including, but not limited to, elevations greater than 2 times the upper limit of normal of AST, ALT or creatinine
Treatment with coenzyme Q10, vitamin E (if taken at a dose 5 times above the daily requirement) or other sources of idebenone within the past month
Parallel participation in another clinical drug trial
Past or present history of abuse of drugs or alcohol
Pregnancy or breast-feeding","Patients ≤ 45 kg/99 lbs: idebenone 1350 mg/day (3 x 150 mg tablets, t.i.d.)

Patients > 45 kg/99 lbs: idebenone 2250 mg/day (5 x 150 mg tablets, t.i.d.)",ChEMBL:CHEMBL252556 | DrugBank:DB09081 | PubChem:3686,Idebenone,COC1=C(OC)C(=O)C(CCCCCCCCCCO)=C(C)C1=O,N06BX13,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00705133,NCT00705133_EG000,No,All,Child | Adult | Older Adult,Phase 2,15,"Inclusion Criteria:

Eligible subjects must have IPF and severe pulmonary arterial hypertension (PAH) documented on standard of care right-heart catheterization (RHC) and planned to receive therapy with treprostinil as recommended by the treating physician.

All subjects must have high resolution CT scan (HRCT) diagnostic of IPF (performed as part of standard of care evaluation) or if available, biopsy proven histological usual interstitial pneumonia (UIP).
Severe pulmonary arterial hypertension defined as a resting mean pulmonary artery pressure (mPAP) > 35 mm Hg; AND pulmonary vascular resistance (PVR) > 3 woods-units; AND pulmonary capillary wedge pressure (PCWP) < 18 mm Hg by right-heart catheterization (RHC) performed as part of standard of care evaluation.
All subjects must be planned to receive treprostinil therapy as recommended by their treating physician.

Exclusion Criteria:

Acute or chronic impairment other than dyspnea (e.g. angina pectoris, intermittent claudication) limiting the ability to perform standard of care six-minute walk tests (6MWT).
Six-minute walk distance (6MWD) < 50 meters at screening or baseline standard of care evaluations
Standard of care pulmonary function test (PFT) showing forced expiratory volume in one second (FEV1)/ forced vital capacity (FVC) ratio < 0.65
Standard of care pulmonary function test (PFT) showing a residual volume >120% predicted
Standard of care high-resolution chest computed tomography (HRCT) showing emphysema extent > 30%
Any investigational therapy as part of a clinical trial for any indication with 30 days before screening
Change in dose of treatment for IPF - investigational agent (gamma interferon-1b, pirfenidone, etanercept, and any other investigational agent intended to treat IPF), corticosteroids, or cytotoxic agents, within 30 days before screening. That is, subjects can be on any of these agents provided the dose is stable for at least 30 days prior to enrollment.
Current treatment for pulmonary hypertension with other prostaglandins (epoprostenol or iloprost)
Change in dose of treatment for PAH - (bosentan, sitaxsentan, ambrisentan, tadalafil, sildenafil, vardenafil, calcium channel blockers, nitrates, digitalis), within 30 days before screening. That is, subjects can be on any of these agents provided the dose is stable for at least 30 days prior to enrollment
Pulmonary rehabilitation initiated within 30 days of baseline.","Patients with pulmonary fibrosis with an advanced pulmonary hypertension phenotype will be treated with parenteral treprostinil in an open-label fashion

Treprostinil: For both SQ and IV routes, treprostinil will be started in the hospital at 1ng/kg/min and titrated up by 1ng/kg/min every 1-3 days as tolerated",ChEMBL:CHEMBL1237119 | DrugBank:DB00374 | PubChem:6918140,Treprostinil,[H][C@@]12Cc3c(cccc3OCC(=O)O)C[C@]1([H])[C@@H](CC[C@@H](O)CCCCC)[C@H](O)C2,B01AC21,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00705159,NCT00705159_EG000,No,All,Child,Phase 4,34,"Inclusion Criteria:

children 0-6 years of age.
clinical diagnosis of blepharoconjunctivitis
Parent/guardian must understand, be willing and able to comply with all treatment and follow-up procedures.
Parent/guardian must understand, be willing and able to provide informed consent and Health Insurance Portability Accountability Act (HIPAA) authorization.

Exclusion Criteria:

Known hypersensitivity to corticosteroids, aminoglycosides, or any component of the study medication.
Subjects who have a history of ocular surgery, including laser procedures, within the past 6 months.
Subjects who are monocular.
Subjects who have a history of any severe/serious ocular pathology or medical condition that could result in the subject's inability to complete the study.
Subjects who have participated in an ophthalmic drug or device research study within 30 days prior to entry in this study.",Drug: Zylet (loteprednol etabonate 0.5% and tobramycin 0.3%)one or two drops in the study eye four times a day (QID).,PubChem:9811635,Loteprednol etabonate/tobramycin,CCOC(=O)OC1(C(=O)OCCl)CCC2C3CCC4=CC(=O)C=CC4(C)C3C(O)CC21C.NCC1OC(OC2C(N)CC(N)C(OC3OC(CO)C(O)C(N)C3O)C2O)C(N)CC1O,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT00705159,NCT00705159_EG002,No,All,Child,Phase 4,34,"Inclusion Criteria:

children 0-6 years of age.
clinical diagnosis of blepharoconjunctivitis
Parent/guardian must understand, be willing and able to comply with all treatment and follow-up procedures.
Parent/guardian must understand, be willing and able to provide informed consent and Health Insurance Portability Accountability Act (HIPAA) authorization.

Exclusion Criteria:

Known hypersensitivity to corticosteroids, aminoglycosides, or any component of the study medication.
Subjects who have a history of ocular surgery, including laser procedures, within the past 6 months.
Subjects who are monocular.
Subjects who have a history of any severe/serious ocular pathology or medical condition that could result in the subject's inability to complete the study.
Subjects who have participated in an ophthalmic drug or device research study within 30 days prior to entry in this study.",Drug: Tobramycin 0.3%. One or two drops in study eye four times a day (QID).,ChEMBL:CHEMBL1747 | DrugBank:DB00684 | PubChem:36294,Tobramycin,NC[C@H]1O[C@H](O[C@H]2[C@H](O)[C@@H](O[C@H]3O[C@H](CO)[C@@H](O)[C@H](N)[C@H]3O)[C@H](N)C[C@@H]2N)[C@H](N)C[C@@H]1O,J01GB01 | S01AA12,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT00705757,NCT00705757_EG001,No,All,Adult | Older Adult,Phase 4,29,"Inclusion Criteria:

patients recently diagnosed with primary open angle glaucoma or ocular hypertension
Caucasian and African American ethnicities
Male and Female
Age 30 and above

Exclusion Criteria:

A history of ocular medication use within the last 12 months
Inflammatory/ allergic skin diseases or dermatitis
presence of periocular hyperpigmented skin lesions
Systemic pigmentation disorders
Use of systemic drugs that can affect skin pigmentation
Visitation of tanning salons, or use of self tanning products
Pregnancy or patients planning to become pregnant in the near future",Participants were assigned to use Xalatan/latanoprost 0.005% ophthalmic sol. one drop qhs for one year in affected eye(s),ChEMBL:CHEMBL1051 | DrugBank:DB00654 | PubChem:5311221,Latanoprost,CC(C)OC(=O)CCC/C=C\C[C@@H]1[C@@H](CC[C@@H](O)CCc2ccccc2)[C@H](O)C[C@@H]1O,S01EE01 | S01EE51,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00706433,NCT00706433_EG000,No,All,Child | Adult | Older Adult,Phase 2,68,"Inclusion Criteria:

Subject is male or non-pregnant female 12 years of age or older.
Females must be post-menopausal, surgically sterile or using a medically acceptable form of birth control, with a negative urine pregnancy test at the Baseline visit.
Subject has provided written and verbal informed consent. A subject under 18 years of age must be accompanied by the parent or legal guardian at the time of assent/consent signing. The parent or legal guardian must also provide informed consent for the subject.
Subject has moderate to severe facial acne vulgaris (including the nose), with at least 20 inflammatory lesions (papules, pustules, nodules).
Subject has moderate to severe acne as defined by an Investigator Global Assessment of 3 or 4 [0 (clear) to 4 (severe) scale].
Subject has a history of recurrent herpes simplex labialis infection in the treatment area AND has had an outbreak within the last 12 months must be placed on antiviral prophylaxis as specified in the protocol.
Subject is willing to comply with study instructions and return to the clinic for required visits.
Subject must have used the same type and brand of make-up, other facial products and hair products (e.g. shampoo, gel, hair spray, mousse, etc.) for at least 1 month prior to the Baseline Visit (General Skin & Hair Care). Upon enrollment, all subjects must a) use exclusively an Investigator approved facial cleanser and b) agree to continue their other General Skin & Hair Care for the entire study.

Exclusion Criteria:

Subject is pregnant, lactating, or is planning to become pregnant during the study.
Subject has a history of cutaneous photosensitization, porphyria, hypersensitivity to porphyrins or photodermatosis.
Subject has any skin pathology or condition that could interfere with the evaluation of the test product or requires the use of interfering topical or systemic therapy.
Subject has greater than 4 facial nodules (nodule = lesion greater than or equal 0.5 cm in diameter)
Subject has an uncorrected coagulation defect or concurrently uses anticoagulants (except aspirin).
Subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study.
Subject is currently enrolled in an investigational drug or device study.
Subject has received an investigational drug or been treated with an investigational device within 30 days prior to the initiation of treatment (baseline).
Subject has facial hair that could interfere with the study assessments in the opinion of the investigator.
Subject is unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function.
Subject may be unreliable for the study including subjects who engage in excessive alcohol intake or drug abuse, or subjects who are unable to return for scheduled follow-up visits.
Subject has a known sensitivity to one or more of the vehicle components (ethyl alcohol, isopropyl alcohol, laureth 4, polyethylene glycol).
Subject has used photosensitizing drugs, e.g. declomycin, tetracycline, sulfa antibiotics, phenothiazines, etc. within a timeframe where photosensitization from these drugs may still be present.
Subject has used OTC acne medicated cleansers or soaps within 2 weeks of the initiation of treatment.
Subject has the need or plans to be exposed to artificial tanning devices or excessive sunlight during the trial.
Subject has used any of the following topical anti-acne preparations on the face: a.) Topical anti-acne treatments including benzoyl peroxide, antibiotics, azelaic acid, corticosteroids and salicylic acid within 2 weeks of the initiation of treatment b.) Retinoids, including tazarotene, adapalene, tretinoin within 4 weeks of the initiation of treatment. c.) Light treatments, microdermabrasion or chemical peels within 8 weeks of the initiation of treatment.
Subject has used any of the following systemic anti-acne medications: a.) Corticosteroids (including intramuscular and intralesional injections) within 4 weeks of the initiation of treatment. Inhaled corticosteroids are allowed if use is stable (stable use is defined as dose and frequency unchanged for at least 2 weeks prior to the initiation of treatment). b.) Antibiotics within 4 weeks of the initiation of treatment. c.) Nicotinamide containing products within 4 weeks of the initiation of treatment. d.) Spironolactone within 8 weeks of the initiation of treatment. d.) Retinoid therapy within 6 months of the initiation of treatment.",Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 1000 seconds (16 minutes and 40 seconds),PubChem:123608,Aminolevulinic Acid Hydrochloride,Cl.NCC(=O)CCC(=O)O,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT00706433,NCT00706433_EG001,No,All,Child | Adult | Older Adult,Phase 2,65,"Inclusion Criteria:

Subject is male or non-pregnant female 12 years of age or older.
Females must be post-menopausal, surgically sterile or using a medically acceptable form of birth control, with a negative urine pregnancy test at the Baseline visit.
Subject has provided written and verbal informed consent. A subject under 18 years of age must be accompanied by the parent or legal guardian at the time of assent/consent signing. The parent or legal guardian must also provide informed consent for the subject.
Subject has moderate to severe facial acne vulgaris (including the nose), with at least 20 inflammatory lesions (papules, pustules, nodules).
Subject has moderate to severe acne as defined by an Investigator Global Assessment of 3 or 4 [0 (clear) to 4 (severe) scale].
Subject has a history of recurrent herpes simplex labialis infection in the treatment area AND has had an outbreak within the last 12 months must be placed on antiviral prophylaxis as specified in the protocol.
Subject is willing to comply with study instructions and return to the clinic for required visits.
Subject must have used the same type and brand of make-up, other facial products and hair products (e.g. shampoo, gel, hair spray, mousse, etc.) for at least 1 month prior to the Baseline Visit (General Skin & Hair Care). Upon enrollment, all subjects must a) use exclusively an Investigator approved facial cleanser and b) agree to continue their other General Skin & Hair Care for the entire study.

Exclusion Criteria:

Subject is pregnant, lactating, or is planning to become pregnant during the study.
Subject has a history of cutaneous photosensitization, porphyria, hypersensitivity to porphyrins or photodermatosis.
Subject has any skin pathology or condition that could interfere with the evaluation of the test product or requires the use of interfering topical or systemic therapy.
Subject has greater than 4 facial nodules (nodule = lesion greater than or equal 0.5 cm in diameter)
Subject has an uncorrected coagulation defect or concurrently uses anticoagulants (except aspirin).
Subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study.
Subject is currently enrolled in an investigational drug or device study.
Subject has received an investigational drug or been treated with an investigational device within 30 days prior to the initiation of treatment (baseline).
Subject has facial hair that could interfere with the study assessments in the opinion of the investigator.
Subject is unable to communicate or cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function.
Subject may be unreliable for the study including subjects who engage in excessive alcohol intake or drug abuse, or subjects who are unable to return for scheduled follow-up visits.
Subject has a known sensitivity to one or more of the vehicle components (ethyl alcohol, isopropyl alcohol, laureth 4, polyethylene glycol).
Subject has used photosensitizing drugs, e.g. declomycin, tetracycline, sulfa antibiotics, phenothiazines, etc. within a timeframe where photosensitization from these drugs may still be present.
Subject has used OTC acne medicated cleansers or soaps within 2 weeks of the initiation of treatment.
Subject has the need or plans to be exposed to artificial tanning devices or excessive sunlight during the trial.
Subject has used any of the following topical anti-acne preparations on the face: a.) Topical anti-acne treatments including benzoyl peroxide, antibiotics, azelaic acid, corticosteroids and salicylic acid within 2 weeks of the initiation of treatment b.) Retinoids, including tazarotene, adapalene, tretinoin within 4 weeks of the initiation of treatment. c.) Light treatments, microdermabrasion or chemical peels within 8 weeks of the initiation of treatment.
Subject has used any of the following systemic anti-acne medications: a.) Corticosteroids (including intramuscular and intralesional injections) within 4 weeks of the initiation of treatment. Inhaled corticosteroids are allowed if use is stable (stable use is defined as dose and frequency unchanged for at least 2 weeks prior to the initiation of treatment). b.) Antibiotics within 4 weeks of the initiation of treatment. c.) Nicotinamide containing products within 4 weeks of the initiation of treatment. d.) Spironolactone within 8 weeks of the initiation of treatment. d.) Retinoid therapy within 6 months of the initiation of treatment.",Aminolevulinic acid HCL (ALA) applied to the entire facial area 45 minutes prior to BLUE light treatment for 500 seconds (8 minutes and 20 seconds),PubChem:123608,Aminolevulinic Acid Hydrochloride,Cl.NCC(=O)CCC(=O)O,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT00706797,NCT00706797_EG000,No,All,Adult | Older Adult,Phase 4,63,"Inclusion Criteria:

Meet the 1987 ACR Revised Criteria for Rheumatoid Arthritis.
Documented evidence, confirmed by a blinded 3rd party assessor, of at least one erosion observed by X-ray at randomization based on X-ray taken at the screening visit.
Have received MTX as stable dose for 28 days prior to the screening visit.

Exclusion Criteria:

Previous treatment with ETN, infliximab, adalimumab, other Tumor necrosis factor (TNF) -a inhibitors, anakinra or other biological agents.
Receipt of any DMARD, other than MTX, within 28 days before screening.","Utilized Disease-Modifying Antirheumatic Drugs (DMARDs) from a list of the 6 most commonly prescribed in the participating countries (Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, cyclosporine A and gold).",ChEMBL:CHEMBL34259 | DrugBank:DB00563 | PubChem:126941,Methotrexate,CN(Cc1cnc2nc(N)nc(N)c2n1)c1ccc(C(=O)N[C@@H](CCC(=O)O)C(=O)O)cc1,L01BA01 | L04AX03,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0
NCT00707161,NCT00707161_EG000,No,All,Adult | Older Adult,Phase 2,6,"Inclusion criteria:

Signed study-specific consent form prior to registration.
Pathologically confirmed malignant melanoma.
Measurable melanoma lesion deemed to require radiation by treating physicians for purposes of local control or palliation. The lesion may be the primary melanoma, a nodal metastasis, or a distant metastasis. Recurrent lesions are allowed.
Lesion has to be measurable clinically or radiographically in 2 dimensions.
Karnofsky Performance Scale (KPS) > 70.

Laboratory values

White blood cells (WBC) > 3000/mm3
Absolute granulocyte count > 1,500
Platelets > 100,000/mm3
Total bilirubin < 2.0 x institutional upper limit of normal
AST or ALT (aminotransferase/alanine aminotransferase) < 2.5 x institutional upper limit of normal
Serum calcium < 1.3 x institutional upper limit of normal
Serum creatinine < 1.5 mg/dL or Creatinine clearance > 50 cc/min,calculated as follows: CCr = 0.85 x (140-age) x (weight in kg) 72 x serum creatinine in mg/dL

Exclusion criteria:

Systemic therapy for malignant melanoma within one month preceding trial enrollment.
Prior irradiation to the planned field.
Concomitant chemotherapy (in addition to cisplatin) or biologic therapy is allowed.
Significant infection or other co-existent medical condition which would prevent the use of full dose chemotherapy.
Pre-existing sensory neuropathy (CTC 3.0 ≥ Grade II)
Pregnancy or lactation.","Radiation therapy given at 50 Gy, 20 fractions, for 4 weeks (2.5 Gy/day). Cisplatin given at 100mg/m2 i.v. every 3 weeks for a total of 2 doses (days 1 and 22) during radiation.",DrugBank:DB00515 | PubChem:5460033 | PubChem:5702198,Cisplatin,Cl[Pt]Cl.N.N,L01XA01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00707174,NCT00707174_EG000,No,All,Adult | Older Adult,Not Applicable,46,"Inclusion Criteria:

The study population will consist of eighty subjects who are 18 years or older and have a biopsy-proven lentigo maligna.
The subjects must have a LM that is in a location amenable to treatment with imiquimod, express a willingness and ability to comply with study requirements, and tolerate an outpatient surgical procedure.
All participants will sign consent documents prior to enrollment.
The typical age of patient that develops a LM is beyond the child-bearing range.

Exclusion Criteria:

In the event that a patient with a LM is pregnant, they will be excluded from the study.
inability to tolerate the surgical procedure
invasive melanoma
previous surgery on the site of interest","Topical imiquimod group:

treat the LM site two centimeters beyond the perimeter margin with topical imiquimod 5% cream Monday thru Friday of each week for a total of twelve weeks. After three months of topical treatment, a one-month wash out period will be observed to allow for resolution of inflammation that can obscure the pathologist's ability to evaluate the excised tumor/treatment site.",ChEMBL:CHEMBL1282 | DrugBank:DB00724 | PubChem:57469,Imiquimod,CC(C)Cn1cnc2c(N)nc3ccccc3c21,D06BB10,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00707980,NCT00707980_EG000,No,All,Adult | Older Adult,Phase 3,834,"Inclusion Criteria:

Has completed the double blind treatment period of either study Lu AA21004_304 (NCT00672620) or LuAA21004_305 (NCT00735709) immediately prior to enrollment in the extension study (ie, the baseline visit is the same visit as the completion visit of the double blind treatment of the preceding protocol).
Suffers from a major depressive episode as the primary diagnosis according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria (classification code 296.xx) at entry into the prior Lu AA21004_304 or Lu AA21004_305 study.

Exclusion Criteria:

In addition to meeting the exclusion criteria for studies Lu AA21004_304 or Lu AA21004_305 at the time of enrollment into those studies respectively, with the exception of the criteria prohibiting previous exposure to Lu AA21004 and investigational drugs, and the criteria prohibiting patients with increased intraocular pressure, or risk of acute narrow-angle glaucoma, the following exclusion criteria apply:

Has Major Depressive Disorder for whom other psychiatric disorders (mania, bipolar disorder, schizophrenia, or any psychotic disorder) have been diagnosed during the prior study.
The participant, in the investigator's opinion, has a significant risk of suicide and/or a score of ≥5 points on item 10 (suicidal thoughts) of the Montgomery Åsberg Depression Rating Scale.
The participant, in the opinion of the investigator, is unlikely to comply with the clinical study protocol or is unsuitable for any reason.
Has a clinically significant moderate or severe ongoing adverse event related to study medication from the prior study.
Has used/uses disallowed concomitant medication.","Vortioxetine 2.5 mg, 5 mg or 10 mg, encapsulated tablets, orally, once daily for up to 52 weeks. For the first week of treatment all participants received 5 mg/day vortioxetine, thereafter, the dose could be increased to 10 mg/day or decreased to 2.5 mg/day, based on participant's response and tolerability as judged by the investigator.",ChEMBL:CHEMBL2104993 | DrugBank:DB09068 | PubChem:9966051,Vortioxetine,Cc1ccc(Sc2ccccc2N2CCNCC2)c(C)c1,N06AX26,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0
NCT00707993,NCT00707993_EG001,No,All,Older Adult,Phase 3,219,"Inclusion Criteria:

Has a diagnosis of type 2 diabetes mellitus with either:

Failed diet and exercise therapy alone as demonstrated by inadequate glycemic control while receiving no antidiabetic treatment within the two months prior to Screening, or
Failed treatment with oral monotherapy alone (may include treatment with two or more antidiabetic agents if for less than 7 days) as demonstrated by inadequate glycemic control within the two months prior to Screening.
Body mass index greater than or equal to 23 kg/m2 and less than or equal to 45 kg/m2.
If regularly using other, non-excluded medications, must be on a stable dose for at least the 4 weeks prior to Screening.
Females of childbearing potential who are sexually active must agree to use a medically accepted means of contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
Able and willing to monitor their own blood glucose concentrations with a home glucose monitor.
No major illness or debility that in the investigator's opinion prohibits the participant from completing the study.

Exclusion Criteria:

Systolic blood pressure greater than or equal to 160 mm Hg and/or diastolic pressure greater than or equal to 100 mm Hg.
Hemoglobin less than or equal to 12 g/dL for males or less than or equal to 10 g/dL for females.
Alanine aminotransferase greater than or equal to 3 times the upper limit of normal.
Calculated creatinine clearance less than or equal to 50 mL/min.
Thyroid-stimulating hormone level outside of the normal range.
History of cancer, other than squamous cell or basal cell carcinoma of the skin, that has not been in full remission for at least 5 years prior to Screening.
History of laser treatment for proliferative diabetic retinopathy within the 6 months prior to Screening.
History of treated diabetic gastroparesis, gastric banding, or gastric bypass surgery.
New York Heart Association Class III or IV heart failure regardless of therapy.
History of coronary angioplasty, coronary stent placement, coronary bypass surgery, or myocardial infarction within the 6 months prior to Screening.
History of any hemoglobinopathy that may affect determination of glycosylated hemoglobin.
History of infection with Human Immunodeficiency Virus.
History of a psychiatric disorder that will affect the participant's ability to participate in the study.
History of angioedema in association with use of angiotensin-converting enzyme inhibitors or angiotensin-II receptor inhibitors.
History of alcohol or substance abuse within the 2 years prior to Screening.
History of treatment with any weight-loss drugs or oral or systemically injected glucocorticoids within the 3 months prior to Screening.
Receipt of any investigational drug within the 30 days prior to Screening.
Prior treatment in an investigational study of alogliptin.
Clinically significant medical abnormality or disease or clinically significant abnormal findings at Screening (other than type 2 diabetes) that, in the opinion of the investigator, should exclude the participant from the study.
Has donated more than 400 mL of blood within the 90 days preceding their participation in the study.
Has hypersensitivity or has had an anaphylactic reaction(s) to any DPP-4 inhibitor drug.","Alogliptin placebo-matching tablets, orally, once daily and glipizide 5 mg to 10 mg, tablets, orally, once daily up to 52 weeks.",ChEMBL:CHEMBL1073 | DrugBank:DB01067 | PubChem:3478,Glipizide,Cc1cnc(C(=O)NCCc2ccc(S(=O)(=O)NC(=O)NC3CCCCC3)cc2)cn1,A10BB07,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT00708422,NCT00708422_EG001,No,All,Adult | Older Adult,Phase 4,115,"Inclusion Criteria:

18 years of age or older.
Diagnosis of primary open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion) or ocular hypertension in at least one eye (study eye).
Use of BAK (benzalkonium chloride) containing intraocular pressure (IOP) lowering medication for a minimum of one year, including latanoprost (Xalatan®) monotherapy for at least 6 months prior to Visit 1.
IOP controllable and stable on the study medication alone (both eyes).
Believed to have ocular surface disease (OSD).
Tear Break-up Time (TBUT) of ≤ 6 seconds in the study eye.
Willing and able to discontinue the use of any topical ocular medication other than the study medication or BAK free artificial tears for the duration of the study.
Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

Current use or use within the last 3 months of cyclosporine ophthalmic emulsion 0.05% (Restasis®), topical ocular steroids, or topical ocular non-steroidal anti-inflammatory drugs.
Current use of punctual plugs.
Women of childbearing potential not using reliable means of birth control.
Women who are pregnant or lactating.
Suspected or diagnosed with Sjogrens's syndrome.
Current use of any brand of artificial tears containing BAK.
Use of any systemic medications on a chronic basis not on a stable dosing regimen for at least 30 days prior to Visit 1, or an anticipated change in dosing regimen of medications during the course of the study.
Intraocular conventional surgery or laser surgery in study eyes less than six months prior to Visit 1.
Current use of contact lenses within 30 days of Visit 1.
Participation in any other investigational study within 30 days prior to Visit 1.
Other protocol-defined exclusion criteria may apply.",One drop self-administered in the study eye(s) once daily at night for 12 weeks,ChEMBL:CHEMBL1051 | DrugBank:DB00654 | PubChem:5311221,Latanoprost,CC(C)OC(=O)CCC/C=C\C[C@@H]1[C@@H](CC[C@@H](O)CCc2ccccc2)[C@H](O)C[C@@H]1O,S01EE01 | S01EE51,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00713284,NCT00713284_EG000,No,All,Adult | Older Adult,Phase 4,13,"Inclusion Criteria I (-1 to 7 days post renal allograft transplant):

Male or female patient 18 years of age or older.
Patient has been fully informed of study procedures and requirements, has signed an IRB approved consent form and is willing and able to follow study procedures.

Exclusion Criteria I (-1 to 7 days post renal allograft transplant):

Patient has previously received an organ transplant.
Patient has an identified donor specific antibody prior to transplant
Patient is known to be seropositive for the human immunodeficiency virus (HIV).
Patient has active Hepatitis C or B infection documented by a positive DNA PCR. Patients who are seropositive for Hepatitis C virus (HCV) or B virus (HBV) but have negative HCV-RNA or HBV-DNA by PCR may be included.
Patient has a current malignancy or a history of malignancy within the past 5 years, except non-metastatic basal or squamous cell carcinoma of the skin that has been treated successfully.
Patient has an uncontrolled infection or unstable medical condition that could interfere with the study objectives.
Patient is currently taking or has been taking an investigational drug in the past 30 days.
Patient has a known hypersensitivity to sirolimus or Myfortic®.
Patient is pregnant or lactating.
Patient is unlikely to comply with the visits scheduled in the protocol.
Patient has any form of substance abuse, psychiatric disorder or a condition that, in the opinion of the investigator, may invalidate communication with the investigator.

Inclusion Criteria II (90 - 180 days post renal allograft transplant):

Patient is 90 to 180 days after having received a primary living- or cadaver-donor renal allograft
Patient has been maintained on a regimen of tacrolimus, Myfortic® and corticosteroids prior to study enrollment.
Patient has a stable allograft defined as calculated GFR > 30 mL/min using Nankivell equation.
Patient has been fully informed of study procedures and requirements, has signed an IRB approved consent form and is willing and able to follow study requirements.
Female patients of child bearing potential must use at least one reliable form of contraception unless they are status post bilateral tubal ligation, bilateral oophorectomy or hysterectomy. Effective contraception must be used for the duration of the study.

Exclusion Criteria II (90 - 180 days post renal allograft transplant):

Patient has experienced an acute graft rejection of ≥ Banff '97 1b or humoral rejection as determined by biopsy within the first 90 days post-transplant
Patient has experienced an acute graft rejection of ≤ Banff 97 1a as determined by biopsy within 30 days prior to Baseline visit.
Patient has untreated hypercholesterolemia defined as triglycerides > 300 or total cholesterol >200 within the previous 30 days.
Patient is currently (< 7 days) leukopenic defined as WBC < 3,000 cells/mL or thrombocytopenic defined as platelets < 100,000 cells/mL.
Patient has significant liver disease, defined as having during the past 30 days continuously elevated AST (SGOT) and/or ALT (SGPT) levels greater than 3 times the upper value of normal range.",All subjects who enroll in this study will be converted from their calcineurin inhibitor to sirolimus.,ChEMBL:CHEMBL413 | DrugBank:DB00877 | PubChem:134760597 | PubChem:138404388 | PubChem:21944094 | PubChem:5284616,Sirolimus,COC1CC2CCC(C)C(O)(O2)C(=O)C(=O)N2CCCCC2C(=O)OC(C(C)CC2CCC(O)C(OC)C2)CC(=O)C(C)C=C(C)C(O)C(OC)C(=O)C(C)CC(C)C=CC=CC=C1C,L01EG04 | L04AA10 | S01XA23,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT00713583,NCT00713583_EG000,No,All,Adult,Phase 2,45,"Inclusion Criteria:

between 18 and 60 years of age
meet Diagnostic and Statistical Manual of Mental Disorders, 4th. Edition (DSM-IV) criteria for current cocaine dependence.
be in acceptable health on the basis of interview, medical history and physical exam.

Exclusion Criteria:

current DSM-IV diagnosis of any psychoactive substance dependence other than cocaine, marijuana, or nicotine.
have a DSM-IV axis I psychiatric disorder or neurological disease or disorder requiring ongoing treatment and/or making study participation unsafe.
have significant current suicidal or homicidal ideation.
have medical conditions contraindicating levodopa/carbidopa pharmacotherapy. Conditions include severe pulmonary disease (bronchial asthma, emphysema), cardiovascular disease (severe or history of myocardial infarction with residual arrhythmias), narrow angle glaucoma, melanoma, history of peptic ulcer, renal function impairment.
taking medications known to have significant drug interactions with levodopa/carbidopa (e.g., monoamine oxidase (MAO) inhibitors, anticonvulsants, haloperidol, phenothiazines, selegiline, anesthetics).
currently or recently (last 3 months) treated for substance use or another psychiatric condition.
having conditions of probation or parole requiring reports of drug use to officers of the court.
impending incarceration.
pregnant or nursing for female patients.
inability to read, write, or speak English.","Levodopa pharmacotherapy, cognitive behavioral therapy (CBT), and contingency management (CM).",DrugBank:DB00988 | PubChem:681,Dopamine,NCCc1ccc(O)c(O)c1,C01CA04,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00714233,NCT00714233_EG000,Accepts Healthy Volunteers,Female,Child | Adult,Phase 3,43,"Inclusion Criteria:

Menstrual irregularity defined as cycle length > 45 days
Overweight as BMI > 25
Clinical evidence of hirsuitism or acne
Testosterone > 50ng/dL

Exclusion Criteria:

History of diabetes mellitus
History of Cushing's disease
History of hyperprolactinemia
Untreated hypo or hyperthyroidism
History of adrenal hyperplasia
Significant renal impairment
Received oral contraceptives, estrogen or progestin or other drugs known to effect lipoprotein metabolism within 2 months of starting the study
Exercise > 10 hours per week",Randomized to Metformin 1700mg daily for 24 weeks,ChEMBL:CHEMBL1431 | DrugBank:DB00331 | PubChem:4091,Metformin,CN(C)C(=N)NC(=N)N,A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00716859,NCT00716859_EG001,No,All,Child | Adult,Phase 3,68,"Inclusion Criteria:

Male or female of 18 years of age or under
Diagnosis of glaucoma
IOP of 22 mmHg or above in at least 1 eye

Exclusion Criteria:

Require surgery for acute angle closure
Have had prior cyclodestructive procedures
Have a history of ocular trauma or surgery in either eye within 3 months of the baseline visit",Latanoprost ophthalmic solution and vehicle; 1 drop of vehicle daily at approximately 8 AM and 1 drop (latanoprost 0.005%) daily at approximately 8 PM.,ChEMBL:CHEMBL1051 | DrugBank:DB00654 | PubChem:5311221,Latanoprost,CC(C)OC(=O)CCC/C=C\C[C@@H]1[C@@H](CC[C@@H](O)CCc2ccccc2)[C@H](O)C[C@@H]1O,S01EE01 | S01EE51,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00717756,NCT00717756_EG000,No,All,Adult | Older Adult,Phase 2,40,"Inclusion Criteria:

Pathologically confirmed HCC or triple phase CT consistent with HCC in a patient with known cirrhosis and AFP > 200 ng/ml.
Disease not amenable to curative surgical resection
Patients must have been previously treated with sorafenib. Patients who are unable to receive sorafenib due to financial reasons are also eligible.
All previous cancer therapy, including radiation, hormonal therapy and surgery, must have been discontinued at least 4 weeks prior to treatment in this study.
No previous thalidomide.
Patients must have radiologically assessable tumor.
ECOG performance status of 0-2 at study entry.
Understand and voluntarily sign an informed consent form.
Age >18 years at the time of signing the informed consent form.
Able to adhere to the study visit schedule and other protocol requirements.

Laboratory test results within these ranges:

Absolute neutrophil count > 1000/mm3
Platelet count > 60,000/mm3
Serum creatinine > 2.0 mg/dL
Total bilirubin > 4 mg/dL
AST (SGOT) and ALT (SGPT) > 5 x ULN.
Females of childbearing potential (FCBP)† must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days prior to and again within 24 hours of starting lenalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy. All patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure. See Appendix: H Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable Birth Control Methods, AND also Appendix: F Education and Counseling Guidance Document
Disease free of prior malignancies for > 2 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma ""insitu"" of the cervix or breast

Exclusion Criteria:

Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide).
Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
Use of any other experimental drug or therapy within 28 days of baseline.
Known hypersensitivity to thalidomide.
The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
Any prior use of lenalidomide.
Concurrent use of other anti-cancer agents or treatments.
Known positive for HIV. (The effect of immune modulation of lenalidomide on patients who are HIV positive is unknown).",lenalidomide: 25 mg po qd x 21 days then 1 week off equals one cycle,ChEMBL:CHEMBL848 | DrugBank:DB00480 | PubChem:216326,Lenalidomide,Nc1cccc2c1CN(C1CCC(=O)NC1=O)C2=O,L04AX04,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00720096,NCT00720096_EG000,No,Female,Adult | Older Adult,Not Applicable,2,"Inclusion Criteria:

Must have history of histologically or cytologically confirmed epithelial ovarian cancer with recurrence.
Must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >20 mm with conventional techniques or as >10 mm with spiral computed tomography CT) scan.
May have had only 2 prior chemotherapy regimens, with at least one regimen containing platinum, and disease recurrence or progression occurring between 0 to 12 months (1 to 365 days)from the platinum-containing regimen. Patients who have been treated with consolidation treatment are allowed and the consolidation will not be considered a separate regimen. Hormonal therapy and immunotherapy will not be considered a prior chemotherapy regimen. Hormonal therapies given to treat the patient's cancer should be stopped at least 30 days prior to dosing on this trial. Typical low-dose hormone replacement therapy to treat postmenopausal symptoms may be continued at the treating physician's discretion.
Life expectancy >6 months.
ECOG performance status 2 or less (Karnofsky 60%).

Must have normal organ and marrow function as defined below:

leukocytes 3,000/microL
absolute neutrophil count 1,500/ microL
platelets 100,000/microL
total bilirubin ≤1.5 X institutional upper limit of normal(ULN) aspartate aminotransferase [AST(SGOT)]/alanine aminotransferase [ALT(SGPT)] ≤2.5 X ULN creatinine within normal institutional limits OR creatinine clearance 60mL/min/1.73m2 for patients with creatinine levels above institutional normal
Ability to understand and willingness to sign a written informed consent document
Measurable disease on CT must be considered amenable to biopsy by Core methods (core biopsy may be radiographically or non-radiographically performed). Potential ability to obtain core material must be reviewed by Principal Investigator (PI) and/or his designates prior to enrollment.
Must consent to biopsy as part of enrolling into trial.
Patients with reproductive potential must use an adequate contraceptive method (e.g. abstinence, intrauterine device, oral contraceptives, barrier device with spermicide or surgical sterilization) during treatment and for three months after completing treatment.
Must have a Multiple Gated Acquisition (MUGA) scan or 2-d echocardiogram indicating an ejection fraction of > 50% or institutional standards within 42 days prior to first dose of study drug. The method used at baseline must be used for later monitoring.

Exclusion Criteria:

Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not version 13, 01/10/08 MCC 15042 16 recovered from adverse events due to agents administered more than 4 weeks earlier.
May not be receiving any other investigational agents concurrently.
Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
History of allergic reactions attributed to compounds of similar chemical or biologic composition to liposomal doxorubicin or topotecan.
Myocardial infarction within 6 months. History of cardiac disease, with New York Heart Association Class II or greater, or clinical evidence of congestive heart failure.
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Women who are pregnant.
Women who are breastfeeding should discontinue breastfeeding.
Human Immunodeficiency Virus (HIV)-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions and increased toxicity.
Patients may have had no other malignancies in the prior 5 years other than non-metastatic, locally-controlled, non-melanomatous cutaneous cancers.
Patients who have received radiation to more than 25% of marrow-bearing areas.",Liposomal Doxorubicin - Chemotherapy single agent systemic.,ChEMBL:CHEMBL417 | ChEMBL:CHEMBL53463 | DrugBank:DB00445 | DrugBank:DB00997 | PubChem:1691 | PubChem:31703 | PubChem:41867,Epirubicin,COc1cccc2c1C(=O)c1c(O)c3c(c(O)c1C2=O)CC(O)(C(=O)CO)CC3OC1CC(N)C(O)C(C)O1,L01DB01 | L01DB03,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT00722722,NCT00722722_EG000,No,All,Adult | Older Adult,Phase 2,3,"Inclusion Criteria:

Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.

Female subject is post-menopausal, surgically sterilized, or she and/or sexual partner are willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study.
Male subject agrees to use an acceptable method for contraception for the duration of the study.
Renal transplant candidates who otherwise meet our acceptance criteria.
Evidence of alloantibody in their serum (panel reactive antibody >20% and specificities determined by single antigen flow bead assay).
Sensitized patients with no living donors or have donor-specific antibody levels too high to undergo successful transplantation using our current protocols (T or B cell crossmatch channel shift >500).

Exclusion Criteria:

Patient has a platelet count of <30 x 10^9/L within 14 days before enrollment.

Patient has an absolute neutrophil count (ANC) of <1.0 x 10^9/L within 14 days before enrollment.
Patient has >Grade 2 peripheral neuropathy within 14 days before enrollment.
Myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any electrocardiogram (ECG) abnormality at Screening has to be documented by the investigator as not medically relevant.
Patient has hypersensitivity to bortezomib, boron or mannitol.
Female subject is pregnant or breast-feeding. Confirmation that the subject is not pregnant must be established by a negative serum B-human chorionic gonadotropin (B-hCG) pregnancy test result obtained during screening. Pregnancy testing is not required for post-menopausal or surgically sterilized women.
Patient has received other investigational drugs within14 days before enrollment.
Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
Diagnosed or treated for malignancy within 5 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy.
Contraindication to kidney transplantation-active infection, comorbid medical conditions, etc.","4 doses of bortezomib (1.3mg/m^2 of body surface area)

Bortezomib: Velcade given in four-dose cycles intravenously (through a vein).",ChEMBL:CHEMBL325041 | DrugBank:DB00188 | PubChem:387447,Bortezomib,CC(C)C[C@H](NC(=O)[C@H](Cc1ccccc1)NC(=O)c1cnccn1)B(O)O,L01XG01 | L01XX32,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00725920,NCT00725920_EG000,No,All,Adult | Older Adult,Phase 4,17,"Inclusion Criteria:

Outpatient, male and female 18 to 60 yrs old
PTSD diagnostic according to DSM-IV criteria
Patients who agree to receive diagnostic after SCID I application by a trained psychiatrist
Sexually active female patients who agree to use contraceptive
Patients who agree to sign the IRB approved informed consent

Exclusion Criteria:

Patients who have schizophrenic disorder, delusional, psychotic depression, schizo-affective, bipolar and dependence to psychoactive substance disorders
Patients who have clinical disorders not compensated, which require clinical treatment as priority
Pregnancy
Previous renal calculosis history
Being under antidepressant, or other psychotropic medications
BMI under 20.",patients receiving the active drug: topiramate,ChEMBL:CHEMBL220492 | DrugBank:DB00273 | PubChem:5284627,Topiramate,[H][C@@]12OC(C)(C)O[C@]1([H])CO[C@@]1(COS(N)(=O)=O)OC(C)(C)O[C@]12[H],A08AA51 | N03AX11,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00726830,NCT00726830_EG000,No,All,Adult | Older Adult,Not Applicable,1,"DISEASE CHARACTERISTICS:

Receiving ongoing care in the outpatient medical oncology setting

Self-reported pain (of any cause) for which long-acting strong opioids (morphine or oxycodone) have been prescribed or administered

Oral morphine-equivalent daily dose (MEDD) of existing opioid regimen (long-acting or immediate-release) 40-300 mg/day
Worst pain score on a scale of 0 (no pain) to 10 (worst pain) of ≥ 5 for ≥ 1 week duration based on verbal self-report AND/OR ≥ 1 persistently bothersome symptom attributed to an opioid side effect (e.g., fatigue, confusion, depressed level of consciousness, memory loss, personality change, anorexia, constipation, dehydration, nausea, vomiting, weight loss, pruritus, urticaria, impotence, reduced libido, and urinary retention or hesitancy)

PATIENT CHARACTERISTICS:

None of the following conditions that could predispose the patient to prolonged QT interval-associated tachycardia:

Serum potassium < 3.0 mg/dL
Cocaine abuse within the past 3 months
Family history of sudden death
Advanced heart failure (ejection fraction < 40% and/or New York Heart Association (NYHA) class III or IV heart disease)
No known or suspected cognitive impairment that could interfere with adherence to the medication plan or self-report of symptoms and side effects
Not pregnant or nursing
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
More than 4 weeks since prior radiotherapy or surgery for local control of cancer or pain palliation
More than 60 days since prior use of the same long-acting opioid (i.e., the new long-acting opioid) that patient is switching to on the study
More than 12 weeks since prior methadone therapy
More than 3 days since prior and no concurrent transdermal fentanyl, oxymorphone, or buprenorphine
Concurrent systemic anticancer therapy or bisphosphonates allowed provided therapy was initiated ≥ 4 weeks ago

Concurrent tricyclic antidepressants, Nonsteroidal Antiinflammatory Drugs (NSAIDs), anticonvulsants, or other adjuvant analgesics or psychostimulants allowed provided therapy was initiated ≥ 2 weeks ago

Dose expected to remain stable until after the first week of opioid rotation on study
No concurrent methadone maintenance therapy for opioid addiction
No concurrent intrathecal infusion of analgesics
No concurrent antiarrhythmic medications (e.g., amiodarone or quinidine)",Participants are switched from their current opioid medication (oxycodone or morphine) to methadone. Participants receive oral methadone 2-3 times daily for 4 weeks.,ChEMBL:CHEMBL350719 | ChEMBL:CHEMBL651 | DrugBank:DB00333 | DrugBank:DB15198 | PubChem:4095 | PubChem:643985,Methadone,CCC(=O)C(CC(C)N(C)C)(c1ccccc1)c1ccccc1,N02AC52 | N07BC02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00727857,NCT00727857_EG002,No,All,Adult | Older Adult,Phase 3,209,"Inclusion Criteria

Has type 2 diabetes.
Has received no treatment with antidiabetic medication in the 12 weeks prior to Screening, other than short-term use defined as less than or equal to 15 days.
A glycosylated hemoglobin greater than or equal to 7.5% and less than or equal to 10.0% at Screening.
Body mass index less than or equal to 45 kg/m2.
Has received counseling on lifestyle modification for type 2 diabetes, including diet and exercise.
Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
Stable condition as determined by a physician.

Exclusion Criteria

Type 1 diabetes.
Unstable angina or heart failure of any etiology with New York Heart Association functional class III or IV.
History of myocardial infarction, cerebrovascular accident, percutaneous coronary intervention, coronary artery bypass graft, or transient ischemic attack in the 6 months prior to Screening.
Male participant has a serum creatinine level greater than or equal to 1.5 mg per dL or female subject has a serum creatinine level greater than or equal to 1.4 mg per dL.
Has a triglyceride level greater than 500 mg per dL.
Male participant has a hemoglobin level less than 10.5 g per dL or female subject has a hemoglobin level less than 10.0 g per dL.
Alanine aminotransferase level of greater than 2.5 times the upper limit of normal, active liver disease, or jaundice.
History of drug abuse (defined as any illicit drug use) or a history of alcohol abuse (defined as regular or daily consumption of more than 2 alcoholic drinks per day) within 2 years prior to Screening.
Has been discontinued from a thiazolidinedione or metformin therapy due to lack of efficacy or clinical or laboratory signs of intolerance.
Previous history of cancer, other than basal cell or stage 1 squamous cell carcinoma, that has not been in remission for at least 5 years prior to the first dose of study medication.
History of acute or chronic metabolic acidosis, including diabetic ketoacidosis with or without coma.
Any disease or condition at Screening or Randomization that would compromise safety, might affect life expectancy, or make it difficult to successfully manage and follow the subject according to the protocol.
Currently participating in another investigational study or has participated in an investigational study within 30 days prior to randomization.

Is required to take or continues taking any disallowed medication, prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including:

Antidiabetic medications other than study medication
Chronically used oral or parenteral glucocorticoids
Niacin greater than 200 mg per day, including niacin-containing products such as Advicor
Chronically used steroid-joint injections","Metformin 850 mg, tablets, orally, twice daily for up to 24 weeks.",ChEMBL:CHEMBL1431 | DrugBank:DB00331 | PubChem:4091,Metformin,CN(C)C(=N)NC(=N)N,A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00731120,NCT00731120_EG002,No,All,Adult | Older Adult,Phase 3,152,"Inclusion Criteria:

Has a primary diagnosis of Generalized Anxiety Disorder according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR®) criteria (classification code 300.02).
Has a Hamilton Anxiety Scale total score ≥ 20.
Has a Hamilton Anxiety Scale score ≥ 2 on both item 1 (anxious mood) and item 2 (tension).
Has a Montgomery-Åsberg Depression Rating Scale total score ≤16.

Exclusion Criteria:

Has 1 or more of the following:

Any current psychiatric disorder other than Generalized Anxiety Disorder as defined in the DSM-IV-TR (as assessed by the Mini International Neuropsychiatric Interview [MINI]).
Current or past history of: manic or hypomanic episode, schizophrenia or any other psychotic disorder, including major depression with psychotic features, mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in the DSM-IV-TR.
Any substance disorder (except nicotine and caffeine) within the previous 6 months as defined in the DSM-IV-TR and participant must have a negative urine drug screen prior to Baseline.
Presence or history of a clinically significant neurological disorder (including epilepsy).
Neurodegenerative disorder (Alzheimer disease, Parkinson disease, multiple sclerosis, Huntington disease, etc.).
Any Axis II disorder that might compromise the study.
Is taking excluded medications.
Has a significant risk of suicide according to the investigator's opinion or has a score ≥5 on Item 10 (suicidal thoughts) of the Montgomery-Åsberg Depression Rating Scale or has made a suicide attempt in the previous 6 months.
Has previously failed to respond to adequate treatment with selective serotonin reuptake inhibitors and/or serotonin-norepinephrine reuptake inhibitors.
Has received electroconvulsive therapy within 6 months prior to Screening.
Is currently receiving formal cognitive or behavioral therapy, systematic psychotherapy, or plans to initiate such therapy during the study.
Has a clinically significant unstable illness.
Has an alanine aminotransferase, aspartate aminotransferase, or total bilirubin level > 1.5 times the upper limit of normal.
Has a serum creatinine of > 1.5 × the upper limit of normal.
Has a previous history of cancer that had been in remission for less than 5 years.
Has thyroid stimulating hormone value outside the normal range.
Has an abnormal electrocardiogram.","Vortioxetine 10 mg encapsulated tablets, orally, once daily for up to 8 weeks.",ChEMBL:CHEMBL2104993 | DrugBank:DB09068 | PubChem:9966051,Vortioxetine,Cc1ccc(Sc2ccccc2N2CCNCC2)c(C)c1,N06AX26,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00732641,NCT00732641_EG000,No,All,Adult | Older Adult,Phase 3,123,"Inclusion Criteria:

Must demonstrate willingness to participate in the study and to adhere to dose and visit schedules
Must be ≤85 years of age of either sex, and any race
Must have stage II or III multiple myeloma with a histological confirmation consistent with the

diagnosis of multiple myeloma (by biopsy of an osteolytic or soft tissue tumour composed of plasma cells or bone marrow aspirate and/or biopsy demonstrating ≥ 10% plasmacytosis). The histological

confirmation should have been obtained prior to the induction chemotherapy or bone marrow transplant chemotherapy

May not have received prior interferon for the treatment of multiple myeloma
Must confirm that he/she is practicing adequate contraception
If a female volunteer of childbearing potential, must have a negative serum pregnancy test

at Screening/Visit 1

-Must be free of any clinically relevant disease (other than multiple myeloma) that would, in the

principal investigator's and/or sponsor's opinion, interfere with the conduct of the study or study

evaluations

Must be able to adhere to the dosing and visit schedules
Clinical laboratory tests (complete blood chemistry [CBC], blood chemistries, urinalysis) must be

consistent with adequate hepatic and renal function, defined as <2 times upper limit of any laboratory normal (ULN) and adequate hematological functions defined as platelets > 50,000/mm^3, Hemoglobin ≥9.0 g/dL, white blood count (WBC) count ≥2000/mm^3

-Must have a complete, partial or minimal response after either one induction chemotherapy

regimen or one myelosuppressive chemotherapeutic treatment followed by peripheral blood stem cell

infusion as a first line treatment. Any type of pre-transplant chemotherapy and conditioning regimen is allowed

-Performance Status Karnofsky score of ≥60% at time of randomization

Exclusion Criteria:

Is a female who is pregnant, or intends to become pregnant during the study
Is nursing, or intends to be nursing during the study
Has used any investigational product within 30 days prior to enrollment

Have any of the following clinical conditions:

Pre existing psychiatric condition, especially depression, or a history of severe psychiatric disorder, such as major psychoses, suicidal ideation and/or suicidal attempt. Subjects with a history of mild depression may be considered for entry into the protocol provided that a pre-treatment assessment of the subject's mental status indicates that the subject is clinically stable and that there is ongoing evaluation of the patient's mental status during the study
Central Nervous System (CNS) trauma or active seizure disorders requiring medication
Significant cardiovascular dysfunction within the previous 6 months before the study starts (eg, angina, congestive heart failure, recent myocardial infarction, severe hypertension or significant arrhythmia) or patient with multigated acquisition (MUGA) or echocardiogram < 40%;
History of prior malignant disease within the previous 5 years before the study starts, except for surgically cured squamous cell or basal cell skin carcinoma or Stage I cervical carcinoma or cervical carcinoma in situ;
Known severe coagulation disorders, thrombophlebitis or pulmonary embolism or decompensate liver disease;
Uncontrolled diabetes mellitus or thyroid dysfunction (not responsive to therapy);
Severe chronic pulmonary disease (eg, chronic obstructive pulmonary disease);
Has active and/or uncontrolled infection
Is in a situation or condition that, in the opinion of the investigator, may interfere with optimal

participation in the study

Is participating in any other clinical study
Is on the staff, affiliated with, or a family member of the staff personnel directly involved with this study
Is allergic to or has sensitivity to the study drug or its excipients","Peginterferon α-2b 35 μg, weekly, subcutaneous (SC), until disease progression or relapse, or for up to a maximum of 5 years.",ChEMBL:CHEMBL1643 | DrugBank:DB00811 | PubChem:37542,Ribavirin,NC(=O)c1ncn([C@@H]2O[C@H](CO)[C@@H](O)[C@H]2O)n1,J05AP01,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT00733421,NCT00733421_EG001,No,Female,Adult | Older Adult,Phase 4,49,"Inclusion Criteria:

Health ASA 1-2 patients 18-65 years of age

Exclusion Criteria:

ASA/NSAID allergy
Renal disease
Lithium therapy
Complicated cardiovascular disease",Tramadol 100 mg slow release twice daily,ChEMBL:CHEMBL1237044 | DrugBank:DB00193 | PubChem:33741,Tramadol,COc1cccc(C2(O)CCCCC2CN(C)C)c1,N02AJ13 | N02AJ14 | N02AJ16 | N02AX02,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00734071,NCT00734071_EG001,No,All,Adult | Older Adult,Phase 3,148,"Inclusion Criteria:

Has a primary diagnosis of Generalized Anxiety Disorder according to the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR®) criteria.
Has a Hamilton Anxiety Scale total score greater than or equal to 20 at Screening and Baseline.
Has a Hamilton Anxiety Scale score greater than or equal to 2 on both Item 1 (anxious mood) and Item 2 (tension) at Screening and Baseline.
Has a Montgomery-Åsberg Depression Rating Scale total score less than or equal to 16 at Screening and Baseline.

Exclusion Criteria:

Has 1 or more of the following:

Any current psychiatric disorder other than Generalized Anxiety Disorder as defined in the DSM-IV-TR (as assessed by the Mini International Neuropsychiatric Interview [MINI]).
Current or past history of: manic or hypomanic episode, schizophrenia or any other psychotic disorder, including major depression with psychotic features, mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in the DSM-IV-TR.
Any substance disorder (except nicotine and caffeine) within the previous 6 months as defined in the DSM-IV-TR® and subject must have a negative urine drug screen prior to Baseline.
Presence or history of a clinically significant neurological disorder (including epilepsy).
Neurodegenerative disorder (Alzheimer disease, Parkinson disease, multiple sclerosis, Huntington disease, etc.).
Any Axis II disorder that might compromise the study.
Is taking excluded medications.
Has a significant risk of suicide according to the investigator's opinion or has a score greater than or equal to 5 on Item 10 (suicidal thoughts) of the Montgomery-Åsberg Depression Rating Scale or has made a suicide attempt in the previous 6 months.
Has previously failed to respond to adequate treatment with selective serotonin reuptake inhibitors and/or serotonin-norepinephrine reuptake inhibitors.
Has received electroconvulsive therapy within 6 months prior to Screening.
Is currently receiving formal cognitive or behavioral therapy, systematic psychotherapy, or plans to initiate such therapy during the study.
Has a clinically significant unstable illness.
Has an alanine aminotransferase, aspartate aminotransferase, or total bilirubin level greater than 1.5 times the upper limit of normal.
Has a serum creatinine of greater than 1.5 times the upper limit of normal.
Has a previous history of cancer that had been in remission for less than 5 years.
Has thyroid stimulating hormone value outside the normal range at Screening and is deemed clinically significant by the investigator.
Has an abnormal electrocardiogram.","Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.",ChEMBL:CHEMBL2104993 | DrugBank:DB09068 | PubChem:9966051,Vortioxetine,Cc1ccc(Sc2ccccc2N2CCNCC2)c(C)c1,N06AX26,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT00735709,NCT00735709_EG001,No,All,Adult | Older Adult,Phase 3,140,"Inclusion Criteria:

Has a primary diagnosis of major depressive episode according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria.
The reported duration of the current major depressive episode is at least 3 months.
Has a Montgomery Åsberg Depression Rating Scale (MADRS) total score ≥26.
A male or a female of childbearing potential who is sexually active agrees to use adequate contraception from Screening throughout the duration of the study and for 1 month after the last dose of study medication.

Exclusion Criteria:

Has 1 or more the following:

Any current psychiatric disorder other than major depressive disorder as defined in the DSM-IV-TR.
Current or past history of: manic or hypomanic episode, schizophrenia or any other psychotic disorder, including major depression with psychotic features, mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in the DSM-IV-TR.
Any substance disorder (except nicotine and caffeine) within the previous 6 months as defined in the DSM-IV-TR. (must have negative urine drug screen prior to Baseline).
Presence or history of a clinically significant neurological disorder (including epilepsy).
Neurodegenerative disorder (Alzheimer disease, Parkinson disease, multiple sclerosis, Huntington disease, etc).
Has a significant risk of suicide according to the investigator's opinion or has a score ≥5 on item 10 (suicidal thoughts) of the Montgomery Åsberg Depression Rating Scale, or has made a suicide attempt in the previous 6 months.
Currently receiving formal cognitive or behavioral therapy, systematic psychotherapy, or plans to initiate such therapy during the study.
Has a clinically significant unstable illness.
Has previously failed to respond to adequate treatment with selective serotonin reuptake inhibitors and/or serotonin-norepinephrine reuptake inhibitors.
Has received electroconvulsive therapy within 6 months prior to Screening.
Has an alanine aminotransferase, aspartate aminotransferase, or total bilirubin level > 1.5 times the upper limit of normal.
Has a serum creatinine of > 1.5 × upper limit of normal.
Has a previous history of cancer that had been in remission for less than 5 years.
Has thyroid stimulating hormone value outside the normal range.
Has an abnormal electrocardiogram.","Vortioxetine 1 mg, encapsulated tablets, orally, once daily for up 8 weeks.",ChEMBL:CHEMBL2104993 | DrugBank:DB09068 | PubChem:9966051,Vortioxetine,Cc1ccc(Sc2ccccc2N2CCNCC2)c(C)c1,N06AX26,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00735709,NCT00735709_EG002,No,All,Adult | Older Adult,Phase 3,140,"Inclusion Criteria:

Has a primary diagnosis of major depressive episode according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria.
The reported duration of the current major depressive episode is at least 3 months.
Has a Montgomery Åsberg Depression Rating Scale (MADRS) total score ≥26.
A male or a female of childbearing potential who is sexually active agrees to use adequate contraception from Screening throughout the duration of the study and for 1 month after the last dose of study medication.

Exclusion Criteria:

Has 1 or more the following:

Any current psychiatric disorder other than major depressive disorder as defined in the DSM-IV-TR.
Current or past history of: manic or hypomanic episode, schizophrenia or any other psychotic disorder, including major depression with psychotic features, mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in the DSM-IV-TR.
Any substance disorder (except nicotine and caffeine) within the previous 6 months as defined in the DSM-IV-TR. (must have negative urine drug screen prior to Baseline).
Presence or history of a clinically significant neurological disorder (including epilepsy).
Neurodegenerative disorder (Alzheimer disease, Parkinson disease, multiple sclerosis, Huntington disease, etc).
Has a significant risk of suicide according to the investigator's opinion or has a score ≥5 on item 10 (suicidal thoughts) of the Montgomery Åsberg Depression Rating Scale, or has made a suicide attempt in the previous 6 months.
Currently receiving formal cognitive or behavioral therapy, systematic psychotherapy, or plans to initiate such therapy during the study.
Has a clinically significant unstable illness.
Has previously failed to respond to adequate treatment with selective serotonin reuptake inhibitors and/or serotonin-norepinephrine reuptake inhibitors.
Has received electroconvulsive therapy within 6 months prior to Screening.
Has an alanine aminotransferase, aspartate aminotransferase, or total bilirubin level > 1.5 times the upper limit of normal.
Has a serum creatinine of > 1.5 × upper limit of normal.
Has a previous history of cancer that had been in remission for less than 5 years.
Has thyroid stimulating hormone value outside the normal range.
Has an abnormal electrocardiogram.","Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up 8 weeks.",ChEMBL:CHEMBL2104993 | DrugBank:DB09068 | PubChem:9966051,Vortioxetine,Cc1ccc(Sc2ccccc2N2CCNCC2)c(C)c1,N06AX26,0.0,0.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00735709,NCT00735709_EG003,No,All,Adult | Older Adult,Phase 3,139,"Inclusion Criteria:

Has a primary diagnosis of major depressive episode according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria.
The reported duration of the current major depressive episode is at least 3 months.
Has a Montgomery Åsberg Depression Rating Scale (MADRS) total score ≥26.
A male or a female of childbearing potential who is sexually active agrees to use adequate contraception from Screening throughout the duration of the study and for 1 month after the last dose of study medication.

Exclusion Criteria:

Has 1 or more the following:

Any current psychiatric disorder other than major depressive disorder as defined in the DSM-IV-TR.
Current or past history of: manic or hypomanic episode, schizophrenia or any other psychotic disorder, including major depression with psychotic features, mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in the DSM-IV-TR.
Any substance disorder (except nicotine and caffeine) within the previous 6 months as defined in the DSM-IV-TR. (must have negative urine drug screen prior to Baseline).
Presence or history of a clinically significant neurological disorder (including epilepsy).
Neurodegenerative disorder (Alzheimer disease, Parkinson disease, multiple sclerosis, Huntington disease, etc).
Has a significant risk of suicide according to the investigator's opinion or has a score ≥5 on item 10 (suicidal thoughts) of the Montgomery Åsberg Depression Rating Scale, or has made a suicide attempt in the previous 6 months.
Currently receiving formal cognitive or behavioral therapy, systematic psychotherapy, or plans to initiate such therapy during the study.
Has a clinically significant unstable illness.
Has previously failed to respond to adequate treatment with selective serotonin reuptake inhibitors and/or serotonin-norepinephrine reuptake inhibitors.
Has received electroconvulsive therapy within 6 months prior to Screening.
Has an alanine aminotransferase, aspartate aminotransferase, or total bilirubin level > 1.5 times the upper limit of normal.
Has a serum creatinine of > 1.5 × upper limit of normal.
Has a previous history of cancer that had been in remission for less than 5 years.
Has thyroid stimulating hormone value outside the normal range.
Has an abnormal electrocardiogram.","Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up 8 weeks.",ChEMBL:CHEMBL2104993 | DrugBank:DB09068 | PubChem:9966051,Vortioxetine,Cc1ccc(Sc2ccccc2N2CCNCC2)c(C)c1,N06AX26,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00736190,NCT00736190_EG000,No,All,Adult | Older Adult,Phase 4,90,"Inclusion Criteria:

Male or female
Asian-American, defined as a person of self-reported Asian ancestry who is residing in the United States (US)
18 through 75 years of age, inclusive
Documented chronic HBV infection, defined as positive serum HBsAg =/> 6 months
HBV DNA =/> 10,000 copies/mL (PCR method)
ALT > ULN and </= 10 × ULN at screening or within the past 12 months prior to screening
Willing and able to provide written informed consent
Negative serum beta-human chorionic gonadotropin (HCG) pregnancy test (females of child-bearing potential)
Estimated glomerular filtration rate (creatinine clearance) =/> 60 mL/min/1.73m^2 by the Cockcroft-Gault equation
Adequate hematologic function (absolute neutrophil count =/> 1,500/mm^3; hemoglobin =/> 10.0 g/dL)
No prior TDF therapy; participants may have taken < 12 weeks of oral anti-HBV therapy, with the last dose =/> 16 weeks prior to screening; participants may have received prior interferon, but must have discontinued interferon therapy =/> 6 months prior to screening

Exclusion Criteria:

Participants who meet any of the following exclusion criteria are not to be enrolled in this study.

Pregnant women, women who are breast feeding or who believe they may wish to become pregnant during the course of the study.
Males and females of reproductive potential who are not willing to use an effective method of contraception during the study. For males, condoms should be used and for females, a barrier contraception method should be used in combination with one other form of contraception.
Decompensated liver disease defined as direct (conjugated) bilirubin > 1.2 X ULN, prothrombin time (PT) > 1.2 X ULN, platelets < 150,000/mm3, or serum albumin < 3.5 g/dL
Prior history of clinical hepatic decompensation (eg, ascites, jaundice, encephalopathy) or variceal hemorrhage
Receipt of prior TDF treatment
Receipt of =/> 12 weeks of oral anti-HBV nucleoside/nucleotide therapy, or receipt of ANY oral anti-HBV treatment < 16 weeks prior to screening
Receipt of interferon (pegylated or not) therapy within 6 months of the Screening Visit
alpha-fetoprotein > 50 ng/mL
Evidence of hepatocellular carcinoma (HCC)
Co-infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis D virus (HDV)
History of significant renal disease (eg, nephrotic syndrome, renal dysgenesis, polycystic kidney disease, congenital nephrosis, acute tubular necrosis, other renal disease)
History of significant bone disease (eg, osteomalacia, chronic osteomyelitis, osteogenesis imperfecta, osteochrondroses, multiple bone fractures)
Significant cardiovascular, pulmonary or neurological disease
Evidence of a gastrointestinal malabsorption syndrome that may interfere with absorption of orally administered medications
History of solid organ or bone marrow transplantation
Ongoing therapy with any of the following: nephrotoxic agents, competitors of renal excretion (eg, probenecid), systemic chemotherapeutic agents, systemic corticosteroids, Interleukin-2 (IL-2) and other immunomodulating agents, investigational agents (except with the expressed approval of the Sponsor); administration of any of the above medications must be discontinued at least 30 days prior to the Baseline Visit and for the duration of the study period
Known hypersensitivity to the study drugs, the metabolites, or formulation excipients
Any other condition (including alcohol or substance abuse) or prior therapy that, in the opinion of the Investigator, would make the participant unsuitable for the study or unable to comply with dosing requirements",Tenofovir disoproxil fumarate 300 mg by mouth daily,PubChem:5486830 | PubChem:6398764,Tenofovir Disoproxil Fumarate,CC(C)OC(=O)OCOP(=O)(COC(C)Cn1cnc2c(N)ncnc21)OCOC(=O)OC(C)C.O=C(O)C=CC(=O)O,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT00736385,NCT00736385_EG000,No,All,Adult | Older Adult,Phase 4,4,"Inclusion Criteria:

biopsy-proven NAFLD, determined within 12 months of study initiation

Exclusion Criteria:

> 20 grams of alcohol/day
impaired oral glucose tolerance test
known diagnosis of diabetes mellitus
hepatitis C infection
cirrhosis","Metformin XR 2000 mg daily

Glucophage (Metformin): metformin XR 2000 mg daily for 12 months",ChEMBL:CHEMBL1431 | DrugBank:DB00331 | PubChem:4091,Metformin,CN(C)C(=N)NC(=N)N,A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0
NCT00737737,NCT00737737_EG000,No,Male,Adult | Older Adult,Phase 4,8,"-INCLUSION CRITERIA:

Clinical evidence of chronic OA by history, examination and radiological examination

a. Pain level of 4/10 or greater on a scale of 0 to 10 over a 2 week screening period
b. Pain for a duration of 3 months or longer present at least 5 out of 7 days a week by history
c. Radiographic evidence of moderate to severe OA in at least one joint selected for study based on the Kellgren and Lawrence scoring scale (Appendix I:Table 2)
Age between 30-65 at study entry. This age range was chosen as osteoarthritis is rare in people younger than 30 and to minimize the effect of the neuroendocrine changes associated with aging on study outcome measures.
Men of all ethnicities
Ability to provide his own consent and to cooperate with study procedures
Willingness to refrain from drinking alcohol during the study because alcohol may exacerbate the sedative effects of morphine
Willingness to refrain from using muscle relaxers, antiepileptic medications and antidepressants within 6 weeks of starting study procedures
Willingness not to be on opioids other than prescribed by the study for the duration of the study and willingness to come off of opioids six weeks prior to starting study procedures

EXCLUSION CRITERIA:

Impaired pulmonary, renal, hepatic, cardiovascular or endocrine-metabolic function or major coexisting medical condition such as cancer, Cushing s disease, and diabetes which may make participation unsafe or interfere with hormone measurements
Prostatic disease or hypertrophy which would make subjects prone to urinary retention or require medication that would interfere with study hormone measurements
Sexual dysfunction including lack of libido, impotence or erectile abnormalities for safety reasons as these symptoms may be worsened by morphine
Rheumatoid arthritis other types of inflammatory arthritis
Use of systemic corticosteroids in the two months before study entry which might interfere with study hormone measurements
Present or past history of alcohol dependence which might predispose subjects to problems with opioid dependence based on 2 or more positive responses to the CAGE questionnaire (the latter group will be referred to psychiatry for further evaluation and excluded from study if found to fulfill psychiatric criteria for alcohol dependence or abuse)
Current usage of any recreational or unauthorized prescription drugs because this may indicate abuse potential based on positive urine drug test at study screening visit
History of opioid abuse at any time in the past based on patient report or a urine drug screen positive for opioids
Major depression based on a score of greater than or equal to 20 on the Beck Depression Inventory at screening, present history of major depression or treatment for major depression because these may effect endocrine function
Hct < 35; anemia or bleeding disorder because subjects will undergo serial blood sampling to assess hormone function
Allergy or inability to tolerate to morphine
Current or past fibromyalgia according to Wolfe criteria (1990)
Present or past history of sleep apnea because of increased risk of respiratory depression with morphine
Body mass index (BMI) > 30kg/m(2) and BMI < 20kg/m(2)
Local steroid injections during the study because weight has significant effects on hormone levels
Addition of or changes to complementary or alternative treatments during the study","Participants will receive MS Contin over a 4 week period starting at 15 mg bid. Doses will titrated upwards as tolerated by increments of 15-30 mg to a highest attained dose or a maximum dose of 90 mg

MS Contin",PubChem:16051935,Morphine Sulfate,CN1CCC23c4c5ccc(O)c4OC2C(O)C=CC3C1C5.CN1CCC23c4c5ccc(O)c4OC2C(O)C=CC3C1C5.O=S(=O)(O)O,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00743093,NCT00743093_EG000,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 4,224,"Inclusion Criteria:

age 18 or older

Exclusion Criteria:

History of acetaminophen ingestion on any of the four days preceding study enrollment
Measurable serum acetaminophen level at time of enrollment
Viral markers of Hepatitis B or C, or viral markers of Hepatitis A with an ALT level greater than ULN during screening laboratory testing
Serum ALT or AST level greater than ULN at Screening or Day 0
Total bilirubin level greater than ULN at Screening or Day 0
INR level greater than ULN at Screening
Alkaline phosphatase level greater than ULN at Screening
Platelet count less than 125 10^9/L at Screening
Known cholelithiasis
Positive pregnancy test at Screening (female participants only)
History of consuming more than an average of 3 alcohol containing drinks daily over the preceding 2 weeks
History of consuming 3 or more alcohol containing drinks on any given day during the 2 weeks prior to study enrollment
New prescription medication started within the previous 30 days
Currently taking isoniazid
Currently taking warfarin
Currently adheres to a fasting type diet as determined by self report
Currently has anorexia nervosa as determined by self report
Participant is clinically intoxicated, psychiatrically impaired or unable to give informed consent for any reason
Known hypersensitivity or allergy to acetaminophen","acetaminophen

acetaminophen : 500 mg caplets; 2 capsules (1 g)/dose; 4 doses (4 g)/day, 4 hours apart for 16 to 40 days.",ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,1.0,1.0,1.0,0.0,0.0,1.0,0.0
NCT00743509,NCT00743509_EG000,No,All,Child | Adult | Older Adult,Phase 2,49,"Inclusion Criteria:

Progressive or recurrent, advanced (unresectable or metastatic) high-grade osteosarcoma, Ewing's or soft tissue sarcoma previously treated with chemotherapy.
Bi-dimensionally measurable lesion(s) on cross-sectional radiography, such as computed tomography or magnetic resonance imaging, within 2 weeks of enrollment.
ECOG/Zubrod performance score 0, 1 or 2.
Total WBC >3,000, neutrophil count >1,000, platelet count >100,000 within 2 weeks of enrollment.
Serum creatinine <2.0 times the institutional upper limit of normal (IULN) within 2 weeks of enrollment.
AST and ALT <2.5 times IULN (or if liver involvement by sarcoma <5 times IULN) within 2 weeks of enrollment.
Able to ingest oral medications.
Sexually active women and men of childbearing potential must agree to use an effective method of birth control during the course of the study and for up to 1 month following the last dose of the study drug, in a manner such that risk of pregnancy is minimized. Surgical sterilization, oral contraceptive pills, intrauterine device, double barrier (e.g. condom and diaphragm or spermicidal agents) or abstinence are acceptable forms of birth control.
Women of childbearing potential must have a negative pregnancy test within 2 weeks prior to treatment.
Patient must be >16 years of age at the time the consent document is signed by the patient.
A paraffin block containing sarcoma, either from a previous surgery or recent biopsy, must be available for correlative studies. If a paraffin block containing sarcoma is not available, patients are required to undergo biopsy to obtain tissue for the correlative studies.

Exclusion Criteria:

Active infection requiring antibiotic treatment.
Diabetes mellitus not under good control (e.g. hemoglobin A1c > 8% or fasting glucose > 180 mg/dl) with oral agents or insulin.
Prior treatment with mTOR inhibitor for sarcoma.
Less than 3 weeks from prior treatment with chemotherapy to start of treatment with cyclophosphamide and sirolimus. Toxicities from prior chemotherapy (except alopecia) should be grade 1 or less before starting treatment with cyclophosphamide and sirolimus.
Prior radiation less than two weeks since the administration of the last fraction of radiation therapy to the start of treatment. Patients must have recovered from grade 2 or higher radiation-associated toxicities to be eligible. All measurable lesions, which are being targeted, must be outside previously radiated fields or have documented progression at least 6 weeks after completion of radiation.
Untreated or active CNS involvement by sarcoma.
Active second malignancy other than carcinoma in situ. Patients with malignancy other than sarcoma in remission are eligible.
Women who are pregnant or breastfeeding.","Sarcoma patients were given oral Cyclophosphamide and Sirolimus (OCR) in 28 day cycles.

Cyclophosphamide and Sirolimus : The dose of cyclophosphamide will start at 200 mg (4 tablets) per day on day 1 and will be taken for 7 days every other week of a 28 day cycle.

Subjects will take 12 mg (12 tablets) of sirolimus on day 1 of treatment as a loading dose followed by 4 mg (4 tablets) daily continuously",ChEMBL:CHEMBL413 | DrugBank:DB00877 | PubChem:134760597 | PubChem:138404388 | PubChem:21944094 | PubChem:5284616,Sirolimus,COC1CC2CCC(C)C(O)(O2)C(=O)C(=O)N2CCCCC2C(=O)OC(C(C)CC2CCC(O)C(OC)C2)CC(=O)C(C)C=C(C)C(O)C(OC)C(=O)C(C)CC(C)C=CC=CC=C1C,L01EG04 | L04AA10 | S01XA23,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0
NCT00744627,NCT00744627_EG001,No,All,Adult | Older Adult,Phase 3,150,"Inclusion Criteria:

Suffers from a primary diagnosis of Generalized Anxiety Disorder according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria.
Has a Hamilton Anxiety Scale total score ≥20 at Screening and Baseline.
Has a Hamilton Anxiety Scale score ≥2 on both Item 1 (anxious mood) and Item 2 (tension) at Screening and Baseline.
Has a Montgomery-Åsberg Depression Rating Scale total score ≤16 at Screening and Baseline.
Male and females of childbearing potential who are sexually active agree to use adequate contraception from Screening throughout the duration of the study and for 1 month after the last dose of study medication.

Exclusion Criteria:

Has received any investigational compound <30 days before Screening or 5 half-lives prior to Screening.
Has received Lu AA21004 in a previous clinical study or as a therapeutic agent.

Has 1 or more of the following:

Any current psychiatric disorder other than Generalized Anxiety Disorder as defined in the DSM-IV-TR.
Current or past history of: manic or hypomanic episode, schizophrenia or any other psychotic disorder, including major depression with psychotic features, mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in the DSM-IV-TR.
Any substance disorder (except nicotine and caffeine) within the previous 6 months as defined in the DSM-IV-TR.
Presence or history of a clinically significant neurological disorder (including epilepsy).
Neurodegenerative disorder (Alzheimer's disease, Parkinson's disease, multiple sclerosis, Huntington disease, etc).
Any Axis II disorder that might compromise the study.

Is required to take excluded medications or it is anticipated that the participant will require treatment with at least 1 of the disallowed concomitant medications during the study including:

Nonsteroidal anti-inflammatory drugs
Rifampin
Macrolide antibiotics
Hormones
Hypoglycemic agents and Insulin
Systemic steroids
Antineoplastics
Antiobesity agents
Antidiarrheal agents (episodic use allowed)
Antifungal agents (episodic topical use allowed)
Antihistamines (episodic use of loratadine, desloratadine, cetirizine allowed)
Cough/cold agents (episodic use allowed but preparations containing pseudoephedrine and narcotics are NOT allowed)
Diuretics (episodic use allowed)
Has a significant risk of suicide according to the investigator's opinion or has a score ≥5 on item 10 (suicidal thoughts) of the Montgomery-Åsberg Depression Rating Scale or has made a suicide attempt in the previous 6 months.
Has previously failed to respond to adequate treatment with selective serotonin reuptake inhibitors and/or serotonin-norepinephrine reuptake inhibitors.
Has received electroconvulsive therapy within 6 months prior to Screening.
Is currently receiving formal cognitive or behavioral therapy, systematic psychotherapy, or plans to initiate such therapy during the study.
Has a clinically significant unstable illness, for example, hepatic impairment or renal insufficiency, or a cardiovascular, pulmonary, gastrointestinal, endocrine, neurological, rheumatologic, immunologic, infectious, skin and subcutaneous tissue disorders, or metabolic disturbance.
Has an alanine aminotransferase, aspartate aminotransferase or bilirubin level >1.5 times the upper limits of normal.
Has a serum creatinine of >1.5 times the upper limits of normal.
Has a previous history of cancer that had been in remission for less than 5 years prior to the first dose of study medication. This criterion does not include those participants with basal cell or stage I squamous cell carcinoma of the skin.
Has clinically significant abnormal vital signs as determined by the investigator.
Has 1 or more laboratory values outside the normal range, based on the blood or urine samples taken at Screening, that are considered by the investigator to be clinically significant.
Has thyroid stimulating hormone value outside the normal range at Screening and is deemed clinically significant by the investigator.
Has an abnormal electrocardiogram as determined by the central reader and confirmed as clinically significant by the investigator.
Has a disease or takes medication that, in the opinion of the investigator, could interfere with the assessments of safety, tolerability, or efficacy.
Has previously participated in this study.","Vortioxetine 5 mg, encapsulated tablets, orally, once daily for up to 8 weeks.",ChEMBL:CHEMBL2104993 | DrugBank:DB09068 | PubChem:9966051,Vortioxetine,Cc1ccc(Sc2ccccc2N2CCNCC2)c(C)c1,N06AX26,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT00745134,NCT00745134_EG000,No,All,Adult | Older Adult,Phase 2,15,"Inclusion Criteria:

All patients must have clinical stage T3,4 N0,1,2 or T2N1,2 adenocarcinoma of the rectum; patients will be clinically staged using endorectal ultrasound, pelvic computed tomography (CT) or magnetic resonance imaging (MRI), and physical examination
Histology must be confirmed with review by the Department of Pathology at MD Anderson Cancer Center (MDACC)
All patients must have no distant metastatic disease in the liver, peritoneum, lungs, or paraaortic lymph nodes
Patients must have a performance status (Karnofsky scale) of 70% or greater
Absolute neutrophil count (ANC) > 1200 cells/mm^3
Platelets > 100,000/mm^3
Total serum bilirubin < 2 mg/dl
Blood urea nitrogen (BUN) < 30 mg/dl
Creatinine < 1.5 mg/dl or creatinine clearance > 50cc/min (estimated as calculated with Cockcroft-Gault equation)
Patients must have signed informed consent indicating that they are aware of the investigational nature of the study, and are aware that participation is voluntary; patients must also agree to refrain from use of additional herbal supplements during the course of the study
Patients will agree to continue contraception for 30 days from the date of the last study drug administration; sexually active males must practice contraception during the study
Postmenopausal woman must have been amenorrheic for at least 12 months to be considered of non-childbearing potential

Exclusion Criteria:

Prior complete course up to 5 Gy of radiotherapy to the pelvis
Pregnant or lactating woman; women of childbearing potential who have not undergone a hysterectomy with either a positive or no pregnancy test at baseline; women / men of childbearing potential not using a reliable and appropriate contraceptive method (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner)
Treatment for other carcinomas within the last five years, except cured non-melanoma skin and treated in-situ cervical cancer
Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or requiring IV antibiotics, cardiac disease New York Heart Association (NYHA) class III or IV, unstable angina pectoris, unstable cardiac arrhythmia or tachycardia (heart rate > 100 beats/minute), or psychiatric illness/ social situations that would limit compliance with the study requirements are excluded
Other serious uncontrolled medical conditions that the investigator feels might compromise study participation
Major surgery within 4 weeks of the start of study treatment
Prior unanticipated severe reaction to fluoropyrimidine therapy or known hypersensitivity to 5-fluorouracil or capecitabine or curcumin
Concurrent use of Coumadin other than low dose (1 mg) Coumadin used for line patency; patients on Coumadin must be changed to Lovenox at least 1 week prior to starting capecitabine
Concurrent use of cimetidine, allopurinol, or aluminium hydroxide and magnesium hydroxide-containing antacids such as Maalox
Sorivudine and brivudine use within 4 weeks of the start of study treatment",Patients undergo radiation therapy 5 days a week for a total of 28 fractions. Patients also receive capecitabine PO BID on the days of radiation therapy and curcumin PO BID in weeks 1-11.5.,ChEMBL:CHEMBL1773 | DrugBank:DB01101 | PubChem:42066809 | PubChem:60953,Capecitabine,CCCCCOC(=O)Nc1nc(=O)n([C@@H]2O[C@H](C)[C@@H](O)[C@H]2O)cc1F,L01BC06,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,1.0,0.0,1.0,1.0,1.0,0.0,1.0,0.0,0.0,1.0,0.0
NCT00751296,NCT00751296_EG000,No,All,Adult | Older Adult,Phase 2,25,"Inclusion Criteria:

Understand and voluntarily sign an informed consent form.
Age ≥18 years at the time of signing the informed consent form.
Able to adhere to the study visit schedule and other protocol requirements.
A confirmed diagnosis of B-cell CLL by NCI Working Group criteria
No prior systemic therapy for CLL. Steroid therapy alone for autoimmune cytopenias (anemia or thrombocytopenia) is NOT considered a prior systemic therapy.
Radiation: Patients may have received prior radiation therapy restricted to ≤ 25% of functioning bone marrow. Patients must be ≥ 4 weeks since last treatment with radiation therapy.
Surgery: previous surgery is permissible. Patient must be ≥ 4 weeks since any major surgery.

Patients must have symptomatic disease requiring therapy. One or more of the following must be present to be eligible:

Symptomatic lymphadenopathy
Hepatomegaly and/or splenomegaly
Anemia (Hb <110 g/L)
Thrombocytopenia (platelets <100)
Fatigue, weight loss, night sweats, fever (without infection) or other constitutional symptoms felt to require treatment as per treating physician discretion
Persistent rise in lymphocyte count with doubling time of < 12 months
ECOG performance status of ≤ 2 at study entry.
Laboratory Requirements: (must be done within 7 days prior to first study drug dose)

Hematology: Absolute granulocytes (AGC) ≥ 1.0 x 109/L Platelets ≥ 50 x 109/L Chemistry: Serum creatinine ≤ 1.5 x UNL Bilirubin ≤ 1.5 x UNL AST (or ALT if AST ≤ 2.5 x UNL not available)

Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL 10 - 14 days prior to therapy and repeated within 24 hours of starting study drug and must either commit to continued abstinence from heterosexual sexual intercourse or begin TWO acceptable methods of birth control, one highly effective methods and one additional effective method AT THE SAME TIME, at least 4 weeks before she starts taking lenalidomide. In addition, sexually active WCBP must agree to ongoing pregnancy testing. Men must agree not to father a child and agrees to use a condom if his partner is of child bearing potential.
Disease free of prior malignancies for ≥ 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma ""insitu"" of the cervix or breast

Exclusion Criteria:

Patients who fulfill any of the following criteria are not eligible for admission to the study:
Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
Pregnant or lactating females. (Lactating females must agree not to breast feed while taking lenalidomide).
Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
Use of any other experimental drug or therapy within 28 days of baseline.
Patients previously or currently receiving treatment with other anti-cancer therapy for CLL
Lymphoproliferative disease other than CLL (includes patients with prolymphocytic leukemia, mantle cell lymphoma, and those who have transformed to a more aggressive lymphoma, or Richter's syndrome).
Known hypersensitivity to thalidomide.
The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
Any prior use of lenalidomide.
Concurrent use of other anti-cancer agents or treatments.
Known positive for HIV or infectious hepatitis, type A, B or C.","Lenalidomide target dose of 10 mg PO OD X 3 weeks (days 1-21) followed by 1 week off therapy (days 22-28) on a 28-day cycle.

Lenalidomide: Subjects will receive lenalidomide, starting at 2.5 mg daily x 3 weeks (days 1-21) and escalating up to a target dose of 10 mg daily X 3 weeks (days 1-21) followed by 1 week off therapy (days 22-28) on a 28 day cycle. Patients will be treated with lenalidomide until disease progression or 2 cycles past CR. (no maximum of cycles).

Dose escalation beyond 10 mg daily to a maximum of 25 mgs daily was permitted for nonresponders.",ChEMBL:CHEMBL848 | DrugBank:DB00480 | PubChem:216326,Lenalidomide,Nc1cccc2c1CN(C1CCC(=O)NC1=O)C2=O,L04AX04,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,1.0,1.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT00759811,NCT00759811_EG000,No,All,Adult | Older Adult,Phase 2 | Phase 3,23,"Inclusion Criteria:

Heart failure functional class measured using the New York Heart Association classification class II, III or IV
Left ventricular fraction <0.45 at the ventriculography
Angiographic coronary lesions higher than 50% or coronary lesion revascularized (coronary artery bypass or percutaneous transluminal coronary angioplasty)

Exclusion Criteria:

Myocardial infarction in the past four months
Coronary artery bypass or percutaneous transluminal coronary angioplasty in the past four months
Left ventricular disfunction diagnosed during a acute coronary syndrome
Those who require revascularization in the following 12 weeks
Hepatic disease (ALT and AST higher than the upper limit of the reference value)
Renal failure (plasma creatinine higher than 2.0mg/dl)
Alcoholism (20 doses per week or more)
Illegal drug use
Rheumatoid arthritis or other inflammatory diseases
Infectious disease
Neoplasm
Anemia (hematocrit lower than 30%)
Currently on any anti-inflammatory drugs
Difficulty in walking
Unable to understand/complete the 36-item Short Form health survey (SF-36)
Those who do not give informed consent",Patients receiving conventional treatment to heart failure who will receive methotrexate 7.5mg oral plus folic acid 5mg oral once a week for 12 weeks.,ChEMBL:CHEMBL34259 | DrugBank:DB00563 | PubChem:126941,Methotrexate,CN(Cc1cnc2nc(N)nc(N)c2n1)c1ccc(C(=O)N[C@@H](CCC(=O)O)C(=O)O)cc1,L01BA01 | L04AX03,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00760006,NCT00760006_EG000,No,All,Child | Adult,Phase 2,224,"Inclusion Criteria:

Children diagnosed as having cleft palates undergoing palatoplasty between the ages of 3 months and 18 years will be included in this study. Palatoplasty is the current standard of care in the sequence of treatment for cleft secondary palates. Pediatric plastic surgeons work primarily with children, and have undergone extensive training during their residencies and pediatric surgical fellowships to do so. Children will be evaluated initially at the Cleft-Craniofacial Center at the Children's Hospital of Pittsburgh of UPMC, which is set up to accommodate children of all ages and their families. Approximately 300 children will be required to contribute to a meaningful analysis.

Exclusion Criteria:

All patients requiring prophylactic antibiotics for spontaneous bacterial endocarditis, with documented allergic reactions to the ampicillin-sulbactam, and with known immunodeficiencies or immunodeficiency associated syndromes, such as the 22q chromosomal deletion, will be excluded from study participation.
Selection will be based on the parent's willingness to allow their child to participate in the study.
Children already receiving antibiotics at the time of their surgery will be evaluated distinctly, though they will not be included in the antibiotic or the placebo groups","Unasyn® is a parenteral antibiotic that combines ampicillin with sulbactam, a beta-lactamase inhibitor. All subjects enrolled in the study will receive a single dose of antibiotic or saline solution (placebo control) intravenously, as the IV will already be in place as standard of care for surgery. The study aims to assess the efficacy of the prophylactic antibiotic in cleft surgery to: decrease the incidence of surgical site infections, speed the progression of postoperative healing, improve the final quality of wound healing achieved, and decrease the rate of palatal fistula formation.

Subjects will receive the antibiotic or the saline placebo 30 minutes prior to the initial incision in their palatoplasty procedure.

Subjects will receive a one time dose of 50mg/kg prior to surgery, not to exceed a total of 2gm",ChEMBL:CHEMBL174 | DrugBank:DB00415 | PubChem:6249,Ampicillin,[H][C@]12SC(C)(C)[C@H](C(=O)O)N1C(=O)[C@H]2NC(=O)[C@H](N)c1ccccc1,J01CA01 | J01CA51 | J01CR50 | S01AA19,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00760461,NCT00760461_EG000,No,All,Adult | Older Adult,Phase 2,44,"Inclusion Criteria:

Male or female
Age 18 and older
Symptoms or manifestations secondary to motility disorders of the upper GI tract. These include gastroparesis, functional dyspepsia, gastroesophageal reflux disease that are refractory to standard therapy.
Patients must have a comprehensive evaluation to eliminate other causes of their symptoms. This includes a history and physical examination. A recent (within 3 years) evaluation of the upper GI tract with either upper endoscopy or upper GI radiographic series. Baseline blood tests suggested are electrolytes, magnesium, and prolactin level.

Patient has signed informed consent for the administration of domperidone that informs the patient of potential adverse events including:

Increased prolactin levels
Breast changes
Extrapyramidal side effects
Cardiac arrhythmias including QT prolongation (increased risk with the drugs listed in the appendix)

Exclusion Criteria:

History of, or current, arrhythmias including ventricular tachycardia, ventricular fibrillation and Torsade des Pointes. Patients with minor forms of ectopy (PACs) are not necessarily excluded.
Clinically significant bradycardia, sinus node dysfunction, or heart block. Prolonged QTc (QTc>450 milliseconds for males, QTc>470 milliseconds for females)
Clinically significant electrolyte disorders. These include significant hypokalemia, hyperkalemia, hypomagnesemia, and hypermagnesemia that cannot be corrected with treatment of these electrolyte abnormalities.
Gastrointestinal hemorrhage or obstruction.
Presence of a prolactinoma (prolactin-releasing pituitary tumor).
Pregnant or breast feedings female.
Known allergy to domperidone",Domperidone: 10 mg 4 times daily 20 mg 4 times daily 30 mg 4 times daily,ChEMBL:CHEMBL219916 | DrugBank:DB01184 | PubChem:153420471 | PubChem:3151,Domperidone,O=c1[nH]c2ccccc2n1CCCN1CCC(n2c(=O)[nH]c3cc(Cl)ccc32)CC1,A03FA03,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00761085,NCT00761085_EG000,No,All,Child | Adult,Not Applicable,47,"Inclusion Criteria:

Greater than or equal to 7 years and less than or equal to 40 years
Confirmed diagnosis of any form of sickle cell disease, including sickle cell anemia, sickle-hemoglobin C disease, and sickle-B thalassemia
Currently experiencing a vaso-occlusive episode (VOE), defined as acute pain in the extremities
Admitted to the inpatient unit for further treatment
Started on morphine patient controlled analgesia and infusion for pain management

Exclusion Criteria:

Diagnosis of acute chest syndrome
New focal neurologic findings or clinical concern of stroke
Aplastic crisis with hemoglobin 2 g/dl below steady-state value
Allergy to morphine or methadone
Any other medical condition that the attending physician deems to be a contraindication to therapy
Liver or renal insufficiency or failure, and congestive heart failure","Methadone comparison to standard of care for pain management

Methadone: Compare to standard of care for pain management of acute episode of pain",ChEMBL:CHEMBL350719 | ChEMBL:CHEMBL651 | DrugBank:DB00333 | DrugBank:DB15198 | PubChem:4095 | PubChem:643985,Methadone,CCC(=O)C(CC(C)N(C)C)(c1ccccc1)c1ccccc1,N02AC52 | N07BC02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00761085,NCT00761085_EG002,No,All,Child | Adult,Not Applicable,47,"Inclusion Criteria:

Greater than or equal to 7 years and less than or equal to 40 years
Confirmed diagnosis of any form of sickle cell disease, including sickle cell anemia, sickle-hemoglobin C disease, and sickle-B thalassemia
Currently experiencing a vaso-occlusive episode (VOE), defined as acute pain in the extremities
Admitted to the inpatient unit for further treatment
Started on morphine patient controlled analgesia and infusion for pain management

Exclusion Criteria:

Diagnosis of acute chest syndrome
New focal neurologic findings or clinical concern of stroke
Aplastic crisis with hemoglobin 2 g/dl below steady-state value
Allergy to morphine or methadone
Any other medical condition that the attending physician deems to be a contraindication to therapy
Liver or renal insufficiency or failure, and congestive heart failure","Methadone comparison to standard of care for pain management

Methadone: Compare to standard of care for pain management of acute episode of pain",ChEMBL:CHEMBL350719 | ChEMBL:CHEMBL651 | DrugBank:DB00333 | DrugBank:DB15198 | PubChem:4095 | PubChem:643985,Methadone,CCC(=O)C(CC(C)N(C)C)(c1ccccc1)c1ccccc1,N02AC52 | N07BC02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00761319,NCT00761319_EG001,No,All,Adult | Older Adult,Phase 3,348,"Inclusion Criteria:

18 years or older.
Ocular Surface Disease Index (OSDI) score and corneal fluorescein staining score as specified in protocol.
Diagnosis of open-angle glaucoma or ocular hypertension in at least one eye.
Intraocular pressure (IOP) controlled with latanoprost 0.005% (XALATAN®) for at least one continuous month prior to Visit 1.
Willing and able to discontinue use of any topical ocular medicine other than the study medication for the duration of the study, including artificial tears.
Best corrected visual acuity of -0.6 logMAR or better in each eye.
Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

Any medical condition (systemic or ophthalmic) that may preclude safe administration of the test article.
Use of contact lenses within 30 days of Visit 1.
Use of contact lenses during the study.
Participation in an investigational drug or device study within 30 days of entering this study.
Other protocol-defined exclusion criteria may apply.",One drop self-administered in the study eye(s) once daily for 90 days,ChEMBL:CHEMBL1051 | DrugBank:DB00654 | PubChem:5311221,Latanoprost,CC(C)OC(=O)CCC/C=C\C[C@@H]1[C@@H](CC[C@@H](O)CCc2ccccc2)[C@H](O)C[C@@H]1O,S01EE01 | S01EE51,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00761735,NCT00761735_EG000,No,All,Child,Phase 3,94,"Inclusion Criteria:

Informed consent must be obtained from the participant or the participant's parent or legal guardian prior to any long-term follow-up study-related procedures. According to local laws and/or IRB/IEC requirements, participants may also need to provide written assent.
The participant must have received at least one dose of peginterferon alfa-2b and ribavirin in the Protocol No. P02538 study.
The participant must have completed the 24-week post-treatment follow-up in the P02538 Part 1 study. All participants whether sustained responders, relapsers, or nonresponders are eligible to participate.

Exclusion Criteria:

Concurrent participation in any other clinical study.
Retreatment with any antiviral or immunomodulatory drug for chronic hepatitis C after completion of, or discontinuation from, the treatment phase of the P02538 Part 1 study.
Any condition that in the opinion of the Investigator would make the participant unsuitable for enrollment.",Pediatric participants who completed treatment with peginterferon alfa-2b (PEG-IFN) plus ribavirin (RBV) in P02538 Part 1 of this study (NCT00104052) were enrolled in a 5-year Long Term Follow-Up (LTFU) during P02538 Part 2 (NCT00761735). No study treatment was administered in Part 2.,ChEMBL:CHEMBL1643 | DrugBank:DB00811 | PubChem:37542,Ribavirin,NC(=O)c1ncn([C@@H]2O[C@H](CO)[C@@H](O)[C@H]2O)n1,J05AP01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00761761,NCT00761761_EG000,No,All,Adult | Older Adult,Phase 3,30,"Inclusion Criteria:

DSMIV-TR diagnosis of Bipolar Disorder
Ages 18 to 65
Men or Women
8th grade education or greater
Able to provide competent written informed consent
Current main mood stabilizer and mood status (YMRS and MADRS scores less than or equal to 10) are stable for greater than or equal to 4 weeks by history.

Exclusion Criteria:

Medically unstable conditions
Known allergy to Sensoril® (or Ashwagandha)
Current cognitive decline is attributable to a diagnosis of dementia or other neurological disorder
Pregnant or lactating women
Mini-mental score (MMSE) less than or equal to 23
Currently receiving donepezil, rivastigamine, or galatamine, or memantine or any marketed agent for slowing memory loss in dementia
Abnormal clinical thyroid status
Currently (or within past 2 weeks) receiving St. John's Wort, Gingko or Omega-3","Sensoril(Ashwagandha)

Sensoril: Sensoril® (or placebo) will be administered using random assignment at a dose of 250mg/day, increasing to a dose of 500mg/day by the second week. The dose of 500mg (or 250mg if tolerability is an issue) will be continued for a total of 8 weeks.",PubChem:265237,Withaferin A,CC1=C(CO)C(=O)OC(C(C)C2CCC3C4CC5OC56C(O)C=CC(=O)C6(C)C4CCC23C)C1,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00762619,NCT00762619_EG001,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 3,105,"Inclusion Criteria:

Males and females in good oral and general health aged 18 to 76 years.
A willingness to read, understand, and sign the Informed Consent Form after the nature of the study has been fully explained to them. Subject should demonstrate willingness to comply with all study procedures and availability for duration of study.
Subjects will use the provided test articles and discontinue the use of other dentifrices and mouthrinses for the duration of the study.
A minimum of 20 natural teeth with facial and lingual scorable surfaces. Teeth that are grossly carious, fully crowned or extensively restored on facial and/or lingual surfaces, orthodontically banded, abutments, or third molars will not be included in the tooth count.
Adequate oral hygiene and no signs of oral neglect.
Subjects will have at least one dental implant and a contralateral natural tooth.
At the first visit subjects will be examined by a dentist for periodontal health.
Selected subjects will have periodontal pockets less than 6mm.
Subjects with gingival index equal to or greater than 1.0 and plaque index equal to or greater than or 1. 5 on the implant tooth will be enrolled. Gingival and plaque indices will be measured during the first visit for the implant. Similarly, these clinical indices (Gingival and plaque index) will be determined for the contralateral natural tooth. (The adjacent teeth will serve as a backup for the studies if control tooth is lost during study).
Subjects who are habitual users of Colgate Total or other oral hygiene formulations with antimicrobial agents will complete a washout phase of 30 days with a commercial fluoride dentifrice prior to enrollment in the study. This washout dentifrice will be identified and obtained by the clinical investigator from an appropriate local source.

Exclusion Criteria:

History of significant adverse effects following use of oral hygiene products such as toothpastes and mouthrinses. Allergy to personal care/consumer products or their ingredients.
Regular use of mouthwash with antimicrobial agents within the past month.
History of diabetes or hepatic or renal disease, or other serious medical conditions or transmittable diseases, e.g. heart disease or AIDS.
History of hepatitis, rheumatic fever, pacemaker, or prosthetic heart valves, heart murmur, mitral valve prolapse or other conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures.
Subjects presenting significant medical conditions or need for long term drug therapy.
Subjects on antibiotic, anti inflammatory or anticoagulant therapy during the month preceding the baseline exam.
Significant oral soft tissue pathology, systemically related gingival enlargement, severe gingivitis (based on a visual examinations) that would interfere with the study.
History of active severe periodontal disease with bleeding gums and loose teeth.
Widespread caries or chronic neglect. Subjects presenting with gross dental caries, severe generalized cervical abrasion and/or enamel abrasion, and large fractured or temporary restorations (based on visual examinations).
Fixed or removable orthodontic appliance or removable partial dentures.
Participation in any clinical study including dental plaque/gingivitis clinical trial involving oral care products, within the last 30 days. History of dental prophylaxis or treatments in the month preceding the start of study.
Self reported pregnancy or lactation.
History or current use of objects to pierce the lips or tongue.
Subjects known to be an alcoholic, or a recovering alcoholic.
History or current use of recreational drugs or narcotics.
Determine smoking status of subjects and exclude current smokers.
Determine reason for placing implants in subject to exclude subjects whose implants were placed for trauma.",fluoride/triclosan/copolymer toothpaste group contained both 1 natural tooth site and 1 dental implant site for clinical assessment.,PubChem:24848164,Sodium fluoride and triclosan,Oc1cc(Cl)ccc1Oc1ccc(Cl)cc1Cl.[F-].[Na+],,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00763412,NCT00763412_EG001,No,All,Child | Adult,Not Applicable,31,"Inclusion Criteria:

Male or females 12 -24 years old
Diagnosis of Cystic Fibrosis by sweat test with exocrine pancreatic insufficiency
Must have a glucose pattern by Oral Glucose Tolerance Test with fasting blood glucose <126 mg/dl and 2 hour: 140 - 199 mg/dl or >200 mg/dl.
Weight must be stable within 5% for 3 months prior to initiation visit
Must be able to reproducibly perform spirometry based on American Thoracic Society guidelines

Exclusion Criteria:

Patients receiving growth hormone therapy or taking insulin
Patients with evidence of liver dysfunction
Patients who are status-post lung or liver transplantation
Patients who have received systemic steroids for more than 28 days during the 6 months prior to the study
Patients with active ABPA on steroids
Patients taking medications that affect glucose metabolism or contraindicated with repaglinide",Repaglinide intervention group of CF pancreatic insufficient patients ages 12-24 years old with impaired glucose tolerance test (IGT) or CFRD without fasting hyperglycemia (CFRD-No FH).,ChEMBL:CHEMBL1272 | DrugBank:DB00912 | PubChem:65981,Repaglinide,CCOc1cc(CC(=O)N[C@@H](CC(C)C)c2ccccc2N2CCCCC2)ccc1C(=O)O,A10BD14 | A10BX02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00768716,NCT00768716_EG000,Accepts Healthy Volunteers,All,Adult,Phase 4,95,"Inclusion Criteria:

self-declared white/Caucasian
self-declared African-American
active
ambulatory
no evidence of medical disease

Exclusion Criteria:

alcohol use of 3 or more drinks per day
HIV or hepatitis (B or C) infection
isoniazid
disulfiram
phenobarbital
phenytoin
carbamazepine
rifampicin
valproic acid
probenecid
St. John's Wort",2 x 500 mg acetaminophen by mouth once,ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00768716,NCT00768716_EG001,Accepts Healthy Volunteers,All,Adult,Phase 4,95,"Inclusion Criteria:

self-declared white/Caucasian
self-declared African-American
active
ambulatory
no evidence of medical disease

Exclusion Criteria:

alcohol use of 3 or more drinks per day
HIV or hepatitis (B or C) infection
isoniazid
disulfiram
phenobarbital
phenytoin
carbamazepine
rifampicin
valproic acid
probenecid
St. John's Wort",2 x 500 mg acetaminophen by mouth once,ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00771173,NCT00771173_EG000,No,Female,Adult | Older Adult,Phase 4,258,"Inclusion Criteria:

1. Adult women undergoing gynecologic surgery who are expected to tolerate oral medication within 12 post-operative hours and require an indwelling catheter for a minimum of 12 post operative hours after start of oral medication.

Exclusion Criteria:

Hypersensitivity to phenazopyridine products (Defined as a having a previous anaphylaxis reaction to phenazopyridine products).

Known contraindications to phenazopyridine HCl:

Renal failure or insufficiency (Defined as having abnormal renal function on previous laboratory testing (BUN/Cr) or as having a known renal disease).
History of hepatic disease or failure (Defined as having known liver disease or having elevated LFTs on previous laboratory testing. Patients who would not otherwise have such testing are not required to undergo special study labs).
Known glucose-6-phosphate dehydrogenase deficiency.
Simultaneous suprapubic catheterization.
Inability to take oral medication within 12 hours after surgery.
Pregnant women.","Participants that are randomized to the phenazopyridine HCl group will receive the study medication (200 mg of phenzopyridine HCl orally) after leaving the operating room. We anticipate the first dose to be given after the patient has left the recovery area. We will continue use of study medication until it has been given up to 24 hours after the first VAS collection or catheter removal, whichever occurs first

phenazopyridine HCl: Phenazopyrdine HCl 200 mg q8h x 24",PubChem:8691,Phenazopyridine hydrochloride,Cl.Nc1ccc(N=Nc2ccccc2)c(N)n1,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00774787,NCT00774787_EG000,No,All,Adult | Older Adult,Phase 4,27,"Inclusion Criteria:

A clinical diagnosis of actinic keratoses

Actinic keratoses in two reasonably bilaterally symmetric areas on the face and/or balding scalp:

each area with a minimum of 25 cm^2 and a maximum of 50 cm^2
each area with at least 6 typical, non-hypertrophic target AKs
with target AK lesion counts of +/- 1 lesion between the areas
each area that the patient can distinguish with respect to study drug application
Able to comply with all study requirements
Are willing and able to give written informed consent

Exclusion Criteria:

Uncontrolled intercurrent or chronic illness
Systemic immunocompromise due to disease or treatment
Clinically relevant systemic autoimmune disease
Pregnant or nursing
Dermatologic disease and/or condition in the treatment area that may be exacerbated by imiquimod or cause difficulty with examination
Participation in another clinical study
Allergies to imiquimod or any of the excipients in the cream

Treatment within the past 90 days with any of the following:

Psoralens plus ultraviolet A therapy
Ultraviolet B therapy
Systemic immunomodulators (e.g. oral or parenteral corticosteroids at greater than physiologic doses, interferons, anti-TNF agents, cytokines)
Chemotherapeutic or cytotoxic agents;
Investigational agent

Treatment within the past 30 days with any of the following:

Surgical excision
Photodynamic therapy
Curettage
Topical corticosteroids
Laser
Dermabrasion
Chemical peel
Imiquimod 5% cream
Topical retinoids
5-fluorouracil
Masoprocol
Pimecrolimus or tacrolimus",Split-face study of cryotherapy of all actinic keratoses in target treatment area (bilaterally symmetrical area on face or balding scalp) followed by random assignment to treatment of half of treatment area with imiquimod 5% cream and of other half to no treatment,ChEMBL:CHEMBL1282 | DrugBank:DB00724 | PubChem:57469,Imiquimod,CC(C)Cn1cnc2c(N)nc3ccccc3c21,D06BB10,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00775606,NCT00775606_EG001,No,All,Adult,Phase 4,5,"Inclusion Criteria:

HIV-1 infection
The absence of exclusionary resistance mutations on a genotypic resistance assay
Antiretroviral (ARV) drug-naïve
Screening HIV-1 RNA >1000 copies/mL
Screening CD4+ T-cell count < 200 cells/ml

Laboratory values obtained within 30 days prior to study entry.

Absolute neutrophil count (ANC) >500/mm3
Hemoglobin >8.0 g/dL
Platelet count >40,000/mm3
AST (SGOT), ALT (SGPT), and alkaline phosphatase <5 x ULN
Total bilirubin <2.5 x ULN
Calculated creatinine clearance ≥60 mL/min (by Cockcroft-Gault equation)
For women of reproductive potential, negative serum or urine pregnancy test within 48 hours prior to initiating study medications.
Contraception requirements
Men and women age >18 years and < 60 years.
Ability and willingness of subject or legal guardian/representative to give written informed consent.

Exclusion Criteria:

Currently breast-feeding.
Use of immunomodulators, vaccines, growth hormone, systemic cytotoxic chemotherapy, or investigational therapy within 30 days prior to study entry.
Known allergy/sensitivity to study drugs, pneumococcal polysaccharide vaccine, tetanus-diphtheria vaccine
Receipt of pneumococcal polysaccharide vaccine or tetanus-diphtheria vaccine in the past 5 years.
Active drug or alcohol use or dependence
Serious illness requiring systemic treatment and/or hospitalization until candidate either completes therapy or is clinically stable on therapy, in the opinion of the site investigator, for at least 14 days prior to study entry.
Requirement for any current medications that are prohibited with any study treatment.
Evidence of any major resistance-associated mutation on any genotype or evidence of significant resistance on any phenotype performed at any time prior to study entry
Current or anticipated imprisonment or involuntary incarceration in a medical facility for psychiatric or physical (e.g., infectious disease) illness
History of, or current bipolar disorder, major depression, schizophrenia or other psychotic disorders",Subjects randomized to Arm B will initiate Efavirenz 600 mg/emtricitabine 200 mg/tenofovir 300 mg QD,ChEMBL:CHEMBL223228 | DrugBank:DB00625 | PubChem:64139,Efavirenz,O=C1Nc2ccc(Cl)cc2[C@@](C#CC2CC2)(C(F)(F)F)O1,J05AG03 | J05AR06 | J05AR11,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00779142,NCT00779142_EG000,No,All,Adult | Older Adult,Not Applicable,2,"Inclusion Criteria:

Adult patients (18 years and older) with clinically significant macular edema (CSME) with visual acuity less than 20/60 to Hand motion in the study eye.
Patients should have persistent CSME three months after laser therapy or three months after intraocular injection of Avastin or triamcinolone. These interventions could be multiple or combined.
Optical coherence tomography (OCT) scan demonstrating more than 275 microns retinal thickness in central subfield of study eye.
Ability to understand study instructions, interventions and potential complications.
History of reasonably controlled Diabetes mellitus (DM), ≤ 8.5HbA1c that has been evaluated in the last 3 months.
Ability to undergo contraceptive protection during and 3 months after intraocular injections.
Clear demonstration (in female patients) of commitment to avoid pregnancy and a negative urine pregnancy test at baseline for women of childbearing potential.
Clear understanding of teratogenic potential of MTX.

Exclusion Criteria:

History of allergy to MTX.
An ocular condition is present such that, in the opinion of the investigator, visual acuity loss would not improve from resolution of macular edema (e.g., foveal atrophy, pigment abnormalities, dense subfoveal hard exudates, nonretinal condition.
An ocular condition is present (other than diabetes) that, in the opinion of the investigator, might affect macular edema or alter visual acuity during the course of the study (e.g., vein occlusion, uveitis or other ocular inflammatory disease, neovascular glaucoma, epiretinal membrane, etc.).
An eye treated for Glaucoma
Eyes that underwent vitrectomy
History of intraocular malignancies.
Intraocular surgery with the prior 3 months.
Recent significant change in diabetic medications.
Insulin usage less than a year.
Life threatening co morbidities such as cancer under therapy.
Use of oral, intravenous, periocular or intraocular corticosteroids (steroids) in prior 3 months.
Liver function that exceeds three times the upper limit of normal at baseline, or within 6 weeks of that appointment.
Pregnant females.
Vitreous hemorrhage (active) in study eye
Anticipation of the need for laser pan retinal photocoagulation in the next 6 months.
Media opacities
Herpetic disease of cornea
Corneal dystrophy with significant corneal edema.
Any major surgery within the last 30 days","Methotrexate intravenous 25mg/ml delivered once or twice (based on the therapeutic response) over a period of 2 months maximum. Total dosage 400ug in each dose. Statistical analysis would not be applicable in this small sample.

Methotrexate intravenous 25mg/ml: Methotrexate intravenous 25mg/ml delivered once or twice (based on the therapeutic response) over a period of 2 months maximum. Total dosage 400ug in each dose. Statistical analysis would not be applicable in this small sample.",ChEMBL:CHEMBL34259 | DrugBank:DB00563 | PubChem:126941,Methotrexate,CN(Cc1cnc2nc(N)nc(N)c2n1)c1ccc(C(=O)N[C@@H](CCC(=O)O)C(=O)O)cc1,L01BA01 | L04AX03,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00780715,NCT00780715_EG003,No,All,Adult | Older Adult,Phase 4,29,"Inclusion Criteria:

Cohort 1 - metformin treatment

Type 2 diabetes diagnosed more than 6 weeks prior to visit 1
GP considers adequate diet and lifestyle advice given
Age >35 and < 80
Age of diabetes diagnosis >35
White European
HbA1c >7% & <=9%
eGFR>=50 ml/min
ALT <= 2.5*ULN
Contactable by telephone

Cohort 2 - 2nd line treatment

Type 2 diabetes
Treated with metformin for more than 3 months; or metformin intolerant
Age >35 and < 80
Age of diabetes diagnosis >35
White European
HbA1c >7% & <=9%
eGFR>=50 ml/min
ALT <= 2.5*ULN
No previous history of heart failure; No patients with documented evidence of left ventricular systolic dysfunction OR with symptoms and signs consistent with a clinical diagnosis of heart failure
No treatment with Gemfibrozil or Rifampicin (CYP2C8 inhibitor or inducer respectively); or with Miconazole or phenylbutazone (increased hypoglycemic effect of gliclazide).
No diagnosis of osteoporosis
Contactable by telephone

Exclusion Criteria:

Cohort 1

Type 1 diabetes
HbA1c >9% or <=7%
eGFR<50 ml/min
ALT > 2.5*ULN
Alcohol consumption in excess of 50 units per week
Pregnancy, lactation or a female planning to conceive within the study period
Any other significant medical reason for exclusion as determined by the investigator

Cohort 2

Type 1 diabetes
HbA1c >9% or <=7%
eGFR< 50 ml/min
ALT > 2.5*ULN
Previous history of heart failure OR documented evidence of left ventricular systolic dysfunction OR symptoms and signs consistent with a clinical diagnosis of heart failure
Ongoing treatment with Gemfibrozil or Rifampicin (CYP2C8 inhibitor or inducer respectively); or with Miconazole or phenylbutazone (increased hypoglycemic effect of gliclazide).
Previous diagnosis of osteoporosis
Pregnancy, lactation or a female planning to conceive within the study period
Any other significant medical reason for exclusion as determined by the investigator","Metformin: Metformin 500 mg od for 1 week, bd for 1 week, 1g mane 500 mg nocte 1 week, 1g bd there after. Total of 6 months treatment",ChEMBL:CHEMBL1431 | DrugBank:DB00331 | PubChem:4091,Metformin,CN(C)C(=N)NC(=N)N,A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00787176,NCT00787176_EG001,Accepts Healthy Volunteers,Female,Adult,Not Applicable,62,"Inclusion Criteria:

Age 18-60
Healthy nulliparous or multiparous women
Term (>36 week gestation)
Singleton pregnancy
Spontaneous labor or with spontaneous rupture of membranes
Receive oxytocin
Request neuraxial analgesia

Exclusion Criteria:

Under 18 years of age
Presence of any systemic disease (e.g., diabetes mellitus, hypertension, preeclampsia)
Use of chronic analgesic medications
Prior administration of systemic opioid labor analgesia
Non-vertex presentation
Induction of labor
Contraindication to neuraxial analgesia.","An intravenous bolus of 1000 mL Lactated Ringers. The dose of oxytocin being administered at time of epidural placement will be halved and not increased for 60 minutes until after placement.

Group B: An intravenous bolus of 1000 mL Lactated Ringers. The dose of oxytocin being administered at time of epidural placement will be halved and not increased for 60 minutes until after placement.",DrugBank:DB11203 | PubChem:5462311,Boron,[B],,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00792077,NCT00792077_EG000,No,All,Adult | Older Adult,Phase 2,6,"Inclusion Criteria:

Describe fatigue as being present every day for most of day for a minimum of 2 weeks and rate fatigue greater than or equal to 4 on a 0-10 scale, in which 0= no fatigue and 10=worst possible fatigue as assessed by MD Anderson symptom Inventory(MDASI).
Have diagnoses of CLL and started on a new cytotoxic therapy or breast cancer receiving new cytotoxic or radiation therapy
Patients will be eligible to participate in this study if they rate sleep disturbance greater than or equal to 4 on a 0-10 scale, in which 0= disturbed sleep is not present and 10 = disturbed sleep as bad as you can imagine as assessed by MDASI.
Have a MDAS of 13 or less.
Able to understand the description of the study and give written informed consent.

Exclusion Criteria:

Patients who are unable to complete the assessment measures or refuse to participate
Patients with known history of brain metastasis.
Patients with known history of sleep apnea.",Participants received lenalidomide 5mg orally daily for 57 +/- 3 days,ChEMBL:CHEMBL848 | DrugBank:DB00480 | PubChem:216326,Lenalidomide,Nc1cccc2c1CN(C1CCC(=O)NC1=O)C2=O,L04AX04,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00795886,NCT00795886_EG000,No,All,Child | Adult,Phase 2,63,"Inclusion Criteria:

Pediatric patients' ages (0 - 21 years) with lymphoid malignancies considered for allogeneic bone marrow transplant from HLA-identical sibling donor, single antigen mismatched related or unrelated donor marrow /peripheral blood stem cell (PBSC) or cord blood available for marrow donation.

First remission:

if remission not achieved by day28
high risk cytogenetic features, including t(9;22) or t(4;11) Second or third remission
Signed informed consent.

Exclusion Criteria:

1. Organ criteria:

Cardiac: ECHO shortening fraction <27%
Renal: Creatinine clearance <60 ml/min/1.73 m2
Hepatic: Bilirubin >1.5 mg/dl, transaminases <3x normal
Infection: active viral, fungal or bacterial infection including HIV.",This includes all study participants.,ChEMBL:CHEMBL413 | DrugBank:DB00877 | PubChem:134760597 | PubChem:138404388 | PubChem:21944094 | PubChem:5284616,Sirolimus,COC1CC2CCC(C)C(O)(O2)C(=O)C(=O)N2CCCCC2C(=O)OC(C(C)CC2CCC(O)C(OC)C2)CC(=O)C(C)C=C(C)C(O)C(OC)C(=O)C(C)CC(C)C=CC=CC=C1C,L01EG04 | L04AA10 | S01XA23,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00798759,NCT00798759_EG001,No,All,Adult | Older Adult,Phase 4,119,"Inclusion Criteria:

18 years or older.
Diagnosis of open-angle glaucoma or ocular hypertension in at least one eye.
Intraocular pressure (IOP) controlled with BAK (benzalkonium chloride) preserved IOP-lowering medication for 1 year, with last 6 months on XALATAN® monotherapy.
Best corrected visual acuity of -0.6 logMAR or better in each eye.
Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

Treatment with BAK preserved artificial tears within 30 days of Visit 1.
Known or suspected Sjogren's disease.
Uncontrolled IOP.
History or evidence of infectious or inflammatory ocular conditions.
Progressive retinal or optic nerve disease.
Ocular laser surgery within 3 months of Visit 1.
Keratorefractive ocular laser procedures, corneal surgery or surgery to the corneal surface within 1 year of Visit 1.
Current use of punctal plugs or punctal cautery.
Use of systemic medications that has not been stable for 30 days prior to Visit 1.
Use of contact lens within 30 days of Visit 1.
Other protocol-defined exclusion criteria may apply.",One drop self administered in the study eye(s) once daily at night for 12 weeks,ChEMBL:CHEMBL1051 | DrugBank:DB00654 | PubChem:5311221,Latanoprost,CC(C)OC(=O)CCC/C=C\C[C@@H]1[C@@H](CC[C@@H](O)CCc2ccccc2)[C@H](O)C[C@@H]1O,S01EE01 | S01EE51,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00799513,NCT00799513_EG000,No,All,Adult | Older Adult,Phase 2,48,"Inclusion Criteria:

Age > 65 years
Age < 65 but not eligible to high-dose chemotherapy and autologous stem cell transplantation
Biopsy-proven DLBCL relapsed to previous combination chemotherapy regimen ± rituximab
PR (Partial Response) or CR (Complete Response) to second-line chemotherapy (ICE or DHAP/DHAOx or MINE regimen) + rituximab
ECOG (Eastern Cooperative Oncology Group) performance status score < 4
Female of childbearing potential (FCBP) must demonstrate to practice a proper contraception to avoid any pregnancy risk during the study and at least 28 days after the discontinuation of the study
Male subjects must agree to practice a proper contraception during any sexual contact with females childbearing potential

Exclusion Criteria:

CNS (Central Nervous System) involvement
Prior ASCT
TTP (Time To Progression) <6 months after first-line therapy
Use of experimental drugs during second-line salvage chemotherapy
Severe concomitant illnesses / medical conditions (e.g. impaired respiratory and/or cardiac function, uncontrolled diabetes mellitus )
Active infectious disease
HIV, HBV (Hepatitis B Virus) or HCV (Hepatitis C Virus) - positivity
Impaired liver function (Bilirubin >2 x upper normal limit; ALT (alanine aminotransferase) /AST (aspartate aminotransferase) /GGT (γ-glutamyltransferase) > 3 x upper normal limit) at one month from salvage chemotherapy conclusion
Impaired renal function (creatinine clearance <50 ml/min) at one month from salvage chemotherapy conclusion
Absolute neutrophil count (ANC) <1000/microL
Platelet count <75.000 /mm3
Hemoglobin <9 g/dL
Non-co-operative behaviour or non-compliance
Psychiatric diseases or conditions that might impair the ability to give informed consent
Pregnant or lactating females","single-agent lenalidomide 25 mg once daily for 21 days out of 28, as maintenance treatment after the end of second-line chemotherapy until progression of disease.

Lenalidomide: single-agent lenalidomide 25 mg once daily for 21 days out of 28, as maintenance treatment after the end of second-line chemotherapy until progression of disease.",ChEMBL:CHEMBL848 | DrugBank:DB00480 | PubChem:216326,Lenalidomide,Nc1cccc2c1CN(C1CCC(=O)NC1=O)C2=O,L04AX04,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00806494,NCT00806494_EG000,No,All,Adult | Older Adult,Phase 4,331,"Inclusion Criteria:

Male or female >18 years old
OAB for >3 months

Exclusion Criteria:

Patients with conditions that would contraindicate for fesoterodine use
Patients with significant hepatic and renal disease or other significant unstable diseases.
OAB symptoms caused by neurological conditions, known pathologies of urinary tract, etc.","Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.",ChEMBL:CHEMBL1201764 | DrugBank:DB06702 | PubChem:6918558,Fesoterodine,CC(C)C(=O)Oc1ccc(CO)cc1[C@H](CCN(C(C)C)C(C)C)c1ccccc1,G04BD11,0.0,0.0,0.0,0.0,0.0,1.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT00810732,NCT00810732_EG000,No,All,Adult | Older Adult,Phase 2,27,"Inclusion Criteria:

Has stage 1-5 chronic kidney disease (CKD) as defined by the Kidney Disease Outcomes Quality Initiative (K/DOQI) with proteinuria, including any of the following aetiologies: immunoglobulin (IgA) nephropathy, polycystic kidney disease (PCKD), congenital abnormalities, reflux nephropathy, focal segmental glomerulosclerosis, minimal change nephropathy, and membranous nephropathy.

Exclusion Criteria:

Required peritoneal dialysis or haemodialysis.
Has kidney disease due to diabetes mellitus, vasculitis, systemic lupus erythematosus, or known renovascular disease; antiglomerular basement membrane disease; or is on immunosuppressive medication.","Participants received Sitaxsentan 100 mg tablet orally, once daily for 6 weeks in either first, second or third intervention period.",ChEMBL:CHEMBL282724 | DrugBank:DB06268 | PubChem:216235,Sitaxentan,Cc1cc2c(cc1CC(=O)c1sccc1S(=O)(=O)Nc1onc(C)c1Cl)OCO2,C02KX03,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00811564,NCT00811564_EG000,No,All,Adult | Older Adult,Phase 4,73,"Inclusion Criteria:

Be at least 18 years of age;
Give written informed consent;
Be in good general health as determined by your doctor;
Have a diagnosis of unilateral or bilateral glaucoma or ocular hypertension;
If you are a female of child bearing potential, you must be willing to practice effective contraception for the duration of the study (i.e., abstinence, spermicide, condoms, or birth control pills);
Understand the study instructions, and be able to follow the study instructions; and
Be likely to complete the entire study period (12 weeks), including all regularly scheduled study visits.

Exclusion Criteria:

Have any active ocular disease other than glaucoma or ocular hypertension that would interfere with study interpretation;
Any systemic disease or clinical evidence of any condition which would make the subject, in the opinion of the investigator, unsuitable for the study or could potentially confound the study results; and
Concurrent participation or prior participation in any investigational drug or device study within the last 30 days prior to the Screening Visit",Fixed combination of brimonidine tartrate 0.2%/timolol maleate 0.5% ophthalmic solution,PubChem:11387895,Combigan,Brc1c(NC2=NCCN2)ccc2nccnc12.CC(C)(C)NCC(O)COc1nsnc1N1CCOCC1,,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00811564,NCT00811564_EG001,No,All,Adult | Older Adult,Phase 4,75,"Inclusion Criteria:

Be at least 18 years of age;
Give written informed consent;
Be in good general health as determined by your doctor;
Have a diagnosis of unilateral or bilateral glaucoma or ocular hypertension;
If you are a female of child bearing potential, you must be willing to practice effective contraception for the duration of the study (i.e., abstinence, spermicide, condoms, or birth control pills);
Understand the study instructions, and be able to follow the study instructions; and
Be likely to complete the entire study period (12 weeks), including all regularly scheduled study visits.

Exclusion Criteria:

Have any active ocular disease other than glaucoma or ocular hypertension that would interfere with study interpretation;
Any systemic disease or clinical evidence of any condition which would make the subject, in the opinion of the investigator, unsuitable for the study or could potentially confound the study results; and
Concurrent participation or prior participation in any investigational drug or device study within the last 30 days prior to the Screening Visit",Latanoprost 0.005% ophthalmic solution,ChEMBL:CHEMBL1051 | DrugBank:DB00654 | PubChem:5311221,Latanoprost,CC(C)OC(=O)CCC/C=C\C[C@@H]1[C@@H](CC[C@@H](O)CCc2ccccc2)[C@H](O)C[C@@H]1O,S01EE01 | S01EE51,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00811850,NCT00811850_EG000,No,All,Adult | Older Adult,Phase 4,15,"Inclusion Criteria:

Age: 30 years or older.
Primary open-angle glaucoma (POAG) or ocular hypertensive in at least one eye.
Best corrected visual acuity at least 20/40 in at least one eye.

Exclusion Criteria:

History of acute angle-closure or a narrow, occludable anterior chamber angle by gonioscopy.
History of chronic or recurrent inflammatory eye diseases (e.g., scleritis, uveitis).
History or signs of intraocular trauma.
Any abnormality preventing reliable applanation tonometry.
Current use of any ophthalmic or systemic steroid which may interfere with this investigation.
Severe, unstable or uncontrolled cardiovascular, renal, or pulmonary disease.","Combigan® (fixed combination of brimonidine tartrate 0.2%/timolol maleate 0.5% ophthalmic solution). One drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks.",PubChem:11387895,Combigan,Brc1c(NC2=NCCN2)ccc2nccnc12.CC(C)(C)NCC(O)COc1nsnc1N1CCOCC1,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00814671,NCT00814671_EG001,No,All,Adult | Older Adult,Phase 2,48,"Inclusion Criteria:

Suspected pulmonary tuberculosis with acid-fast bacilli in a stained smear of expectorated sputum. Patients having extra-pulmonary manifestations of tuberculosis, in addition to smear-positive pulmonary disease, are eligible for enrollment.
No prior history of tuberculosis disease or tuberculosis treatment
No treatment with fluoroquinolones in the 2 months preceding initiation of study drugs.
Age > 18 years
Weight ≥ 50 kg and ≤ 80 kg
Karnofsky score of at least 60 (requires occasional assistance but is able to care for most of his/her needs; see Appendix)
Signed informed consent
Ability to adhere with study follow-up
Women with child-bearing potential must agree to practice an adequate (barrier) method of birth control or to abstain from heterosexual intercourse during study therapy.
HIV negative, or HIV-positive with CD4 > 200 cells/cu mm

Laboratory parameters done at, or 14 days prior to, screening (with results available for review by study personnel):

Serum alanine aminotransferase (ALT) activity ≤ 2 times the upper limit of normal
Serum total bilirubin level ≤ 2 times the upper limit of normal
Serum creatinine level less than or equal to the upper limit of normal
Hemoglobin level of at least 7.0 g/dL
Platelet count of at least 100,000/mm3
Negative pregnancy test (women of childbearing potential)

Exclusion Criteria:

Pregnant or breast-feeding
Known intolerance or allergy to any of the study drugs
Concomitant disorders or conditions for which isoniazid (INH), rifamycins, pyrazinamide (PZA), or ethambutol (EMB) are contraindicated. These include severe hepatic damage, acute liver disease of any cause, and acute uncontrolled gouty arthritis.
Current or planned therapy, during the intensive phase of TB therapy with cyclosporine or tacrolimus, or HIV antiretroviral (ARV) therapy, which have unacceptable interactions with rifamycins.
Any medical or psychosocial condition, which, in the view of the study investigator, makes study participation inadvisable.
Pulmonary silicosis
Central nervous system TB","Rifampin 600mg daily

Rifampin: rifampin 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks",ChEMBL:CHEMBL374478 | DrugBank:DB01045 | PubChem:135398735 | PubChem:135403807 | PubChem:135441414 | PubChem:135449527 | PubChem:135476790 | PubChem:135512673 | PubChem:135550179 | PubChem:135876149 | PubChem:135900090 | PubChem:135921123 | PubChem:135921134 | PubChem:135925261 | PubChem:135925741 | PubChem:135932822 | PubChem:136122621 | PubChem:136136478 | PubChem:136246612 | PubChem:136601293 | PubChem:136619758 | PubChem:136709103 | PubChem:137016821 | PubChem:137086834 | PubChem:137225336 | PubChem:137270779 | PubChem:137286743 | PubChem:137287990 | PubChem:154825551 | PubChem:163059759,RIFAMPIN,COC1C=COC2(C)Oc3c(C)c(O)c4c(O)c(c(C=NN5CCN(C)CC5)c(O)c4c3C2=O)NC(=O)C(C)=CC=CC(C)C(O)C(C)C(O)C(C)C(OC(C)=O)C1C,J04AB02 | J04AM02 | J04AM05 | J04AM06 | J04AM07 | J04BA50 | J04BA51,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00816907,NCT00816907_EG001,No,All,Adult | Older Adult,Phase 4,75,"Inclusion Criteria:

Outpatients with a diagnosis of schizophrenia or schizoaffective disorder, as defined by DSM-IV-TR criteria and confirmed by the Structured Clinical Interview for DSM-IV (SCID)
Duration of illness greater than 1 year, as defined by having initiated antipsychotic treatment at least 1 year prior to study entry
Adequate decisional capacity to make a choice about participating in this research study
Body mass index (BMI) at or greater than 27
Currently being treated with one or a combination of two antipsychotic medications (typical or atypical) and on that drug regimen for at least 2 months prior to study entry, with stable dosages for at least 1 month
If taking antidepressants, mood stabilizers, or anxiolytics, the dose must be stable for at least 1 month prior to study entry
Willing to use an adequate method of contraception to avoid pregnancy throughout the study and for up to 4 weeks after the study. Acceptable methods include oral, injectable, or implanted contraceptives; intrauterine devices or barrier methods such as condoms; and diaphragms and spermicides.

Exclusion Criteria:

Inpatient status
Clinical Global Impression Severity (CGI-S) score greater than 6
Currently being treated with more than two antipsychotic medications
Fasting glucose greater than 125
Diagnosis of diabetes mellitus or treatment with insulin or oral hypoglycemics
Previous or current treatment with metformin
Diagnosis of congestive heart failure
Renal impairment, as defined by a serum creatinine level greater than 1.5 in males or greater than 1.4 in females, or creatinine estimated glomerular filtration rate (GFR) outside of normal limits
Hepatic disease, as defined by aspartate transaminase (AST), alanine transaminase (ALT), or c-glutamyl transferase (CGT) greater than 1.5 times upper limit of normal (ULN), or total bilirubin greater than 1.2 times ULN
Metabolic acidosis, as defined by serum carbon dioxide less than the lower limit of normal
Known hypersensitivity to metformin
Pregnant or breastfeeding
Recent (in the past 30 days) or scheduled radiological studies involving iodinated contrast material
Alcohol abuse or dependence within the past month, as determined by the SCID
Other serious and unstable medical condition in the judgment of the investigator
Diagnosis of mental retardation, delirium, or dementia, as defined by DSM-IV-TR
Failed to discontinue 4 weeks prior to study entry any medication used for weight loss
Concurrent treatment with certain drugs that are known to increase metformin blood levels should be discussed with the Project Medical Officer.",Metformin 500 mg pills over-encapsulated up to 4 pills daily as tolerated,ChEMBL:CHEMBL1431 | DrugBank:DB00331 | PubChem:4091,Metformin,CN(C)C(=N)NC(=N)N,A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00817063,NCT00817063_EG000,No,All,Adult | Older Adult,Phase 3,296,"Inclusion Criteria:

all types of chronic hand eczema, lasting for at least 6 months since initial diagnosis
rated as severe by the physician
unresponsive to highly potent topical corticosteroids, such as clobetasol

Exclusion Criteria:

patients whose disease is adequately controlled by standard non-medicated therapy, including potent topical steroids, skin moisturizers, and avoidance of allergens and irritants
patients with known allergens and irritants, who have not made a reasonable effort to avoid the substances
patients with psoriasis lesions
active fungal, bacterial or viral infections of the hands
female patients who are pregnant or breastfeeding
female patients of childbearing potential who cannot use or will not commit to use two effective methods of contraception",Participants with severe CHE rated as refractory during the run-in period were randomized to receive 30 mg of alitretinoin oral soft capsule once daily up to 24 weeks.,ChEMBL:CHEMBL38 | ChEMBL:CHEMBL547 | ChEMBL:CHEMBL705 | DrugBank:DB00523 | DrugBank:DB00755 | DrugBank:DB00982 | PubChem:444795 | PubChem:449171 | PubChem:5282379,Tretinoin,CC(C=CC1=C(C)CCCC1(C)C)=CC=CC(C)=CC(=O)O,D10AD01 | D10AD04 | D10AD51 | D10AD54 | D10BA01 | D11AH04 | L01XF01 | L01XF02,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT00819741,NCT00819741_EG001,No,All,Adult | Older Adult,Phase 4,214,"Inclusion Criteria:

Diagnosed with type 2 diabetes
Never taken oral antidiabetic drugs before
HbA1c greater than 8.5 %
BMI (Body Mass Index) less than or equal to 35 kg/m^2

Exclusion Criteria:

Known or suspected allergy to repaglinide, metformin, or any of the excipients in the medications
Taken an investigational drug in another clinical trial within 4 weeks prior to this trial
Impaired liver function, defined as ASAT (aspartate aminotransferase) or ALAT (alanine aminotransferase) equal to or greater than 2 times upper normal limit
Have a clinically significant, active disease of the gastrointestinal, pulmonary, neurological, renal, genitourinary, and haematological systems
Severe uncontrolled or untreated hypertension (sitting diastolic blood pressure (BP) equal to or greater than 100 mmHg or systolic BP equal to or greater than 180 mmHg)
Impaired renal function
Acute or chronic acidosis or if there are plans to have a radiographic material containing iodine
Have a clinically significant, active cardiovascular disease, or decompensated heart failure
Treatment with systemic corticosteroids within the past two months prior to screening","Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily.",ChEMBL:CHEMBL1272 | DrugBank:DB00912 | PubChem:65981,Repaglinide,CCOc1cc(CC(=O)N[C@@H](CC(C)C)c2ccccc2N2CCCCC2)ccc1C(=O)O,A10BD14 | A10BX02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00820573,NCT00820573_EG001,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 4,16,"Inclusion Criteria:

Patients must meet all of the following inclusion criteria to participate in the study.
Patients with screening values/findings outside ranges described in the protocol may have one repeat determination performed and if the repeat value satisfies the criterion, they may continue in the screening process.
If the repeat value does not satisfy the criterion, the principal investigator will review the abnormal laboratory value and decide whether the subject may continue in the screening process.
All screening laboratory measurements are to be performed after an overnight fast ≥10 hours in duration.
Patients must be able to communicate meaningfully with the investigator and must be legally competent to provide written informed consent.
Patients can be either male or female.
Patients are ≥18 and ≤70 years of age on the day of signing informed consent.
Patients must meet the current American Diabetes Association criteria for the diagnosis of type 2 diabetes mellitus
Patients must be on diet or diet plus exercise therapy.
Patients must have a HbA1c ≥ 7.5% and ≤ 9.5%
Patients must have a BMI of 23-40 kg/m2

Patients must have the following laboratory values:

Hematocrit Males ≥ 34 vol%
Females ≥ 33vol%
Serum creatinine ≤ 1.5 mg/dL in males and ≤ 1.4 mg/dL in females
AST (SGOT): ≤ 2.5 times upper limit of normal
ALT (SGPT): ≤ 2.5 times upper limit of normal
Alkaline phosphatase ≤ 2.5 times upper limit of normal
If serum creatinine is > 1.5 mg/dl in males and > 1.4 mg/dl in females, the Principal Investigator can include the patient if the measured GFR is >70 ml/min (24 hour creatinine clearance)
Patients must have been on a stable dose of allowed chronic medications for ≥30 days prior to entering the study.
Only patients whose body weight has been stable (±4 pounds) over the three months prior to the study will be included.

Exclusion Criteria:

Patients are excluded from participation in the study if they meet any of the following criteria:

Patient has type 1 diabetes.
Patient has received insulin for more than one week within the previous year prior to entry.
Patient has been treated with exenatide or a non-TZD, oral antihyperglycemic agent within the last 2 months or with a TZD (pioglitazone or rosiglitazone) within the last 4 months.
Patient is receiving any medications with known adverse effects on glucose tolerance (e.g., systemic glucocorticoids, psychotropic drugs like clozapine, olanzapine, haloperidol, risperidone). Note: Patients may be taking stable doses of estrogens, other hormonal replacement therapy, or lipid and blood pressure lowering agents if the patient has been on these agents for the prior three months.
Patient has evidence of a significant cardiovascular disorder within 6 months of signing informed consent (e.g. acute coronary syndrome, coronary artery intervention, stroke or transient ischemic neurological disorder) or has New York Heart Association Classification greater than Class 2; or has significant findings on ECG (other than non-specific ST-T wave changes); or peripheral vascular disease (history of claudication); or has dyspnea on exertion of one flight or less, or abnormal breath sounds on auscultation.
Patient has a history of intolerance or hypersensitivity to a DPP-4 inhibitor or to metformin.
Patient is pregnant or plans to become pregnant within the projected duration of the study.",all subjects after receiving 6 weeks of metformin therapy,ChEMBL:CHEMBL1431 | DrugBank:DB00331 | PubChem:4091,Metformin,CN(C)C(=N)NC(=N)N,A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00822172,NCT00822172_EG001,No,All,Adult | Older Adult,Phase 4,83,"Inclusion Criteria:

The subject is >40 years old.
The subject has a diagnosis of Intermittent Claudication (IC) due to Peripheral Artery Disease (PAD).
Ankle brachial index (ABI) < 0.90 in at least one extremity, or if Ankle brachial index (ABI)is ≥ 0.90 to ≤ 1.0, a reduction of at least 20% in Ankle brachial index (ABI), in at least one extremity, when measured within 1 minute after claudication-limiting treadmill testing. If the subject has non-compressible arteries then a toe brachial index (TBI) < 0.70 is required in at least one extremity.
Symptoms of Intermittent Claudication (IC)must be stable for at least 3 months prior to Screening 1.
Peak Walking Time (PWT) of ≥ 1 to ≤ 12 minutes on a Gardner protocol at Screening 2.
If the subject is currently on statin therapy, they need to have been on statin therapy for at least 3 months prior to Screening 1. Subjects who have recently discontinued statin therapy must ""wash-out"" for at least one month prior to Screening 1.
Tolerance to background therapy of cilostazol (approximately 2 weeks of 50 mg by mouth (PO) twice daily (BID), approximately 1 week of 100 mg PO BID) between Screening 2 and Baseline Visit.
Subjects must be either male or females that are post-menopausal, surgically incapable of bearing children or if they are of childbearing potential must have a negative serum pregnancy test at Screening 1 and a negative urine pregnancy test at Day 0 and must agree to use double-barrier contraceptive methods until the end of investigational therapy (Day 180 Visit).
The subject is able to comply with scheduled visits, treatment plan and laboratory tests.
The subject is willing to participate in this study as documented by written informed consent.
During the tolerance phase of the Screening period, the subject demonstrates at least 70% compliance with cilostazol and is willing to continue treatment.

Exclusion Criteria:

Evidence of critical limb ischemia (CLI) (e.g., ischemic rest pain or ischemic ulceration).
The subject has had a major amputation of the leg or any other amputation that limits walking ability.
The subject has diabetes mellitus type 1 or poorly controlled diabetes mellitus type 2 (hemoglobin A1c (HbA1c) > 10).
The subject has had a transient ischemic attack (TIA) or deep vein thrombosis in the last 3 months.
The subject has had a stroke within the last 6 months.
The subject has participated in an angiogenic gene therapy study, unless known to be given placebo.

The subject has any of the following laboratory parameters at Screening 1:

Alanine aminotransferase (ALT), aspartate aminotransferase (AST) or total bilirubin >3 times the upper limit of normal (ULN)
Serum creatinine >2.5 mg/dL
Hemoglobin (Hb) <10 g/dL
White blood cell (WBC) count <3.0 x 103/µL; or > 15 x 103/µL
Platelet count <100 x 103/µL
The subject walks less than 1 minute at 2 miles per hour (mph), 0% grade as determined during the Screening 1 treadmill familiarization.
The subject has clinically significant electrocardiogram (ECG) abnormalities at rest or changes during exercise or post-exercise at Screening 2 or Day 0.
The subject has any history or clinical evidence of congestive heart failure (CHF), with which the clinician-investigator concurs.
The subject has uncontrolled hypertension (resting blood pressure (BP) > 180/100 mmHg) or uncontrolled arrhythmic disorders at Screening 1.
History of coronary or peripheral revascularization within 6 months prior to Screening 1.
The subject plans to undergo coronary or peripheral revascularization during the course of the study.
The subject is currently taking L-carnitine or medication for claudication (including pentoxifylline or cilostazol). In this situation, the subject would become eligible for Screening 1 after a 6 week washout of the medication.
Subjects currently taking or those who anticipate taking ketoconazole, itraconazole, or erythromycin. The subject would become eligible for Screening 1 immediately after completion of therapy or discontinuation of the drug(s).
The subject has a known, active malignancy that requires active anti-neoplastic therapy. (stable basal cell skin cancer allowed. Cancer being treated soley with hormonal therapy is allowed.)
The subject has a severe co-morbidity with an expected survival of less than 2 years.
The subject's Peak Walking Time (PWT) is limited by symptoms other than claudication (e.g., shortness of breath (SOB), fatigue, angina, arthritis, etc.). If, in the opinion of the investigator, the subject were to improve their Peak Walking Time (PWT) from study therapy to the extent that his or her walking would then be limited by a symptom other than claudication, the subject should not be enrolled.
The subject has a history of alcohol or other substance abuse within 6 months of Screening 1.
The subject has an inability to tolerate oral medication administration.
The subject has a known or suspected allergy to the study medication(s) or class of study medication(s) (cilostazol or L-carnitine) to be administered.
The subject has initiated an exercise training program within 3 months of Screening 1, has the inability to maintain his or her current level of physical activity throughout the study, or the subject plans on enrolling in an exercise training program during the study.
The subject plans to change his/her smoking status during the planned duration of this study (subjects will be advised that stopping smoking is best for his/her health).
The subject is currently pregnant or breastfeeding.
The subject has received an investigational drug or biological agent within 30 days prior to Screening 1.
The subject is currently participating in or plans to enroll in another clinical trial during this study.
The subject has any other clinically significant medical or psychiatric condition that in the opinion of the Investigator could impact the subject's ability to successfully complete this trial.
In the Investigator's opinion, the subject experienced any Adverse Events (AEs) during the tolerance phase of the Screening period that present a potential ongoing safety concern.","cilostazol : Background therapy beginning at 50mg (1 pill) taken by mouth two times per day for two to three weeks. Then 100 mg (1 pill) to be taken by mouth two times per day (morning and evening) for one to two weeks.

Randomized therapy will consist of 100 mg (1 pill) to be taken by mouth two times per day (morning and evening) for approximately 180 days.",ChEMBL:CHEMBL799 | DrugBank:DB01166 | PubChem:2754,Cilostazol,O=C1CCc2cc(OCCCCc3nnnn3C3CCCCC3)ccc2N1,B01AC23,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00826748,NCT00826748_EG000,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 4,24,"Inclusion Criteria:

All Smokers (Treated and Non-Treated)

All study individual should be enrolled in Weill-IRB protocol #0005004439 entitled ""Evaluation of the Lungs of Normal (Smokers, Ex-smokers, Non-Smokers) Individuals with Segmental Bronchopulmonary Lung Lavage, Bronchial Brushing, and Bronchial Wall Biopsy""
All study subjects should be able to provide informed consent
Current smokers with 15-to 40 pack-year history
All study individuals should be healthy as per protocol #0005004439 entitled ""Evaluation of the Lungs of Normal (Smokers, Ex-smokers, Non-Smokers) Individuals with Segmental Bronchopulmonary Lung Lavage, Bronchial Brushing, and Bronchial Wall Biopsy""

Non-Smokers

All study individual should be enrolled in Weill-IRB protocol #0005004439 entitled ""Evaluation of the Lungs of Normal (Smokers, Ex-smokers, Non-Smokers) Individuals with Segmental Bronchopulmonary Lung Lavage, Bronchial Brushing, and Bronchial Wall Biopsy""
All study subjects should be able to provide informed consent
All study individual should be healthy as per protocol #0005004439 entitled ""Evaluation of the Lungs of Normal (Smokers, Ex-smokers, Non-Smokers) Individuals with Segmental Bronchopulmonary Lung Lavage, Bronchial Brushing, and Bronchial Wall Biopsy""

Exclusion Criteria:

All Smokers

Smokers intending to quit smoking in the next 14 days.
Individuals already receiving any lung related inhalers
Females who are pregnant or nursing

Non-Smokers

Exclusion Criteria:

Non-smokers who intend to start smoking in the next 14 days
Individuals already receiving any lung related inhalers
Females who are pregnant or nursing",Treated Smokers will be administered with 320 micrograms (mcg) of beclomethasone daily from Day 1 to Day 7 via a metered dose inhaler (QVAR 80 HFA) delivering 80 micrograms of beclomethasone per puff. The dose will be 2 puffs twice a day for 7 days.,PubChem:11957468 | PubChem:133687604 | PubChem:134688323 | PubChem:155903696 | PubChem:16218996 | PubChem:163285100 | PubChem:20469 | PubChem:2308 | PubChem:24867475,Beclomethasone,CC1CC2C3CCC4=CC(=O)C=CC4(C)C3(Cl)C(O)CC2(C)C1(O)C(=O)CO,A07EA07,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00827242,NCT00827242_EG000,No,Male,Adult | Older Adult,Phase 3,161,"Inclusion Criteria:

Men 45 years of age or older with Benign Prostatic Hyperplasia (BPH) also referred to as BPH-LUTS [lower urinary tract symptoms] based on the disease diagnostic criteria at the start of study.
Provide signed informed consent at the start of the study.
Have not taken Finasteride therapy for at least 3 months before study drug is dispensed and Dutasteride therapy for at least 6 months before study drug is dispensed.
Have not taken other BPH therapy (including herbal preparations), overactive bladder (OAB) therapy, or erectile dysfunction (ED) therapy for at least 4 weeks prior to study drug is dispensed.
Agree not to use any other approved or experimental pharmacologic BPH, OAB, or ED treatments anytime during the study
Have LUTS with a Total International Prostate Symptom Score (IPSS) greater than or equal to 13 when study drug is dispensed.
Have reduced peak urine flow rate when study drug is dispensed (measured by a special toilet equipment).
Demonstrate compliance with study drug administration requirements.

Exclusion Criteria:

Treated with nitrates for a cardiac conditions.
Have unstable angina or angina that requires treatment.
Have had any of the following in the past 90 days: Heart attack, also known as a myocardial infarction (MI); Heart bypass surgery (called coronary artery bypass graft surgery); Had a procedure to open up blood vessels in the heart known as angioplasty or stent placement (percutaneous coronary intervention).
Have very high or very low blood pressure
Have problems with kidneys, liver, or nervous system.
Have uncontrolled diabetes.
Have had a stroke or a significant injury to brain or spinal cord.
Have prostate cancer, are being treated for cancer or have clinical evidence of prostate cancer (Prostate-Specific Antigen [PSA] greater than 10 nanograms/milliliter [ng/ml] at the start of study).","Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive tadalafil 5 mg orally once daily over a 12-week period.",ChEMBL:CHEMBL779 | DrugBank:DB00820 | PubChem:110635,Tadalafil,[H][C@]12Cc3c([nH]c4ccccc34)[C@@H](c3ccc4c(c3)OCO4)N1C(=O)CN(C)C2=O,C02KX52 | C02KX54 | G04BE08 | G04CA54 | G04CB51,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00828295,NCT00828295_EG000,No,All,Child,Phase 3,74,"MAIN INCLUSION CRITERIA

Male or female patient aged more than 28 days (full term) up to and including 16 years.

Inpatient scheduled to undergo surgical procedures requiring general endotracheal anesthesia, including:

ear, nose and throat surgery;
eye surgery;
orchidopexy;
plastic reconstructive surgery;
herniorraphy;
orthopedic surgery).
American Society of Anesthesiologists (ASA) physical status I, II or III.
Patient scheduled to receive nitrous oxide during the maintenance phase of anesthesia.
Patient scheduled to be hospitalized for at least 72 hours after wake up of surgery
For female of childbearing potential: the patient and her parent(s)/legal guardian(s) were counseled on the importance of not becoming pregnant before or during the study and the patient must have a negative pregnancy test at the pre-treatment visit and at the study treatment visit.

MAIN EXCLUSION CRITERIA

For infant aged more than 12 months: a history of gastro-esophageal reflux.
For patient aged 28 days to 6 years: patient who received any investigational drugs within 90 days prior to Day 1. For patient aged 6 up to 16 years inclusive: patient who received any investigational drugs within 30 days prior to Day 1.
Patient scheduled to undergo emergency surgery.
Patient scheduled to receive regional (spinal) anesthesia in conjunction with general endotracheal anesthesia.
Patient scheduled to receive propofol during the maintenance phase of anesthesia.
Patient with vomiting from any organic cause.
Any drug with a potential anti-emetic effect within 24 hours prior to the administration of anesthesia.
Any vomiting, retching, or nausea in the 24 hours preceding the administration of anesthesia.","Single dose IV Palonosetron 1 mcg/kg (up to a maximum total dose of 0.075 mg)

palonosetron: palonosetron IV 1 mcg/kg",ChEMBL:CHEMBL1189679 | DrugBank:DB00377 | PubChem:6337614,Palonosetron,[H][C@]12CCCc3cccc(c31)C(=O)N([C@@H]1CN3CCC1CC3)C2,A04AA05 | A04AA55,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT00828295,NCT00828295_EG001,No,All,Child,Phase 3,76,"MAIN INCLUSION CRITERIA

Male or female patient aged more than 28 days (full term) up to and including 16 years.

Inpatient scheduled to undergo surgical procedures requiring general endotracheal anesthesia, including:

ear, nose and throat surgery;
eye surgery;
orchidopexy;
plastic reconstructive surgery;
herniorraphy;
orthopedic surgery).
American Society of Anesthesiologists (ASA) physical status I, II or III.
Patient scheduled to receive nitrous oxide during the maintenance phase of anesthesia.
Patient scheduled to be hospitalized for at least 72 hours after wake up of surgery
For female of childbearing potential: the patient and her parent(s)/legal guardian(s) were counseled on the importance of not becoming pregnant before or during the study and the patient must have a negative pregnancy test at the pre-treatment visit and at the study treatment visit.

MAIN EXCLUSION CRITERIA

For infant aged more than 12 months: a history of gastro-esophageal reflux.
For patient aged 28 days to 6 years: patient who received any investigational drugs within 90 days prior to Day 1. For patient aged 6 up to 16 years inclusive: patient who received any investigational drugs within 30 days prior to Day 1.
Patient scheduled to undergo emergency surgery.
Patient scheduled to receive regional (spinal) anesthesia in conjunction with general endotracheal anesthesia.
Patient scheduled to receive propofol during the maintenance phase of anesthesia.
Patient with vomiting from any organic cause.
Any drug with a potential anti-emetic effect within 24 hours prior to the administration of anesthesia.
Any vomiting, retching, or nausea in the 24 hours preceding the administration of anesthesia.","Single dose IV Palonosetron 3 mcg/kg (up to a maximum total dose of 0.25 mg)

palonosetron: palonosetron 3mcg/kg IV",ChEMBL:CHEMBL1189679 | DrugBank:DB00377 | PubChem:6337614,Palonosetron,[H][C@]12CCCc3cccc(c31)C(=O)N([C@@H]1CN3CCC1CC3)C2,A04AA05 | A04AA55,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT00829439,NCT00829439_EG000,No,All,Child,Phase 1,16,"Inclusion Criteria:

Angelman syndrome, confirmed by molecular testing
Must be willing to come for research visit on 2 days, exactly 1 week apart

Exclusion Criteria:

On levodopa, carbidopa, or any dopamine agonists in the 2 weeks prior to participation
Other medical conditions that may be associated with developmental or cognitive delays
More than 2 clinical seizures per month
Used monoamine oxidase (MAO) inhibitors within the last 2 weeks
Used phenytoin within the last 2 weeks
Used phenothiazines, butyrophenones, and thioxanthenes within last 2 weeks
Hypersensitive to levodopa or carbidopa
Cardiovascular disease or instability
Respiratory diseases, including asthma, emphysema, chronic cough, and shortness of breath
Liver disease
Stomach or intestinal ulcers
Kidney disease
Hematological problems, including anemia, leucopenia, and thrombocytopenia
Used investigational drugs/interventions within the past three months","Other Names:

Sinemet L-dopa

Dosages are based on levodopa.

Each cohort of 3 subjects will be placed on an increasing dose of levodopa (2, 5, 10, and 15 mg/kg/day) for 1 week, provided subjects in the preceding cohort tolerated the lower dose.

Levodopa/Carbidopa is a combined formulation that will be dispensed as capsules. It should be taken 3 times a day.

Levodopa/Carbidopa (4:1): Dosages are based on levodopa.

Each cohort of 3 subjects will be placed on an increasing dose of levodopa (2, 5, 10, and 15 mg/kg/day) for 1 week, provided subjects in the preceding cohort tolerated the lower dose.

Levodopa/Carbidopa is a combined formulation that will be dispensed as capsules. It should be taken 3 times a day.",DrugBank:DB00988 | PubChem:681,Dopamine,NCCc1ccc(O)c(O)c1,C01CA04,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00832455,NCT00832455_EG000,No,All,Child,Phase 4,445,"Inclusion Criteria:

Patient Is Diagnosed With Asthma For At Least 6 Months
Patient's Peak Expiratory Flow (PEF) Is 80% Of Predicted Value (Appendix 10)
Patient Is Currently Untreated, Or Patient Is A User Of Short-Acting 2-Agonist On An As-Needed Basis, Or Patient Is A User Of Ics At Any Dosage
Physician And/Or Patient Are Dissatisfied With Current Controller Therapy, Or Patient Is Reluctant To Take Ics Therapy, Or Patient Is Insufficiently Controlled Due To Non-Adherence With Current Therapy Through The Preceding 6 Weeks

Exclusion Criteria:

As Per Canadian Guidelines, Patient Is On A Laba Alone (Formoterol (Oxeze), Salmeterol (Serevent)) Or A Combination Product (Advair Or Symbicort)
Patient Is Well Controlled, Adherent And Satisfied With Current Controller Therapy","Montelukast 4-5 mg for 12 weeks, oral tablet",PubChem:23663996,Montelukast Sodium,CC(C)(O)c1ccccc1CCC(SCC1(CC(=O)[O-])CC1)c1cccc(C=Cc2ccc3ccc(Cl)cc3n2)c1.[Na+],,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT00833638,NCT00833638_EG000,Accepts Healthy Volunteers,Male,Adult | Older Adult,Phase 4,121,"Inclusion Criteria:

Male and at least 18 years old, with at least a 3-month history of erectile dysfunction (ED).
Anticipate having same adult female sexual partner during the study.
Agree to make at least 4 sexual intercourse attempts with the female partner during the 4-week run-in phase without medication.
Agree to make at least 1 sexual intercourse attempt per day with the female partner during days 1-4 following randomization (with a minimum of three attempts required during that period). Also agree to make at least 3 intercourse attempts during days 5-14 following randomization.
Agree not to use any other ED treatment during the study and for 24 hours after the final study visit.

Partner Inclusion Criteria:

Female and at least 18 years old.
Agree to make at least 4 sexual intercourse attempts with the male sexual study partner during the 4-week run-in phase without medication.
Agree to make at least 1 sexual intercourse attempt per day with the male partner during days 1-4 following randomization
Agree to make at least 3 intercourse attempts during days 5-14 following randomization.

Exclusion Criteria:

Previous or current treatment with tadalafil or any phosphodiesterase type 5 (PDE5) inhibitor on a daily basis for once daily use.
ED caused by other primary sexual disorders, or untreated or inadequately treated endocrine disease.
History of radical prostatectomy, other pelvic surgery or penile implant.
Clinically significant penile deformity in the opinion of the investigator.
Clinically significant renal insufficiency, or hepatobiliary disease as determined by the investigator.
Glycosylated hemoglobin of >11%.
Present with chronic stable angina treated with long-acting nitrates, or with chronic stable angina requiring short-acting nitrates in the last 90 days, or with angina occurring during sexual intercourse in the last 6 months.
Have any significant cardiac conditions as described in the protocol exclusion criteria.
Have a history of significant central nervous system injuries within the last 6 months.
Have a history of Human Immunodeficiency Virus infection.
Have any condition that would interfere with the subject's ability to provide informed consent or comply with study instructions, would place subject at increased risk, or might confound the interpretation of the study results.
Currently receive treatment with nitrates, cancer chemotherapy, or antiandrogens (except finasteride taken as Propecia or Proscar, or Avodart [dutasteride]).
History of drug, alcohol, or substance abuse within the past 6 months, as assessed by the investigator.
Previously completed or withdrawn from any other study investigating tadalafil for once daily use.
Received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
Prior ineffective treatment with any PDE5 inhibitor in the opinion of the investigator.",No drug during baseline period followed by tadalafil 2.5 mg for 14 days.,ChEMBL:CHEMBL779 | DrugBank:DB00820 | PubChem:110635,Tadalafil,[H][C@]12Cc3c([nH]c4ccccc34)[C@@H](c3ccc4c(c3)OCO4)N1C(=O)CN(C)C2=O,C02KX52 | C02KX54 | G04BE08 | G04CA54 | G04CB51,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00833638,NCT00833638_EG001,Accepts Healthy Volunteers,Male,Adult | Older Adult,Phase 4,118,"Inclusion Criteria:

Male and at least 18 years old, with at least a 3-month history of erectile dysfunction (ED).
Anticipate having same adult female sexual partner during the study.
Agree to make at least 4 sexual intercourse attempts with the female partner during the 4-week run-in phase without medication.
Agree to make at least 1 sexual intercourse attempt per day with the female partner during days 1-4 following randomization (with a minimum of three attempts required during that period). Also agree to make at least 3 intercourse attempts during days 5-14 following randomization.
Agree not to use any other ED treatment during the study and for 24 hours after the final study visit.

Partner Inclusion Criteria:

Female and at least 18 years old.
Agree to make at least 4 sexual intercourse attempts with the male sexual study partner during the 4-week run-in phase without medication.
Agree to make at least 1 sexual intercourse attempt per day with the male partner during days 1-4 following randomization
Agree to make at least 3 intercourse attempts during days 5-14 following randomization.

Exclusion Criteria:

Previous or current treatment with tadalafil or any phosphodiesterase type 5 (PDE5) inhibitor on a daily basis for once daily use.
ED caused by other primary sexual disorders, or untreated or inadequately treated endocrine disease.
History of radical prostatectomy, other pelvic surgery or penile implant.
Clinically significant penile deformity in the opinion of the investigator.
Clinically significant renal insufficiency, or hepatobiliary disease as determined by the investigator.
Glycosylated hemoglobin of >11%.
Present with chronic stable angina treated with long-acting nitrates, or with chronic stable angina requiring short-acting nitrates in the last 90 days, or with angina occurring during sexual intercourse in the last 6 months.
Have any significant cardiac conditions as described in the protocol exclusion criteria.
Have a history of significant central nervous system injuries within the last 6 months.
Have a history of Human Immunodeficiency Virus infection.
Have any condition that would interfere with the subject's ability to provide informed consent or comply with study instructions, would place subject at increased risk, or might confound the interpretation of the study results.
Currently receive treatment with nitrates, cancer chemotherapy, or antiandrogens (except finasteride taken as Propecia or Proscar, or Avodart [dutasteride]).
History of drug, alcohol, or substance abuse within the past 6 months, as assessed by the investigator.
Previously completed or withdrawn from any other study investigating tadalafil for once daily use.
Received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
Prior ineffective treatment with any PDE5 inhibitor in the opinion of the investigator.",No drug during baseline period followed by tadalafil 5 mg for 14 days.,ChEMBL:CHEMBL779 | DrugBank:DB00820 | PubChem:110635,Tadalafil,[H][C@]12Cc3c([nH]c4ccccc34)[C@@H](c3ccc4c(c3)OCO4)N1C(=O)CN(C)C2=O,C02KX52 | C02KX54 | G04BE08 | G04CA54 | G04CB51,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00835198,NCT00835198_EG000,No,All,Child | Adult | Older Adult,Phase 4,82,"Inclusion Criteria:

Facial acne vulgaris characterized by the following:

30-100 facial inflammatory lesions; and, 25-100 facial non-inflammatory lesions;
Stable disease, non-rapidly regressing facial acne vulgaris; and, less than or equal to 3 nodules and/or cysts (diameter greater than or equal to 1cm)
Female subjects of childbearing potential must have a negative pregnancy test at baseline and practice reliable method of contraception throughout the study

Exclusion Criteria:

Non-compliance with washout period;
History of clinically significant anemia or hemolysis;
Skin disease/disorder that might interfere with diagnosis or evaluation of acne vulgaris;
Allergy or sensitivity to any component of the test medications",Tretinoin gel 0.025%,ChEMBL:CHEMBL38 | ChEMBL:CHEMBL547 | ChEMBL:CHEMBL705 | DrugBank:DB00523 | DrugBank:DB00755 | DrugBank:DB00982 | PubChem:444795 | PubChem:449171 | PubChem:5282379,Tretinoin,CC(C=CC1=C(C)CCCC1(C)C)=CC=CC(C)=CC(=O)O,D10AD01 | D10AD04 | D10AD51 | D10AD54 | D10BA01 | D11AH04 | L01XF01 | L01XF02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00835861,NCT00835861_EG000,No,Female,Adult | Older Adult,Phase 2,14,"Inclusion Criteria:

Receiving prenatal care at University of North Carolina (UNC), Chapel Hill Obstetric clinics and planning delivery at UNC Women's Hospital
Diagnosis of Diabetes prior to pregnancy with use of an oral hypoglycemic agent or dietary control
Diagnosis of early gestational diabetes prior to 20 weeks gestation via abnormal 3 hour glucose challenge testing using the national diabetes data group (NDDG)criteria
Less than 24 weeks at study enrollment
Singleton or twin pregnancy
English or Spanish speaking
Able to give informed consent

Exclusion Criteria:

End organ complications of diabetes (retinopathy, renal insufficiency, etc.)
Prior need for insulin for glycemic control
History of diabetic ketoacidosis (DKA) or hyperosmolar state
Prior adverse reaction (ie. lactic acidosis) or allergy to Metformin
Kidney or liver disease
Significant medical co-morbidities (lupus, cystic fibrosis, etc.) Hypertension controlled on one medication, well controlled asthma, and well controlled thyroid disease are not excluded.","Standard diet and glucose self-monitoring education. Initiated on Metformin 500 BID if medication naïve, or continued on their current dosage of Metformin if taking it prior to pregnancy. Dosage titrated to a maximum of 2250 mg/day based on review of self-reported fasting and post prandial glucose values during visits. .NPH Insulin treatment added for those unable to achieve glycemic control with Metformin alone.",ChEMBL:CHEMBL1431 | DrugBank:DB00331 | PubChem:4091,Metformin,CN(C)C(=N)NC(=N)N,A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00836693,NCT00836693_EG000,No,Male,Adult | Older Adult,Phase 3,147,"Inclusion Criteria:

You are male and aged at least 18 years.
Have a history of erectile dysfunction (ED)(defined as the consistent inability to achieve and/or maintain an erection sufficient to permit satisfactory sexual intercourse) of at least 3 months duration.
Agree not to use any other treatment for ED, including herbal and over-the-counter (OTC) medications, during the study
You agree to make at least four sexual intercourse attempts with the female sexual study partner during the 4-week run-in period without medication
Your entry laboratory test results and medical tests meet study requirements
You agree to use the study drug only as instructed by your study doctor and staff and to return any unused study drug and containers at the end of the study or as otherwise instructed by the study doctor.
If currently using cholesterol lowering medications (for example: statins) or medications to lower blood pressure (example: angiotensin-converting enzyme (ACE) inhibitors or calcium channel blocker medications), you need to be on a stable dose and you and your study doctor do not expect any dose change during the study.

Exclusion Criteria:

You have received previous or current treatment with tadalafil or any other PDE5 inhibitor.
Currently receives treatment with doxazosin, nitrates, cancer chemotherapy, or anti-androgens (except finasteride e.g. Propecia™ or Proscar®, or dutasteride e.g. Avodart®).
You have had significant heart disease as determined by your doctor in charge of this study or a member of the doctor's staff.
Have a history of significant central nervous system injuries (including stroke or spinal cord injury) within the last 6 months.
Have a history of loss of vision in one eye because of nonarteritic anterior ischemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with previous PDE5 inhibitor exposure.",Tadalafil 5 milligrams administered orally once a day over 12 weeks. Dosing started at 5 mg tadalafil daily (or matching placebo) and could be down-titrated to 2.5 mg tadalafil daily (or matching placebo) based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.),ChEMBL:CHEMBL779 | DrugBank:DB00820 | PubChem:110635,Tadalafil,[H][C@]12Cc3c([nH]c4ccccc34)[C@@H](c3ccc4c(c3)OCO4)N1C(=O)CN(C)C2=O,C02KX52 | C02KX54 | G04BE08 | G04CA54 | G04CB51,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00838682,NCT00838682_EG000,No,All,Child | Adult | Older Adult,Phase 4,54,"Inclusion Criteria:

Bleeding peptic ulcer: Among patients suspected to have upper GI bleeding based on hematemesis or melena, those with peptic ulcers(Forrest I, IIa and IIb) in whom active bleeding, non-bleeding visible vessels and fresh blood clots are observed on upper GI endoscopy performed within 24 hours after the hospitalization
patients who achieved primary hemostasis with endoscopic hemostasis procedure via upper GI endoscopy

Exclusion Criteria:

Patients who refuse endoscopic procedure
Patients with complications from gastric ulcer that require operative treatment prior to upper GI endoscopic treatment(e.g., gastric outlet obstruction, peptic ulcer perforation)
Pregnancy
Patients with serious concurrent diseases such as malignant tumors or end-stage diseases
History of previous gastrectomy or vagotomy
Known hypersensitivity to proton pump inhibitors
Elderly patients
Epilepsy","Oral Rabeprazole 20 mg twice daily for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.",ChEMBL:CHEMBL1219 | DrugBank:DB01129 | PubChem:5029,Rabeprazole,COCCCOc1ccnc(CS(=O)c2nc3ccccc3[nH]2)c1C,A02BC04 | A02BC54 | A02BD12 | A02BD13 | M01AA05 | M02AA03,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00844597,NCT00844597_EG000,No,Male,Child,Phase 1 | Phase 2,4,"Inclusion Criteria:

Has provided written informed assent (as required by EC) and parents/guardians have provided written informed consent.
Has an out-of-frame deletion(s) that could be corrected by skipping exon 51 based on DNA sequencing data from the candidate.
Is male and between the ages of ≥ 5 years and ≤ 15 years.
Has a muscle biopsy analysis showing < 5% revertant fibres present at baseline.
DNA sequencing of the candidate's dystrophin exon 51 confirms that no DNA polymorphisms are present that could compromise PMO duplex formation or there is confirmation of in vitro dystrophin production after AVI-4658 exposure to fibroblast or myoblast in vitro cultures.
Intact right and left bicep muscles or alternative arm muscle group.
Is able to walk independently at least 25 meters.
Has a forced vital capacity (FVC) ≥ 50% of predicted and does not require ventilatory support or supplemental oxygen.
Receives the standard of care for DMD as recommended by the DMD care recommendations from the North Star UK and TREAT-NMD.
The parent(s) or legal guardian and Subject have undergone counselling about the expectations of this protocol and agree to participate.
The parent(s) or legal guardian and Subject intend to comply with all study evaluations and return for all study activities.

Exclusion Criteria:

A DNA polymorphism within exon 51 that may compromise PMO duplex formation.
Known antibodies to dystrophin.
Lacks intact right and left bicep muscles or alternative arm muscle group.
A calculated creatinine clearance less than 70% of predicted normal for age based on the Cockcroft and Gault Formula.
A left ventricular ejection fraction (EF) of < 35% and/or fractional shortening of <25% based on echocardiography (ECHO)during screening.
A history of respiratory insufficiency as defined by need for intermittent or continuous supplemental oxygen.
A severe cognitive dysfunction rendering the potential subject unable to understand and comply with the study protocol.
Any known immune deficiency or autoimmune disease.
A known bleeding disorder or has received chronic anticoagulant treatment within three months of study entry.
Receipt of pharmacologic treatment, apart from corticosteroids, that might affect muscle strength or function within 8 weeks of study entry (viz., growth hormone, anabolic steroids).
Surgery within 3 months of study entry or planned for anytime during the duration of the study.
Another clinically significant illness at time of study entry.
Subject or parent has active psychiatric disorder, has adverse psychosocial circumstances,recent significant emotional loss, and/or history of depressive or anxiety disorder that might interfere with protocol compliance.
Use of any experimental treatments, has participated in any DMD interventional clinical trial within 4 weeks of study entry or participated in the AVI-4658-33 intramuscular (i.m.) trial.",Subjects in this group received a 0.5 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60 minute period,PubChem:131842141,Casimersen 5'-cytosine modification,CN(C)P(=O)(OCC1CNCC(n2ccc(N)nc2=O)O1)N1CCN(C(=O)OCCOCCOCCO)CC1,,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0
NCT00844597,NCT00844597_EG001,No,Male,Child,Phase 1 | Phase 2,2,"Inclusion Criteria:

Has provided written informed assent (as required by EC) and parents/guardians have provided written informed consent.
Has an out-of-frame deletion(s) that could be corrected by skipping exon 51 based on DNA sequencing data from the candidate.
Is male and between the ages of ≥ 5 years and ≤ 15 years.
Has a muscle biopsy analysis showing < 5% revertant fibres present at baseline.
DNA sequencing of the candidate's dystrophin exon 51 confirms that no DNA polymorphisms are present that could compromise PMO duplex formation or there is confirmation of in vitro dystrophin production after AVI-4658 exposure to fibroblast or myoblast in vitro cultures.
Intact right and left bicep muscles or alternative arm muscle group.
Is able to walk independently at least 25 meters.
Has a forced vital capacity (FVC) ≥ 50% of predicted and does not require ventilatory support or supplemental oxygen.
Receives the standard of care for DMD as recommended by the DMD care recommendations from the North Star UK and TREAT-NMD.
The parent(s) or legal guardian and Subject have undergone counselling about the expectations of this protocol and agree to participate.
The parent(s) or legal guardian and Subject intend to comply with all study evaluations and return for all study activities.

Exclusion Criteria:

A DNA polymorphism within exon 51 that may compromise PMO duplex formation.
Known antibodies to dystrophin.
Lacks intact right and left bicep muscles or alternative arm muscle group.
A calculated creatinine clearance less than 70% of predicted normal for age based on the Cockcroft and Gault Formula.
A left ventricular ejection fraction (EF) of < 35% and/or fractional shortening of <25% based on echocardiography (ECHO)during screening.
A history of respiratory insufficiency as defined by need for intermittent or continuous supplemental oxygen.
A severe cognitive dysfunction rendering the potential subject unable to understand and comply with the study protocol.
Any known immune deficiency or autoimmune disease.
A known bleeding disorder or has received chronic anticoagulant treatment within three months of study entry.
Receipt of pharmacologic treatment, apart from corticosteroids, that might affect muscle strength or function within 8 weeks of study entry (viz., growth hormone, anabolic steroids).
Surgery within 3 months of study entry or planned for anytime during the duration of the study.
Another clinically significant illness at time of study entry.
Subject or parent has active psychiatric disorder, has adverse psychosocial circumstances,recent significant emotional loss, and/or history of depressive or anxiety disorder that might interfere with protocol compliance.
Use of any experimental treatments, has participated in any DMD interventional clinical trial within 4 weeks of study entry or participated in the AVI-4658-33 intramuscular (i.m.) trial.",Subjects in this group received a 1.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60 minute period,PubChem:131842141,Casimersen 5'-cytosine modification,CN(C)P(=O)(OCC1CNCC(n2ccc(N)nc2=O)O1)N1CCN(C(=O)OCCOCCOCCO)CC1,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT00844857,NCT00844857_EG000,No,All,Child,Phase 4,170,"Inclusion Criteria:

Male or female inpatients or outpatients, 10-17 years of age, who have not reached their 18th birthday prior to screening. Patient must weigh at least 20 kilograms (kg) at screening.
Must meet diagnostic criteria for current major depressive episode of Bipolar I Disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Version (DSM-IV-TR) and confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School Aged Children-Present and Lifetime (K-SADS-PL)
Patients entering the study will also be scored by the Children's Depression Rating Scale-Revised (CDRS-R) (entry score of greater than or equal to 40) as well as the adolescent-structured Young Mania Rating Scale (YMRS) (entry score of less than or equal to 15 with YMRS Item 1 [elevated mood] score less than equal to 2).

Exclusion Criteria:

Patients will be excluded if they are, in the opinion of the investigator, actively suicidal
Have an acute, serious or unstable medical condition
Have clinically significant laboratory abnormalities
Have had one or more seizures of unclear etiology
Have a current or lifetime diagnosis of any of the following according to DSM-IV criteria: Schizophrenia, Schizophreniform Disorder, Schizoaffective Disorder, Delusional Disorder, Psychotic Disorder Not Otherwise Specified, Delirium of any type, Amnestic Disorder, any Substance-Induced Disorder, or any Psychotic Disorder due to a General Medical Condition, unless there is substantive reason to believe patient was misdiagnosed","OFC 3/25 mg administered orally as an initial dose beginning at randomization, 6/25 mg at Visit 3 (Day 3), 6/50 mg at Visit 4 (Week 1), and 12/50 mg at Visit 5 (Week 2). If no tolerability or safety issues occurred after Visit 5 the participant continued on the maximum tolerated dose, not to exceed 12/50 mg and not less than 6/25 mg, for a total of 8 weeks.",ChEMBL:CHEMBL41 | DrugBank:DB00472 | PubChem:3386,Fluoxetine,CNCCC(Oc1ccc(C(F)(F)F)cc1)c1ccccc1,N06AB03 | N06CA03,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00845676,NCT00845676_EG000,No,All,Adult | Older Adult,Phase 4,21,"Inclusion Criteria:

Newly acquired HCV infection of 6 months or less duration
Detectable HCV RNA at study entry
HIV infection, any CD4 count

Exclusion Criteria:

Pregnant or intent to become pregnant within 24 weeks of study completion
Uncontrolled depression
Other serious liver disease
Other safety parameters must be met","Combination therapy with open-label pegylated interferon alfa-2a (PEG-IFN) + ribavirin (RBV): Pegylated interferon alfa-2a 180 mcg subcutaneous injection once weekly for 24 weeks. Ribavirin 1000-1200mg daily, dosed according to body weight and divided twice daily, for 12-24 weeks",ChEMBL:CHEMBL1643 | DrugBank:DB00811 | PubChem:37542,Ribavirin,NC(=O)c1ncn([C@@H]2O[C@H](CO)[C@@H](O)[C@H]2O)n1,J05AP01,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00848081,NCT00848081_EG001,No,Male,Adult | Older Adult,Phase 3,158,"Inclusion Criteria:

Stable on alpha blocker therapy for the treatment of BPH for at least 4 weeks prior to starting the study.

Have not taken the following treatments within the indicated duration and agree not to use at any time during the study:

All other Benign Prostatic Hyperplasia therapy (including herbal preparations) for at least 4 weeks prior to receiving study medication.
Overactive Bladder therapy (including antimuscarinics) for at least 4 weeks prior to receiving study medication.
Erectile Dysfunction therapy (including herbal preparations) for at least 4 weeks prior to receiving study medication.
If taking finasteride or dutasteride, must have been taking treatment for at least 6 months.

Exclusion Criteria:

Currently receiving alpha-blocker therapy for the treatment of hypertension.
History of symptoms associated with orthostasis, including recurrent episodes of dizziness, lightheadedness, loss of consciousness, or syncope.
Treated with nitrates for any cardiac conditions.
Have had any of the following in the past 90 days: Heart attack, also known as a myocardial infarction (MI); Heart bypass surgery (called coronary artery bypass graft surgery); Had a procedure to open up blood vessels in the heart known as angioplasty or stent placement (percutaneous coronary intervention).
Have problems with kidneys, liver, or nervous system
Have uncontrolled diabetes
Have prostate cancer, are being treated for cancer or have clinical evidence of prostate cancer (PSA greater than 10 ng/ml at the start of study).
Have had a stroke or a significant injury to brain or spinal cord.",Tadalafil 5 mg taken by mouth once daily for 12 weeks,ChEMBL:CHEMBL779 | DrugBank:DB00820 | PubChem:110635,Tadalafil,[H][C@]12Cc3c([nH]c4ccccc34)[C@@H](c3ccc4c(c3)OCO4)N1C(=O)CN(C)C2=O,C02KX52 | C02KX54 | G04BE08 | G04CA54 | G04CB51,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00848393,NCT00848393_EG000,No,All,Child,Phase 2,17,"Inclusion Criteria:

Childrens with the diagnosis of tetralogy of fallot, ventricular septal defect and atrioventricular septal defect who are under one year of age.

Exclusion Criteria:

Patients who are having reoperation.
Patients with comorbidities, such as heart failure.
Patients receiving digoxin preoperatively.","patients in this arm will receive a total of 25 mcg/kg of Fentanyl (High Dose) in two divided doses. first half will be given at induction and the second half will be given before incision.

Fentanyl (High Dose): 25 mcg/kg in two divided doses. half the dose will be given at induction and the second half will be given prior to incision.",ChEMBL:CHEMBL596 | DrugBank:DB00813 | PubChem:3345,Fentanyl,CCC(=O)N(c1ccccc1)C1CCN(CCc2ccccc2)CC1,N01AH01 | N01AH51 | N02AB03,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00848393,NCT00848393_EG001,No,All,Child,Phase 2,16,"Inclusion Criteria:

Childrens with the diagnosis of tetralogy of fallot, ventricular septal defect and atrioventricular septal defect who are under one year of age.

Exclusion Criteria:

Patients who are having reoperation.
Patients with comorbidities, such as heart failure.
Patients receiving digoxin preoperatively.","patients in this group will receive a total of 10mcg/kg of Fentanyl (Low Dose). half the dose will be given at induction and the second half will be given before incision

Fentanyl (Low Dose): patients will receive a total of 10mcg/kg of Fentanyl (Low Dose). half the dose will be given at induction and the second half before incision.",ChEMBL:CHEMBL596 | DrugBank:DB00813 | PubChem:3345,Fentanyl,CCC(=O)N(c1ccccc1)C1CCN(CCc2ccccc2)CC1,N01AH01 | N01AH51 | N02AB03,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00853125,NCT00853125_EG000,No,All,Adult | Older Adult,Phase 2,10,"DISEASE CHARACTERISTICS:

Histologically confirmed renal cell carcinoma

Primary lesion or metastatic site demonstrating clear cell variant with < 25% of any other histology
Radiographically measurable disease by RECIST criteria
Initiated treatment with sunitinib malate ≤ 6 weeks ago
No radiographically detectable brain metastases by MRI or CT scan

HLA-partially matched related donor available, as determined by serologic and/or DNA typing

Appropriate HLA match (≥ 2/6 HLA A, B, DR match)

PATIENT CHARACTERISTICS:

ECOG performance status 0-1
Absolute neutrophil count > 1,500/mm³
Platelet count > 100,000/mm³
Total bilirubin ≤ 2.0 times upper limit of normal (ULN)
AST ≤ 3.0 times ULN
Calculated creatinine clearance ≥ 40 mL/min
Cardiac ejection fraction ≥ 50%
QTc interval < 500 msec by EKG
Not pregnant
Negative pregnancy test
Fertile patients must use effective contraception
No known HIV positivity

None of the following within the past 6 months:

Myocardial infarction
Severe/unstable angina
Coronary/peripheral artery bypass graft
Symptomatic congestive heart failure
Cerebrovascular accident or transient ischemic attack
Pulmonary embolism
No ongoing ventricular cardiac dysrhythmias ≥ grade 2, according to NCI CTCAE v3.0
No history of serious ventricular arrhythmia (e.g., ventricular tachycardia > 3 beats in a row)
No ongoing atrial fibrillation
No other malignancies within the past 3 years, other than basal cell skin cancer, squamous cell skin cancer, in situ cervical cancer, or ductal or lobular carcinoma in situ of the breast
No other concurrent serious illness

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
No prior systemic therapy for metastatic renal cell carcinoma
No prior immunotherapy
No prior VEGF-targeted or mTOR-targeted therapies
No concurrent cytochrome P450 enzyme-inducing antiepileptic drugs (e.g., phenytoin, carbamazepine, or phenobarbital), St. John's wort, ketoconazole, dexamethasone, dysrhythmic drugs (e.g., terfenadine, quinidine, procainamide, sotalol, probucol, bepridil, indapamide, or flecainide), haloperidol, risperidone, rifampin, grapefruit, or grapefruit juice
No other concurrent investigational anticancer agents","therapeutic allogeneic lymphocytes: Patients with a partially HLA-matched family member who can serve as a hematopoietic stem cell transplant donor will receive partially HLA-matched irradiated donor lymphocytes approximately every 8 weeks depending upon response

sunitinib malate: Sunitinib will be administered orally at a dose of 50 mg qd for 4 consecutive weeks followed by 2 weeks off for every cycle.",PubChem:6456015,Sunitinib Malate,CCN(CC)CCNC(=O)c1c(C)[nH]c(C=C2C(=O)Nc3ccc(F)cc32)c1C.O=C(O)CC(O)C(=O)O,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00855582,NCT00855582_EG000,No,Male,Adult | Older Adult,Phase 3,198,"Inclusion Criteria:

Have BPH Lower Urinary Tract Symptoms (LUTS) based on the disease diagnostic criteria at 1st screening.
Have a history of ED based on the disease diagnostic criteria at 1st screening.
Have LUTS with a Total International Prostate Symptom Score (IPSS) greater than or equal to 13 at 2nd screening.
Have bladder outlet obstruction as defined by a Peak Urine Flow Rate (Qmax) of greater than or equal to 4 to less than or equal to 15 milliliter (mL)/second (sec) (from a prevoid total bladder volume as assessed by ultrasound of greater than or equal to 150 to less than or equal to 550 mL and a minimum voided volume of 125 mL) at 2nd screening.
Make at least 4 sexual intercourse attempts during the 4-weeks after 2nd screening as recorded in the Sexual Encounter Profile (SEP) diary.
Are sexually active with an adult female partner, and expect to remain sexually active with the same adult female partner for the duration of the study.
Agree not to use any other approved or experimental BPH, overactive bladder (OAB), or ED treatments as indicated in the protocol at any time during the study.
Have not taken treatments indicated in the protocol prior to the 2nd screening.

Exclusion Criteria:

Current treatment with nitrates.
Prostate-specific antigen (PSA) greater than 10.0 nanogram (ng)/mL at 1st screening.
PSA greater than or equal to 4.0 to less than or equal to 10.0 ng/mL at 1st screening if prostate malignancy has not been ruled out to the satisfaction of a urologist.
Clinical evidence of prostate cancer.
Bladder postvoid residual volume (PVR) greater than or equal to 300 mL by ultrasound determination at 1st screening.
History or clinical evidence of certain pelvic, bladder, urinary tract, or urinary retention conditions described in the protocol.
Lower urinary tract instrumentation (including prostate biopsy) within 30 days of 1st screening.
Clinical evidence of severe hepatic impairment at 1st screening.
Current neurologic disease or condition associated with neurogenic bladder (for example, Parkinson's disease or multiple sclerosis).
History of significant renal insufficiency as defined by the protocol.
History of ED caused by other primary sexual disorders including premature ejaculation or ED caused by untreated endocrine disease.
Presence of penile deformity judged by the investigator to be clinically significant.
History of certain cardiac or cardiovascular conditions described in the protocol.
History of resuscitated cardiac arrest.
Current treatment with certain medications described in the protocol.
Scheduled or planned surgery (or any procedure requiring general, spinal, or epidural anesthesia) during the course of the study.
History of significant central nervous system injuries (including stroke or spinal cord injury) within 6 months of 1st screening.
Glycosylated hemoglobin (HbA1c) greater than 9% at 1st screening.
Prior treatment with phosphodiesterase type 5 (PDE5) inhibitors judged by the investigator to be ineffective. However, if the investigator judges that a subject's lack of response to as-needed PDE5 inhibitors is the result of inadequate coordination between dosing and sexual activity with a treatment, the subject may be enrolled.",2.5 mg tablet once daily by mouth for 12 weeks.,ChEMBL:CHEMBL779 | DrugBank:DB00820 | PubChem:110635,Tadalafil,[H][C@]12Cc3c([nH]c4ccccc34)[C@@H](c3ccc4c(c3)OCO4)N1C(=O)CN(C)C2=O,C02KX52 | C02KX54 | G04BE08 | G04CA54 | G04CB51,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00855582,NCT00855582_EG001,No,Male,Adult | Older Adult,Phase 3,208,"Inclusion Criteria:

Have BPH Lower Urinary Tract Symptoms (LUTS) based on the disease diagnostic criteria at 1st screening.
Have a history of ED based on the disease diagnostic criteria at 1st screening.
Have LUTS with a Total International Prostate Symptom Score (IPSS) greater than or equal to 13 at 2nd screening.
Have bladder outlet obstruction as defined by a Peak Urine Flow Rate (Qmax) of greater than or equal to 4 to less than or equal to 15 milliliter (mL)/second (sec) (from a prevoid total bladder volume as assessed by ultrasound of greater than or equal to 150 to less than or equal to 550 mL and a minimum voided volume of 125 mL) at 2nd screening.
Make at least 4 sexual intercourse attempts during the 4-weeks after 2nd screening as recorded in the Sexual Encounter Profile (SEP) diary.
Are sexually active with an adult female partner, and expect to remain sexually active with the same adult female partner for the duration of the study.
Agree not to use any other approved or experimental BPH, overactive bladder (OAB), or ED treatments as indicated in the protocol at any time during the study.
Have not taken treatments indicated in the protocol prior to the 2nd screening.

Exclusion Criteria:

Current treatment with nitrates.
Prostate-specific antigen (PSA) greater than 10.0 nanogram (ng)/mL at 1st screening.
PSA greater than or equal to 4.0 to less than or equal to 10.0 ng/mL at 1st screening if prostate malignancy has not been ruled out to the satisfaction of a urologist.
Clinical evidence of prostate cancer.
Bladder postvoid residual volume (PVR) greater than or equal to 300 mL by ultrasound determination at 1st screening.
History or clinical evidence of certain pelvic, bladder, urinary tract, or urinary retention conditions described in the protocol.
Lower urinary tract instrumentation (including prostate biopsy) within 30 days of 1st screening.
Clinical evidence of severe hepatic impairment at 1st screening.
Current neurologic disease or condition associated with neurogenic bladder (for example, Parkinson's disease or multiple sclerosis).
History of significant renal insufficiency as defined by the protocol.
History of ED caused by other primary sexual disorders including premature ejaculation or ED caused by untreated endocrine disease.
Presence of penile deformity judged by the investigator to be clinically significant.
History of certain cardiac or cardiovascular conditions described in the protocol.
History of resuscitated cardiac arrest.
Current treatment with certain medications described in the protocol.
Scheduled or planned surgery (or any procedure requiring general, spinal, or epidural anesthesia) during the course of the study.
History of significant central nervous system injuries (including stroke or spinal cord injury) within 6 months of 1st screening.
Glycosylated hemoglobin (HbA1c) greater than 9% at 1st screening.
Prior treatment with phosphodiesterase type 5 (PDE5) inhibitors judged by the investigator to be ineffective. However, if the investigator judges that a subject's lack of response to as-needed PDE5 inhibitors is the result of inadequate coordination between dosing and sexual activity with a treatment, the subject may be enrolled.",5 mg tablet once daily by mouth for 12 weeks.,ChEMBL:CHEMBL779 | DrugBank:DB00820 | PubChem:110635,Tadalafil,[H][C@]12Cc3c([nH]c4ccccc34)[C@@H](c3ccc4c(c3)OCO4)N1C(=O)CN(C)C2=O,C02KX52 | C02KX54 | G04BE08 | G04CA54 | G04CB51,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00857623,NCT00857623_EG000,No,All,Adult | Older Adult,Phase 2,62,"Inclusion Criteria:

Provision of informed consent prior to any study specific procedures.
Clinical diagnosis of painful diabetic neuropathy.
non-fertile females

Exclusion Criteria:

Other pain that may confound assessment of neuropathic pain.
Ongoing significant peripheral arterial diseases, skin ulcers, or amputation in the lower extremities.
History of psychotic disorders among first degree relatives.","Capsule, once daily 12 mg AZD2066 day 1-4 and 18 mg AZD2066 day 5-28",DrugBank:DB12644 | DrugBank:DB17078,AZD2066,C[C@@H](Oc1nnc(-c2ccncc2)n1C)c1cc(-c2cccc(Cl)c2)on1,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00861757,NCT00861757_EG001,No,Male,Adult | Older Adult,Phase 3,151,"Inclusion Criteria:

Asian males, with benign prostatic hyperplasia (BPH) for at least 6 months prior to initiation and IPSS score greater than or equal to 13 at the beginning of the treatment
Agree not to use any other approved or experimental pharmacologic BPH, erectile dysfunction (ED) and overactive bladder (OAB) treatments at any time during the study.
Have not taken Finasteride or Dutasteride therapy, Anti-androgenic hormone or any other BPH therapy, ED or OAB therapy for specified duration of time prior to the beginning of the treatment

Exclusion Criteria:

Prostate specific antigen (PSA) score beyond acceptable range defined for study at initiation
History of urinary retention or lower urinary tract (bladder) stones within 6 months of initiation
History of urinary urethral obstruction due to stricture, valves, sclerosis, or tumor at initiation
Clinical evidence of prostate cancer at initiation
Clinical evidence of any of the bladder or urinary tract conditions, which may affect lower urinary tract symptom at initiation
History of cardiac conditions, including Angina requiring certain treatment with nitrates, unstable angina defined for study, positive cardiac stress test before starting the study
History of significant central nervous system injuries (including stroke or spinal cord injury within 6 months of initiation)
Use of any nitrates, cancer chemotherapy, androgens, antiandrogens, estrogens, luteinizing hormone-releasing hormone (LHRH)agonists/antagonists, or anabolic steroids at initiation","Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks",ChEMBL:CHEMBL779 | DrugBank:DB00820 | PubChem:110635,Tadalafil,[H][C@]12Cc3c([nH]c4ccccc34)[C@@H](c3ccc4c(c3)OCO4)N1C(=O)CN(C)C2=O,C02KX52 | C02KX54 | G04BE08 | G04CA54 | G04CB51,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00861757,NCT00861757_EG002,No,Male,Adult | Older Adult,Phase 3,155,"Inclusion Criteria:

Asian males, with benign prostatic hyperplasia (BPH) for at least 6 months prior to initiation and IPSS score greater than or equal to 13 at the beginning of the treatment
Agree not to use any other approved or experimental pharmacologic BPH, erectile dysfunction (ED) and overactive bladder (OAB) treatments at any time during the study.
Have not taken Finasteride or Dutasteride therapy, Anti-androgenic hormone or any other BPH therapy, ED or OAB therapy for specified duration of time prior to the beginning of the treatment

Exclusion Criteria:

Prostate specific antigen (PSA) score beyond acceptable range defined for study at initiation
History of urinary retention or lower urinary tract (bladder) stones within 6 months of initiation
History of urinary urethral obstruction due to stricture, valves, sclerosis, or tumor at initiation
Clinical evidence of prostate cancer at initiation
Clinical evidence of any of the bladder or urinary tract conditions, which may affect lower urinary tract symptom at initiation
History of cardiac conditions, including Angina requiring certain treatment with nitrates, unstable angina defined for study, positive cardiac stress test before starting the study
History of significant central nervous system injuries (including stroke or spinal cord injury within 6 months of initiation)
Use of any nitrates, cancer chemotherapy, androgens, antiandrogens, estrogens, luteinizing hormone-releasing hormone (LHRH)agonists/antagonists, or anabolic steroids at initiation","Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks",ChEMBL:CHEMBL779 | DrugBank:DB00820 | PubChem:110635,Tadalafil,[H][C@]12Cc3c([nH]c4ccccc34)[C@@H](c3ccc4c(c3)OCO4)N1C(=O)CN(C)C2=O,C02KX52 | C02KX54 | G04BE08 | G04CA54 | G04CB51,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00862563,NCT00862563_EG002,No,All,Adult | Older Adult,Phase 2,21,"Inclusion Criteria:

To be admitted into this study candidates must meet the following criteria:

DSM-IV-TR Diagnosis of Alcohol Dependence.
A minimal level of an average of 28 standard drinks per week for women or 35 drinks per week for men over a baseline 28 day consecutive period prior to the screening session during the 90 day time line follow-back.
Male or Female 21- 65 years of age.
Able to provide informed consent and comprehend study procedures.
Negative urine toxicological screen for opioids, cocaine, amphetamines, methamphetamine, and benzodiazepines. The test may be repeated for opioids or benzodiazepines shown to be medically prescribed for an acute disorder. The urine test may also be repeated if the Investigator deems necessary.
A score of >8 on the Alcohol Use Disorder Identification Test (AUDIT) during screening.
Must be suitable for outpatient management of alcoholism.
Express desire to stop drinking or reduce alcohol consumption.
Provide contact information for themselves or an alternate contact that the staff will call in case of missed appointment.
Women must be postmenopausal for at least one year, be surgically sterile, or be using an effective method of birth control.
Must be able to take oral medications, adhere to the regimen and be willing to return for follow up visits.

Exclusion Criteria:

Subjects meeting the following criteria will be excluded from the study:

Dependent on DSM IV-TR drugs or substances other than ethanol, nicotine, or caffeine.
DSM IV-TR diagnosis of any current Axis I diagnosis other than alcohol dependence, nicotine dependence, or caffeine dependence that in the opinion of the study physicians might require intervention with either pharmacological or non-pharmacological therapy that will interfere with the course of the study.
Receiving inpatient treatment for alcohol dependence, other then alcohol detoxification, within 4 weeks prior to enrollment into this study.
Subjects with a score of 10 or greater on the Clinical Institute Withdrawal Assessment for Alcohol-Revised on first or second visits.
Being treated with acamprosate, disulfiram or naltrexone within two weeks prior to randomization:
Currently being treated with any of the following medications: a) antipsychotic agents. b) antimanic or anticonvulsant agents. c) sedative- hypnotics. d) chronic opioid treatment. e) psychomotor stimulants- amphetamine derivatives, methylphenidate
Subjects who are legally mandated to participate in an alcohol treatment program.
Use of any medication known to inhibit or induce cytochrome P450 3A4 enzymes.
Subjects who have attempted suicide or who have had suicidal ideation within 30 days of their first visit.
Subjects with renal disease or history of kidney stones.
Subjects with AST or ALT >3 times the upper limit of the normal range during screening.
History of significant neurological disorder.
Subjects who are pregnant (as assessed by serum HCG) or lactating.
Subjects known to have clinically significant medical conditions that in the opinion of the study physician would preclude administration of the study medications or limit participation in the clinical trial.
Subjects with history of treatment with levetiracetam, topiramate or zonisamide.
Score of 25 or less on the Folstein Mini- Mental examination.
History of anticonvulsant-induced rash.
Taking drugs that contain ""sulfa"" moiety, such as sulfonamides, sulfonylureas, carbonic anhydrase inhibitors, thiazides, and loop diuretics (except ethacrynic acid).
During the 2 weeks prior to screening subjects who report average drinks per day that are within the guidelines for safe levels of alcohol consumption (i.e. 2 drinks/ day males; 1 drink/day females-HHS standard) will be excluded.

Subjects with a sulfa allergy.

-","topiramate: Topiramate will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses 300 mg topiramate.",ChEMBL:CHEMBL220492 | DrugBank:DB00273 | PubChem:5284627,Topiramate,[H][C@@]12OC(C)(C)O[C@]1([H])CO[C@@]1(COS(N)(=O)=O)OC(C)(C)O[C@]12[H],A08AA51 | N03AX11,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT00862745,NCT00862745_EG000,Accepts Healthy Volunteers,Female,Adult | Older Adult,Phase 4,322,"Inclusion Criteria:

Ambulatory females ≥ 18 years old
Urge Urinary Incontinence (subject-reported) for ≥ 3 months prior to Screening (Visit 1)
On the 3IQ: Response b to Question 3: During the last 3 months, did you leak urine most often: b. When you had the urge or the feeling that you needed to empty your bladder, but could not get to the toilet fast enough?
On a 3-day bladder diary, documentation of an average of 1 UUI episode per 24 hours (3 UUI episodes in 3 days)
Capability of understanding and having signed the informed consent form after full discussion of the research nature of the treatment and its risk and benefits
Ability to perform all procedures and tests required by the protocol
Willingness to remain on stable medication regime for duration of the randomized controlled trial. Participants will be asked to not add new medications during the randomized controlled trial, such as diuretics and other medications which may affect their voiding pattern.

Exclusion Criteria:

Any condition that would contraindicate their usage of fesoterodine including: hypersensitivity to the active drug (fesoterodine fumarate) and its ingredients or any of the excipients, history of urinary retention, gastric retention, uncontrolled narrow angle glaucoma, myasthenia gravis, severe hepatic impairment (Child Pugh C), severe ulcerative colitis, toxic megacolon, fistula or a hole in your bladder or rectum, birth defect leading to urine leakage, and urine leakage starting in childhood.
Clinically significant hepatic or renal disease.
Neurologic conditions such as stroke, multiple sclerosis, spinal cord injury, or Parkinson's disease.
Symptomatic pelvic organ prolapse defined as participant report of feeling or seeing a bulge outside the vagina within the past 3 months.
History of lower urinary tract/pelvic surgery (e.g. surgery for incontinence in the past 5 years, surgery in the past 6 months for prolapse or hysterectomy), intra-vesical therapy (botox), and/or bulk injections within the past 6 months.
A known history of interstitial cystitis or a significant pain component associated with OAB symptoms, uninvestigated hematuria, urogenital cancer, interstitial or external radiation to the pelvis or external genitalia.
Urinary tract infection (UTI) as shown by the results of the urinalysis at screening or recurrent urinary tract infection (RUTIs) defined as treatment for UTI >3 times in the last year.
Use of any electrostimulation, bladder training, or pelvic floor exercises (with certified incontinence practitioners) within 4 weeks of Screening.
Received study medication in any previous fesoterodine clinical trial.
Prior failure for either efficacy or tolerability of ≥ 2 OAB medications in the last year. (failure: inadequate symptom control after two medications for a minimum of one month each)
Has been treated within 2 weeks prior to Screening and/or is currently being treated with: - Any drug treatment for overactive bladder, including antimuscarinic OAB medications.
Any drugs with significant anticholinergic and antispasmodic effects (see exception for tricyclic antidepressants below)
Has started treatment with tricyclic antidepressants or estrogens within 4 weeks prior to Screening and/or is not on a stable dose.
Intermittent or unstable use of diuretics. Treatment with diuretics initiated within 2 weeks prior to baseline is not permitted.
Treatment with potent CYP3A4 inhibitors, such as clarithromycin, ketoconazole, and itraconazole within 2 weeks prior to Screening.
Administration of medications capable of inducing hepatic enzyme metabolism or transport (e.g., barbiturates, rifampicin, carbamazepine, phenytoin, primidone, or St. John's Wort) in the past 30 days.
Previously received any investigational drug within 30 days prior to trial entry.
Alcohol and/or any other drug abuse in the opinion of the investigator.
Participants who are pregnant, nursing, or with a positive urine pregnancy test or who are intending to become pregnant within 3 months after the completion of the trial.
Participants that have been pregnant (> 20 weeks gestation) in the previous 6 months.
Participants of childbearing potential who are heterosexually active but unwilling or unable to use an adequate form of contraception to prevent pregnancy during the study. Reliable contraceptive methods may include intrauterine devices (IUD), contraceptive pills of combination type, hormonal implants, injectable contraceptives or latex condoms with a spermicide.
Participants who have any medical (including known history of major hematological, renal, cardiovascular, or hepatic abnormalities) or psychological condition or social circumstances that would impair their ability to participate reliably in the trial, or those who may increase the risk to themselves or others by participating.
Participants who, in the opinion of the investigator, are not likely to complete the trial for whatever reason.",fesoterodine 4 mg (1 tablet) for 2 weeks with the option to increase to fesoterodine 8 mg or stay at fesoterodine 4 mg for 10 weeks for a total of 12 weeks of study medication.,ChEMBL:CHEMBL1201764 | DrugBank:DB06702 | PubChem:6918558,Fesoterodine,CC(C)C(=O)Oc1ccc(CO)cc1[C@H](CCN(C(C)C)C(C)C)c1ccccc1,G04BD11,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT00869557,NCT00869557_EG001,No,All,Adult | Older Adult,Phase 2,23,"Inclusion Criteria:

Plasma HIV-1 RNA levels ≥ 5,000 copies/mL
No prior use of any approved or experimental anti-HIV drug
Normal electrocardiogram (ECG)
Adequate renal function: estimated glomerular filtration rate ≥ 80 mL/min according to the Cockcroft-Gault formula
Hepatic transaminases ≤ 2.5 x upper limit of normal (ULN)
Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin
Adequate hematologic function
Cluster determinant 4 (CD4) cell count > 50 cells/µL
Serum amylase ≤ 1.5 x ULN
Normal thyroid-stimulating hormone
Negative serum pregnancy test (for females of childbearing potential only)
Males and females of childbearing potential must agree to utilize highly effective contraception methods from screening throughout the duration of study treatment and for 12 weeks following the last dose of study drugs
Life expectancy ≥ 1 year
Ability to understand and sign a written informed consent form

Exclusion Criteria:

New acquired immunodeficiency syndrome (AIDS)-defining condition diagnosed within the 30 days prior to screening
Documented drug resistance to nucleoside reverse transcriptase inhibitors or nonnucleoside reverse transcriptase inhibitors or primary protease inhibitor resistance mutation(s)
Hepatitis B surface antigen positive
Hepatitis C antibody positive
Participants experiencing cirrhosis
Participants experiencing ascites
Participants experiencing encephalopathy
Females who are breastfeeding
Positive serum pregnancy test (for females of childbearing potential)
Vaccinated within 90 days of study dosing
History or family history of Long QT Syndrome or family history of sudden cardiac death or unexplained death in an otherwise healthy individual under the age of 30
Presence or history of cardiovascular disease, cardiomyopathy, and/or cardiac conduction abnormalities
Prolonged QTcF interval at screening
PR interval ≥ 200 msec or ≤ 120 msec on ECG at screening
QRS ≥ 120 msec on ECG at screening
Implanted defibrillator or pacemaker
Participants receiving ongoing therapy with any disallowed medications
Current alcohol or substance use judged to potentially interfere with participant study compliance
History of or ongoing malignancy (including untreated carcinoma in situ) other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, noninvasive cutaneous squamous carcinoma
Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to baseline
Participation in any other clinical trial without prior approval
Medications contraindicated for use with EFV, EVG, COBI, FTC, or TDF
Any known allergies to the excipients of Atripla or Stribild tablets
Any other clinical condition or prior therapy that would make the participant unsuitable for the study or unable to comply with the dosing requirements",Atripla QHS and placebo to match Stribild QD were administered during the double blind phase.,ChEMBL:CHEMBL223228 | DrugBank:DB00625 | PubChem:64139,Efavirenz,O=C1Nc2ccc(Cl)cc2[C@@](C#CC2CC2)(C(F)(F)F)O1,J05AG03 | J05AR06 | J05AR11,1.0,0.0,0.0,0.0,0.0,1.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT00879060,NCT00879060_EG000,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 4,53,"Inclusion Criteria:

Hypertrophic cardiomyopathy
Able to swallow pills
No prior septal reduction therapy
Negative serum or hCG pregnancy test

Exclusion Criteria:

Unable or unwilling to perform treadmill cardiopulmonary exercise test
Prior surgical myectomy or alcohol septal ablation
Known or suspected infiltrative or glycogen storage disease
Significant coronary artery disease, defined as atherosclerotic coronary artery narrowing >70% of the luminal diameter by coronary angiography
Severe obstructive pulmonary disease, defined as forced expiratory volume in 1 second (FEV1) <50% of predicted.
Prior intolerance or adverse reaction to aldosterone receptor antagonist.
History of hyper or hypoaldosteronism
Baseline serum potassium >5.0 mmol/L.
Calculated creatinine clearance <30 ml/min using Cockcroft-Gault formula.
Pregnant or breast feeding
Poorly controlled systemic hypertension, defined as systolic blood pressure ≥150 mmHg or diastolic pressure ≥100 mmHg, during 2 clinic visits.
Known conditions associated with elevated serum concentrations of PIIINP (e.g., chronic liver disease, diabetes mellitus, tumors, pulmonary fibrosis, bone and rheumatoid diseases, extensive wounds) or PINP (e.g., alcoholic liver disease, metabolic bone disease, thyroid disorders), including recent trauma (≤2 weeks) or surgery (≤6 months)
Taking drugs known to directly influence collagen metabolism including, amiodorone, ACE or angiotensin II inhibitors, aldosterone antagonists, statins, glucocorticoids and estrogens
Patients with ICDs/pacemakers will be recruited in the study, but will be excluded from the CMR component.","Experimental group includes individuals diagnosed with HCM between the ages of 18-55 (up to 50 for men). At time of randomization subjects randomized to experimental group will be initiated on 25mg of spironolactone. Serum potassium and creatinine levels will be drawn at baseline, weeks 1,4,5 and months 3,6,9, and 12. If at week 4, serum potassium is <5.5 mmol/L and serum creatinine-baseline creatinine is <0.5 mg/dl, the study drug will be increased to the target dose of 50mg once daily for 12 months of follow-up. If a subject experiences an increase in serum potassium or creatinine above these parameters at week 4, the study drug will be decreased in half from current dosage. If on 25mg daily, subject will be instructed to decrease to 25mg every other day. Subjects who experience hyperkalemia or increased creatinine levels on 25mg every other day will have the drug discontinued.",ChEMBL:CHEMBL1393 | DrugBank:DB00421 | PubChem:5833,Spironolactone,[H][C@]12CC[C@]3(C)[C@]4(CCC(=O)O4)CC[C@@]3([H])[C@]1([H])[C@]([H])(SC(C)=O)CC1=CC(=O)CC[C@@]12C,C03DA01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00879645,NCT00879645_EG001,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 1,6,"Inclusion Criteria:

For normal subjects arm (CrCL > 80 ml/min): Healthy male and female subjects age 18 to 70 years of age inclusive. Pregnant women are excluded and women of child-bearing potential must agree to the use of medically reliable contraceptive methods for the duration of the study and for 30 days after study.

For renally impaired arm: Male and female - pregnant women are excluded and women of child-bearing potential must agree to the use of medically reliable contraceptive methods for the duration of the study and for 30 days after study. Subjects with mild, moderate and severe renal function aged between 18 to 70 years old

Body mass index (BMI) within the range of 18 to 40 kg/m2
Electrocardiogram (ECG) recording without clinically relevant abnormalities
Having had no febrile or infectious disease for at least seven days prior to dosing of study drug
Able to communicate well with the study staff and to understand and comply with the requirements of the study, understand and sign the written informed consent

Exclusion Criteria:

High risk patients who may need an urgent dialysis during clinical conduct portion of the study (from Day -1 until last PK sampling on Day 7)
All smokers.
More than moderate alcohol consumption (>35 g ethanol regularly or > 2 drinks per day )
Any history of alcohol or drug abuse
Any active physical or psychiatric disease, acute or chronic
Any clinically relevant history of drug hypersensitivity, asthma, urticaria or other severe allergic diathesis
Pregnant or nursing women
Blood donation within 30 days
Participation in any clinical study within 30 days prior to the treatment phase of this study
Lab values outside of reference range and clinically relevant liver function tests (AST, ALT, gamma-GT)
Positive tests for HIV antibodies, Hepatitis B-virus surface antigen (HBsAg), Anti-Hepatitis C-virus antibodies (Anti-HCV)",Healthy subjects received soduim sufide intravenously at 1.5 mg/kg/hr for 3 hours,DrugBank:DB11159,Sodium sulfide,[Na+].[Na+].[S-2],,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT00879996,NCT00879996_EG000,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 4,54,"Inclusion Criteria:

chronic back pain
opioid addiction
not successful with abstinence
at least 18 years old
able to understand spoken English
live in Western New York State (Erie or Niagara county)
have health insurance or ability to pay for health care
no methadone or buprenorphine treatment within past year
not member of a vulnerable population (e.g., pregnancy, prisoner)

Exclusion Criteria:

homelessness
unable to give consent (e.g., dementia, psychosis)
serious heart or lung disease
taking a medication that could interact with methadone or buprenorphine
pregnancy",Methadone 10-60 mg per day in 2-4 divided doses for 6 months,ChEMBL:CHEMBL350719 | ChEMBL:CHEMBL651 | DrugBank:DB00333 | DrugBank:DB15198 | PubChem:4095 | PubChem:643985,Methadone,CCC(=O)C(CC(C)N(C)C)(c1ccccc1)c1ccccc1,N02AC52 | N07BC02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00885365,NCT00885365_EG000,No,All,Child | Adult | Older Adult,Phase 3,156,"Inclusion Criteria:

Patients of either sex aged ≥ 6;
Clinical diagnosis of cystic fibrosis defined as: (1)Patients preferably registered in the National Registry of CF (or other documents depending on country legislation); (2) Evidence of two or more typical pulmonary clinical features observed in CF, e.g., persistent colonization/infection with typical CF pathogens, chronic cough and sputum production, persistent chest radiography abnormalities, airway obstruction, nasal polyps and/or digital clubbing;
Positive response in the standard sweat test (sweat chloride concentration ≥ 60 mmol/l for the standard method or ≥ 80 mmol/L for a microduct technique) documented in the clinical records and/or gene mutation documented in the clinical records;
Chronic colonization of P. aeruginosa: presence in a sputum or throat culture of a minimum of 2 positive samples for P. aeruginosa over the previous 12 months and/or presence of more than two precipitating antibodies against P. aeruginosa;
Sputum containing P. aeruginosa susceptible to tobramycin (defined as a zone diameter ≥ 16 mm after testing with 10 µg tobramycin disk or as a minimal inhibition concentration based on microdilution testing system) as identified by local laboratory at screening visit;
Forced expiratory volume in 1 sec (FEV₁) ≥ 40% and ≤ 80% of the predicted normal value;
Written informed consent obtained by parents/legal representative according to local regulations) and by the patient (when appropriate).

Exclusion Criteria:

Administration of antipseudomonal antibiotic therapy by any route in the previous 4 weeks;
Evidence of impaired renal function (serum creatinine level ≥ 1.5 mg/dl);
Evidence of impaired auditory function (auditory threshold in either ear above 20 dB at frequencies between 250 and 8000Hz);
Sputum culture containing Burkholderia cepacia;
Patients with end-stage lung disease, candidates for heart-lung transplantation;
History of other clinically significant cardiac, renal, neurological, gastrointestinal, hepatic or endocrine disease related to cystic fibrosis, whose sequelae and/or treatment can interfere with the results of the present study;
Female subjects: pregnant or with active desire to be pregnant, lactating mother or lack of efficient contraception in a subject with child-bearing potential (i.e., contraceptive methods other than rod containing a hormone that prevents user from getting pregnant and that will be placed under the skin, syringes that contain a contraceptive hormone, combined birth control pill, i.e., such that contains two hormones, some intrauterine devices (IUDs) and sexual abstinence). A pregnancy test in urine is to be carried out in women of a fertile age at screening and at the last clinic visit;
Known hypersensitivity to aminoglycosides;
Patients with evidence of alcohol or drug abuse, likely to be not compliant with the study protocol or likely to be not compliant with the study treatments;
Participation in another clinical trial with an investigational drug in the four weeks preceding the screening visit.",tobramycin / Bramitob administered 300mg twice a day for 4 weeks,ChEMBL:CHEMBL1747 | DrugBank:DB00684 | PubChem:36294,Tobramycin,NC[C@H]1O[C@H](O[C@H]2[C@H](O)[C@@H](O[C@H]3O[C@H](CO)[C@@H](O)[C@H](N)[C@H]3O)[C@H](N)C[C@@H]2N)[C@H](N)C[C@@H]1O,J01GB01 | S01AA12,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT00885365,NCT00885365_EG001,No,All,Child | Adult | Older Adult,Phase 3,168,"Inclusion Criteria:

Patients of either sex aged ≥ 6;
Clinical diagnosis of cystic fibrosis defined as: (1)Patients preferably registered in the National Registry of CF (or other documents depending on country legislation); (2) Evidence of two or more typical pulmonary clinical features observed in CF, e.g., persistent colonization/infection with typical CF pathogens, chronic cough and sputum production, persistent chest radiography abnormalities, airway obstruction, nasal polyps and/or digital clubbing;
Positive response in the standard sweat test (sweat chloride concentration ≥ 60 mmol/l for the standard method or ≥ 80 mmol/L for a microduct technique) documented in the clinical records and/or gene mutation documented in the clinical records;
Chronic colonization of P. aeruginosa: presence in a sputum or throat culture of a minimum of 2 positive samples for P. aeruginosa over the previous 12 months and/or presence of more than two precipitating antibodies against P. aeruginosa;
Sputum containing P. aeruginosa susceptible to tobramycin (defined as a zone diameter ≥ 16 mm after testing with 10 µg tobramycin disk or as a minimal inhibition concentration based on microdilution testing system) as identified by local laboratory at screening visit;
Forced expiratory volume in 1 sec (FEV₁) ≥ 40% and ≤ 80% of the predicted normal value;
Written informed consent obtained by parents/legal representative according to local regulations) and by the patient (when appropriate).

Exclusion Criteria:

Administration of antipseudomonal antibiotic therapy by any route in the previous 4 weeks;
Evidence of impaired renal function (serum creatinine level ≥ 1.5 mg/dl);
Evidence of impaired auditory function (auditory threshold in either ear above 20 dB at frequencies between 250 and 8000Hz);
Sputum culture containing Burkholderia cepacia;
Patients with end-stage lung disease, candidates for heart-lung transplantation;
History of other clinically significant cardiac, renal, neurological, gastrointestinal, hepatic or endocrine disease related to cystic fibrosis, whose sequelae and/or treatment can interfere with the results of the present study;
Female subjects: pregnant or with active desire to be pregnant, lactating mother or lack of efficient contraception in a subject with child-bearing potential (i.e., contraceptive methods other than rod containing a hormone that prevents user from getting pregnant and that will be placed under the skin, syringes that contain a contraceptive hormone, combined birth control pill, i.e., such that contains two hormones, some intrauterine devices (IUDs) and sexual abstinence). A pregnancy test in urine is to be carried out in women of a fertile age at screening and at the last clinic visit;
Known hypersensitivity to aminoglycosides;
Patients with evidence of alcohol or drug abuse, likely to be not compliant with the study protocol or likely to be not compliant with the study treatments;
Participation in another clinical trial with an investigational drug in the four weeks preceding the screening visit.",tobramycin / TOBI administered 300mg twice a day for 4 weeks,ChEMBL:CHEMBL1747 | DrugBank:DB00684 | PubChem:36294,Tobramycin,NC[C@H]1O[C@H](O[C@H]2[C@H](O)[C@@H](O[C@H]3O[C@H](CO)[C@@H](O)[C@H](N)[C@H]3O)[C@H](N)C[C@@H]2N)[C@H](N)C[C@@H]1O,J01GB01 | S01AA12,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT00887562,NCT00887562_EG000,No,All,Child | Adult | Older Adult,Phase 2,10,"Inclusion Criteria:

Diagnosis of MELAS with confirmed A3243G mtDNA mutation, or evidence of central nervous system involvement (cognitive problems, migraines, memory loss)
Cerebral lactate level equal to or greater than 5.0 i.u. at baseline
Patients at least 8 and < 65 years of age at baseline
Patients with a body weight > 37 kg/82 lbs at baseline
Stable co-medication/vitamins/supplements within 1 month prior to baseline
Patients who in the opinion of the investigator are able to comply with the requirements of the study, including swallowing the study medication
Negative urine pregnancy test at screening and baseline (female patients of childbearing potential)

Exclusion Criteria:

Contraindication to MRS (e.g. metal implant, claustrophobia)
Stroke like event within 2 months prior to baseline
Treatment with idebenone at any dose, or coenzyme Q10 at doses above 100mg/d within 1 month prior to baseline
Inadequate contraception use
Pregnancy and/or breast-feeding
Clinically significant abnormalities of clinical hematology or biochemistry including, but not limited to, elevations greater than 1.5 times the upper limit of normal of aspartate aminotransferase (AST), alanine aminotransferase (ALT) or creatinine
Current abuse of drugs or alcohol
Participation in a trial of another investigational drug within the last month
Other factor that, in the investigator's opinion, excludes the patient from entering the study","Idebenone 900 mg/day

Idebenone: 900 mg/day for 1 month",ChEMBL:CHEMBL252556 | DrugBank:DB09081 | PubChem:3686,Idebenone,COC1=C(OC)C(=O)C(CCCCCCCCCCO)=C(C)C1=O,N06BX13,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00892606,NCT00892606_EG000,No,All,Adult | Older Adult,Phase 4,75,"Inclusion Criteria:

ASA I-III
Ages 18-65 years
Presenting for lower extremity orthopedic surgery involving fracture of long bones at University of Louisville Hospital
Surgery expected to last more than one hour
Patient expected to have moderate to severe post-operative pain
Patient refused regional anesthesia or has a contraindication to regional anesthesia

Exclusion Criteria:

Any known contraindications to methadone including hypothyroidism, Addison's disease, prostatic hypertrophy, or urethral stricture.
Difficulty or inability to understand the study or protocol
Known renal or hepatic dysfunction
BMI> 35
Known respiratory or cardiovascular problems, such as obstructive sleep apnea or oxygen saturation of less than 92% on room air
Taking any of the known drugs that induce or inhibit the cytochrome p450 enzyme systems. Common examples of these drugs are antifungal, antiretroviral, barbiturates, dexamethasone, and macrolide antibiotics.
Pregnancy
Taking preoperative opioids for more than 2 weeks before the surgery","Patients will receive 0.2 mg/kg of methadone IV immediately after intubation

Methadone: Patients will receive 0.2 mg/kg of methadone IV immediately after intubation",ChEMBL:CHEMBL350719 | ChEMBL:CHEMBL651 | DrugBank:DB00333 | DrugBank:DB15198 | PubChem:4095 | PubChem:643985,Methadone,CCC(=O)C(CC(C)N(C)C)(c1ccccc1)c1ccccc1,N02AC52 | N07BC02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00894413,NCT00894413_EG001,No,All,Adult | Older Adult,Phase 2,25,"Inclusion Criteria:

Histologically confirmed, previously untreated invasive head and neck squamous cell carcinoma OR histologically confirmed not yet treated recurrent head and neck squamous cell carcinoma (must be at least 3 months after diagnosis and completion of treatment for primary disease or last recurrence).
Disease location amenable to biopsy in outpatient clinical setting or operative biopsy within routine accepted schedule and practice of clinical care
No medical contraindication to biopsy of target lesion.
ECOG performance status 0-1

Required laboratory data (to be obtained within 4 weeks of initiation):

Platelets > 75,000/mm³
Calculated Creatinine Clearance (CRCL)> 60 mL/min iii. Total serum bilirubin < 1.5 mg/dL.
No intercurrent illness likely to prevent protocol therapy or surgical resection
Patients with a history of a curatively treated malignancy must be disease-free and have a survival prognosis that exceeds five years.
Female patients must not be pregnant or breast feeding. A negative pregnancy test is required within 14 days of randomization for all women of childbearing potential.
Willingness and ability to give signed written informed consent.

Exclusion Criteria:

Known severe hypersensitivity to tadalafil or any of the excipients of this product
Patients who have a concurrent malignancy or a history of previous malignancy treated with curative therapy within the last 3 months (other than squamous/basal cell cancer of the skin or cervical cancer) who have a survival prognosis of < 5 years.
Treatment with a non-approved or investigational drug within 30 days before day 1 of trial treatment.
Incomplete healing from previous oncologic or other major surgery.
Pregnancy or breast feeding (women of childbearing potential).
As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease).
Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the trial.
Current therapy with ketoconazole or oral antifungal therapy.
History of significant hypotensive episode requiring hospitalization.
A history of acute myocardial infarction within prior 3 months, uncontrolled angina,
Uncontrolled arrhythmia, or uncontrolled congestive heart failure
Age < 18

History of any of the following cardiac conditions:

Angina requiring treatment with long-acting nitrates.
Angina requiring treatment with short-acting nitrates within 90 days of planned tadalafil administration.
Unstable angina within 90 days of visit 1 (Braunwald 1989).
Positive cardiac stress test without documented evidence of subsequent, effective cardiac intervention.

History of any of the following coronary conditions within 90 days of planned tadalafil administration:

Myocardial Infarction.
Coronary artery bypass graft surgery.
Percutaneous coronary intervention (for example, angioplasty or stent placement).
Any evidence of heart disease (NYHA≥Class III as defined in Protocol Attachment LVHG.3) within 6 months of planned tadalafil administration
Current treatment with nitrates.
Current systemic treatment with a potent cytochrome P450 3A4 (CYP3A4) inhibitor such as ketoconazole or ritonavir.
Received treatment within the last 30 days with a drug or device that has not received regulatory approval for any indication at the time of Visit 1.
Prior chronic immune suppressive state (AIDS, immunosuppressive therapy).
History of hypotension and/or blindness during prior treatment with Tadalafil or other PDE-5 inhibitors.
prior history of non-arterial ischemic optic retinopathy",Tadalafil: 20 mg once daily for 10 - 14 days,ChEMBL:CHEMBL779 | DrugBank:DB00820 | PubChem:110635,Tadalafil,[H][C@]12Cc3c([nH]c4ccccc34)[C@@H](c3ccc4c(c3)OCO4)N1C(=O)CN(C)C2=O,C02KX52 | C02KX54 | G04BE08 | G04CA54 | G04CB51,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00901199,NCT00901199_EG000,No,All,Child | Adult | Older Adult,Phase 2,22,"Inclusion Criteria:

Transfusion Dependent Thalassemia
If iron between 5-15 mg/g dry liver by SQUID, subject must have a documented endocrinopathy or cardiac finding
Older than 8 years

Exclusion Criteria:

Participating on another interventional clinical trial",Treatment with Deferasirox (Exjade) and Deferoxamine (DFO) with dosing based on baseline iron overload.,ChEMBL:CHEMBL556 | DrugBank:DB00746 | PubChem:2973,Deferoxamine,CC(=O)N(O)CCCCCNC(=O)CCC(=O)N(O)CCCCCNC(=O)CCC(=O)N(O)CCCCCN,V03AC01,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00903682,NCT00903682_EG001,No,All,Adult | Older Adult,Phase 2,78,"Inclusion Criteria:

Documented HIV-1 infection
In the judgement of the investigator, it is appropriate to initiate ARV therapy based on the patients medical condition and taking into account applicable guidelines for the treatment of HIV-1 infection
Patient has access to an investigator-selected ARV regimen post-study in accordance with applicable guidelines for the treatment of HIV-1 infection
HIV-1 plasma viral load at screening >= 5000 HIV-1 RNA (copies/ml)
Predicted phenotypic sensitivity to the currently approved NNRTIs and to the N(t)RTIs in their background regimen at screening

Exclusion Criteria:

Any previous treatment with a therapeutic HIV vaccine or use of ARVs, including use of NVP for the prevention of vertical HIV transmission
The presence of at least one of the mutations that are specific indicators of transmitted (or primary) drug resistance
Known infection with HIV-2 or with HIV-1 group O
Category C AIDS defining illness, except stable Kaposi's Sarcoma, wasting syndrome if not progressive
Pneumocystis jiroveci/carinii Pneumonia (PCP) that is considered not cured
Specific grade 3 or 4 laboratory abnormalities",EFV 600mg once daily (1x600mg tablet) + 2 NRTIs + 4 ETR placebo tablets for 48 weeks,ChEMBL:CHEMBL223228 | DrugBank:DB00625 | PubChem:64139,Efavirenz,O=C1Nc2ccc(Cl)cc2[C@@](C#CC2CC2)(C(F)(F)F)O1,J05AG03 | J05AR06 | J05AR11,1.0,0.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0
NCT00905268,NCT00905268_EG000,No,All,Child | Adult | Older Adult,Phase 3,57,"Inclusion Criteria:

Documented diagnosis of FRDA with confirmed FRDA mutations
Patients 8 years of age or older at baseline
Patients with body weight ≥ 25kg
Patients who in the opinion of the investigator are able to comply with the requirements of the study, including swallowing the medication
Negative urine pregnancy test at screening and at baseline (women of childbearing potential)

Exclusion Criteria:

Treatment with idebenone or Coenzyme Q10 within the past 1 month
Pregnancy and/or breast-feeding
Clinically significant abnormalities of clinical haematology or biochemistry including, but not limited to, elevations greater than 1.5 times the upper limit of normal of SGOT, SGPT, or creatinine
Past or present history of abuse of drugs or alcohol","Patients under/equal 45 kg: idebenone 180 mg/day Patients over 45 kg: idebenone 360 mg/day

idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals.",ChEMBL:CHEMBL252556 | DrugBank:DB09081 | PubChem:3686,Idebenone,COC1=C(OC)C(=O)C(CCCCCCCCCCO)=C(C)C1=O,N06BX13,0.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT00908466,NCT00908466_EG000,No,All,Adult | Older Adult,Phase 1,15,"Inclusion Criteria:

Males and females greater than or equal to 18 years of age;
Able to give informed consent and attend all study visits;

Have diagnosis of uveitis determined by the Investigator to be non infectious;

Have active uveitis, defined as having at least 1+ Vitreous Haze and/or at least 1+ Vitreous Cell Count (SUN scale), and:

are receiving no other treatment; or,
are receiving prednisone ≥10 mg/day (or equivalent dose of another corticosteroid) and/or at least 1 other systemic immunosuppressant; or, b. Have inactive disease, defined as having 0.5+ Vitreous Haze or less and a grade of 0.5+ Vitreous Cell Count or less (SUN scale), and:
are receiving prednisone <10 mg/day (or equivalent dose of another corticosteroid) and/or at least 1 other systemic immunosuppressant.
Have posterior, intermediate, or panuveitis; for panuveitis, if an anterior component is present, it must be less than the posterior component;
Sufficient inflammation to require systemic treatment and, based on the Investigator's decision, warrants intravitreal or subconjunctival treatment;
Best-corrected (ETDRS) visual acuity of 20/40 to 20/400 (approximately 70 to 20 letters) in the study eye;
Best- corrected ETDRS visual acuity of 20/400 or better in the fellow eye (approximately 20 letters).

Exclusion Criteria:

Patients with bilateral uveitis who are receiving systemic immunosuppressive therapy (e.g., methotrexate, cyclosporine, cyclophosphamide, chlorambucil, mycophenolate mofetil, tacrolimus, or azathioprine) other than prednisone or other corticosteroids for the treatment of the uveitis, and the uveitis in the fellow eyes, in the opinion of the investigator, cannot be controlled with standard local therapies alone;

Any significant ocular disease that could compromise vision in the study eye. These include, but are not limited to:

Diabetic retinopathy: proliferative diabetic retinopathy (PDR) or non-proliferative diabetic retinopathy (NPDR) that compromise the vision.
Age-related macular degeneration;
Myopic degeneration with active subfoveal choroidal neovascularization.

Any of the following treatments within 90 days prior to Day 0 or anticipated use of any of the following treatments to the study eye:

Intravitreal injections (including but not limited to steroids or anti-vascular endothelial growth factors);
Posterior subtenon's steroids.
Intraocular surgery within 90 days prior to Day 0 in the study eye;
Capsulotomy within 30 days prior to Day 0 in the study eye;
If the patient has had glaucoma surgery (trabeculectomy or aqueous shunt device), there must be adequate conjunctiva
History of vitreoretinal surgery or scleral buckling
Any ocular surgery (including cataract extraction or capsulotomy) of the study eye anticipated within the first 180 days following Day 0;
Intraocular pressure ≥25 mmHg in the study eye (glaucoma patients maintained on no more than 2 topical medications with intraocular pressure (IOP) <25 mmHg are allowed to participate);
Pupillary dilation inadequate for quality stereoscopic fundus photography in the study eye;
Media opacity that would limit clinical visualization;
Presence of any form of ocular malignancy in the study eye, including choroidal melanoma;
History of herpetic infection in the study eye or adnexa;
Presence of known active or inactive toxoplasmosis in either eye;
Ocular or periocular infection in either eye;
Participation in other investigational drug or device clinical trials within 30 days prior to Day 0, or planning to participate in other investigational drug or device clinical trials within 180 days following Day 0. This includes both ocular and non-ocular clinical trials.","Will receive intravitreal injections of sirolimus 352 µg in study eye on Days 0, 60, and 120.

Sirolimus (rapamycin): Will receive intravitreal injections of sirolimus (rapamycin) 352 µg in study eye on Days 0, 60, and 120.",ChEMBL:CHEMBL413 | DrugBank:DB00877 | PubChem:134760597 | PubChem:138404388 | PubChem:21944094 | PubChem:5284616,Sirolimus,COC1CC2CCC(C)C(O)(O2)C(=O)C(=O)N2CCCCC2C(=O)OC(C(C)CC2CCC(O)C(OC)C2)CC(=O)C(C)C=C(C)C(O)C(OC)C(=O)C(C)CC(C)C=CC=CC=C1C,L01EG04 | L04AA10 | S01XA23,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00908466,NCT00908466_EG001,No,All,Adult | Older Adult,Phase 1,15,"Inclusion Criteria:

Males and females greater than or equal to 18 years of age;
Able to give informed consent and attend all study visits;

Have diagnosis of uveitis determined by the Investigator to be non infectious;

Have active uveitis, defined as having at least 1+ Vitreous Haze and/or at least 1+ Vitreous Cell Count (SUN scale), and:

are receiving no other treatment; or,
are receiving prednisone ≥10 mg/day (or equivalent dose of another corticosteroid) and/or at least 1 other systemic immunosuppressant; or, b. Have inactive disease, defined as having 0.5+ Vitreous Haze or less and a grade of 0.5+ Vitreous Cell Count or less (SUN scale), and:
are receiving prednisone <10 mg/day (or equivalent dose of another corticosteroid) and/or at least 1 other systemic immunosuppressant.
Have posterior, intermediate, or panuveitis; for panuveitis, if an anterior component is present, it must be less than the posterior component;
Sufficient inflammation to require systemic treatment and, based on the Investigator's decision, warrants intravitreal or subconjunctival treatment;
Best-corrected (ETDRS) visual acuity of 20/40 to 20/400 (approximately 70 to 20 letters) in the study eye;
Best- corrected ETDRS visual acuity of 20/400 or better in the fellow eye (approximately 20 letters).

Exclusion Criteria:

Patients with bilateral uveitis who are receiving systemic immunosuppressive therapy (e.g., methotrexate, cyclosporine, cyclophosphamide, chlorambucil, mycophenolate mofetil, tacrolimus, or azathioprine) other than prednisone or other corticosteroids for the treatment of the uveitis, and the uveitis in the fellow eyes, in the opinion of the investigator, cannot be controlled with standard local therapies alone;

Any significant ocular disease that could compromise vision in the study eye. These include, but are not limited to:

Diabetic retinopathy: proliferative diabetic retinopathy (PDR) or non-proliferative diabetic retinopathy (NPDR) that compromise the vision.
Age-related macular degeneration;
Myopic degeneration with active subfoveal choroidal neovascularization.

Any of the following treatments within 90 days prior to Day 0 or anticipated use of any of the following treatments to the study eye:

Intravitreal injections (including but not limited to steroids or anti-vascular endothelial growth factors);
Posterior subtenon's steroids.
Intraocular surgery within 90 days prior to Day 0 in the study eye;
Capsulotomy within 30 days prior to Day 0 in the study eye;
If the patient has had glaucoma surgery (trabeculectomy or aqueous shunt device), there must be adequate conjunctiva
History of vitreoretinal surgery or scleral buckling
Any ocular surgery (including cataract extraction or capsulotomy) of the study eye anticipated within the first 180 days following Day 0;
Intraocular pressure ≥25 mmHg in the study eye (glaucoma patients maintained on no more than 2 topical medications with intraocular pressure (IOP) <25 mmHg are allowed to participate);
Pupillary dilation inadequate for quality stereoscopic fundus photography in the study eye;
Media opacity that would limit clinical visualization;
Presence of any form of ocular malignancy in the study eye, including choroidal melanoma;
History of herpetic infection in the study eye or adnexa;
Presence of known active or inactive toxoplasmosis in either eye;
Ocular or periocular infection in either eye;
Participation in other investigational drug or device clinical trials within 30 days prior to Day 0, or planning to participate in other investigational drug or device clinical trials within 180 days following Day 0. This includes both ocular and non-ocular clinical trials.","Will receive subconjunctival injections of sirolimus 1320 µg in the study eye on Days 0, 60, and 120.

Sirolimus (rapamycin): Will receive subconjunctival injections of sirolimus 1320 µg in the study eye on Days 0, 60, and 120.",ChEMBL:CHEMBL413 | DrugBank:DB00877 | PubChem:134760597 | PubChem:138404388 | PubChem:21944094 | PubChem:5284616,Sirolimus,COC1CC2CCC(C)C(O)(O2)C(=O)C(=O)N2CCCCC2C(=O)OC(C(C)CC2CCC(O)C(OC)C2)CC(=O)C(C)C=C(C)C(O)C(OC)C(=O)C(C)CC(C)C=CC=CC=C1C,L01EG04 | L04AA10 | S01XA23,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00909532,NCT00909532_EG001,No,All,Child | Adult | Older Adult,Phase 3,83,"Inclusion Criteria:

Confirmed diagnosis of cystic fibrosis (CF) and G551D mutation in at least 1 allele
Forced expiratory volume in 1 second (FEV1) of 40% to 90% (inclusive) of predicted normal for age, gender, and height at Screening.
No clinically significant abnormalities that would have interfered with the study assessments, as judged by the investigator
Willing to use highly effective birth control methods during the study

Exclusion Criteria:

History of any illness or condition that might confound the results of the study or pose an additional risk in administering study drug to the subject
Acute respiratory infection, pulmonary exacerbation, or changes in therapy for pulmonary disease within 4 weeks of Day 1 of the study
History of alcohol, medication or illicit drug abuse within one year prior to Day 1
Abnormal liver function ≥ 3x the upper limit of normal
Abnormal renal function at Screening
History of solid organ or hematological transplantation
Pregnant, planning a pregnancy, breast-feeding, or unwilling to follow contraception requirements
Ongoing participation in another therapeutic clinical study or prior participation in an investigational drug study within 30 days prior to Screening
Use of inhaled hypertonic saline treatment
Concomitant use of any inhibitors or inducers of cytochrome P450 3A4 (CYP 3A4)",Oral tablet of 150 mg of ivacaftor q12h for up to 48 weeks.,ChEMBL:CHEMBL2010601 | DrugBank:DB08820 | DrugBank:DB15141 | PubChem:16220172 | PubChem:71470491,Ivacaftor,CC(C)(C)c1cc(C(C)(C)C)c(NC(=O)c2c[nH]c3ccccc3c2=O)cc1O,R07AX02 | R07AX30 | R07AX31 | R07AX32,0.0,0.0,1.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,1.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT00909727,NCT00909727_EG001,No,All,Child,Phase 3,26,"Inclusion Criteria:

Weighing at least 15 kg
Confirmed diagnosis of cystic fibrosis (CF) and G551D mutation in at least 1 allele
Forced expiratory volume in 1 second (FEV1) of 40% to 105% (inclusive) of predicted normal for age, gender, and height (Knudson standards) at Screening
Able to swallow tablets
As judged by the investigator, parent or legal guardian and subject must have been able to understand protocol requirements, restrictions, and instructions, and the parent or legal guardian should have been able to ensure that the subject complied with, and was likely to complete, the study as planned
Parent or legal guardian must have signed the informed consent form and corresponding assent must be obtained from the subject
Willing to use at least 1 highly effective birth control method during the study
No clinically significant abnormalities that would have interfered with the study assessments, as judged by the investigator

Exclusion Criteria:

History of any illness or condition that might confound the results of the study or pose an additional risk in administering study drug to the subject
Acute respiratory infection, pulmonary exacerbation, or changes in therapy for pulmonary disease within 4 weeks of Day 1 of the study
Abnormal liver function ≥ 3x the upper limit of normal
Abnormal renal function at Screening
History of solid organ or hematological transplantation
Ongoing participation in another therapeutic clinical study or prior participation in an investigational drug study within 30 days prior to Screening
Use of inhaled hypertonic saline treatment
Concomitant use of any inhibitors or inducers of cytochrome P450 3A4 (CYP 3A4)",Oral tablet of 150 mg of ivacaftor q12h for up to 48 weeks,ChEMBL:CHEMBL2010601 | DrugBank:DB08820 | DrugBank:DB15141 | PubChem:16220172 | PubChem:71470491,Ivacaftor,CC(C)(C)c1cc(C(C)(C)C)c(NC(=O)c2c[nH]c3ccccc3c2=O)cc1O,R07AX02 | R07AX30 | R07AX31 | R07AX32,0.0,0.0,1.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT00911937,NCT00911937_EG001,No,All,Adult | Older Adult,Phase 4,463,"Inclusion Criteria:

Mean urinary frequency of >=8 micturitions per 24 hours as verified by the screening bladder diary prior to Start of Placebo run in visit (Visit 2)
Mean number of micturition related urgency episodes >=3 per 24 hours as verified by the screening bladder diary prior to Start of Placebo run in /Visit 2 (Urgency episodes are defined as those with Urinary Sensation Scale rating >=3)
Mean number of micturition related nocturnal urgency episodes >=2 but no more than 8 episodes per 24 hours as verified by the bladder diary at Visit 2 (nocturnal urgency episodes are defined as those with Urinary Sensation Scale rating of >3 recorded in the bed time section of the bladder diary)

Exclusion Criteria:

A known recent history or previous diagnosis of any sleep disorder such as obstructive sleep apnea, primary insomnia, periodic limb movement, parasomnia
Nocturia due to other underlying uncontrolled conditions, such as congestive heart failure, diabetes mellitus, diabetes insipidus, polyuria of any cause, etc.",Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.,ChEMBL:CHEMBL1201764 | DrugBank:DB06702 | PubChem:6918558,Fesoterodine,CC(C)C(=O)Oc1ccc(CO)cc1[C@H](CCN(C(C)C)C(C)C)c1ccccc1,G04BD11,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00918463,NCT00918463_EG000,No,All,Adult | Older Adult,Phase 2,2,"Inclusion Criteria:

Must understand and voluntarily sign an informed consent form.
Must be > = 18 years of age at the time of signing the informed consent form.
Must be able to adhere to the study visit schedule and other protocol requirements.
Biopsy-proven aggressive Diffuse Large B-Cell Lymphoma.
Relapsed or refractory to previous therapy for lymphoma.
Subjects must have received at least one prior combination chemotherapy regimen. There is no limit on the number of prior therapies.
Subjects who have relapsed following an autologous stem cell transplant are eligible.
Subjects must have measurable disease on cross sectional imaging that is at least 2 cm in the longest diameter.
Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2.
Life expectancy of > = 90 days (3 months).
Ability to take oral medication: dasatinib tablets may be swallowed as a whole.
Adequate organ function:

Total bilirubin <2.0 times Upper Limit of Normal (ULN) Serum Na, K, Mg, Phos, and Ca > Lower Limit of Normal (LLN) Hemoglobin, neutrophil count, platelets, PT/PTT all grade 0-1 Serum creatinine concentration <1.5 x institutional upper limit of normal (ULN). Serum SGOT/AST or SGPT/ALT < 2.5 x institutional upper limit of normal (ULN).

Concomitant medications:

Patient agrees to discontinue St. Johns Wort while receiving dasatinib
IV biphosphonates will be withheld for the first 8 weeks of dasatinib therapy due to risk of hypocalcemia.
Females of childbearing potential (FCBP) must agree to use two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual intercourse during the following time periods related to this study: 1) for at least 28 days before starting study drug; 2) while participating in the study; and 3) for at least 28 days after discontinuation from the study. The two methods of reliable contraception must include one highly effective method (i.e. intrauterine device (IUD), hormonal [birth control pills, injections, or implants], tubal ligation, partner's vasectomy) and one additional effective (barrier) method (i.e. latex condom, diaphragm, cervical cap). FCBP must be referred to a qualified provider of contraceptive methods if needed.
Before starting study drug:
Female Subjects: FCBP must have two negative pregnancy tests (sensitivity of at least 50 mIU/mL) prior to starting study drug. The first pregnancy test must be performed within 10-14 days prior to the start of study drug and the second pregnancy test must be performed within 24 hours prior to the start of study drug. The subject may not receive study drug until the Investigator has verified that the results of these pregnancy tests are negative; Will be warned that sharing study drug is prohibited and will be counseled about pregnancy precautions and potential risks of fetal exposure; Must agree to abstain from donating blood during study participation and for at least 28 days after discontinuation from the study.
Male Subjects: Must agree to use a latex condom during sexual contact with females of childbearing potential while participating in the study and for at least 28 days following discontinuation from the study even if he has undergone a successful vasectomy; Will be warned that sharing study drug is prohibited and will be counseled about pregnancy precautions and potential risks of fetal exposure; Must agree to abstain from donating blood, semen, or sperm during study participation and for at least 28 days after discontinuation from the study.
During study participation and for 28 days following discontinuation from the study:
All Subjects: No more than a 30-day supply of study drug will be dispensed at a time.

Female Subjects:

FCBP with regular cycles must agree to have pregnancy tests weekly for the first 28 days of study participation and then every 28 days while on study, at study discontinuation, and at day 28 following discontinuation from the study. If menstrual cycles are irregular, the pregnancy testing must occur weekly for the first 28 days and then every 14 days while on study, at study discontinuation, and at days 14 and 28 following discontinuation from the study.
In addition to the required pregnancy testing, the Investigator must confirm with FCBP that she is continuing to use two reliable methods of birth control at each visit.
Counseling about pregnancy precautions and the potential risks of fetal exposure must be conducted at a minimum of every 28 days. During counseling, subjects must be reminded to not share study drug and to not donate blood.
Pregnancy testing and counseling must be performed if a subject misses her period or if her pregnancy test or her menstrual bleeding is abnormal. Study drug treatment must be discontinued during this evaluation.
Females must agree to abstain from breastfeeding during study participation and for at least 28 days after discontinuation from the study.

Male Subjects:

Counseling about the requirement for latex condom use during sexual contact with females of childbearing potential and the potential risks of fetal exposure must be conducted at a minimum of every 28 days. During counseling, subjects must be reminded to not share study drug and to not donate blood, sperm, or semen.
If pregnancy or a positive pregnancy test does occur in a study subject or the partner of a male study subject during study participation, study drug must be immediately discontinued.

Exclusion Criteria:

Subjects who are candidates for and willing to undergo an autologous stem cell transplant.
Subjects who are post allogeneic stem cell transplant.
All subjects with active central nervous system (CNS) lymphoma. Subjects with previous CNS lymphoma that have been treated with chemotherapy, radiotherapy or surgery who have remained asymptomatic for 90 days (3 months) and demonstrate, no CNS lymphoma, as shown by lumbar puncture, CT scan or MRI, are eligible. (If required, lumbar puncture, CT or MRI should be performed during screening process.) Subjects should not be receiving corticosteroids.
Prior history of malignancies other than NHL (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) unless the subject has been free of the disease for > = 365 days (1 year).
Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
Known positive for HIV.
Pregnant or lactating females.
Concomitant Medications: Category I drugs that are generally accepted to have a risk of causing Torsades de Pointes including: (Patients must discontinue drug 7 days prior to starting dasatinib) quinidine, procainamide, disopyramide, amiodarone, sotalol, ibutilide, dofetilide, erythromycin, clarithromycin, chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide, cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone,halofantrine, levomethadyl, pentamidine, sparfloxacin, lidoflazine

Concurrent medical condition which may increase the risk of toxicity, including:

Pericardial or pleural effusion of any grade
Clinically-significant coagulation or platelet function disorder (e.g. known von Willebrand's disease)

History of significant bleeding disorder unrelated to cancer, including:

Diagnosed congenital bleeding disorders (e.g., von Willebrand's disease)
Diagnosed acquired bleeding disorder within one year (e.g., acquired anti-factor VIII antibodies)
Ongoing or recent (< = 3 months) clinically significant gastrointestinal bleeding

Cardiac symptoms within 6 months:

Uncontrolled angina, congestive heart failure, or MI
History of clinically significant ventricular arrythmias: fibrillation, Torsades de pointes, or tachycardia.
Prolonged QTc interval on pre-entry electrocardiogram (> 450msec).
Prior use of dasatinib.
Use of any standard or experimental anti-cancer drug therapy within 28 days of the initiation (Day 1) of study drug therapy.
Known active Hepatitis B or C.
Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious) illness.",dasatinib: 100 mg daily dosing,ChEMBL:CHEMBL1421 | DrugBank:DB01254 | PubChem:3062316,Dasatinib,Cc1nc(Nc2ncc(C(=O)Nc3c(C)cccc3Cl)s2)cc(N2CCN(CCO)CC2)n1,L01EA02 | L01XE06,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0
NCT00918866,NCT00918866_EG000,No,All,Adult | Older Adult,Phase 4,16,"Inclusion Criteria:

Appropriate candidate scheduled to undergo right heart catheterization and measurement of pulmonary artery hemodynamics for clinical reasons
Be male or female above the age of 18
Female patients who no longer have child-bearing potential

Women of Child-Bearing Potential(WOCBP) who:

are not pregnant and have been using an adequate and medically approved method of contraception
have a negative urine pregnancy test
Be able and willing to communicate effectively with study center personnel.

Exclusion Criteria:

Women who are pregnant or lactating
Known hypersensitivity or contraindication to or greater heart block
Previous heart transplant
Known right-to-left shunt (including atrial septal defect)
Severe pulmonary artery hypertension (i.e., > 75 mmHg
Current uncontrolled ventricular tachycardia
Second-degree or greater heart block
Any contraindications for the use of a right heart catheter",Subjects with pulmonary arterial pressure (PAP) of < or = to 35 mmHg.,ChEMBL:CHEMBL1663 | DrugBank:DB00556 | PubChem:6432,Perflutren,FC(F)(F)C(F)(F)C(F)(F)F,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00918957,NCT00918957_EG000,No,All,Child | Adult,Phase 3,30,"Inclusion Criteria:

Written informed consent given by adults or by the parents/legal guardian in combination with the patient's assent, if capable of assenting, before any assessment was performed

Confirmed diagnosis of Cystic Fibrosis (CF) by the presence of one or more clinical features of CF in addition to:

a quantitative pilocarpine iontophoresis sweat chloride test of >60 mEq/L; or
identification of well-characterized disease-causing mutations in each CFTR gene; or
an abnormal nasal transepithelial potential difference characteristic of CF.
Forced Expiratory Volume in one second (FEV1) at screening must have been ≥25% and ≤80% of normal predicted values for age, sex, and height based on Knudson criteria
P. aeruginosa must have been present in a sputum/deep-throat cough swab culture (or bronchoalveolar lavage [BAL]) within 6 months prior to screening and in the sputum/deep-throat cough swab culture at the screening visit
Able to expectorate a sputum sample or provide a deep throat cough swab at screening
Able to comply with all protocol requirements
Use of an effective means of contraception in females of childbearing potential
Clinically stable in the opinion of the investigator to be treated according to this protocol

Exclusion Criteria:

FEV1 at baseline (Visit 2) <25% or >80% of normal predicted values for age, sex, and height based on Knudson criteria, and/or FEV1 at baseline (Visit 2) deviated by ≥10% from the FEV1 measured at screening (Visit 1)
Any use of inhaled anti-pseudomonal antibiotics within 4 months prior to screening
Any use of systemic anti-pseudomonal antibiotics within 28 days prior to study drug administration
Serum creatinine 2 mg/dL or above, blood urea nitrogen (BUN) 40 mg/dL or above, or an abnormal urinalysis defined as 2+ or greater proteinuria
Known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics
Signs and symptoms of acute pulmonary disease, e.g. pneumonia, pneumothorax
Administration of any investigational drug within 30 days prior to enrollment
Any previous exposure to tobramycin dry powder for inhalation (TIP)
Administration of loop diuretics within 7 days prior to study drug administration
Initiation of treatment with chronic macrolide therapy within 28 days prior to study drug administration
Initiation of treatment with dornase alfa within 28 days prior to study drug administration
Initiation of treatment with inhaled steroids (or increased dose) within 28 days prior to study drug administration
Initiation of treatment with inhaled hypertonic saline (HS) within 28 days prior to study drug administration
Personal history of abnormal hearing or family history of abnormal hearing other than typical hearing loss associated with the aging process
Known abnormal result from any audiology testing (defined as either a unilateral puretone audiometry test showing a threshold elevation >20 dB at any frequency across the frequency range 0.25 kHz to 8 kHz or the absence of emission at the evoked otoacoustic emission test)
History of sputum culture or throat swab (or BAL) culture yielding Burkholderia cepacia (B. cepacia) within 2 years prior to screening and/or sputum culture yielding B. cepacia at screening
Hemoptysis of more than 60 mL at any time within 30 days prior to study drug administration
History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of evidence of local recurrence or metastases
Patients with clinically significant laboratory abnormalities (not associated with the study indication) at screening
Patients or caregivers with a history of noncompliance to medical regimens and patients or caregivers who are considered potentially unreliable
Pregnant or nursing (lactating) women
Women of child-bearing potential unless they used two reliable birth control methods

Other protocol-defined inclusion/exclusion criteria may apply","Tobramycin 28 mg powder. The TIP dose of 112 mg twice a day (bis in diem = b.i.d.), given in a cycle of 28 days on treatment followed by 28 days off treatment.",ChEMBL:CHEMBL1747 | DrugBank:DB00684 | PubChem:36294,Tobramycin,NC[C@H]1O[C@H](O[C@H]2[C@H](O)[C@@H](O[C@H]3O[C@H](CO)[C@@H](O)[C@H](N)[C@H]3O)[C@H](N)C[C@@H]2N)[C@H](N)C[C@@H]1O,J01GB01 | S01AA12,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT00920426,NCT00920426_EG000,No,All,Adult | Older Adult,Phase 2,8,"Inclusion Criteria:

A subject will be eligible for inclusion in this study only if all of the following criteria apply:

Male or female between 18 and 65 years of age inclusive, at the time of signing the informed consent.
A female subject is eligible to participate if she is of non-childbearing potential, defined as:
Pre-menopausal females with a documented bilateral oophorectomy, tubal ligation or hysterectomy; or
Postmenopausal defined as 12 months of spontaneous amenorrhea. A follicle stimulating hormone level will be performed to confirm post-menopausal status. For this study, FSH levels > 40 MlU/ml and estradiol < 40 pg/ml (<140 pmol/L) is confirmatory.
Male subjects must agree to use one of the contraception methods listed in Section 8.1. This criterion must be followed from the time of the first dose of study medication until 14 days after the last dose of study medication.
CD4+ cell count greater than or equal to 200 cells/mm3 and plasma HIV-1 RNA greater than or equal to 5000 copies/mL at Screening.
No current antiretroviral therapy and have not received any in the 12 weeks prior to first dose.
For subjects who have received antiretroviral treatment in the past, adequate treatment options to construct HAART therapy with at least 3 active antiretrovirals for Optimized Therapy, as selected by the Investigator.
Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.

Exclusion Criteria

A subject will not be eligible for inclusion in this study if any of the following criteria apply:

A positive screening Hepatitis B surface antigen; positive screening hepatitis C virus (HCV) antibody and detectable HCV ribonucleic acid (RNA) on subsequent testing. If the hepatitis C antibody is positive but the HCV RNA is undetectable, the subject may be included in the study.
AST and ALT > 3ULN at Screening. A single repeat is allowed for eligibility determination.
Inadequate renal function at Screening, defined as either a serum creatinine >1.5 mg/dL or a calculated creatinine clearance (CrCl) ≤ 50 mL/min. A single repeat serum creatinine is allowed to determine eligibility.
Any acute laboratory abnormality at screening which, in the opinion of the investigator, should preclude the subject's participation in the study of an investigational compound. Any grade 4 laboratory abnormality at screening, with the exception of CPK, will exclude a subject from study participation unless the investigator can provide a compelling explanation for the laboratory result(s) and has the assent of the sponsor. A single repeat is allowed for eligibility determination.
A positive drug screen at screening and baseline. A minimum list of drugs that will be screened for include amphetamines, barbiturates, cocaine or PCP.
History of regular alcohol consumption, defined as an average weekly intake of >14 drinks for males or >7 drinks for females, within 6 months of Screening.

Note: One drink is equivalent to 12 g of alcohol: 12 ounces (360 ml) of beer, 5 ounces (150 ml) of wine or 1.5 ounces (45 ml) of 80 proof distilled spirits.

Any condition (including alcohol or drug abuse) which, in the opinion of the investigator, could interfere with the subject's ability to comply with the dosing schedule and protocol evaluations or which might compromise the safety of the subject.
Prior treatment with an integrase inhibitor (greater than or equal to 1 dose).
Treatment with radiation therapy or cytotoxic chemotherapeutic agents within 30 days of study drug administration or anticipated need for such treatment within the study.
Treatment with immunomodulating agents (such as systemic corticosteroids, interleukins, interferons) or any agent with known anti-HIV activity (such as hydroxyurea or foscarnet) within 30 days of study drug administration.
Treatment with any vaccine within 30 days prior to receiving study medication.
An active Center for Disease Control and Prevention (CDC) Category C disease, except cutaneous Kaposi's sarcoma not requiring systemic therapy during the trial.
Pregnant females as determined by positive serum or urine hCG test at screening or prior to dosing.
Lactating females.
Use of multivitamins or antacids within 24 hours prior to the first dose of investigational product.
History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation. In addition, if heparin is used during PK sampling, subjects with a history of sensitivity to heparin or heparin-induced thrombocytopenia should not be enrolled.

Note: Study medications refer to GSK1265744 or placebo.

The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
History of clinically relevant pancreatitis or hepatitis within the previous 6 months.
Subjects with a pre-existing condition interfering with normal gastrointestinal anatomy or motility, hepatic and/or renal function, that could interfere with the absorption, metabolism, and/or excretion of the study drugs.
Exclusion Criteria for Screening ECG (A single repeat is allowed for eligibility determination):

Exclusion Criteria for Screening ECG:

Males Females Heart rate <45 and >100 bpm <50 and >100 bpm QRS duration >120 msec >120 msec QTc interval (Bazett) > 450 msec > 450 msec Non-sustained (≥ 3 consecutive beats) or sustained ventricular tachycardia. Sinus Pauses >3 seconds. 2nd degree (Type II) or higher AV block. Evidence of previous myocardial infarction (pathologic Q waves, S-T segment changes (except early repolarization)).","GSK1265744 30 mg once daily was previously studied in study ITZ111451 part C HIV cohort, NCT00659191. Eligible participants received repeat doses of GSK1265744 30 mg (6x5 mg) oral tablets once daily for 10 days.",ChEMBL:CHEMBL2403238 | DrugBank:DB11751 | PubChem:54713659,Cabotegravir,[H][C@@]12Cn3cc(C(=O)NCc4ccc(F)cc4F)c(=O)c(O)c3C(=O)N1[C@@H](C)CO2,J05AJ04,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT00920426,NCT00920426_EG001,No,All,Adult | Older Adult,Phase 2,7,"Inclusion Criteria:

A subject will be eligible for inclusion in this study only if all of the following criteria apply:

Male or female between 18 and 65 years of age inclusive, at the time of signing the informed consent.
A female subject is eligible to participate if she is of non-childbearing potential, defined as:
Pre-menopausal females with a documented bilateral oophorectomy, tubal ligation or hysterectomy; or
Postmenopausal defined as 12 months of spontaneous amenorrhea. A follicle stimulating hormone level will be performed to confirm post-menopausal status. For this study, FSH levels > 40 MlU/ml and estradiol < 40 pg/ml (<140 pmol/L) is confirmatory.
Male subjects must agree to use one of the contraception methods listed in Section 8.1. This criterion must be followed from the time of the first dose of study medication until 14 days after the last dose of study medication.
CD4+ cell count greater than or equal to 200 cells/mm3 and plasma HIV-1 RNA greater than or equal to 5000 copies/mL at Screening.
No current antiretroviral therapy and have not received any in the 12 weeks prior to first dose.
For subjects who have received antiretroviral treatment in the past, adequate treatment options to construct HAART therapy with at least 3 active antiretrovirals for Optimized Therapy, as selected by the Investigator.
Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.

Exclusion Criteria

A subject will not be eligible for inclusion in this study if any of the following criteria apply:

A positive screening Hepatitis B surface antigen; positive screening hepatitis C virus (HCV) antibody and detectable HCV ribonucleic acid (RNA) on subsequent testing. If the hepatitis C antibody is positive but the HCV RNA is undetectable, the subject may be included in the study.
AST and ALT > 3ULN at Screening. A single repeat is allowed for eligibility determination.
Inadequate renal function at Screening, defined as either a serum creatinine >1.5 mg/dL or a calculated creatinine clearance (CrCl) ≤ 50 mL/min. A single repeat serum creatinine is allowed to determine eligibility.
Any acute laboratory abnormality at screening which, in the opinion of the investigator, should preclude the subject's participation in the study of an investigational compound. Any grade 4 laboratory abnormality at screening, with the exception of CPK, will exclude a subject from study participation unless the investigator can provide a compelling explanation for the laboratory result(s) and has the assent of the sponsor. A single repeat is allowed for eligibility determination.
A positive drug screen at screening and baseline. A minimum list of drugs that will be screened for include amphetamines, barbiturates, cocaine or PCP.
History of regular alcohol consumption, defined as an average weekly intake of >14 drinks for males or >7 drinks for females, within 6 months of Screening.

Note: One drink is equivalent to 12 g of alcohol: 12 ounces (360 ml) of beer, 5 ounces (150 ml) of wine or 1.5 ounces (45 ml) of 80 proof distilled spirits.

Any condition (including alcohol or drug abuse) which, in the opinion of the investigator, could interfere with the subject's ability to comply with the dosing schedule and protocol evaluations or which might compromise the safety of the subject.
Prior treatment with an integrase inhibitor (greater than or equal to 1 dose).
Treatment with radiation therapy or cytotoxic chemotherapeutic agents within 30 days of study drug administration or anticipated need for such treatment within the study.
Treatment with immunomodulating agents (such as systemic corticosteroids, interleukins, interferons) or any agent with known anti-HIV activity (such as hydroxyurea or foscarnet) within 30 days of study drug administration.
Treatment with any vaccine within 30 days prior to receiving study medication.
An active Center for Disease Control and Prevention (CDC) Category C disease, except cutaneous Kaposi's sarcoma not requiring systemic therapy during the trial.
Pregnant females as determined by positive serum or urine hCG test at screening or prior to dosing.
Lactating females.
Use of multivitamins or antacids within 24 hours prior to the first dose of investigational product.
History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation. In addition, if heparin is used during PK sampling, subjects with a history of sensitivity to heparin or heparin-induced thrombocytopenia should not be enrolled.

Note: Study medications refer to GSK1265744 or placebo.

The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
History of clinically relevant pancreatitis or hepatitis within the previous 6 months.
Subjects with a pre-existing condition interfering with normal gastrointestinal anatomy or motility, hepatic and/or renal function, that could interfere with the absorption, metabolism, and/or excretion of the study drugs.
Exclusion Criteria for Screening ECG (A single repeat is allowed for eligibility determination):

Exclusion Criteria for Screening ECG:

Males Females Heart rate <45 and >100 bpm <50 and >100 bpm QRS duration >120 msec >120 msec QTc interval (Bazett) > 450 msec > 450 msec Non-sustained (≥ 3 consecutive beats) or sustained ventricular tachycardia. Sinus Pauses >3 seconds. 2nd degree (Type II) or higher AV block. Evidence of previous myocardial infarction (pathologic Q waves, S-T segment changes (except early repolarization)).",Eligible participants received double-blind 5 mg GSK1265744 oral tablet once daily for 10 days.,ChEMBL:CHEMBL2403238 | DrugBank:DB11751 | PubChem:54713659,Cabotegravir,[H][C@@]12Cn3cc(C(=O)NCc4ccc(F)cc4F)c(=O)c(O)c3C(=O)N1[C@@H](C)CO2,J05AJ04,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00921843,NCT00921843_EG000,No,All,Child | Adult,Phase 4,61,"Inclusion Criteria:

Age 5-18
Undergoing General anesthesia and surgery with anticipated postoperative inpatient stay of greater than or equal to 3 days
Signed, written, informed consent from legal guardians and assent from patient

Exclusion Criteria:

History of or known liver or kidney disease","Methadone administration 0.1mg/kg

Methadone: Subjects will receive methadone as their intraoperative opioid.",ChEMBL:CHEMBL350719 | ChEMBL:CHEMBL651 | DrugBank:DB00333 | DrugBank:DB15198 | PubChem:4095 | PubChem:643985,Methadone,CCC(=O)C(CC(C)N(C)C)(c1ccccc1)c1ccccc1,N02AC52 | N07BC02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00921843,NCT00921843_EG001,No,All,Child | Adult,Phase 4,61,"Inclusion Criteria:

Age 5-18
Undergoing General anesthesia and surgery with anticipated postoperative inpatient stay of greater than or equal to 3 days
Signed, written, informed consent from legal guardians and assent from patient

Exclusion Criteria:

History of or known liver or kidney disease","Methadone administration 0.2mg/kg

Methadone: Subjects will receive methadone as their intraoperative opioid",ChEMBL:CHEMBL350719 | ChEMBL:CHEMBL651 | DrugBank:DB00333 | DrugBank:DB15198 | PubChem:4095 | PubChem:643985,Methadone,CCC(=O)C(CC(C)N(C)C)(c1ccccc1)c1ccccc1,N02AC52 | N07BC02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00924404,NCT00924404_EG000,No,All,Adult | Older Adult,Not Applicable,53,"We now have two arms to this study.

Group I: Immunocompetent subjects with chronic rhinosinusitis

Inclusion Criteria:

56 Adult subjects (18 or older) presenting to the ENT(ears, nose, throat) clinics who meet the diagnosis of chronic rhinosinusitis (CRS). Definition of CRS: Presence of at least 2 of the following 4 signs/symptoms for 12 weeks or longer despite medical management:

Anterior and/or posterior mucopurulent drainage
Nasal obstruction
Facial pain, pressure, and/or fullness
Decreased sense of smell
In addition, objective evidence of sinus mucosal disease must be demonstrated on sinus CT imaging or direct endoscopic examination.

Exclusion Criteria:

Cystic fibrosis
Fungal sinusitis
Immunocompromised status (use of long term oral steroids (> 30 days), AIDS, active malignancy or chemotherapy)
Known Ciliary disorders
Sinonasal tumors
Pregnancy

Group 2: CRS with antibody deficiency

56 Adult subjects (18 or older) presenting to the Allergy clinic who meet the diagnosis of chronic rhinosinusitis (CRS). Definition of CRS: Presence of at least 2 of the following 4 signs/symptoms for 12 weeks or longer despite medical management:

Anterior and/or posterior mucopurulent drainage
Nasal obstruction
Facial pain, pressure, and/or fullness
Decreased sense of smell
In addition, objective evidence of sinus mucosal disease must be demonstrated on sinus CT imaging or direct endoscopic examination.

Exclusion criteria:

Cystic Fibrosis Sinonasal tumors Pregnancy","isotonic xylitol for sinus rinse

Xylitol: 5% solution for sinus rinse",ChEMBL:CHEMBL96783 | DrugBank:DB11195 | PubChem:6912,Xylitol,OC[C@@H](O)[C@H](O)[C@@H](O)CO,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00927472,NCT00927472_EG001,No,All,Child | Adult | Older Adult,Phase 3,128,"Inclusion Criteria:

Confirmed active head lice infestation

Exclusion Criteria:

Allergy to pediculicides or hair care products
Scalp conditions other than head lice
Previous head lice treatment within the past 4 weeks
Current antibiotic treatment","Nix applied to scalp for 10 minutes

Permethrin 1% rinse: Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head lice are still present.",ChEMBL:CHEMBL1525 | DrugBank:DB04930 | PubChem:40326 | PubChem:62086,Permethrin,CC1(C)C(C=C(Cl)Cl)C1C(=O)OCc1cccc(Oc2ccccc2)c1,P03AC04 | P03AC54,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT00928135,NCT00928135_EG001,No,All,Child | Adult | Older Adult,Phase 1 | Phase 2,30,"Inclusion Criteria:

Subjects with CF (medical record evidence of CFTR(Cystic fibrosis transmembrane conductance regulator) mutation or sweat chloride test or nasal voltage difference, and 1 or more clinical findings of CF),
Age 12 or greater
FEV1 > 30% predicted(within the last 14 days and oxygen saturation > 90% on FiO2(fraction of inspired oxygen) ≤ 50%,
Admitted for an exacerbation,
Use of effective contraception in women,
Able to provide written informed consent.

Exclusion Criteria:

Pregnancy,
History of asthma based on methacholine challenge or bronchial hyperresponsiveness on PFTS(Pulmonary Function Test),
Hemoptysis more than 60 mL within the last 30 days,
Use of any investigational study drug within the last 30 days,
Initiation of hypertonic saline within the last 30 days,
A serum creatinine 2 mg/dl or more
Active malignancy in the last year
Antibiotics for CF exacerbation as an outpatient in the last 2 weeks
B cepacia colonization
Waiting list for lung transplant
Lack of FEV1 data from the last 14 days
Previous participation in this study","5 ml of 15% xylitol twice daily

Xylitol: 15% xylitol solution for aerosol; Dosage: 5 ml twice a day (BID)",ChEMBL:CHEMBL96783 | DrugBank:DB11195 | PubChem:6912,Xylitol,OC[C@@H](O)[C@H](O)[C@@H](O)CO,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT00930579,NCT00930579_EG000,No,Female,Adult | Older Adult,Phase 2,33,"Inclusion Criteria:

Histologically-confirmed operable invasive breast cancer or ductal carcinoma in situ (DCIS) who undergo core needle biopsy followed by surgical excision at least 2 weeks after enrollment
Body mass index > 25
Age ≥ 21 years
No prior chemotherapy, radiation therapy, or surgery within 6 months of study entry
Signed informed consent

Exclusion Criteria:

History of diabetes mellitus requiring medical therapy
Treatment with other investigational drugs within 6 months of study entry
Significant renal impairment with a creatinine > 1.4 mg/dl
Other serious intercurrent medical illness","Women with newly diagnosed early invasive breast cancer will receive Metformin

Metformin: 1500 mg per day, divided 500 mg in the morning and 1000 mg in the evening, for at least two weeks prior to surgery",ChEMBL:CHEMBL1431 | DrugBank:DB00331 | PubChem:4091,Metformin,CN(C)C(=N)NC(=N)N,A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT00931255,NCT00931255_EG001,No,All,Adult | Older Adult,Phase 4,15,"Inclusion Criteria:

Age => 18.
Recipient of a deceased donor kidney transplant.
Delayed graft function, defined as need for dialysis during first week after surgery or slow graft function, defined as creatinine >=3.0 by post-op day 5 without requiring dialysis
Stable serum creatinine for 2 weeks prior to enrollment.
Able to give informed consent.
Compliant with medical regimen and clinic visits.

Exclusion Criteria:

Episode of acute rejection within 4 weeks prior to enrollment.
Calculated GFR < 30 ml/min.
Interstitial fibrosis & tubular atrophy in transplant biopsy higher than grade II (Banff""05 update).
Proteinuria > 500 mg/24 h or spot urine protein/creatinine > 0.5.
Total fasting cholesterol level > 300 mg/dl or triglyceride > 500 mg/dl despite optimal lipid lowering therapy.
Recipient of pancreas or liver allografts.
Leukopenia (WBC < 3000 mm3) within 2 weeks prior to enrollment.
Leukopenia (WBC < 2000 mm3) within 4 weeks prior to enrollment.
Thrombocytopenia (platelets count < 100,000/mm3) within 2 weeks prior to enrollment.
Unwilling to comply with study protocol.
Enrollment in another drug trial that precludes use of sirolimus.
Diagnosis of malignancy within 2 years prior to enrollment, except adequately treated non-melanoma skin cancer.
For women, pregnancy.
Allergy to iodine","5 mg, PO , daily

Sirolimus: 5 mg, PO, daily based on 24 hour serum blood levels, adjusted according to protocol",ChEMBL:CHEMBL413 | DrugBank:DB00877 | PubChem:134760597 | PubChem:138404388 | PubChem:21944094 | PubChem:5284616,Sirolimus,COC1CC2CCC(C)C(O)(O2)C(=O)C(=O)N2CCCCC2C(=O)OC(C(C)CC2CCC(O)C(OC)C2)CC(=O)C(C)C=C(C)C(O)C(OC)C(=O)C(C)CC(C)C=CC=CC=C1C,L01EG04 | L04AA10 | S01XA23,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00931528,NCT00931528_EG000,Accepts Healthy Volunteers,Male,Adult | Older Adult,Phase 3,111,"Inclusion Criteria:

Clinical stage T1b-T2b (AJCC, 6th ed.) adenocarcinoma of the prostate within 6 months of registration
Clinically negative lymph nodes as established by imaging (pelvic ± abdominal CT or MR), nodal sampling, or dissection within 3 months prior to registration. Patients with lymph nodes equivocal or questionable by imaging are eligible if the nodes are ≤ 1.5 cm. Lymph node assessment is optional, and at investigator discretion, for patients with Gleason Score <7.
No evidence of bone metastases (M0) on bone scan within 3 months prior to registration. Equivocal bone scan findings are allowed if plain films are negative for metastasis. Bone metastases assessment is optional, and at investigator discretion, for patients with Gleason Score <7.

Baseline serum prostatic specific antigen (PSA) value performed with an FDA-approved assay (e.g., Abbott, Hybritech) within 3 months prior to registration.

-4.1 Any of the following combinations of factors (NOTE: tumor found in 1 or both lobes on biopsy, but not palpable, will not alter T stage):

T1b-T2b disease, Gleason Score <7 and serum total PSA that is <20 ng/ml or
T1b-T2b disease, Gleason Score ≥7 and PSA that is <15 ng/ml
Serum total testosterone level prior to the initiation of radiation therapy (RT) within normal range according to institutional guidelines
Zubrod Performance Status 0 or 1 (Appendix III)
Age ≥ 18 years
Treatment that will consist of either external beam RT alone to the prostate ± seminal vesicles only at a dose between 75 Gy and 79.2 Gy or brachytherapy alone (NOTE: treatment with combined external RT and brachytherapy excludes patient participation)

Pretreatment (before starting prostate cancer treatment) erectile function as measured by IIEF Question 1, ""How often were you able to get an erection during sexual activity?"" - with responses of:

""sometimes (about half the time)"" [response 3] or
""most times (much more than half the time)"" [response 4] or
""almost always/always"" [response 5]
History of prior tadalafil use: Document usual dosage per sexual encounter, date of last dose, and patient's response (No; Yes-Unsatisfactory Response; Yes-Satisfactory Response). Regardless of past experience, the patient is eligible if he agrees to adhere to protocol and take only tadalafil or placebo prescribed on study.
Although patients with partners are targeted for recruitment, patients without partners or without partners willing to participate are eligible. Patients (and spouses/partners, if willing to participate) must be able to provide study-specific informed consent.

Exclusion Criteria:

The patient's participation in another medical research study that involves the treatment of ED
Previous or concomitant invasive cancer (American Joint Committee on Cancer [AJCC] Stage >0), other than localized basal cell or squamous cell skin carcinoma (AJCC Stage 0-II), or a hematological malignancy (e.g., leukemia, lymphoma, myeloma) unless continually disease free for at least 5 years
History of myocardial infarction within the last year
Heart failure in the last 6 months
Uncontrolled arrhythmias, hypotension (<90/50mm Hg), or uncontrolled hypertension (>170/100 mm Hg)
Stroke within the last 6 months
Use of luteinizing hormone-releasing hormone (LHRH) agonist androgen suppression (e.g., Lupron, Zoladex), anti-androgen (e.g., Casodex, Eulexin, Nilandron), or estrogenic (e.g., diethylstilbestrol) agents within the last 6 months
Current use of any organic nitrate or as needed nitrates (e.g., use of nitroglycerin)
Current use of cimetidine, ketoconazole, itraconazole, erythromycin, or ritonavir
Known moderate to severe renal insufficiency or end-stage renal disease
Known severe hepatic impairment
Use of mechanical (vacuum) devices, intracorporeal, intraurethral, topical, or oral (sildenafil, tadalafil, vardenafil) agents as therapy for ED or supplements to enhance sexual function within 5-7 days prior to the start of RT. Patients who discontinue these therapies remain eligible if they can meet eligibility criteria

Pretreatment (before starting prostate cancer treatment) ED as measured by IIEF Question 1, ""How often were you able to get an erection during sexual activity?"" - with responses of:

""no sexual activity"" [response 0] or
""almost never/never"" [response 1] or
""a few times (much less than half the time)"" [response 2]
Prior penile implant or history of bilateral orchiectomy
Prior prostatectomy, prostatic cryosurgery or high-intensity focused ultrasound (HIFU), radionuclide prostate brachytherapy, or chemotherapy for prostate cancer
Prior or anticipated combined external RT and brachytherapy
Prior or anticipated external RT to the pelvic ± para-aortic lymph nodes
Acquired Immune Deficiency Syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Protocol-specific requirements may also exclude immunocompromised patients.
Anatomical genital abnormalities or concurrent conditions that in the estimation of the physician would prohibit sexual intercourse or prevent study completion
Major medical or psychiatric illness which, in the opinion of the investigator, would prevent completion of treatment or would interfere with follow-up","Beginning ≤ 7 days after the start of radiotherapy, patients receive oral tadalafil 5mg once daily for 24 weeks.",ChEMBL:CHEMBL779 | DrugBank:DB00820 | PubChem:110635,Tadalafil,[H][C@]12Cc3c([nH]c4ccccc34)[C@@H](c3ccc4c(c3)OCO4)N1C(=O)CN(C)C2=O,C02KX52 | C02KX54 | G04BE08 | G04CA54 | G04CB51,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT00939094,NCT00939094_EG000,No,All,Adult | Older Adult,Phase 2,42,"Inclusion Criteria:

Provision of informed consent prior to any study specific procedures.
Male or non-fertile females
Painful symptoms due to neuropathic pain for a period of 3 months to 5 years, associated with mechanical allodynia and/or punctate hyperalgesia.

Exclusion Criteria:

Other pain that may confound assessment of neuropathic pain.
Diagnosis of any severe neurological disease.
History of significant psychiatric disease/condition and/or history of psychotic disorders among first degree relatives.","AZD2066, 12 mg capsule",DrugBank:DB12644 | DrugBank:DB17078,AZD2066,C[C@@H](Oc1nnc(-c2ccncc2)n1C)c1cc(-c2cccc(Cl)c2)on1,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00939692,NCT00939692_EG001,Accepts Healthy Volunteers,All,Adult,Phase 1,26,"Inclusion Criteria:

Sex: Male or Female; similar proportions of each preferred.
Age: At least 18 - 55 years (inclusive).
Weight: BMI (Body Mass Index) 19 kg/m2 - 30 kg/m2 (inclusive).

Qualifying subjects must be in good health and physical condition as determined by medical history, complete physical examination, and laboratory tests, all obtained within four (4) weeks prior to study start. The subject may not have a history of significant past illness expected to affect the investigation. The normal status of subjects will be confirmed by the following procedures:

Laboratory Tests: Serum pregnancy test (female subjects only), hemoglobin, hematocrit, RBC, WBC, platelet count, differential count, serum electrolytes (Na, K, Cl), fasting blood glucose, BUN, bilirubin, creatinine, AST, ALT, LD, alkaline phosphatase, urinalysis, drugs of abuse, HIV, Hepatitis B, and Hepatitis C will be done for screening purposes.
Laboratory values which are greater than 20% of the normal range will not qualify unless specifically accepted by a physician who is an investigator or sub-investigator for the clinical trial. Results of a serum pregnancy test (female subjects only), HIV, Hepatitis B, Hepatitis C, and drugs of abuse must be negative or non-reactive for the subject to qualify for the study.
Electrocardiogram: A 12-lead electrocardiogram (ECG) will be obtained for all subjects. The original tracings, plus interpretation, will be included in the case report form packet.
Subjects must read and sign the Consent Form.

Exclusion Criteria:

Subjects not complying with the above inclusion criteria must be excluded from the study.

In addition, any one (1) of the conditions listed below will exclude a subject from the study:

History of treatment for alcoholism, substance abuse, or drug abuse within the past 24 months.
History of malignancy, stroke, diabetes, cardiac, renal or liver disease, or other serious illness.
History of GERD (gastroesophageal reflux disease), malabsorption syndrome, colon cancer, or chronic colitis, including Crohn's disease.
History of treatment for asthma within the past five (5) years.
History of predisposition to renal calculi.
History of surgery within the past eight (8) weeks.
History of application of tattoo(s) within the past 30 days.
History of body piercing(s) within the past 30 days.
Females who are pregnant or lactating.
History of hypersensitivity to topiramate or any anticonvulsant medication.

Conditions upon screening which might contraindicate or require that caution be used in the administration of topiramate, including:

Sitting systolic blood pressure below 90 mm Hg, or diastolic pressure below 50 mm Hg.
Heart rate less than 50 beats per minute after a 5-minute rest in a seated position.
Inability to read and/or sign the consent form.
Treatment with any other investigational drug during the 30 days prior to the initial dosing for this study.
Subjects who have donated blood within 30 days prior to the initial dosing for this study.
Subjects who smoke more than 10 cigarettes per day.
Subjects who do not tolerate venipuncture.
Subjects who have difficulty fasting or consuming standardized meals.","tablet containing 25 mg of topiramate (Topamax®, Ortho-McNeil Neurologics, Inc.)",ChEMBL:CHEMBL220492 | DrugBank:DB00273 | PubChem:5284627,Topiramate,[H][C@@]12OC(C)(C)O[C@]1([H])CO[C@@]1(COS(N)(=O)=O)OC(C)(C)O[C@]12[H],A08AA51 | N03AX11,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00941668,NCT00941668_EG000,Accepts Healthy Volunteers,All,Adult,Phase 4,24,"Inclusion Criteria:

Subjects must be adult males or females 18 to 60 years old
Subjects must be able and willing to follow study procedures and instructions
Subjects must have generalized, moderate plaque-associated gingivitis as determined by the Investigator or designee during the screening examination
Subjects must present with at least 20 teeth in the functional dentition, excluding third molars
Each subject must have at least four teeth with probing depths of 4-5 millimeters and at least 30% of sites bleeding to gentle probing

Exclusion Criteria:

Subjects who have chronically used (two weeks or more) Total (Triclosan/Copolymer) dentifrice within 6 months prior to enrollment
Subjects with gross oral pathology, including widespread caries or chronic neglect, extensive restoration, pre-existing gross plaque and calculus, or soft or hard tissue tumor of the oral cavity
Subjects with periodontitis as indicated by periodontal pocketing 6 millimeters at screening
Subjects with a history of early onset periodontitis or acute necrotizing ulcerative gingivitis
Subjects with concomitant endodontic or periodontal therapy other than prophylaxis within 6 months prior to enrollment
Subjects with orthodontic appliances or removable partial dentures
Subjects chronically treated (two weeks or more) with any medication known to affect inflammation or periodontal status or (aspirin, nonsteroidal anti-inflammatory drugs, steroids, statins, phenytoin, calcium antagonists, cyclosporin and coumadin) within one month of the screening examination. All other medications for chronic medical conditions should be initiated at least three months prior to enrollment
Subjects who currently smoke or who report using tobacco products within one year of screening.
Subjects who have been treated with antibiotics for medical or dental reasons within 3 months prior to enrollment
Subjects having clinically significant or unstable organic disease; subjects having compromised healing potential such as those with diabetes mellitus or connective tissue disorders; subjects having heart murmurs, histories of rheumatic fever, valvular disease or prosthetic joint replacement necessitating antibiotic prophylaxis
Female subjects who report being pregnant
Subjects who use hormonal contraceptives must have started the method 30 days prior to the screening examination.
Subjects with active infectious diseases such as hepatitis, human immunodeficiency virus or Tuberculosis
Subjects diagnosed with human immunodeficiency virus (HIV) or subjects that are immunocompromised as determined by the Investigator
Medical condition which precludes not eating/drinking for approximately 8 hours.",triclosan/copolymer/fluoride toothpaste,PubChem:24848164,Sodium fluoride and triclosan,Oc1cc(Cl)ccc1Oc1ccc(Cl)cc1Cl.[F-].[Na+],,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00941681,NCT00941681_EG000,No,All,Adult | Older Adult,Phase 2,12,"Inclusion Criteria:

The patient has signed an Informed Consent Form/Patient Information Sheet for this study approved by the governing Institutional Review Board (IRB) or Independent Ethics Committee (IEC)
The patient is at least 18 years old at the time of consent
Left ventricular ejection fraction (LVEF) ≤ 35% as determined by the Investigator within 3 weeks prior to enrollment
Treated for at least 4 weeks with a beta blocker and an ACE inhibitor (and/or an ARB) unless not tolerated. If prescribed, diuretics must have been administered according to a consistent regimen for at least 4 weeks.
Diagnosed with heart failure for ≥ 3 months prior to enrollment
Patient is considered to be an appropriate candidate for study enrollment as determined by the patient's clinical laboratory findings, vital signs and ECGs within normal range, or if outside of the normal range not deemed clinically significant in the opinion of the Investigator
For female patients only: The patient is post-menopausal (≥ 1 year) or sterilized, or if she is of childbearing potential, she is not breastfeeding, her pregnancy test is negative, she has no intention to become pregnant during the course of the study, and she is using contraceptive drugs or devices. For male patients only: Male patients agree for the duration of the study and 10 weeks after the end of the study to use a condom during sexual intercourse with female partners who are of reproductive potential and to have female partners use an additional effective means of contraception (eg, diaphragm plus spermicide, or oral contraceptives) or the male subject must agree to abstain from sexual intercourse for 10 weeks after the end of the study.

Exclusion Criteria:

Patient has been hospitalised for heart failure, acute coronary syndrome, myocardial infarction, coronary revascularisation, transient ischemic attack or stroke, cardiac arrhythmia, or major surgery within 6 weeks prior to enrollment
Poorly controlled hypertension defined as blood pressure > 150/95 mmHg, documented on at least 2 separate occasions prior to enrollment
The patient has a supine heart rate ≥ 100 beats per minute after 10 minutes of rest
Patient has a troponin I at screening that is above the upper limit of normal
The patient has severe aortic or mitral stenosis
The patient has active myocarditis; clinically significant restrictive, constrictive, or hypertrophic obstructive cardiomyopathy; clinically significant congenital heart disease; history of major organ transplantation
The patient has Canadian Cardiovascular Society Class IV angina
Patient is on chronic anti-arrhythmic therapy, with the exception of amiodarone
Patient has impaired renal function defined as an estimated GFR ≤ 30 ml/min/1.73 m2 calculated by the Modification of Diet in Renal Disease (MDRD) equation
Patient is currently taking, or has taken within 14 days prior to enrollment, a potent CYP3A4 inhibitor (medication or food). Patient is currently taking, or has taken within 28 days prior to enrollment, a potent CYP3A4 inducer (medication or food).
The patient has hepatic impairment defined as a total bilirubin > 3 mg/dL, or an ALT or AST > 2 times the upper limit of normal
Concomitant non-cardiovascular disease that is expected to reduce life expectancy to less than 1 year
The patient has received an investigational drug or device within 30 days or 5 half-lives, whichever is greater, of enrollment
Patient has, in the opinion of the Investigator, a condition that compromises the ability of the subject to give written informed consent or to comply with study procedures, including scheduled self-administration of oral CK-1827452
The patient has had any prior treatment with CK-1827452",Modified-release (MR) 50 mg dose of CK-1827452 twice a day (BID) for 10 days.,ChEMBL:CHEMBL1800955 | DrugBank:DB11816 | PubChem:11689883,OMECAMTIV MECARBIL,COC(=O)N1CCN(Cc2cccc(NC(=O)Nc3ccc(C)nc3)c2F)CC1,C01CX10,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00941681,NCT00941681_EG002,No,All,Adult | Older Adult,Phase 2,12,"Inclusion Criteria:

The patient has signed an Informed Consent Form/Patient Information Sheet for this study approved by the governing Institutional Review Board (IRB) or Independent Ethics Committee (IEC)
The patient is at least 18 years old at the time of consent
Left ventricular ejection fraction (LVEF) ≤ 35% as determined by the Investigator within 3 weeks prior to enrollment
Treated for at least 4 weeks with a beta blocker and an ACE inhibitor (and/or an ARB) unless not tolerated. If prescribed, diuretics must have been administered according to a consistent regimen for at least 4 weeks.
Diagnosed with heart failure for ≥ 3 months prior to enrollment
Patient is considered to be an appropriate candidate for study enrollment as determined by the patient's clinical laboratory findings, vital signs and ECGs within normal range, or if outside of the normal range not deemed clinically significant in the opinion of the Investigator
For female patients only: The patient is post-menopausal (≥ 1 year) or sterilized, or if she is of childbearing potential, she is not breastfeeding, her pregnancy test is negative, she has no intention to become pregnant during the course of the study, and she is using contraceptive drugs or devices. For male patients only: Male patients agree for the duration of the study and 10 weeks after the end of the study to use a condom during sexual intercourse with female partners who are of reproductive potential and to have female partners use an additional effective means of contraception (eg, diaphragm plus spermicide, or oral contraceptives) or the male subject must agree to abstain from sexual intercourse for 10 weeks after the end of the study.

Exclusion Criteria:

Patient has been hospitalised for heart failure, acute coronary syndrome, myocardial infarction, coronary revascularisation, transient ischemic attack or stroke, cardiac arrhythmia, or major surgery within 6 weeks prior to enrollment
Poorly controlled hypertension defined as blood pressure > 150/95 mmHg, documented on at least 2 separate occasions prior to enrollment
The patient has a supine heart rate ≥ 100 beats per minute after 10 minutes of rest
Patient has a troponin I at screening that is above the upper limit of normal
The patient has severe aortic or mitral stenosis
The patient has active myocarditis; clinically significant restrictive, constrictive, or hypertrophic obstructive cardiomyopathy; clinically significant congenital heart disease; history of major organ transplantation
The patient has Canadian Cardiovascular Society Class IV angina
Patient is on chronic anti-arrhythmic therapy, with the exception of amiodarone
Patient has impaired renal function defined as an estimated GFR ≤ 30 ml/min/1.73 m2 calculated by the Modification of Diet in Renal Disease (MDRD) equation
Patient is currently taking, or has taken within 14 days prior to enrollment, a potent CYP3A4 inhibitor (medication or food). Patient is currently taking, or has taken within 28 days prior to enrollment, a potent CYP3A4 inducer (medication or food).
The patient has hepatic impairment defined as a total bilirubin > 3 mg/dL, or an ALT or AST > 2 times the upper limit of normal
Concomitant non-cardiovascular disease that is expected to reduce life expectancy to less than 1 year
The patient has received an investigational drug or device within 30 days or 5 half-lives, whichever is greater, of enrollment
Patient has, in the opinion of the Investigator, a condition that compromises the ability of the subject to give written informed consent or to comply with study procedures, including scheduled self-administration of oral CK-1827452
The patient has had any prior treatment with CK-1827452",Modified-release (MR) 100 mg dose of CK-1827452 twice a day (BID) for 10 days,ChEMBL:CHEMBL1800955 | DrugBank:DB11816 | PubChem:11689883,OMECAMTIV MECARBIL,COC(=O)N1CCN(Cc2cccc(NC(=O)Nc3ccc(C)nc3)c2F)CC1,C01CX10,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00942708,NCT00942708_EG000,No,All,Child | Adult | Older Adult,Phase 2,6,"Inclusion Criteria:

Signed informed consent prior to any study-mandated procedure
PAH of the following subtypes: idiopathic PAH WHO functional class II-III
Catheterization within one week showing mPAP >=25, wedge or LV end diastolic pressure ≤15, and PVR > 4 wood units, and baseline fick cardiac output results available
Age 16-75
Able to complete a six minute walk distance
Women of childbearing potential*: negative serum pre-treatment pregnancy test + consistently and correctly uses a reliable method of contraception** Oral approved PAH therapy for >3 months with no change in dose for > 1 month

Exclusion Criteria:

PAH with connective tissue disease, congenital heart disease, portal hypertension, glycogen storage disease, Gaucher's disease, hereditary hemorrhagic telangiectasia, hemoglobinopathy, myeloproliferative disorders.
Moderate to severe obstructive or restrictive lung disease: forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) < 70% and FEV1 < 60% of predicted value after bronchodilator administration. -or- total lung capacity (TLC) < 60% of predicted.
Systemic systolic blood pressure <100 mmHg Breastfeeding
Significant liver, renal or other medical disease preventing completion of the study procedures or with life expectancy <12 months, or any other acute or chronic physical impairment (other than dyspnea), limiting the ability to comply with study requirements","Fluoxetine will be added starting at 20 mg and titrated as tolerated to 80 mg daily.

Fluoxetine:

Week 1-2 20 mg daily Week 3-4 40 mg daily Week 5-12 40mg BID",ChEMBL:CHEMBL41 | DrugBank:DB00472 | PubChem:3386,Fluoxetine,CNCCC(Oc1ccc(C(F)(F)F)cc1)c1ccccc1,N06AB03 | N06CA03,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0
NCT00943683,NCT00943683_EG001,No,All,Child,Not Applicable,175,"Inclusion Criteria:

Patient is in good, stable health
Patient has been fed solid foods for at least 1 month
Patients had at least 3 episodes of asthma or asthma-like symptoms, all occurring after 8 weeks of age; at least one within 6 months of the Prestudy Visit
Patients had to be in need of a controller therapy according to criteria established in the Global Initiative for Asthma (GINA) guidelines

Exclusion Criteria:

Patient was hospitalized at the start of the study or required a visit to the emergency room due to asthma with in past 2 weeks",Montelukast 4-mg oral granules mixed with applesauce once daily at bedtime for 6 weeks,PubChem:23663996,Montelukast Sodium,CC(C)(O)c1ccccc1CCC(SCC1(CC(=O)[O-])CC1)c1cccc(C=Cc2ccc3ccc(Cl)cc3n2)c1.[Na+],,0.0,0.0,0.0,1.0,0.0,1.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT00946920,NCT00946920_EG001,No,Male,Adult | Older Adult,Phase 3,283,"Inclusion Criteria:

18 years or older.
Has a histological confirmed prostate cancer Gleason graded).
Has a screening testosterone above 2.2 ng/mL.
Rising prostate-specific antigen (PSA).
Has Eastern Cooperative Oncology Group (ECOG) score of ≤ 2.
Has a life expectancy of at least one year.

Exclusion Criteria:

Current or previous hormone therapy.
Has received therapy with finasteride and dutasteride within 12 weeks and 25 weeks, respectively, prior to screening.
Has a history of severe untreated asthma, anaphylactic reactions, or severe urticaria and/or angioedema.
Has a heart insufficiency.
Has a previous history or presence of another malignancy, other than prostate cancer or treated squamous/basal cell carcinoma of the skin, within the last five years.
Has a clinically significant medical condition (other than prostate cancer) including, but not limited to, renal, haematological, gastrointestinal, endocrine, cardiac, neurological, or psychiatric disease and alcohol or drug abuse or any other condition which may affect the patient's health or the outcome of the trial as judged by the Investigator.
Has received an investigational drug within the last 28 days before the Screening Visit or longer if considered to possibly influencing the outcome of the current trial.
Is candidate for curative therapy, i.e. radical prostatectomy or radiotherapy.","Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. An initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants).",PubChem:16052011,Goserelin Acetate,CC(=O)O.CC(C)CC(NC(=O)C(COC(C)(C)C)NC(=O)C(Cc1ccc(O)cc1)NC(=O)C(CO)NC(=O)C(Cc1c[nH]c2ccccc12)NC(=O)C(Cc1cnc[nH]1)NC(=O)C1CCC(=O)N1)C(=O)NC(CCCN=C(N)N)C(=O)N1CCCC1C(=O)NNC(N)=O,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT00948428,NCT00948428_EG000,No,All,Adult | Older Adult,Phase 3,181,"Inclusion Criteria:

Subjects were male or non-pregnant females, 18 years of age or older, in generally good health. Females who were post-menopausal, surgically sterile or using a medically acceptable form of birth control with a negative urine pregnancy test at the Baseline visit.
Subjects provided written and verbal informed consent.
Subjects presented to the clinic with at least 4 but no more than 12 visible, discrete nonhyperkeratotic, nonhypertrophic actinic keratosis lesions within a 25 cm2 Treatment Area on the face and/or anterior scalp.
Subjects were willing and able to comply with study instructions and return to the clinic for required visits.

Exclusion Criteria:

Subjects who were lactating, or planning to become pregnant during the study.
Subjects had hyperkeratotic, hypertrophic or large mat-like AKs within the 25 cm2 Treatment Area.
Subjects who had the need or were planning to be exposed to artificial tanning devices or excessive sunlight during the trial.
Subjects who were immunosuppressed (e.g., HIV, systemic malignancy, graft vs. host disease, etc.).
Subjects who experienced an unsuccessful outcome from previous imiquimod therapy.
Subjects with known hypersensitivity or previous allergic reaction to any of the active or inactive components of the study drugs.
Within 2 months: Facial and/or Anterior Scalp: laser resurfacing, photodynamic therapy, chemical peels, dermabrasion, topical application of 5-FU, imiquimod, diclofenac sodium or other treatments for AK or photodamage.
Subjects who used the following systemic, oral or topical therapies for the periods specified prior to entry into the study:

Within 2 days: Topicals of any kind to the selected Treatment Area. Within 2 weeks: Facial topical medications: corticosteroids, alpha- hydroxyacids (e.g., glycolic acid, lactic acid, etc. greater than 5%), beta-hydroxyacid (salicylic acid greater than 2%), urea - greater than 5% or prescription retinoids (e.g., tazarotene, adapalene, tretinoin) to the face and/or anterior scalp.

Within 2 weeks: Cryotherapy to lesions adjacent to or within the 25 cm2 Treatment Area.

Within 4 weeks: Systemic steroid therapy: chemotherapeutic agents, psoralens, immunotherapy, or retinoids.","Imiquimod cream, 5%

Imiquimod: 5% topical cream dispensed in individual 0.25 g sachets applied twice a week for 16 weeks",ChEMBL:CHEMBL1282 | DrugBank:DB00724 | PubChem:57469,Imiquimod,CC(C)Cn1cnc2c(N)nc3ccccc3c21,D06BB10,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT00948428,NCT00948428_EG001,No,All,Adult | Older Adult,Phase 3,179,"Inclusion Criteria:

Subjects were male or non-pregnant females, 18 years of age or older, in generally good health. Females who were post-menopausal, surgically sterile or using a medically acceptable form of birth control with a negative urine pregnancy test at the Baseline visit.
Subjects provided written and verbal informed consent.
Subjects presented to the clinic with at least 4 but no more than 12 visible, discrete nonhyperkeratotic, nonhypertrophic actinic keratosis lesions within a 25 cm2 Treatment Area on the face and/or anterior scalp.
Subjects were willing and able to comply with study instructions and return to the clinic for required visits.

Exclusion Criteria:

Subjects who were lactating, or planning to become pregnant during the study.
Subjects had hyperkeratotic, hypertrophic or large mat-like AKs within the 25 cm2 Treatment Area.
Subjects who had the need or were planning to be exposed to artificial tanning devices or excessive sunlight during the trial.
Subjects who were immunosuppressed (e.g., HIV, systemic malignancy, graft vs. host disease, etc.).
Subjects who experienced an unsuccessful outcome from previous imiquimod therapy.
Subjects with known hypersensitivity or previous allergic reaction to any of the active or inactive components of the study drugs.
Within 2 months: Facial and/or Anterior Scalp: laser resurfacing, photodynamic therapy, chemical peels, dermabrasion, topical application of 5-FU, imiquimod, diclofenac sodium or other treatments for AK or photodamage.
Subjects who used the following systemic, oral or topical therapies for the periods specified prior to entry into the study:

Within 2 days: Topicals of any kind to the selected Treatment Area. Within 2 weeks: Facial topical medications: corticosteroids, alpha- hydroxyacids (e.g., glycolic acid, lactic acid, etc. greater than 5%), beta-hydroxyacid (salicylic acid greater than 2%), urea - greater than 5% or prescription retinoids (e.g., tazarotene, adapalene, tretinoin) to the face and/or anterior scalp.

Within 2 weeks: Cryotherapy to lesions adjacent to or within the 25 cm2 Treatment Area.

Within 4 weeks: Systemic steroid therapy: chemotherapeutic agents, psoralens, immunotherapy, or retinoids.","Aldara™ (imiquimod) cream, 5%

Aldara™: 5% topical cream dispensed in individual 0.25 g sachets applied twice a week for 16 weeks",ChEMBL:CHEMBL1282 | DrugBank:DB00724 | PubChem:57469,Imiquimod,CC(C)Cn1cnc2c(N)nc3ccccc3c21,D06BB10,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00955266,NCT00955266_EG000,No,All,Adult | Older Adult,Phase 4,8,"Inclusion Criteria:

Men and women greater than 18 years of age
Undergoing primary elective valve surgery at Brigham and Women's Hospital
Consented for Transesophogeal Echocardiography (TEE) as part of routine intra-operative care and monitoring

Exclusion Criteria:

Patients not consented for TEE as part of routine intra-operative care
Any absolute contraindication to TEE
Ionized calcium level < 0.80 mmol/L near separation from CPB
Myocardial infarction (MI) or acute coronary syndromes < 3 months prior to surgery due to the presence of pre-operative diastolic dysfunction in infarcted or ischemic myocardium
Ejection fraction (EF) < 35%
Atrial fibrillation / flutter the absence of an A wave on mitral inflow Doppler
Heart rate (HR) > 100 during 2 data point collections due to E / A wave superimposition","Calcium chloride, 10mg/kg

Calcium Chloride: Calcium chloride 10mg/kg in 50cc NS delivered over 5 minutes",ChEMBL:CHEMBL1200668 | DrugBank:DB01164,CALCIUM CHLORIDE,[Ca+2].[Cl-].[Cl-],A11GB01 | A12AA07 | B05XA07 | G04BA03,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00956254,NCT00956254_EG001,No,All,Adult | Older Adult,Phase 3,9,"DISEASE CHARACTERISTICS:

Diagnosis of cancer and meets 1 of the following criteria:

Mild mucositis, defined as grade 1 (erythema of the mucosa) or 2 (patchy ulcerations or pseudomembranes) on the day of study drug administration.
No mucositis, defined as normal oral cavity upon examination on the day of study drug administration.
Opioid-tolerant, defined as patients who are taking ≥ 60 mg of oral morphine/day, ≥ 30 mg of oxycodone/day, ≥ 8 mg of oral hydromorphone/day, or an equianalgesic dose of another opioid for ≥ 7 days for cancer-related pain.
Persistent pain related to cancer or its treatment over the past 7 days.
No brain metastases with signs or symptoms of increased intracranial pressure.

PATIENT CHARACTERISTICS:

Negative pregnancy test.
Agree to be confined to study site for approximately 12 hours, to eat only the food served by the study unit during the study confinement period, and to consume all food provided at the designated meal or snack times.
No history of major organ system impairment or disease that, in the investigator's or his/her designee's opinion, could increase the risk associated with the use of opioids.
No uncontrolled hypertension despite antihypertensive therapy or history of hypertensive crisis within the past 2 years.
No recent history (within the past 2 years) of transient ischemic attacks, neural vascular disease, stroke, or cerebral aneurysms.
No intolerable side effects to opioids or fentanyl.

PRIOR CONCURRENT THERAPY:

See Disease Characteristics.
More than 30 days since prior investigational agents.
More than 14 days since prior monoamine oxidase inhibitors.
No prior participation in either Insys Fentanyl Sublingual Spray Phase III study INSYS-INS-05-001 or INSYS-INS-06-007.

No other concurrent use of any fentanyl product.

Patients who have received Actiq®, Fentora®, or Duragesic® are eligible after a 7-day washout.
No concurrent medications (prescription, over-the-counter, vitamin, or herbal substances) except for hormonal contraceptives and/or ≤ 3 doses of acetaminophen at ≤ 1 g each.",Participants received a single administration of fentanyl sublingual spray 100 µg sublingually.,ChEMBL:CHEMBL596 | DrugBank:DB00813 | PubChem:3345,Fentanyl,CCC(=O)N(c1ccccc1)C1CCN(CCc2ccccc2)CC1,N01AH01 | N01AH51 | N02AB03,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00956930,NCT00956930_EG001,No,All,Adult | Older Adult,Phase 2,19,"DISEASE CHARACTERISTICS:

Hepatocellular Carcinoma confined to the liver that is unresectable with surgery or unable to be treated with radiofrequency ablation diagnosed by biopsy or imaging criteria (CT/MRI)
No segmental, lobar, or main portal vein thrombosis as evidenced by CT or MRI imaging

Inclusion Criteria

Adults > 18 years old of either gender
Diagnosis of liver confined HCC confirmed by histology or American Association for the Study of Liver Diseases (AASLD) guidelines [59,60] [appendix A].
Lesions < 1 cm in diameter have a low likelihood of being malignant and should be followed. Lack of growth over 1-2 years suggests it is not HCC.
AFP >200 and radiological evidence (arterial hypervascularity) of lesion > 2 cm does not require biopsy.
Two imaging modalities (triphasic CT, MRI, ultrasound, angiography) demonstrating ""arterial hypervascularity"" in the background of cirrhosis does not require biopsy
One imaging modality with a lesion with arterial hypervascularity with wash out in early or delayed venous phase, does not require a biopsy
Atypical appearances on imaging requires a biopsy.
Non-conclusive biopsy requires closer monitoring
For non-cirrhotics (by biopsy or imaging findings), diagnosis of HCC requires biopsy
Patients with <50% liver involvement
Measurable liver confined disease with bi-dimensional measurements, required within 4 weeks of screening. Lesions reported on imaging as ""too small to characterize"", abdominal lymph nodes < 2.0 cm or ascites in the setting of cirrhosis are not considered metastatic disease unless cytology proven.
No segmental, lobar or main portal vein thrombosis as evidence by cross sectional imaging
Prior resection permitted, no prior systemic, ablative or infusion therapy permitted
Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2 [appendix B]
Childs score of A or B [appendix C]
Required lab parameters within 28 days of screening
Serum bilirubin ≤ 2.0 mg/dl (unless segmental infusion can be performed
AST and ALT ≤ 5 times upper limit of normal (ULN)
Creatinine ≤ 1.5 times ULN
Prothrombin time (PT)/ International normalized ratio (INR) ≤ 2.3 or PT ≤ 6 seconds above control. If subjects are being anticoagulated they can participate if proof of no coagulation abnormality existed prior to use of anticoagulants
Negative serum or urine pregnancy test for females of child bearing potential
Ability to understand and sign the informed consent; patient must have signed informed consent prior to registration on study
Women of childbearing potential and sexually active males must use contraception while on study
Lesions must be treatable angiographically by either radioembolization or chemoembolization.

Exclusion criteria

Cardiac disease: Congestive heart failure > class II New York Heart Association (NYHA). Patients must not have unstable angina (angina symptoms at rest) or new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months.
Patients with infiltrative HCC are not eligible.
Patients with bulk disease (≥70% tumor replacement of liver) are not eligible.
Patients with ≥50% tumor replacement of liver, with an albumin < 3.0 g/dl are not eligible.
Major surgery within 4 weeks prior to the screening visit
Active clinically serious infection > Common Toxicity Criteria for Adverse Events (CTCAE v 4.0) Grade 2
Any condition (psychological, physical or use/abuse of substances) which, in the opinion of the principal investigator (PI) or a sub-investigator (sub-I), would possibly endanger the subject during their participation in the study, or allow for non-compliance with the investigational drug and treatment under study.
Due to the experimental nature of the therapy and the unknown risk to a fetus, pregnant and/or lactating women are not eligible to participate in this study.
In the opinion of the investigator, patient is not a candidate/lesion not amenable for RFA (e.g. lesion location, shape, abnormal coagulation parameters, multi-focality).","Patients undergo chemoembolization (TACE) with mitomycin C, doxorubicin hydrochloride, and cisplatin by hepatic artery infusion for approximately 1-3 courses.

Doxorubicin: 75mg fixed dose",ChEMBL:CHEMBL417 | ChEMBL:CHEMBL53463 | DrugBank:DB00445 | DrugBank:DB00997 | PubChem:1691 | PubChem:31703 | PubChem:41867,Epirubicin,COc1cccc2c1C(=O)c1c(O)c3c(c(O)c1C2=O)CC(O)(C(=O)CO)CC3OC1CC(N)C(O)C(C)O1,L01DB01 | L01DB03,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT00958919,NCT00958919_EG001,No,All,Adult | Older Adult,Not Applicable,14,"Inclusion Criteria:

Male or female patient 50 years of age or older;
A diagnosis of COPD defined by American Thoracic Society-European Respiratory Society criteria
Current or former smoker with a smoking history of greater than or equal to 10 pack-years;
A post-bronchodilator forced expiratory volume in one second (FEV1) greater than or equal to 30% predicted and less than or equal to 80% predicted; AND
A post-bronchodilator FEV1/forced vital capacity ratio less than 70%; and clinically stable COPD.

Exclusion Criteria:

Any patient who has a concomitant disease that might interfere with study procedures or evaluation;
Inability to perform resistive breathing maneuvers; OR
Any current use of a narcotic medication.",10mg/25ml Intravenous,ChEMBL:CHEMBL80 | DrugBank:DB01183 | PubChem:5284596,Naloxone,C=CCN1CC[C@]23c4c5ccc(O)c4O[C@H]2C(=O)CC[C@@]3(O)[C@H]1C5,A06AH04 | N02AA53 | N02AA55 | N02AX51 | V03AB15,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00960141,NCT00960141_EG001,No,All,Child | Adult | Older Adult,Phase 3,326,"Inclusion Criteria:

Patient has a documented clinical history of seasonal allergic rhinitis symptoms that become worse during the study season
Patient is a non-smoker
Patient is in good mental and physical health

Exclusion Criteria:

Patient is hospitalized
Patient is a woman who is <8 weeks postpartum or is breast feeding
Patient intends to move or vacation away during the study
Patient is a current or past abuser of alcohol or illicit drugs",Montelukast 10 mg tablet and Loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.,PubChem:23663996,Montelukast Sodium,CC(C)(O)c1ccccc1CCC(SCC1(CC(=O)[O-])CC1)c1cccc(C=Cc2ccc3ccc(Cl)cc3n2)c1.[Na+],,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00960570,NCT00960570_EG000,Accepts Healthy Volunteers,All,Adult,Phase 1,30,"Inclusion Criteria:

Healthy adults 18-45 years of age
Non-smoking
Non-pregnant (post-menopausal, surgically sterile or using effective contraceptive measures)
Body mass index (BMI) less than 30
Medically healthy on the basis of medical history and physical examination
Hemoglobin > or = to 12g/dL
Completion of the screening process within 28 days prior to dosing
Provision of voluntary written informed consent

Exclusion Criteria:

Recent participation (within 28 days) in other research studies
Recent significant blood donation or plasma donation
Pregnant or lactating
Test positive at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HbsAg), or hepatitis C virus (HCV)
Recent (2-year) history or evidence of alcoholism or drug abuse
History or presence of significant cardiovascular, pulmonary, hepatic, gallbladder or biliary tract, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease
Subjects who have used any drugs or substances known to inhibit or induce cytochrome (CYP) P450 enzymes and/or P-glycoprotein (P-gp) within 28 days prior to the first dose and throughout the study
Drug allergies to fenofibric acid or efavirenz","On the morning of Day 1, subjects received a single dose of efavirenz 600 mg after an overnight fast of at least 10 hours, followed by a 21 day washout period.",ChEMBL:CHEMBL223228 | DrugBank:DB00625 | PubChem:64139,Efavirenz,O=C1Nc2ccc(Cl)cc2[C@@](C#CC2CC2)(C(F)(F)F)O1,J05AG03 | J05AR06 | J05AR11,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00962429,NCT00962429_EG000,No,All,Adult | Older Adult,Phase 2,7,"Inclusion Criteria:

diagnosis of CIDP
on a stable dose of immunotherapy for at least 3 months before enrolling in the study

Exclusion Criteria:

myelopathy or evidence of central demyelination
persistent neurological deficits from stroke, CNS trauma, or peripheral neuropathy from other causes (eg, diabetes mellitus, IgM, paraproteinaemia, or uraemic, toxic, or familial neuropathy)
evidence of systemic disease that might cause neuropathy
heart diseases (congestive heart failure or arrhythmia)
pulmonary conditions (asthma or CIPD)
rheumatoid conditions (such as rheumatoid arthritis)
renal failure","alpha lipoic acid

lipoic acid: Subjects will be started on a single daily dose of 600 mg of alpha lipoic acid or placebo for the first 4 weeks and then increased to 1200 mg for the remainder of the study.",ChEMBL:CHEMBL33864 | DrugBank:DB00166 | PubChem:6112 | PubChem:864,Lipoic acid,O=C(O)CCCCC1CCSS1,A16AX01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00962429,NCT00962429_EG001,No,All,Adult | Older Adult,Phase 2,7,"Inclusion Criteria:

diagnosis of CIDP
on a stable dose of immunotherapy for at least 3 months before enrolling in the study

Exclusion Criteria:

myelopathy or evidence of central demyelination
persistent neurological deficits from stroke, CNS trauma, or peripheral neuropathy from other causes (eg, diabetes mellitus, IgM, paraproteinaemia, or uraemic, toxic, or familial neuropathy)
evidence of systemic disease that might cause neuropathy
heart diseases (congestive heart failure or arrhythmia)
pulmonary conditions (asthma or CIPD)
rheumatoid conditions (such as rheumatoid arthritis)
renal failure","sugar pill

lipoic acid: Subjects will be started on a single daily dose of 600 mg of alpha lipoic acid or placebo for the first 4 weeks and then increased to 1200 mg for the remainder of the study.",ChEMBL:CHEMBL33864 | DrugBank:DB00166 | PubChem:6112 | PubChem:864,Lipoic acid,O=C(O)CCCCC1CCSS1,A16AX01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00963040,NCT00963040_EG001,No,All,Adult | Older Adult,Not Applicable,18,"Inclusion Criteria:

Headache on equal to or more than 15 days per month for at least 6 months; the headaches can be migraine or tension.
More than half of the monthly headaches are of moderate or severe intensity on the 4-point categorical pain rating scale and are assessed as 6 or higher on the 11-point numerical pain rating scale.
Headaches typically last for at least 4 hours.
Subjects are on a stable headache treatment, if any, for at least 2 months.

Exclusion Criteria:

Headache symptoms assessed to be predominately occipital.
Allergy to oxytocin.
History of addictive behavior (e.g. alcoholism, drug abuse).
History of significant psychiatric disorder.
History of clinically-significant, functionally-impairing cardiovascular or pulmonary disease.
Upper-respiratory tract infection at the time of randomization.
Past or current history of any condition that may hinder study procedures or confuse interpretation of data.
Nasal obstruction of any cause as determined at screening.
Major surgery or trauma within 4 weeks of screening.
Women who are pregnant as evidenced by a serum HCG, nursing, or trying to conceive.
Use of intranasally administered medications, for example, vasoconstrictors or corticosteroids, within 2 weeks of randomization.
Use of an investigational medication or device within 30 days of randomization.
Unable or unwilling to adhere to the study-specific procedures and restrictions.
Any condition that in the opinion of the investigator would compromise the safety of the subject or the quality of the data.
Alanine aminotransaminase (ALT) or aspartate aminotransaminase (AST) equal or greater than 3 times the upper limit of normal (ULN).
Serum creatinine of equal or greater than 1.8 mg/dL. Resting, sitting systolic blood pressure equal or greater than 160 mmHg or diastolic blood pressure equal or greater than 100 mmHg at screening. For patients with previously diagnosed hypertension, antihypertensive medications must be stable for at least 30 days prior to screening.",Administration of placebo similar to oxytocin arm: 4 actuations in each nostril of sterile water with in-clinic observation for 2 hours post-dose in the TI004 study,ChEMBL:CHEMBL1098659 | DrugBank:DB09145 | PubChem:10129877 | PubChem:24602 | PubChem:962,Water,O,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00963040,NCT00963040_EG003,No,All,Adult | Older Adult,Not Applicable,8,"Inclusion Criteria:

Headache on equal to or more than 15 days per month for at least 6 months; the headaches can be migraine or tension.
More than half of the monthly headaches are of moderate or severe intensity on the 4-point categorical pain rating scale and are assessed as 6 or higher on the 11-point numerical pain rating scale.
Headaches typically last for at least 4 hours.
Subjects are on a stable headache treatment, if any, for at least 2 months.

Exclusion Criteria:

Headache symptoms assessed to be predominately occipital.
Allergy to oxytocin.
History of addictive behavior (e.g. alcoholism, drug abuse).
History of significant psychiatric disorder.
History of clinically-significant, functionally-impairing cardiovascular or pulmonary disease.
Upper-respiratory tract infection at the time of randomization.
Past or current history of any condition that may hinder study procedures or confuse interpretation of data.
Nasal obstruction of any cause as determined at screening.
Major surgery or trauma within 4 weeks of screening.
Women who are pregnant as evidenced by a serum HCG, nursing, or trying to conceive.
Use of intranasally administered medications, for example, vasoconstrictors or corticosteroids, within 2 weeks of randomization.
Use of an investigational medication or device within 30 days of randomization.
Unable or unwilling to adhere to the study-specific procedures and restrictions.
Any condition that in the opinion of the investigator would compromise the safety of the subject or the quality of the data.
Alanine aminotransaminase (ALT) or aspartate aminotransaminase (AST) equal or greater than 3 times the upper limit of normal (ULN).
Serum creatinine of equal or greater than 1.8 mg/dL. Resting, sitting systolic blood pressure equal or greater than 160 mmHg or diastolic blood pressure equal or greater than 100 mmHg at screening. For patients with previously diagnosed hypertension, antihypertensive medications must be stable for at least 30 days prior to screening.",Administration of placebo similar to oxytocin arm: 7 actuations of sterile with 5-minute intervals followed by 4 hours post-dose of in-clinic observation in the TI005 study.,ChEMBL:CHEMBL1098659 | DrugBank:DB09145 | PubChem:10129877 | PubChem:24602 | PubChem:962,Water,O,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT00963469,NCT00963469_EG001,No,All,Child | Adult | Older Adult,Phase 3,448,"Inclusion Criteria:

Patient has a history of seasonal allergic rhinitis that worsens during the study season
Patient is a nonsmoker
Patient is in good health physical and mental health

Exclusion Criteria:

Patient is hospitalized
Patient is a woman who is < 8 weeks postpartum or is breastfeeding
Patient plans to move or vacation away during the study
Patient has had any major surgery with in past 4 weeks
Patient is a current or past abuser of alcohol or illicit drugs",Montelukast 10-mg tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks,PubChem:23663996,Montelukast Sodium,CC(C)(O)c1ccccc1CCC(SCC1(CC(=O)[O-])CC1)c1cccc(C=Cc2ccc3ccc(Cl)cc3n2)c1.[Na+],,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00964002,NCT00964002_EG000,No,Male,Adult | Older Adult,Phase 2,59,"DISEASE CHARACTERISTICS:

Histologically confirmed prostate cancer

Metastatic disease
Castration-refractory disease
No clinical symptoms related to disease progression

PATIENT CHARACTERISTICS:

WHO performance status 0-2

PRIOR CONCURRENT THERAPY:

Not specified","Patients will receive efavirenz 600 mg daily as oral tablets at bedtime and in fast condition (1-2 hours far from dinner) until objective biological, radiological or clinical disease progression or study discontinuation (withdrawal of consent or when the patient meets one criterion for treatment discontinuation).

Individual dose escalation will be possible: if biological progression occurs at month 3, dose could be increased to 1200 mg/day in asymptomatic and non radiological progression patients (by step of 200 mg every 15 days).

efavirenz",ChEMBL:CHEMBL223228 | DrugBank:DB00625 | PubChem:64139,Efavirenz,O=C1Nc2ccc(Cl)cc2[C@@](C#CC2CC2)(C(F)(F)F)O1,J05AG03 | J05AR06 | J05AR11,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00974220,NCT00974220_EG001,No,All,Adult | Older Adult,Not Applicable,16,"Inclusion Criteria:

Post-bronchodilator forced expiratory volume in 1 sec (FEV1) 30-79% predicted, FEV1/forced vital capacity (FVC) ratio <70%;
Clinically stable as defined by no changes in medication dosage or frequency of administration with no exacerbations or hospital admissions in the preceding 6 weeks;
A cigarette smoking history ≥20 pack-years;
Significant chronic activity-related dyspnea as defined by a Baseline Dyspnea Index focal score ≤ 6;
Body mass index (BMI) between 18.5 and 30.0 kg/m2;
Able to perform all study procedures and provide/sign informed consent.

Exclusion Criteria:

A diffusing capacity of the lung for carbon monoxide (DLCO) <40 %predicted;
Presence of active cardiopulmonary disease other than COPD that could contribute to dyspnea and exercise limitation;
Clinical diagnosis of sleep disordered breathing;
A history/clinical evidence of asthma, atopy and/or nasal polyps;
History of allergy or adverse reaction to fentanyl;
Presence of important contraindications to clinical exercise testing, including inability to exercise because of neuromuscular or musculoskeletal disease(s);
Use of daytime oxygen or exercise-induced arterial oxygen desaturation to <80% on room air;
Use of antidepressant drugs (i.e., monoamine oxidase inhibitors, serotonin reuptake inhibitors) in previous 2 weeks;
Use of opioid or pain relieving drugs (e.g., morphine, fentanyl, oxycodone, hydromorphone, methadone, levorphanol, codeine, hydrocodone, meperidine) in previous 4 weeks.",nebulized fentanyl citrate (50 mcg),ChEMBL:CHEMBL596 | DrugBank:DB00813 | PubChem:3345,Fentanyl,CCC(=O)N(c1ccccc1)C1CCN(CCc2ccccc2)CC1,N01AH01 | N01AH51 | N02AB03,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00974480,NCT00974480_EG001,Accepts Healthy Volunteers,Female,Adult,Not Applicable,40,"Inclusion Criteria:

Subjects are female, between 45 and 55 years of age.
Females of childbearing potential have had a negative urine pregnancy test prior to randomization.
Subjects are willing to use adequate contraceptive method or are surgically sterile (including tubal ligation), post-menopausal, abstinent or with a same-sex partner. Adequate means of contraception include; intra-uterine device (IUD) in use for 30 days before Day 0, barrier methods and spermicide in use at least 14 days before Day 0 or oral contraceptive in use for at least 30 days before Day 0.
Subjects are willing to avoid prolonged exposure to UV radiation for the duration of the study.
Subjects are capable of giving written informed consent.
Subjects have changes associated with facial skin aging/photodamaged skin.

Exclusion Criteria:

Subjects are male.
Subjects are pregnant or lactating.
Subjects have a known allergy to Redermic, Rejuva-A™ or to any component of the tested products.
Subjects have made use of tretinoin, adapalene, tazarotene or other topical medications for the treatment of facial skin aging during the 12 weeks preceding Day 0.
Subjects have applied topical alpha hydroxyl acids within 28 days of Day 0.
Subjects have used or plan to use systemic corticosteroids within 28 days of Day 0 or during the study.
Subjects have made use of a non-medication topical product directed at improving skin aging during the 28 days preceding Day 0.
Subjects have a hypersensitivity to any retinoids.
Subjects have a history of alcohol or drug abuse in the past year.
Subjects are participating in another interventional study.
Subjects have had a previous intense pulsed light treatment to the face.
Subjects have had a previous laser treatment to the face directed at improving skin aging.
Subjects have the presence of skin diseases such as psoriasis or dermatitis on the face that could interfere with study evaluations.
Planned or unavoidable exposure to intense ultraviolet (UV) radiation during the study (such as sun tanning salons, vacations in a sunny climate or outdoor worker).
Subjects have had a botulinum toxin A injection treatment on the face within 2 years of Day 0 or plan to receive this treatment during the study.
Subjects have had a filler injection (collagen, hyaluronic acid, etc..) on the face within 2 years of Day 0 or plan to receive this treatment during the study.","Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remained there until the end of study. Neutral cream was applied to the face in the morning every day for 24 weeks.",ChEMBL:CHEMBL38 | ChEMBL:CHEMBL547 | ChEMBL:CHEMBL705 | DrugBank:DB00523 | DrugBank:DB00755 | DrugBank:DB00982 | PubChem:444795 | PubChem:449171 | PubChem:5282379,Tretinoin,CC(C=CC1=C(C)CCCC1(C)C)=CC=CC(C)=CC(=O)O,D10AD01 | D10AD04 | D10AD51 | D10AD54 | D10BA01 | D11AH04 | L01XF01 | L01XF02,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00975143,NCT00975143_EG000,No,All,Child | Adult,Phase 3,464,"Inclusion Criteria:

Severe recalcitrant nodular acne, which in the opinion of the investigator is compatible with isotretinoin treatment.
Ten (10) or more nodular lesions (facial and/or truncal).
Treatment-naïve patients without any prior exposure to systemic isotretinoin or other retinoids.
Age between 12 and 54 years.
Weight between 40 and 110 kg.
Negative serum human chorionic gonadotropin (hCG) pregnancy test consistent with a non-pregnant state (females only).
No significant disease or clinically significant finding in a physical examination.
No clinically significant abnormal laboratory value.
No clinically significant abnormal vital sign measurement.
Patients presenting with stable and controlled diabetes mellitus (Types I and II) may be included in the study. However, patients should not have had a hospitalization for any diabetes related complications in the last 12 months, and must be on stable medication for the preceding 6 months. To be included in the study, the patients should have Hemoglobin-A1c values ≤ 6.5% at screening and in the test done 3 - 4 months previously.
Patients with previously diagnosed Polycystic Ovarian Syndrome (PCOS) may be included in the study if in the opinion of the investigator they do not have any other clinically significant abnormality (e.g. metabolic syndrome or elevated lipids).

Exclusion Criteria:

Female patients will be excluded from the study if they:

Are pregnant;
Are at high risk for becoming pregnant or likely to become pregnant during treatment;
Will be breast-feeding or considering breast feeding during the course of the study.
Known history or presence of any clinically significant unstable medical condition(s) which in the opinion of the investigator could pose a risk for the safety of the patient including any previous history of gastrointestinal disease.
Patients with any skin disease or other condition that might interfere with the evaluation of recalcitrant nodular acne.
Patients will be interviewed using the SCID-CT current and lifetime modules for Major Depression, Mania, and Psychosis. Patients with a lifetime history of psychosis will be excluded. Patients with a history of major depressive, manic, hypomanic or mixed episodes will not be excluded unless they have had an episode during the preceding year.
Patients with any past or current psychotic symptoms.
Patients reporting any suicidal behaviour (including attempts, interrupted attempts, aborted attempts, or other preparatory behaviours), within the past year, or serious suicidal ideation in the past year, will be excluded from study participation.
A lifetime history of wishing to be dead, non-specific active suicidal thoughts or active suicidal ideation without intent to act will not result in exclusion.
Known history or suspected carcinoma.
Known history of liver or kidney disorders (hepatic and renal insufficiency).
Known history or current pseudotumor cerebri (benign intracranial hypertension).
Patients with HLA-B27 related disease, rheumatoid arthritis, rickets or other vitamin D depletion disease or phosphate metabolic disease, severe scoliosis > 15 Cobb angle, history of back surgery/injuries, ongoing use of anticonvulsants known to affect bone metabolism and other genetic or acquired rheumatologic and joint diseases.
All pediatric patients with serum 25-hydroxyvitamin D levels < 20 ng/mL.
Patients with hearing disorders who in the opinion of the investigator would not be able to participate in audiometric testing for the study.
Hypersensitivity or idiosyncratic reaction to isotretinoin, Vitamin A and/or any other drug substances with similar activity.
Allergy to soy beans, soy bean oil or any other ingredients in the study medications.
On a special diet within four weeks prior to drug administration (e.g., liquid, protein, raw food diet).
Difficulty consuming two (2) meals a day to sustain weight and health.","CIP-Isotretinoin 10 mg and 20 mg capsules taken with meals, at an initial titration dose of approximately 0.5 mg/kg/day, divided into 2 doses for the first 4 weeks, followed by approximately 1 mg/kg/day divided into 2 doses for 16 weeks",ChEMBL:CHEMBL38 | ChEMBL:CHEMBL547 | ChEMBL:CHEMBL705 | DrugBank:DB00523 | DrugBank:DB00755 | DrugBank:DB00982 | PubChem:444795 | PubChem:449171 | PubChem:5282379,Tretinoin,CC(C=CC1=C(C)CCCC1(C)C)=CC=CC(C)=CC(=O)O,D10AD01 | D10AD04 | D10AD51 | D10AD54 | D10BA01 | D11AH04 | L01XF01 | L01XF02,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT00975143,NCT00975143_EG001,No,All,Child | Adult,Phase 3,460,"Inclusion Criteria:

Severe recalcitrant nodular acne, which in the opinion of the investigator is compatible with isotretinoin treatment.
Ten (10) or more nodular lesions (facial and/or truncal).
Treatment-naïve patients without any prior exposure to systemic isotretinoin or other retinoids.
Age between 12 and 54 years.
Weight between 40 and 110 kg.
Negative serum human chorionic gonadotropin (hCG) pregnancy test consistent with a non-pregnant state (females only).
No significant disease or clinically significant finding in a physical examination.
No clinically significant abnormal laboratory value.
No clinically significant abnormal vital sign measurement.
Patients presenting with stable and controlled diabetes mellitus (Types I and II) may be included in the study. However, patients should not have had a hospitalization for any diabetes related complications in the last 12 months, and must be on stable medication for the preceding 6 months. To be included in the study, the patients should have Hemoglobin-A1c values ≤ 6.5% at screening and in the test done 3 - 4 months previously.
Patients with previously diagnosed Polycystic Ovarian Syndrome (PCOS) may be included in the study if in the opinion of the investigator they do not have any other clinically significant abnormality (e.g. metabolic syndrome or elevated lipids).

Exclusion Criteria:

Female patients will be excluded from the study if they:

Are pregnant;
Are at high risk for becoming pregnant or likely to become pregnant during treatment;
Will be breast-feeding or considering breast feeding during the course of the study.
Known history or presence of any clinically significant unstable medical condition(s) which in the opinion of the investigator could pose a risk for the safety of the patient including any previous history of gastrointestinal disease.
Patients with any skin disease or other condition that might interfere with the evaluation of recalcitrant nodular acne.
Patients will be interviewed using the SCID-CT current and lifetime modules for Major Depression, Mania, and Psychosis. Patients with a lifetime history of psychosis will be excluded. Patients with a history of major depressive, manic, hypomanic or mixed episodes will not be excluded unless they have had an episode during the preceding year.
Patients with any past or current psychotic symptoms.
Patients reporting any suicidal behaviour (including attempts, interrupted attempts, aborted attempts, or other preparatory behaviours), within the past year, or serious suicidal ideation in the past year, will be excluded from study participation.
A lifetime history of wishing to be dead, non-specific active suicidal thoughts or active suicidal ideation without intent to act will not result in exclusion.
Known history or suspected carcinoma.
Known history of liver or kidney disorders (hepatic and renal insufficiency).
Known history or current pseudotumor cerebri (benign intracranial hypertension).
Patients with HLA-B27 related disease, rheumatoid arthritis, rickets or other vitamin D depletion disease or phosphate metabolic disease, severe scoliosis > 15 Cobb angle, history of back surgery/injuries, ongoing use of anticonvulsants known to affect bone metabolism and other genetic or acquired rheumatologic and joint diseases.
All pediatric patients with serum 25-hydroxyvitamin D levels < 20 ng/mL.
Patients with hearing disorders who in the opinion of the investigator would not be able to participate in audiometric testing for the study.
Hypersensitivity or idiosyncratic reaction to isotretinoin, Vitamin A and/or any other drug substances with similar activity.
Allergy to soy beans, soy bean oil or any other ingredients in the study medications.
On a special diet within four weeks prior to drug administration (e.g., liquid, protein, raw food diet).
Difficulty consuming two (2) meals a day to sustain weight and health.","(Generic) Isotretinoin 10 mg and 20 mg capsules taken with meals, at an initial titration dose of approximately 0.5 mg/kg/day, divided into 2 doses for the first 4 weeks, followed by approximately 1 mg/kg/day divided into 2 doses for 16 weeks",ChEMBL:CHEMBL38 | ChEMBL:CHEMBL547 | ChEMBL:CHEMBL705 | DrugBank:DB00523 | DrugBank:DB00755 | DrugBank:DB00982 | PubChem:444795 | PubChem:449171 | PubChem:5282379,Tretinoin,CC(C=CC1=C(C)CCCC1(C)C)=CC=CC(C)=CC(=O)O,D10AD01 | D10AD04 | D10AD51 | D10AD54 | D10BA01 | D11AH04 | L01XF01 | L01XF02,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT00979550,NCT00979550_EG000,No,All,Child | Adult,Phase 2,7,"Inclusion Criteria:

Male or female patient between the ages of 2 and 60 years with a vascular malformation that is seeking cosmetic treatment.
All races will be included as well as male and female.
Clinical data on the usage of Aldara below the age of 2 years is limited and therefore all patients in the study will have to be at least 2 years of age.
The majority of port wine stains are initially treated during childhood
In order to determine the effectiveness of Aldara as an adjunct to laser therapy of Port Wine Stains, some of the patients in the study need to have lesions that have not undergone previous treatment.

Exclusion Criteria:

Patients under the age of 2 or over the age of 60.
Patients that have serious medical problems that would put them at risk of the anesthesia.
Patients that have sensitivity reactions to the ingredients in the product including imiquimod, isostearic acid, cetyl alcohol, stearyl alcohol, white petrolatum, polysorbate 60, sorbitan monostearate, glycerin, xanthan gum, purified water, benzyl alcohol, methylparaben, and propylparaben.
Patients who are pregnant or have significant immunodeficiency or autoimmune diseases.",Imiquimod (Aldara cream) will be applied nightly for four weeks after standard of care laser treatment for port wine stain.,ChEMBL:CHEMBL1282 | DrugBank:DB00724 | PubChem:57469,Imiquimod,CC(C)Cn1cnc2c(N)nc3ccccc3c21,D06BB10,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00982488,NCT00982488_EG003,No,All,Adult | Older Adult,Phase 2,3,"Key Inclusion Criteria

Signed written informed consent
Received treatment in protocols CA180-005, CA180-006, CA180-013, CA180-015 or CA180-017, or CA180-039
Received clinical benefit with dasatinib or imatinib (study CA180017) in the opinion of the Investigator
Men and women, ages 18 and older

Key Exclusion Criteria

A serious uncontrolled medical disorder or active infection that would impair the ability of the patient to receive protocol therapy
Dementia or altered mental status that would prohibit the understanding or rendering of informed consent
Patients currently taking drugs, including but not limited to quinidine, procainamide, disopyramide, amiodarone, sotalol, ibutilide, dofetilide, erythromycins, clarithromycin, chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide, ziprasidone, cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone, halofantrine, levomethadyl, pentamidine, sparfloxacin, and lidoflazine, which are generally accepted to have a risk of causing Torsades de Pointes
Patients taking medications known to be potent CYP3A4 inhibitors (ketoconazole, ritonavir) or inducers (rifampin, efavirenz)","Participants with advanced phase disease, myeloid blast phase (MBP), were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID. Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.",ChEMBL:CHEMBL1421 | DrugBank:DB01254 | PubChem:3062316,Dasatinib,Cc1nc(Nc2ncc(C(=O)Nc3c(C)cccc3Cl)s2)cc(N2CCN(CCO)CC2)n1,L01EA02 | L01XE06,0.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT00982930,NCT00982930_EG000,No,All,Child | Adult,Phase 3,55,"Inclusion Criteria:

Completed all visits in study CTBM100C2303, and visit 4 took place not more than 5 days before enrollment into this study.
Confirmed diagnosis of cystic fibrosis participants with P. aeruginosa infection.
Forced Expiratory Volume in One Second (FEV1) at screening (study CTBM100C2303) must be between 25% and 80% of normal predicted values.

Exclusion Criteria:

Any use of inhaled anti-pseudomonal antibiotics between the termination of the core trial CTMB100C2303 and the enrollment into this study.
Known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics.","Participants received 112 mg (four 28 mg capsules) of TIP administered by the T-326 Inhaler, b.i.d., given in a cycle of 28 days on treatment followed by 28 days off treatment (one cycle = 56 days) for up to 3 cycles.",ChEMBL:CHEMBL1747 | DrugBank:DB00684 | PubChem:36294,Tobramycin,NC[C@H]1O[C@H](O[C@H]2[C@H](O)[C@@H](O[C@H]3O[C@H](CO)[C@@H](O)[C@H](N)[C@H]3O)[C@H](N)C[C@@H]2N)[C@H](N)C[C@@H]1O,J01GB01 | S01AA12,0.0,0.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT00982995,NCT00982995_EG000,No,All,Adult | Older Adult,Phase 2,3,"Inclusion Criteria:

Patient must be at least 18 years old.
Patient must have a terminal diagnosis, with estimated survival of 6 months or less.
Patients must have nausea and/or vomiting, not relieved with 1 or more anti-nausea medications. If the patient is treated with an anti-nausea medication, a minimum of 2 hours should pass to ensure that the medication is given a chance to be effective. If there is no relief after 2 hours, then the patient may be treated with palonosetron.
Patient's medications must be reviewed. Any medications possibly causing nausea should be stopped if possible. For example, if an opiate is suspected of causing nausea, another opiate should be substituted. However, if this is not effective, or if a medication change cannot be made, then the patient would be eligible for this study.
Patient must be able to understand and sign informed consent
Patients who have a bowel obstruction that will not be relieved by surgery may be enrolled. This includes patients whose obstruction is technically unresectable, or who are medically too ill to endure a surgery, or who refuse surgical intervention for any reason

Exclusion Criteria:

Patient has received chemotherapy in the past 28 days.

Assessment of possible causes of the nausea and vomiting should be done and recorded. If a reversible cause of the nausea is identified, that cause should be treated if possible. If the treatment relieves the nausea, then the patient is excluded from this study. Possible reversible causes of nausea and vomiting that should be excluded are:

Other medical conditions such as benign positional vertigo, etc.","Palonosetron 0.25 mg I.V. bolus

Palonosetron: Palonosetron 0.25 mg as an I.V. bolus. After Palonosetron treatment, no other nausea medication will be given for 2 hours. At that point, if no relief from nausea or vomiting has occured then other anti-nausea medications may be prescribed, and patient will be taken off study. If relief from nausea and vomiting as a result of the Palonosetron occurs, patient will not receive any more anti-nausea medication unless nausea recurs. If it does recur and patient wishes to be retreated with Palonosetron. This may be repeated for a total of 3 doses, as long as it is providing relief.",ChEMBL:CHEMBL1189679 | DrugBank:DB00377 | PubChem:6337614,Palonosetron,[H][C@]12CCCc3cccc(c31)C(=O)N([C@@H]1CN3CCC1CC3)C2,A04AA05 | A04AA55,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT00986310,NCT00986310_EG000,No,All,Adult | Older Adult,Not Applicable,2,"Inclusion Criteria:

Adult patients with temporal lobe epilepsy, aged 18-65.
Medical intractability of seizures such that VET to determine candidacy for epilepsy surgery is determined to be clinically appropriate for the patient by the primary treating epileptologist.
Intelligence Quotient >70.
Native English speaker or adequate fluency in English to provide informed consent.
Female patients of child-bearing potential must be using an acceptable method of contraception, including abstinence.

Exclusion Criteria:

Progressive neurological disease.
Severe depression, bipolar disease or psychosis.
History of suicidal ideation or intent.
Clinically significant concurrent medical illness, including hepatic or renal insufficiency and diabetes.
Pregnant or lactating women.
Current heavy alcohol or illicit drug use.
Patients already taking fluoxetine or other selective serotonin reuptake inhibitors (SSRIs).
Concurrent use of monoaminoxidase inhibitors, antipsychotic agents, antidepressant agents other than SSRIs or frequent use of triptan agents.
History of a previous allergic reaction or adverse effects with SSRIs.
History of serotonin syndrome.","Patients will be randomized to receive either 20 mg/day of fluoxetine (one pill) or placebo (one pill), to be started one week prior to the scheduled hospital admission date. The dose will be increased to two pills per day on day 1 of hospitalization bringing the total dose of fluoxetine to 40 mg/day in patients randomized to receive this medication. On the day of discharge from the hospital, the study medication will be reduced to 1 pill per day and the patient will be instructed to stop the medication one week following discharge.

Fluoxetine: Subjects randomized to fluoxetine will receive 20mg/day (one pill) for one week. The dose will be increased to 40mg/day (two pills) for the duration of hospitalization for VET. The dose will be decreased to 20 mg/day (one pill) from the day of hospital discharge for one week, at which time the medication will be discontinued.",ChEMBL:CHEMBL41 | DrugBank:DB00472 | PubChem:3386,Fluoxetine,CNCCC(Oc1ccc(C(F)(F)F)cc1)c1ccccc1,N06AB03 | N06CA03,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00990509,NCT00990509_EG000,No,All,Adult | Older Adult,Phase 2,5,"Inclusion Criteria:

Primary supratentorial ICH
< 48 hours from symptom onset
Age >18
Signed informed consent obtained from the patient or patient's legally authorized representative

Exclusion Criteria:

ICH volume < 5 cc
Glasgow Coma Scale < 6
Surgical evacuation anticipated
Pre-existing medical, neurological or psychiatric disease that would confound the neurological, functional, or imaging evaluations
Pregnancy or breastfeeding
Hemodynamic instability (SBP < 100 mmHg, > 200 mmHg)
Current participation in another experimental treatment protocol
Renal impairment with GFR < 30 or Creatinine > 2.0
History of or known allergy to albumin
History of or known severe allergy to rubber latex
Episode/exacerbation of congestive heart failure (CHF) from any cause in the last 6 months. (An episode of congestive heart failure is any heart failure that required a change in medication, diet or hospitalization)
Acute myocardial infarction in the last 6 months
Elevated serum troponin level on admission > 0.1 mcg/L
Known valvular heart disease with CHF in the last 6 months
Known (or in the investigator's judgment) existence of severe aortic stenosis or mitral stenosis
Cardiac surgery involving thoracotomy (e.g., coronary artery bypass graft (CABG), valve replacement surgery) in the last 6 months
Suspicion of aortic dissection on admission
Acute arrhythmia (including any tachy- or bradycardia) with hemodynamic instability on admission (systolic blood pressure < 100 mmHg).
Findings on physical examination of any of the following: (1) jugular venous distention (JVP > 4 cm above the sternal angle); (2) 3rd heart sound; (3) resting tachycardia (heart rate > 100/min) attributable to congestive heart failure; (4) abnormal hepatojugular reflux; (5) lower extremity pitting edema attributable to congestive heart failure or without apparent cause; (6) bilateral rales; and/or (7) if a chest x-ray is performed, definite evidence of pulmonary edema, bilateral pleural effusion, or pulmonary vascular redistribution.
Current acute or chronic lung disease requiring supplemental chronic or intermittent oxygen therapy.
Prosthetic heart valves
Contraindication to MRI (metal implant, etc.)
Documented left ventricular ejection fraction < 35%","Albumin: Three (3) daily IV infusions of 1.25 g/kg Albumin (25%) on Days 1-3 following enrollment.

Brain MRI with and without contrast: All subjects will receive 3 brain MRI studies, regardless of if they are randomized into Albumin or Placebo condition.

MRIs will be with and without contrast will be performed at:

Baseline
48 hours after enrollment(approximately Day 3)
96 hours after drug treatment begins (approximately Day 5)",ChEMBL:CHEMBL1663 | DrugBank:DB00556 | PubChem:6432,Perflutren,FC(F)(F)C(F)(F)C(F)(F)F,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT00993967,NCT00993967_EG000,No,All,Child | Adult | Older Adult,Phase 3,200,"Inclusion Criteria:

Completion of 52 weeks in study SNT-III-001
Body weight ≥ 25 kg
Negative urine pregnancy test
Eligibility to participate in the present extension study as confirmed by investigator

Exclusion Criteria:

Safety or tolerability issues arising during the course of SNT-III-001 which in the opinion of the investigator preclude further treatment with idebenone
Clinically significant abnormalities of haematology or biochemistry including, but not limited to, elevations greater than 1.5 times the upper limit of SGOT, SGPT or creatinine
Parallel participation in another clinical drug trial
Pregnancy or breast-feeding
Abuse of drugs or alcohol","1350 mg/day or 2250 mg/day for patients weighing ≤45 kg or >45 kg, respectively.In case of poor tolerability, dose reduction to 450 mg/day or 900 mg/day, respectively, were allowed.

idebenone: Idebenone 1350 mg/d, patients < or equal 45 kg Idebenone 2250 mg/d, patients > 45 kg",ChEMBL:CHEMBL252556 | DrugBank:DB09081 | PubChem:3686,Idebenone,COC1=C(OC)C(=O)C(CCCCCCCCCCO)=C(C)C1=O,N06BX13,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT00995761,NCT00995761_EG000,No,All,Adult | Older Adult,Phase 2,48,"Inclusion Criteria:

patients who were≥ 65 years of age and they had an Easten Cooperative Oncology Group (ECOG) performance status (PS) of 0-2, or the patients who were < 65 years of age and they had an ECOG PS 2
histologically confirmed non-small cell carcinoma
stages IIIB-IV disease
adequate hematologic parameters (hemoglobin concentration of at least 9.0 g/dL, absolute neutrophil count ≥1,500/mm3, and platelet count ≥100,000/mm3), renal function (serum creatinine ≤1.5 mg/dL), and liver function (total bilirubin ≤1.5 mg/dL and serum transaminase level less than twice the upper limit of normal)
at least one bi-dimensionally measurable lesion, according to the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1

Exclusion Criteria:

Active infection
Prior chemotherapy, radiotherapy or surgery for their disease,
A history of myocardial infarction in the last 3 months before entry to the study
Uncontrolled congestive heart failure or hypertension
Uncontrolled diabetes mellitus, pregnancy, lactation or a prior second primary cancer except for cervix cancer in situ or skin cancer
All the patients provided written informed consent before they entered the study","docetaxel 40mg/m2 on day 1,15 every 4weeks cisplatin 40mg/m2 on day 1,15 every 4weeks",DrugBank:DB00515 | PubChem:5460033 | PubChem:5702198,Cisplatin,Cl[Pt]Cl.N.N,L01XA01,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00996164,NCT00996164_EG000,No,Female,Adult,Phase 3,543,"Inclusion criteria:

Premenopausal women who are 18 years old and older
Primary diagnosis of hypoactive sexual desire disorder, generalized acquired type according to Diagnostic and Statistical Manual of Mental Disorder, Fourth Edition, Text Revision, at least 24 weeks in duration.
Stable, monogamous heterosexual relationship for at least one year.
Willing to discuss sexual issues.
Willing to engage in sexual activity at least once a month
Normal pap smear
Must use medically acceptable method of contraception
Able to comply with daily use of a handheld entry device

Exclusion criteria:

Patients who have taken any medication in the protocol List of Prohibited Medications within 30 days before the screening visit.
Patients who meet Diagnostic and Statistical Manual of Mental Disorder, Fourth Edition, Text Revision for: Sexual aversion disorder, substance induced sexual dysfunction, Dyspareunia, vaginismus, gender identity disorder, paraphilia, sexual dysfunction do to a general medical condition.
Partner with inadequately treated organic or psychosexual dysfunction
History of Major Depressive Disorder within six months prior to the screening visit or history of suicidal behavior.
Sexual function impaired by psychiatric disorder
Sexual function impaired by gynecological disorder
Major life stress that could impair sexual function
Substance abuse",flibanserin 100mg po qd,ChEMBL:CHEMBL231068 | DrugBank:DB04908 | PubChem:6918248,Flibanserin,O=c1[nH]c2ccccc2n1CCN1CCN(c2cccc(C(F)(F)F)c2)CC1,G02CX02,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT00996372,NCT00996372_EG000,No,Female,Adult | Older Adult,Phase 3,468,"Inclusion criteria:

Naturally postmenopausal women of any age with at least one ovary
Diagnosis of Hypoactive Sexual Desire Disorder, generalized acquired type,of at least six months duration
Stable, monogamous heterosexual relationship for at least one year
Willing to discuss sexual issues
Willing to engage in sexual activity at least once a month
Normal Pap smear
Normal mammogram
Normal uterine lining
Able to comply with daily use of handheld data entry device

Exclusion criteria:

Sexual dysfunctions other than HSDD, such as Sexual Aversion Disorder, Substance-induced Sexual Dysfunction, Dyspareunia, Vaginismus, Gender Identity Disorder, Paraphilia and Sexual Dysfunction due to a General Medical Condition
Partner with inadequately treated organic or psychosexual dysfunction
Sexual function impaired by psychiatric disorder
Sexual function impaired by gynecological disorder
Major Depression
Suicidal behavior or ideation
Major life stress that could impair sexual function
Substance abuse","flibanserin 100mg po qd

flibanserin : patients will be randomized to flibanserin or placebo in a double-blind manner",ChEMBL:CHEMBL231068 | DrugBank:DB04908 | PubChem:6918248,Flibanserin,O=c1[nH]c2ccccc2n1CCN1CCN(c2cccc(C(F)(F)F)c2)CC1,G02CX02,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT00996931,NCT00996931_EG000,No,Male,Child,Phase 2,6,"Inclusion Criteria:

Diagnosis of autistic spectrum disorder as defined by DSM-IV criteria.
Inflammatory CSF and serum markers with elevated level of TNF-Alfa (> 50pg/ml) or other Cytokine markers such as IL-1, IL-6 or MECP-1, or serum levels of such cytokines greater than 2X normal levels even in absence of CSF markers.

or

Patients with interictal epiliptiform EEG changes in the absences of clinical seizures, if CSF inflammatory markers are identified.
Patients will maintain any other baseline medications for autistic problems or EEG treatment as long as on these for prior 6-8 weeks with no dosage changes. Mentally impaired minors require a parent or legal guardian to sign the informed consent.

Exclusion Criteria:

-Diagnosis of PPD-NOS and other autism spectrum disorders.
Any serious medical condition, laboratory abnormality, genetic, brain, structural, or psychiatric illness that would prevent the subject from participating.
History of neutropenia, thrombocytopenia or other types of myelosuppression or risk factors for myelosuppression.
History or risk factors for thromboembolic events.
Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
Use of any other experimental drug or therapy within 28 days of baseline.
Current use of steroids (e.g. dexamethasone, prednisone), anthracyclines (Doxil, Adriamycin).
Known hypersensitivity to thalidomide.
The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
Any prior use of lenalidomide.
Known positive for HIV or infectious hepatitis, type A, B or C or tuberculosis.",Six patients will receive 2.5 mg oral daily for 12 weeks,ChEMBL:CHEMBL848 | DrugBank:DB00480 | PubChem:216326,Lenalidomide,Nc1cccc2c1CN(C1CCC(=O)NC1=O)C2=O,L04AX04,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01001806,NCT01001806_EG001,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 4,126,"Inclusion Criteria:

Subjects must be 18 years of age or older.
Scheduled for cataract surgery by phacoemulsification.
Subject must be willing to comply with all study requirements and be willing to give informed consent.

Exclusion Criteria:

Any subject that has a history of uveitis or active iritis.
Subject can have no previous eye surgery, with the exception of refractive surgery, but not within 6 months.
No ocular use of prostaglandins within 2 weeks of surgery.
Use of oral, injectable or topical ophthalmic steroids, nonsteroidal anti-inflammatory (NSAIDS) or immunosuppressants within 14 days prior to surgery.
Contraindications to NSAIDS.
Active ocular infection.",Xibrom to be given 1 drop BID the day before surgery and 3 doses the day of surgery prior to surgery,PubChem:23663409,Duract,Nc1c(CC(=O)[O-])cccc1C(=O)c1ccc(Br)cc1.O.[Na+],,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01002573,NCT01002573_EG001,No,All,Child,Phase 3,53,"Inclusion Criteria:

Have written informed consent provided by legal parent, guardian, or authorized agent prior to participation in the study or study-only related procedures.
Be between birth (28 weeks to < 40 weeks gestational age) to ≤ 16 years of age.
Have new (less than 7 days) onset of fever, documented by temperature greater than or equal to 101.0 ºF (38.3 ºC).

Exclusion Criteria:

Have inadequate intravenous access.
Have received antipyretic drug therapy within 2 hours before dosing.
Have any history of allergy or hypersensitivity to NSAIDs or aspirin.
Have received another investigational drug within the past 30 days.
Be otherwise unsuitable for the study, in the opinion of the Investigator.
Have a fever due to hyperthermia.
Pregnant or nursing.","Acetaminophen, 10mg/kg

acetaminophen: Acetaminophen, 10mg/kg",ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT01005901,NCT01005901_EG000,No,All,Adult | Older Adult,Phase 3,550,"Inclusion Criteria:

1. Diagnosis of COPD (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2008) and:

Smoking history of at least 10 pack-years
Post-bronchodilator FEV1 < 80% and ≥ 30% of the predicted normal value
Post-bronchodilator FEV1/FVC (forced vital capacity) < 70%

Exclusion Criteria:

Patients who have had a lower respiratory tract infection within 6 weeks prior to Visit 1
Patients with concomitant pulmonary disease
Patients with a history of asthma
Any patient with lung cancer or a history of lung cancer
Patients with a history of certain cardiovascular comorbid conditions
Patients with a known history and diagnosis of alpha-1 antitrypsin deficiency
Patients in the active phase of a supervised pulmonary rehabilitation program
Patients contraindicated for tiotropium or ipratropium treatment or who have shown an untoward reaction to inhaled anticholinergic agents Other protocol-defined inclusion/exclusion criteria may apply",Glycopyrronium bromide 50µg delivered once daily via Single Dose Dry Powder Inhaler (SDDPI). At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.,ChEMBL:CHEMBL1201335 | DrugBank:DB00986 | PubChem:3494,GLYCOPYRRONIUM,C[N+]1(C)CCC(OC(=O)C(O)(c2ccccc2)C2CCCC2)C1,A03AB02 | A03CA05 | D11AA01 | R03AL04 | R03AL07 | R03AL09 | R03AL11 | R03AL12 | R03BB06,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT01007591,NCT01007591_EG001,No,All,Child,Phase 3,13,"Inclusion Criteria:

Clinical diagnosis of psoriasis vulgaris involving the face
Clinical signs of psoriasis vulgaris on the trunk and/or on the limbs, or earlier diagnosed with psoriasis vulgaris on the trunk and/or limbs. The extent and severity of psoriasis vulgaris on trunk and/or limbs should be amenable to topical therapy with any of the allowed medications
An extent of psoriatic involvement of the face of at least 5 cm2 (the sum of all facial lesions)
Treatment areas (the face and the intertriginous areas) amenable to topical treatment with a maximum of 30 g (6 to 11 years) or 45 g (12 to 17 years) of ointment per week
Disease severity graded as mild, moderate or severe according to the investigator's global assessment of disease severity of the face
Aged 6 to 17 years

Exclusion Criteria:

Systemic treatment with therapies other than biologicals with a potential effect on psoriasis vulgaris within the 4-week period prior to randomisation
Systemic treatment with biological therapies (marketed or not marketed) with a possible effect on psoriasis vulgaris within 4 weeks (etanercept), 2 months (adalimumab, alefacept, infliximab), 4 months (ustekinumab) or 4 weeks/5 half-lives (which-ever is longer) for experimental biological products prior to randomisation
PUVA therapy or Grenz ray therapy within the 4-week period prior to randomisation
UVB therapy within the 2-week period prior to randomisation
Topical treatment of psoriasis vulgaris lesions on the face or on the intertriginous areas within the 2-week period prior to randomisation
Topical treatment with very potent WHO group IV corticosteroids within the 2-week period prior to randomisation
Initiation of or expected changes to concomitant medication that may affect psoriasis vulgaris (e.g., beta blockers, anti-malaria drugs, lithium and ACE inhibitors) during the treatment phase of the study
Current diagnosis of erythrodermic, exfoliative or pustular psoriasis",Hydrocortisone: Applied once daily,ChEMBL:CHEMBL389621 | DrugBank:DB00741 | PubChem:5754,Hydrocortisone,[H][C@@]12CC[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)CC[C@@]21C,A01AC03 | A07EA02 | C05AA01 | D07AA02 | D07BA04 | D07CA01 | D07XA01 | H02AB09 | R01AD60 | S01BA02 | S01BB01 | S01CA03 | S01CB03 | S02BA01 | S02CA03 | S03CA04,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT01011413,NCT01011413_EG001,No,All,Child | Adult | Older Adult,Phase 3,321,"Inclusion Criteria:

HIV-1 positive by licensed diagnostic test
aged >16 years of age (or minimum age as determined by local regulations or as legal requirements dictate)
50 < cluster of differentiation (CD)4 <500 cells/µL
No prior AIDS-defining illness, using the Center for Diseases Control 1993 Case Definition (except pulmonary tuberculosis)
HIV RNA ≥1000 copies/mL
no prior exposure to antiretroviral therapy (ART) (including short course ART for preventing MTCT)
calculated creatinine clearance (CLCr) more than or equal to 50 mL/min (Cockcroft-Gault formula)
provision of written informed consent.

Exclusion Criteria:

the following laboratory values:

absolute neutrophil count (ANC) <500 cells/μL
hemoglobin <7.0 g/dL
platelet count <50,000 cells/μL
alanine aminotransferase and/or aspartate aminotransferase >5 x upper limit of normal
pregnant women or nursing mothers
active opportunistic or malignant disease not under adequate control
use of immunomodulators within 30 days prior to screening
use of any prohibited medications
current alcohol or illicit substance use that might adversely affect study participation","Eligible patients will be centrally randomised to receive TDF (300mg qd)/FTC (200mg qd) + EFV (400mg qd; 2 x 200mg + 1 x 200mg placebo qd).

Efavirenz: 2 x EFV 200mg tablets plus 1x matched EFV placebo tablet once daily",ChEMBL:CHEMBL223228 | DrugBank:DB00625 | PubChem:64139,Efavirenz,O=C1Nc2ccc(Cl)cc2[C@@](C#CC2CC2)(C(F)(F)F)O1,J05AG03 | J05AR06 | J05AR11,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0
NCT01016561,NCT01016561_EG000,No,Female,Adult | Older Adult,Not Applicable,12,"Inclusion Criteria:

Subjects must have histologically confirmed squamous cell, adenosquamous or adenocarcinoma of the cervix
Subjects must have non-metastatic FIGO Stage Ia-IVa cervical cancer
Claustrophobic subjects must agree to be sedated during MRI procedures
ECOG performance status of 0-2

Exclusion Criteria:

Subjects with an inability to tolerate MR imaging
Subjects who have had prior surgery for treatment of disease other than exploratory laparotomy or biopsy
Study subjects who have contraindication to MRI scanning such as but not limited to subjects with pacemakers, metal fragments in the eye or certain metallic implants
Women of childbearing potential who have a positive result on screening serum pregnancy test","Patients undergo external beam radiotherapy (3-dimensional conformal OR intensity-modulated) and 4-6 insertions of MRI-guided intracavitary brachytherapy over 8 weeks. Patients also receive cisplatin IV over 30-60 minutes for 5-6 weeks during radiotherapy.

intracavitary balloon brachytherapy

external beam radiation therapy

intensity-modulated radiation therapy

radiation therapy treatment planning/simulation

3-dimensional conformal radiation therapy

Cisplatin",DrugBank:DB00515 | PubChem:5460033 | PubChem:5702198,Cisplatin,Cl[Pt]Cl.N.N,L01XA01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01019980,NCT01019980_EG001,No,All,Child,Phase 4,2,"Inclusion Criteria:

Male and female outpatients, aged 2 to 6 years presenting tympanic temperature ≥ 38.5 ° C and no greater than 39.5° C, associated with acute upper respiratory tract infections
Parents or legal representatives who have provided written informed consent and provided a phone number for the call at end of study

Exclusion Criteria:

History of hypersensitivity to any drugs or excipients of the study
Any medication, surgical, or medical condition, which might significantly alter the absorption, distribution, metabolism, or excretion of medications
Background or suspected hematological disorders, febrile seizures, asthma, peptic ulcer or gastrointestinal bleeding
Neurological and hemodynamics disorders
Evidence of liver or kidney impairment or heart failure
Patients who have received previous treatment with antipyretics; acetaminophen (up to 4 hrs), NSAIDs (up to 6 hrs) or antibiotic therapy (at least 12 hours)
Any surgical or medical condition, which in the opinion of the investigator, may place the patient at risk

Other protocol-defined inclusion/exclusion criteria may apply",This study was cancelled. No patients were enrolled in this group.,ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01022762,NCT01022762_EG000,No,All,Adult | Older Adult,Phase 4,216,"Inclusion Criteria:

Type 2 diabetes
Oral anti-diabetic drug (OAD) naïve (unsystematic OAD treatment 6 months prior to this trial is allowed)
Insulin naïve (less than 1 week of daily use of insulin therapy before trial start is allowed)
Lipid-lowing agent naïve
HbA1c: 6.5-8.5%
Fasting glucose: 6.1-13.0 mmol/L (110-234 mg/dl)
Body Mass Index (BMI): 20-35 kg/m^2
Be able and willing to perform self-monitored plasma glucose (SMPG)
Be able and willing to eat 3 main meals per day
Only applicable to subjects who will participate in the subgroup study: Be able and willing to perform and complete IVGTT (intravenous glucose tolerance test) at additional visits

Exclusion Criteria:

Known or suspected allergy to repaglinide, gliclazide, or related products (for example sulfonamide or other sulphonylureas (SUs)), or any of the excipients in the study drugs
Previous participation in this study
Participation in a study of another investigational drug within 1 month prior to study start","1 mg repaglinide twice daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 4 mg three times daily",ChEMBL:CHEMBL1272 | DrugBank:DB00912 | PubChem:65981,Repaglinide,CCOc1cc(CC(=O)N[C@@H](CC(C)C)c2ccccc2N2CCCCC2)ccc1C(=O)O,A10BD14 | A10BX02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01026831,NCT01026831_EG000,No,All,Adult | Older Adult,Phase 3,320,"Inclusion Criteria:

Patient has been diagnosed with primary open-angle glaucoma, pigmentary glaucoma, capsular glaucoma/pseudoexfoliation, or ocular hypertension
Patient has a mean (or median) IOP of >=23 and =<36 in at least one eye at the 0800 hours time point at the Baseline Visit.
Patient has <5 mmHg difference in mean (or median) IOP between eyes at each time point (0800 hours, 1000 hours, and 1600 hours) at Baseline.
Patient is currently using a prescribed ocular hypotensive medication and has been on a stable dose for 30 days prior to screening, or patient is drug-naive (those who have never used or who have not used ocular hypotensive medication for at least 4 weeks prior to screening)
Patient is able to safely discontinue current ocular hypotensive medication during up to the 4-week washout period
Patient has vision corrected to 20/80 or better in each eye
Patient is willing and able to avoid wearing contact lenses from 4 weeks prior to dosing through 24 hour after final dosing
Patient is willing and able to self-administer or has an able person available on a daily basis to assist with administration of study medications
Patient is not pregnant and not planning to become pregnant during the study
Patient is male or female ≥18 of age on the day of signing the informed consent

Exclusion Criteria:

Patient is unable to use study medication in the affected eye(s)
Patient has a history of inflammatory ocular surface disease or anterior or posterior uveitis in either eye
Patient has a history of retinal detachment, diabetic retinopathy, or other progressive retinal disease
Patient has experienced significant visual field loss within the last year
Patient has had intraocular surgery in either eye in the last 4 months
Patient has a history of glaucoma surgery or refractive surgery in either eye
Patient is currently taking two or more anti-glaucoma medications (except Cosopt™ or its generic formulation)
Patient has previously used tafluprost
Patient has a history of cardiovascular disorder within 6 months prior to screening
Patient has a history of bronchial asthma, wheezing, pneumonia, COPD, other pulmonary disease, or abnormal chest x-ray
Patient has a mean (or median) IOP >36 mmHg in either eye at the Screening Visit or at any time point (0800 hours, 1000 hours, and 1600 hours) of the Baseline Visit.","One drop of preservative-free vehicle per eye in the morning, and one drop of preservative-free tafluprost (0.0015%) per eye in the evening for 12 weeks.",ChEMBL:CHEMBL1963683 | DrugBank:DB08819 | PubChem:9868491,Tafluprost,CC(C)OC(=O)CCC/C=C\C[C@@H]1[C@@H](/C=C/C(F)(F)COc2ccccc2)[C@H](O)C[C@@H]1O,S01EE05,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01027793,NCT01027793_EG000,Accepts Healthy Volunteers,Female,Child | Adult,Phase 4,10,"Inclusion Criteria:

Female subjects, aged between 11 and 25 years
Female subjects of childbearing age that present a negative urine pregnancy test and are using an effective contraceptive method for at least 3 months prior the study
Subjects that have thin (1-5mm) recent(less than 6 months of evolution),reddish or purple line stretch marks. The striae should be symmetrical and it could be located in the abdomen,breasts, upper arms, thighs (both inner and outer), hips, and buttocks
Subjects agreeing to take part of the study, after being fully informed of the purpose and the nature of the investigation and after having signed the informed consent form
Subjects with sufficient schooling and awareness to enable them to cooperate to the degree required by this protocol
Subjects who had never received treatment for striae in the studied area

Exclusion Criteria:

Subjects whose medical history and physical examination present clinical pathology, as marfan Syndrome, cushing, systemic autoimmune or neurological diseases
Pregnant or women in breastfeeding, or women planning to become pregnant
Previous treatment for striae in the local area of the study.
Subjects that are in use of tretinoin or glycolic acid in the local area of the study.
Presence of white striae in the local area of the study
History of Connective Tissue Disease
History of keloid development or skin healing problems
Subjects that are taking medications associated with striae development, as systemic corticosteroids, indinavir, hormonal replacement therapy
Hypersensibility to retinoic acid
Subjects who intend to get tan in the area of the study, through exposure of sun or tanning machines during the study
Subjects that have a variation in their weight of more than 2 kg in a period of four months prior the study
Predisposition for chronic inflammatory process
Subjects with chronic diseases as diabetes, cardiopathy, neoplasm, HIV and autoimmune diseases (vitiligo, lupus)","Group 1 will receive tretinoin cream 0.05% (Vitanol A, Stiefel) that should be applied daily in areas affected by stretch marks, in both sides, for a period of 16 weeks.

Tretinoin cream 0.005%: Group 1 will receive tretinoin cream 0.05%(Vitanol A, Stiefel) that should be applied daily in areas affected by stretch marks, in both sides, for a period of 16 weeks.",ChEMBL:CHEMBL38 | ChEMBL:CHEMBL547 | ChEMBL:CHEMBL705 | DrugBank:DB00523 | DrugBank:DB00755 | DrugBank:DB00982 | PubChem:444795 | PubChem:449171 | PubChem:5282379,Tretinoin,CC(C=CC1=C(C)CCCC1(C)C)=CC=CC(C)=CC(=O)O,D10AD01 | D10AD04 | D10AD51 | D10AD54 | D10BA01 | D11AH04 | L01XF01 | L01XF02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT01027884,NCT01027884_EG001,No,Male,Child | Adult,Phase 3,32,"Inclusion Criteria:

Patients 10 - 18 years of age at Baseline.
Signed and dated informed consent.
Documented diagnosis of DMD or severe dystrophinopathy and clinical features consistent of typical DMD at diagnosis (i.e. documented delayed motor skills and muscle weakness by age 5 years). DMD should be confirmed by mutation analysis in the dystrophin gene or by substantially reduced levels of dystrophin protein (i.e. absent or <5% of normal) on Western blot or immunostain.
Ability to provide reliable and reproducible repeat PEF within 15% of the first assessment (i.e. Baseline vs. Screening).
Patients assessed by the investigator as willing and able to comply with the requirements of the study, possess the required cognitive abilities and are able to swallow study medication.

Exclusion Criteria:

Patients dependent on assisted ventilation at Screening and/or Baseline (defined as non-invasive nocturnal ventilation, daytime non-invasive ventilation or continuous invasive ventilation).
Patients with documented DMD-related hypoventilation for which assisted ventilation is needed according to current standard of care guidelines (e.g. FVC< 30%) or is required in the opinion of the Investigator.
Patients with a percent predicted PEF > 80% at Baseline.
Patients unable to form a mouth seal to allow precise respiratory flow measurements and mouth pressures.
Symptomatic heart failure (high probability of death within one year of Baseline) and/or symptomatic ventricular arrhythmias.
Participation in the previous Phase II or Phase II Extension study (SNT-II-001 or SNT-II-001-E) for idebenone.
Participation in any other therapeutic trial and/or intake of any investigational drug within 90 days prior to Baseline.
Use of carnitine, creatine, glutamine, oxatomide, or any herbal medicines within 30 days prior to Baseline.
Use of coenzyme Q10 or vitamin E (if taken at a dose of 5 times above the daily physiological requirement) within 30 days prior to Baseline.
Any previous use of idebenone.
Any concomitant medication with a depressive or stimulating effect on respiration or the respiratory tract.
Planned or expected spinal fixation surgery during the study period (as judged by the investigator).
Asthma, bronchitis/COPD, bronchiectasis, emphysema, pneumonia or the presence of any other non-DMD respiratory illness that affects PEF.

Chronic use of beta-2 agonists or any use of other bronchodilating medication (e.g. inhaled steroids, sympathomimetics, anticholinergics).

Please note: Chronic use if defined as a daily intake for more than 14 days.

Moderate or severe hepatic impairment or severe renal impairment.

Prior or ongoing medical condition or laboratory abnormality that in the Investigator's opinion could adversely affect the safety of the subject.

Please note: Patients who suffer from a severe, unstable condition including (but not limited to) cancer, auto-immune diseases, haematological diseases, metabolic disorders or immunodeficiencies, and who are at risk of an aggravation unrelated to the study condition, can only be included in the study if accepted in writing by the Sponsor's Medical Monitor.

Relevant history of or current drug or alcohol abuse or use of any tobacco/marijuana products/smoking
Known individual hypersensitivity to idebenone or to any of the ingredients/excipients of the study medication

Systemic glucocorticoid therapy

Chronic use of systemic glucocorticoid therapy for DMD related conditions within 12 months of Baseline (the ""12 month non-use period"")
More than 2 rounds of acute systemic glucocorticoid burst therapy (of ≤2 week duration) for non-DMD related conditions within the 12 month non-use period
Use of any round of systemic glucocorticoid burst therapy of longer than 2 weeks duration within the 12 month non-use period
Use of systemic glucocorticoid burst therapy less than 8 weeks prior to baseline",Two150 mg tablets were taken three times a day with meals (total dose 900 mg daily).,ChEMBL:CHEMBL252556 | DrugBank:DB09081 | PubChem:3686,Idebenone,COC1=C(OC)C(=O)C(CCCCCCCCCCO)=C(C)C1=O,N06BX13,0.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT01028027,NCT01028027_EG000,No,All,Adult | Older Adult,Phase 3,177,"Inclusion Criteria:

Subjects must have a clinical diagnosis of BKC in at least one eye
Subjects must be willing to discontinue contact lens use for the duration of the study
Subjects who are able and willing to comply with all treatment and follow- up/study procedures.

Exclusion Criteria:

Subjects participating in any drug or device clinical investigation within 30 days prior to entry into this study and/or during the period of study participation.
Subjects who have any uncontrolled systemic disease or debilitating disease.
Subjects who have a known hypersensitivity to the study drugs or their components (including benzalkonium chloride) or contraindications to tobramycin or ocular corticosteroids.
Subjects who use any topical or systemic ophthalmic medications listed as disallowed in the study protocol, within the specified time frame prior to Visit 1.
Subjects who have a disease or conditions which the Investigator determines could interfere with the safety and efficacy evaluations of the study drug.
Subjects having ocular surgery (including laser surgery) in either eye within the past three months.","Loteprednol etabonate 0.5% and tobramycin 0.3% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.",PubChem:9811635,Loteprednol etabonate/tobramycin,CCOC(=O)OC1(C(=O)OCCl)CCC2C3CCC4=CC(=O)C=CC4(C)C3C(O)CC21C.NCC1OC(OC2C(N)CC(N)C(OC3OC(CO)C(O)C(N)C3O)C2O)C(N)CC1O,,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01031420,NCT01031420_EG000,No,All,Adult | Older Adult,Phase 2,40,"Inclusion Criteria:

histologically confirmed urothelial carcinoma of bladder, ureter, or renal pelvis. T2-T4 and muscle invasion must be established by TURBT. Upper tract must be high grade. N0-N1 are eligible.

candidate for radical cystectomy, nephroureterectomy, or segmental ureterectomy with goal of cure.

->/= 18 years old

ECOG performance status 0-1.
Adequate marrow and organ function.
May enter on therapeutic anticoagulation if it can be safely held during perioperative period.
No women of childbearing potential, pregnant or breastfeeding.
LVEF >/= 50 %
Patients with history of other non-urothelial malignancies may enroll if: 1)no evidence of distant disease w/in last year. 2)No anticancer treatment for >/= 1 year other than adjuvant treatment or treatment for secondary prevention. 3) Less than 360 mg/m2 lifetime dose of adriamycin.
ability to understand and willingness to sign written informed consent and HIPAA.

Exclusion Criteria:

Intravesicular therapy w/in 4 weeks of study entry or those who have not recovered from adverse effects of such agents administered more than 4 weeks earlier.
Patients may not be receiving any investigational agents within 4 weeks of study entry.
History of allergic reactions attributed to compounds of similar chemical or biologic composition to Methotrexate, Vinblastine, Adriamycin or Cisplatin or other agents used in the study.
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Pregnant women are excluded from this study due to the potential for teratogenic or abortifacient effects of cytotoxic chemotherapy.

Known HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with cytotoxic chemotherapy. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy.

-. Patients who have undergone prior pelvic radiation are excluded due to risk of life threatening myelosuppression.

Patients who have received any previous systemic chemotherapy or radiation therapy for urothelial carcinoma or cytotoxic chemotherapy for another malignancy within 1 year of study entry are ineligible.","standard doses of MVAC given every 14 days x 3.

single arm dose dense MVAC: standard doses of methotrexate, vinblastine, adriamycin, and cisplatin given every 14 days.",ChEMBL:CHEMBL417 | ChEMBL:CHEMBL53463 | DrugBank:DB00445 | DrugBank:DB00997 | PubChem:1691 | PubChem:31703 | PubChem:41867,Epirubicin,COc1cccc2c1C(=O)c1c(O)c3c(c(O)c1C2=O)CC(O)(C(=O)CO)CC3OC1CC(N)C(O)C(C)O1,L01DB01 | L01DB03,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01031498,NCT01031498_EG001,No,All,Adult | Older Adult,Phase 2,51,"Inclusion Criteria:

Patients > 18 years with acute myelogenous leukemia or high-risk myelodysplastic syndrome undergoing chemotherapy with high dose cytarabine (1.5 or 2gm/m^2) containing regimens.
Patients must sign an informed consent indicating they are aware of the investigational nature of this study, in keeping with the policies of the hospital.

Exclusion Criteria:

Patients with emesis or grade 2 nausea (oral intake is significantly decreased) or 3 nausea (no significant intake requiring intravenous fluids)</= 24 hours before chemotherapy.
Patients with ongoing emesis due to any organic etiology.
Patients with known hypersensitivity to the study drug or to other selective 5-HT3 receptor antagonists.","Palonosetron once a day 0.25 mg IV injection for 5 days, given over 30 seconds, 30 minutes before chemotherapy.",ChEMBL:CHEMBL1189679 | DrugBank:DB00377 | PubChem:6337614,Palonosetron,[H][C@]12CCCc3cccc(c31)C(=O)N([C@@H]1CN3CCC1CC3)C2,A04AA05 | A04AA55,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01031498,NCT01031498_EG002,No,All,Adult | Older Adult,Phase 2,50,"Inclusion Criteria:

Patients > 18 years with acute myelogenous leukemia or high-risk myelodysplastic syndrome undergoing chemotherapy with high dose cytarabine (1.5 or 2gm/m^2) containing regimens.
Patients must sign an informed consent indicating they are aware of the investigational nature of this study, in keeping with the policies of the hospital.

Exclusion Criteria:

Patients with emesis or grade 2 nausea (oral intake is significantly decreased) or 3 nausea (no significant intake requiring intravenous fluids)</= 24 hours before chemotherapy.
Patients with ongoing emesis due to any organic etiology.
Patients with known hypersensitivity to the study drug or to other selective 5-HT3 receptor antagonists.","Palonosetron once a day 0.25 mg IV injection on Days 1, 3, and 5 of chemotherapy, given over 30 seconds, 30 minutes before chemotherapy.",ChEMBL:CHEMBL1189679 | DrugBank:DB00377 | PubChem:6337614,Palonosetron,[H][C@]12CCCc3cccc(c31)C(=O)N([C@@H]1CN3CCC1CC3)C2,A04AA05 | A04AA55,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01033565,NCT01033565_EG000,No,All,Child,Phase 4,1,"Inclusion Criteria:

Male or female children,
ages 4-8 years,
diagnosed with an ASD, including
Pervasive Developmental Disorder NOS (PDD, NOS),
Asperger's Syndrome, or
Autistic Disorder, and followed in the Munroe Meyer Developmental Pediatrics Clinic. Documented impaired sleep maintenance (ISM) based on parent-report and 7 day somnolog (sleep diary).
Clinician rating of 4 (moderately ill) or worse on CGI-S. Rating is based on the clinician's experience with evaluating and treating this patient population.
Previous discussion during a clinic appointment about sleep difficulties, including review of sleep hygiene and basic behavioral interventions/strategies.
Current problems of overnight awakenings recorded on the Children's Sleep Habits Questionnaire (CSHQ) despite behavioral intervention.
Stable psychotropic medication treatment for the past 4 weeks.

Exclusion Criteria:

Treatment with Melatonin or Melatonin CR during the past month or previous failed treatment with Melatonin CR.

Presence of a previously unevaluated medical condition which may be the etiology of the nighttime awakenings. There is no contraindication for use of Melatonin CR in patients with obstructive sleep apnea.","Subjects receive Natrol (sustained release melatonin) 5mg tablet 30 minutes prior to bedtime for 10 to 14 days

Natrol : 5mg of sustained released melatonin. One tablet given 30 minutes prior to bedtime.",PubChem:54600498,Natrol,O=C(O)C(O)C(O)C(=O)O.[Bi].[Na+],,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01038609,NCT01038609_EG000,No,All,Adult | Older Adult,Phase 2,50,"Inclusion Criteria:

- Subjects who were in general good health, experiencing moderate to severe pain following bunionectomy surgery and who were willing to remain confined for approximately 4 days following surgery for study procedures.

Exclusion Criteria:

Subjects who underwent Base wedge osteotomy and/or Long-Z hart bunionectomy procedures
Allergic reaction to study medications
Pregnant or breastfeeding females
Clinically significant lab abnormalities at screening
Positive hepatitis testing at screening
Clinically significant or uncontrolled medical disorders or illness at screening
Active malignancy or chemotherapy
Any history of drug or alcohol abuse/addiction
Known or suspected history of human immunodeficiency virus (HIV); requires treatment with monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants (TCAs) or butyrophenones
History of major depressive episode or major psychiatric disorder
Current systemic corticosteroid therapy
Inability to refrain from smoking during or alcohol during stay at investigative site","1 dose of 1 placebo capsule (for morphine extended release) plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).",ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01042158,NCT01042158_EG000,No,All,Adult | Older Adult,Phase 4,24,"Inclusion Criteria:

A right heart catheterization done at baseline with a mean pulmonary artery pressure (mPAP) ≥ 25mmHg, pulmonary artery wedge pressure (PAWP) ≤ 15mmHg, and pulmonary vascular resistance (PVR) ≥3 Woods units.
Scleroderma defined as systemic sclerosis with diffuse or limited scleroderma meeting the American College of Rheumatology (ACR) criteria (33). Cases will be included if they meet clinical features that satisfy ACR criteria for a diagnosis of scleroderma or the presence of three of five features of the CREST syndrome are identified; or there is the presence of definite Raynaud's phenomenon, abnormal nail fold capillaries typical of scleroderma and the presence of a specific scleroderma related auto-antibody. Limited skin involvement is defined as skin tightening distal to elbows and knees with or without facial involvement; and diffuse skin involvement, tightening proximal to these joints or truncal involvement.
Subjects will be older than 18 years of age with a diagnosis of PAH-SSc.
Subjects will be NYHA functional class II or III.
6 minute walk distance ≥ 100 meters and ≤ 500 meters at screening and baseline.
Negative urine pregnancy test for women of childbearing age at screening and baseline visits.
Ability and willingness to provide written informed consent

Exclusion Criteria:

Right heart catheterization reveals evidence of pulmonary venous hypertension (pulmonary capillary wedge pressure > 15 mm Hg).
Significant chronic obstructive: Forced expiratory volume in 1 second to forced expiratory volume ratio < 70% and a forced expiratory volume in 1 second less than 60% of predicted.

Interstitial lung disease

Based on a combination of pulmonary function tests and chest radiography.
Patients will be excluded if they have a total lung capacity less than 60% of predicted and included if the total lung capacity was ≥ 70%. Patients with a total lung capacity between 60 and 70% of predicted are included if their computed tomography scan demonstrates only minimal interstitial fibrosis
Portal hypertension.
Severe obstructive sleep apnea.
Chronic thromboembolic disease.
Positive antibodies to the human immunodeficiency virus.
History of anorexigen use including fen-phen.
Any other disease known to be associated with pulmonary hypertension.
Subjects with other etiology for pulmonary hypertension besides PAH-SSc.
Subjects with liver function abnormalities (ALT or Aspartate Aminotransferase (AST) > 3 times the upper limit of normal at screening or at baseline) or chronic liver disease.
Advanced kidney failure (GFR < 30 ml/min at screening or at baseline).
Acute decompensation of underlying illness or hospitalization for pulmonary hypertension within 4 weeks prior to enrollment.
Prior chronic therapy with an endothelin-receptor antagonist, PDE V inhibitor, or a prostacyclin analogue.
History of hypersensitivity reaction or adverse effect related to ambrisentan or tadalafil.
History of implantable permanent pacemaker or any metallic objects in the body.
Participation in a clinical study involving an investigational drug or device within four weeks before the screening visit.
Pregnant or lactating women.
Concomitant use of nitrates (any form) either regularly or intermittently
Concomitant use of potent Cytochrome P3A (CYP3A) inhibitors (eg, ritonavir, ketoconazole, itraconazole)
Any additional contraindications and precautions specified in the package inserts for Tadalafil (Adcirca) and Ambrisentan (Letairis) not listed above.","This will be a 36-week, single group, open label study assessing the effects of Tadalafil plus Ambrisentan combination therapy in patients with pulmonary arterial hypertension associated with the scleroderma spectrum of disease (PAH-SSD).

tadalafil and ambrisentan upfront combination therapy: tadalafil 20 mg qd and ambrisentan 5 mg qd. Up-titration of study medications will occur at week 4 (ambrisentan 10 mgs daily and tadalafil 40 mg qd). If a subject experiences an intolerable adverse event as a result of an uptitration in the study drug dose, the dose of study drug maybe down titrated to 20 mg of tadalafil and/or 5mg of ambrisentan. If the subject is still experiencing an intolerable adverse event, then the investigator will withdraw the subject from the study.",ChEMBL:CHEMBL779 | DrugBank:DB00820 | PubChem:110635,Tadalafil,[H][C@]12Cc3c([nH]c4ccccc34)[C@@H](c3ccc4c(c3)OCO4)N1C(=O)CN(C)C2=O,C02KX52 | C02KX54 | G04BE08 | G04CA54 | G04CB51,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01044030,NCT01044030_EG000,No,All,Child,Phase 3,160,"Inclusion Criteria:

Six months to five years of age
General good health
History of at least three episodes of AOM in previous 12 months, at least one of which occurred within the previous six months
English or Spanish speaking

Exclusion Criteria:

History of tympanostomy tubes
Intestinal malabsorption or chronic diarrhea
Diabetes mellitus
Any inborn error of metabolism
Parent/guardian unreachable by telephone
Known allergy to any of the study solution components (xylitol, sorbitol, sodium carboxymethylcellulose, potato starch, glycerin, potassium sorbate, natural berry flavoring).",Xylitol syrup: 7.5 mL (5 grams) by mouth three times daily,ChEMBL:CHEMBL96783 | DrugBank:DB11195 | PubChem:6912,Xylitol,OC[C@@H](O)[C@H](O)[C@@H](O)CO,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT01044056,NCT01044056_EG002,No,Female,Adult,Phase 4,8,"Inclusion Criteria:

Subject is at least 18 but not older than 40 years of age on Day 1 of treatment.
Subject has uterus and ovaria in situ
Subject who does not use hormonal contraception and is willing to use adequate nonhormonal contraceptive measures during the timeframe between screening and start treatment.
Subject is able and willing to refrain from caffeine and/or xanthine containing food and/or beverages (e.g. coffee, tea, cola or chocolate) from 24 hours before the first administration of the trial medication until the last PK blood sample.
Subject is willing not to consume grapefruit containing products 14 days prior to the start of the first administration of the trial medication until the last PK blood sample.
Subject is willing to refrain from smoking from 7 days prior to first administration of the trial medication until the last pharmacokinetic blood sample.
Subject is willing to refrain from alcohol containing products from 24 hours prior to first administration of the trial medication until the last pharmacokinetic blood sample.

Exclusion Criteria:

Contraindications for use of NuvaRing, contraceptive patch and oral contraceptive:
Presence or history of venous thrombosis, with or without the involvement of pulmonary embolism.
Presence or history of arterial thrombosis (e.g. cerebrovascular accident, myocardial infarction) or prodromi of a thrombosis (e.g. angina pectoris or transient ischaemic attack).
Known predisposition for venous or arterial thrombosis, with or without hereditary involvement such as Activated Protein C (APC) resistance, antithrombin-III deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinaemia, antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant) and Factor V Leiden mutation.
Diabetes mellitus with vascular involvement
The presence of a severe or multiple risk factor(s) for venous or arterial thrombosis (to be judged by the (sub-) investigator
Presence or history of severe hepatic disease as long as liver function values had not returned to normal or were judged to be clinically significant by the investigator.
Presence or history of liver tumours (benign or malignant).
Known or suspected malignant conditions of the genital organs or the breasts, if sex-steroid-influenced.
Undiagnosed vaginal bleeding.
Hypersensitivity to the active substances or to any of the excipients of NuvaRing, contraceptive patch and oral contraceptive.
Migraine with focal aura
Known or suspected pregnancy
Breastfeeding, or within 2 months after stopping breastfeeding on the day preceding the first administration of trial medication (Day -1).
Clinically significant abnormal laboratory, ECG (electrocardiogram) vital signs, physical and gynecological findings at screening.
A significant (history of) allergic or other serious disease, particularly gastrointestinal tract disease.
Smoking more than 5 cigarettes or 1 pipe or 1 cigar per day for a period of at least 3 months prior to screening.
Using any systemic medication (including over the counter (OTC) medication) during the 14 days prior to the day preceding the first administration of trial medication (Day -1), except for oral contraceptive used for synchronization and occasional Ibuprofen.
Used any drug or substance that is known to induce drug-metabolizing enzymes within two months prior to the start of synchronization.
Received a contraceptive by injection, an implant or hormonal intra-uterine device within 6 months of the day preceding the first administration of trial medication (Day -1), or a hormonal implant or hormonal intra-uterine device removed within 6 months of the day preceding the first administration of trial medication (Day -1).
Participated in a drug trial and was administered an investigational drug during the 90 days prior to start of synchronization.
Donated blood during the 90 days prior to the day preceding the first administration of trial medication (Day -1).
History (within the last 2 years) of excessive alcohol use, use of solvents or of drug abuse.
Positive drug test at screening and/or admission (Day -1), or a positive alcohol test at admission (Day -1).
Clinically significant abnormal cervical smear result (papaninecolaou (PAP) III or higher) at screening.
Acute or chronic hepatitis B/C or human immune deficiency virus (HIV) 1&2 infection.","Nuvaring(R), one nring for a period of 21 days, inserted vaginally. Dose: per ring 11.7 mg etonrgestrel (ENG) and 2.7 mg EE releasing a daily average amount of 0.120 mg etonorgestrel and 0.015 mg EE",PubChem:9960701,Nuvaring,C#CC1(O)CCC2C3CCC4=CC(=O)CCC4C3C(=C)CC21CC.C#CC1(O)CCC2C3CCc4cc(O)ccc4C3CCC21C,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT01050790,NCT01050790_EG000,No,All,Adult | Older Adult,Not Applicable,17,"Inclusion criteria:

Patients with a diagnosis of multiple myeloma, who have residual measurable disease (in partial remission or with stable disease) and are eligible to undergo an autologous stem cell transplant will be able to participate in this trial; measurable disease will comprise of either, quantifiable serum or urinary, M protein or free light chains in the presence of a positive immunofixation or bone marrow plasma cells > 5%
Patients who have received prior lenalidomide therapy will be eligible if >= partial response (PR) was observed on a prior lenalidomide containing regimen and patients did not progress while receiving lenalidomide; isolated bone lytic lesions in the absence of measurable para-proteins will not be considered measurable disease
A minimum period of two weeks must have elapsed following the prior myeloma therapy; this does not include therapy with bisphosphonates
Eastern Cooperative Oncology Group (ECOG) performance status =< 2
No clinical evidence of uncontrolled viral, fungal, bacterial infection
Negative serology for human immunodeficiency virus (HIV)
Serum bilirubin =< 1.5 times upper limit of normal (ULN)
Serum glutamic oxaloacetic transaminase (SGOT)/serum glutamic pyruvic transaminase (SGPT) =< 3x ULN
Calculated creatinine clearance >= 60ml/min by Cockcroft-Gault formula; creatinine clearance >= 60 ml/min or serum creatinine =< 2.0 mg/dL
Absolute neutrophil count (ANC) >= 1500/uL
Platelet count >= 100,000/ uL
Hemoglobin (Hgb) >= 10 g/dL following recovery from last therapy
Cardiac and pulmonary function adequate for transplant
Ability to sign informed consent
All study participants must be registered into the mandatory RevAssist program, and be willing and able to comply with the requirements of RevAssist
Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10-14 days prior to and again within 24 hours of prescribing lenalidomide (prescriptions must be filled within 7 days) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide; FCBP must also agree to ongoing pregnancy testing
Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy

Exclusion criteria:

Known or suspected hypersensitivity to azacitidine or mannitol
Patients with multiple myeloma refractory to therapy with lenalidomide; progression following discontinuation of prior therapy with lenalidomide is allowed as long as patients have not failed rechallenge with lenalidomide
Pregnant or breast feeding
Other concomitant malignancies
Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form
Concurrent use of other anti-cancer agents or treatments
Known hypersensitivity to thalidomide or lenalidomide","azacitidine: 75 mg/sq m daily for 5 days

lenalidomide: 10 mg p.o. daily, Days 6-21",ChEMBL:CHEMBL848 | DrugBank:DB00480 | PubChem:216326,Lenalidomide,Nc1cccc2c1CN(C1CCC(=O)NC1=O)C2=O,L04AX04,1.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT01053156,NCT01053156_EG000,No,All,Child,Not Applicable,66,"Inclusion Criteria:

Must have fragile X syndrome with molecular documentation
Current pharmacological treatment regimen has been stable for at least 4 weeks

Exclusion Criteria:

Subjects who plan to initiate or change pharmacologic or non-pharmacologic interventions during the course of the study
subjects who are unable to take oral medication
subjects who have been on minocycline previously
subjects who are allergic to minocycline or tetracyclines
subjects who are pregnant
subjects with history of lupus or hepatic dysfunction","Minocycline dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing >45 kg receiving 100 mg once daily.",PubChem:54685925,Minocycline hydrochloride,CN(C)c1ccc(O)c2c1CC1CC3C(N(C)C)C(=O)C(C(N)=O)=C(O)C3(O)C(=O)C1=C2O.Cl,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT01053637,NCT01053637_EG000,No,All,Child,Not Applicable,85,"Inclusion Criteria:

Age 2 to 17 years
Laceration of the skin and/or subcutaneous tissue requiring sutures
American Society of Anesthesiologists (ASA) score of I or II

Exclusion Criteria:

Major injuries in addition to laceration (suspected fracture, intracranial, intrathoracic, or intraabdominal bleeding or organ injury)
Abnormal neurologic examination (such as head injury)
Severe congenital heart disease
Pregnancy
Known opiate or acetaminophen allergy
Require conscious sedation
Have had narcotic or acetaminophen administration within 4 previous hours","Patients will receive 0.17 mg/kg hydrocodone component to a max of 10 mg hydrocodone.

hydrocodone/acetaminophen: 0.17 mg/kg hydrocodone component to max of 10 mg. If dose is vomited within 5 minutes, second dose may be administered.",ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01054222,NCT01054222_EG000,No,All,Older Adult,Phase 4,31,"Inclusion Criteria:

Subjects must have previously completed fesoterodine study A0221045 [in Portugal]
Subjects must be recommended for inclusion by the investigator

Exclusion Criteria:

Conditions or states excluding use of fesoterodine e.g. contraindication to fesoterodine
Predominant stress incontinence as determined by the investigator",Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).,ChEMBL:CHEMBL1201764 | DrugBank:DB06702 | PubChem:6918558,Fesoterodine,CC(C)C(=O)Oc1ccc(CO)cc1[C@H](CCN(C(C)C)C(C)C)c1ccccc1,G04BD11,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01054976,NCT01054976_EG000,No,All,Adult | Older Adult,Phase 4,92,"Inclusion Criteria:

Alzheimer's disease according to the criteria of DSM-IV, NINCDS-ADRDA
K-MMSE (Korean - Mini Mental State Exam) is 10 to 24
Reliable Guardian available to the patients
Patient or guardian provided written informed consent before entering into the clinical trial

Exclusion Criteria:

Acetylcholine esterase inhibitors used to treat dementia taken within 30 days of the beginning in this clinical trial
Neurodegenerative diseases (eg Parkinson's disease, Pick's disease, Huntington's disease, Down syndrome)
Dementia related to head trauma and dementia related to brain damage due to cerebral hypoxia (hypoxic brain damage after cardiopulmonary resuscitation, hypoxic brain damage after surgery, hypoxic brain damage due to addiction, hypoxic brain damage due to shock)
brain tumor, nerve syphilis, meningitis, encephalitis
epilepsy",8 mg/day for 4 weeks; 16 mg/day thereafter,ChEMBL:CHEMBL659 | DrugBank:DB00674 | PubChem:9651,Galantamine,[H][C@]12C[C@@H](O)C=C[C@]13CCN(C)Cc1ccc(OC)c(c13)O2,N06DA04,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01057901,NCT01057901_EG000,No,Female,Adult | Older Adult,Phase 3,376,"Inclusion criteria:

Naturally postmenopausal women of any age with at least one ovary
Diagnosis of Hypoactive Sexual Desire Disorder, generalized acquired type,of at least six months duration
Stable, monogamous heterosexual relationship for at least one year
Willing to discuss sexual issues
Willing to engage in sexual activity at least once a month
Normal Pap smear
Normal mammogram
Normal uterine lining
Able to comply with daily use of handheld data entry device

Exclusion criteria:

Sexual dysfunctions other than HSDD, such as Sexual Aversion Disorder, Substance-induced Sexual Dysfunction, Dyspareunia, Vaginismus, Gender Identity Disorder, Paraphilia and Sexual Dysfunction due to a General Medical Condition
Partner with inadequately treated organic or psychosexual dysfunction
Sexual function impaired by psychiatric disorder
Sexual function impaired by gynecological disorder
Major Depression
Suicidal behavior or ideation
Major life stress that could impair sexual function
Substance abuse","Flibanserin 100 mg administered at bedtime

Flibanserin: Flibanserin 100mg administered at bedtime for 24 weeks",ChEMBL:CHEMBL231068 | DrugBank:DB04908 | PubChem:6918248,Flibanserin,O=c1[nH]c2ccccc2n1CCN1CCN(c2cccc(C(F)(F)F)c2)CC1,G02CX02,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01058941,NCT01058941_EG000,No,All,Adult | Older Adult,Phase 1 | Phase 2,34,"Inclusion Criteria:

55 years or older
Probable AD by National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association - NINCDS/ADRDA criteria
MMSE between 15-26
Caregiver/study partner that can accompany participant to all study visits
Stable use of cholinesterase inhibitors and memantine permitted - doses must be stable for 4 months prior to study enrollment
Stable doses of over-the-counter antioxidants (e.g. vitamin E, ginkgo biloba) are permitted - dose must be stable for 4 months prior to study enrollment
Stable dose of lipid lowering medication - dose must be stable for 4 months prior to study enrollment
Geriatric Depression Scale (GDS) - Score of < 5
General health status that will not interfere with the participant's ability to complete the study.
Screening laboratory values within normal limits or, if abnormal, deemed clinically insignificant by the investigator
Sufficient English language skills to complete all testing

Exclusion Criteria:

Non-AD dementia
Residence in nursing home facility at screening visit (residence in community assisted living and long-term care facilities in which the participant still performs majority of basic activities of daily living will not be an exclusion)
History of clinically significant stroke (stroke with neurologic deficits > 6 months after diagnosis)
Health conditions such as cancer diagnosed < 5 years prior to enrollment (prostate cancer gleason grade < 3 and non metastatic skin cancers are acceptable), liver disease, history of ventricular fibrillation or ventricular tachycardia, major psychiatric disorder, central nervous system diseases (e.g. brain tumor, seizure disorder)
Insulin dependent diabetes or uncontrolled diabetes (diabetes controlled on medications other than insulin are acceptable)
Hyperlipidemic (triglycerides >500 mg/dl, LDL > 160 mg/dl, total cholesterol >240 mg/dl). LDL levels between 160 mg/dl and 165 mg/dl will be reviewed by the PI and included if judged to be safe. Patients who have a history or hyperlipidemia, but are not taking lipid-lowering medications due to potential memory impairment side effects will be reviewed on a case-by-case basis by the PI and enrolled in the study if deemed safe by PI and the patient's primary care provider.
Fish intake of one 6 ounce serving > once a week less than 4 months prior to enrollment
Omega-3 fatty acid supplement intake (e.g. fish oil capsules, cod liver oil, or flaxseed oil) less than 4 months prior to enrollment
Lipoic Acid supplementation less than 1 month prior to enrollment
Taking systemic corticosteroids, neuroleptics, antiparkinsonian agents, and narcotic analgesics. Certain low dose antipsychotic use will be reviewed by the principle investigator on a case-by-case basis and may be allowed if determined that dose is not strong enough to affect performance on cognitive evaluations. Low dose sinemet and dopamine agonist taken once a day for restless leg syndrome is not an exclusion.
Contraindications to MRI (for subjects enrolled at Bend, Medford, and Klamath sites that decide not to undergo MRI, this will not be an exclusion).
Enrollment in another study","lipoic acid and fish oil concentrate

lipoic acid and fish oil concentrate: lipic acid (600 milligrams per day) and fish oil concentrate (3 grams per day) for 18 months",ChEMBL:CHEMBL33864 | DrugBank:DB00166 | PubChem:6112 | PubChem:864,Lipoic acid,O=C(O)CCCCC1CCSS1,A16AX01,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,1.0,0.0,1.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0
NCT01060124,NCT01060124_EG000,No,All,Adult | Older Adult,Phase 4,103,"Inclusion Criteria:

Participants who complains of cancer pain
Participants who have taken non-opioid analgesics for the past one month for cancer pain relief purpose, but still have average 4 or higher pain level on the Visual Analogue Scale (VAS) for the last 24 hours
Participants with an estimated life expectancy of at least 2 months
Participants who are able to communicate with the investigator
Participants who can avoid getting pregnant appropriately if there is a possibility of pregnancy during this study period

Exclusion Criteria:

Participants participating in another clinical trial
Participants with a history of oversensitive reaction to a narcotic analgesic or with an existing history of drug abuse
Participants who have active skin disease, avoiding application of the transdermal system
Participants with a history of CO2 (carbon di-oxide) retention (i.e. chronic obstructive pulmonary disease)
Participants undergoing chemotherapy/radiotherapy right now or is going to get chemotherapy/radiotherapy within the study period",Fentanyl D-trans was applied as transdermal patch releasing drug at the rate of 12.5 microgram per hour (mcg/hr) for 3 days with a dose ranging from 12 mcg/hr to 50 mcg/hr.,ChEMBL:CHEMBL596 | DrugBank:DB00813 | PubChem:3345,Fentanyl,CCC(=O)N(c1ccccc1)C1CCN(CCc2ccccc2)CC1,N01AH01 | N01AH51 | N02AB03,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01062009,NCT01062009_EG001,No,All,Child,Phase 1 | Phase 2,6,"Inclusion Criteria:

Admission to pediatric intensive care unit
Age between 1 month and 10 years
Pediatric Risk of Mortality III score > 5, OR presence of at least 1 new organ failure
Anticipated pediatric intensive care unit length of stay > 3 days
Ability of parent or legal guardian to provide informed consent

Exclusion Criteria:

Known zinc deficiency
Pre-existing bone marrow failure
New or existing diagnosis of diabetes mellitus
Limitation of care orders in place
New diagnosis of brain injury, encephalopathy
Clinical contraindication for zinc supplementation","250 mcg/kg/day supplemental IV zinc sulfate divided every 8 hours for 7 days

Zinc sulfate: Zinc sulfate 200 mcg/ml in Normal Saline",ChEMBL:CHEMBL1200929 | DrugBank:DB09322 | PubChem:24424,ZINC SULFATE,O=S(=O)([O-])[O-].[Zn+2],A12CB01 | B05XA18 | C05AX04,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT01062009,NCT01062009_EG002,No,All,Child,Phase 1 | Phase 2,6,"Inclusion Criteria:

Admission to pediatric intensive care unit
Age between 1 month and 10 years
Pediatric Risk of Mortality III score > 5, OR presence of at least 1 new organ failure
Anticipated pediatric intensive care unit length of stay > 3 days
Ability of parent or legal guardian to provide informed consent

Exclusion Criteria:

Known zinc deficiency
Pre-existing bone marrow failure
New or existing diagnosis of diabetes mellitus
Limitation of care orders in place
New diagnosis of brain injury, encephalopathy
Clinical contraindication for zinc supplementation","500 mcg/kg/day supplemental IV zinc sulfate q8 hours for 7 days

Zinc sulfate: Zinc sulfate 200 mcg/ml in Normal Saline",ChEMBL:CHEMBL1200929 | DrugBank:DB09322 | PubChem:24424,ZINC SULFATE,O=S(=O)([O-])[O-].[Zn+2],A12CB01 | B05XA18 | C05AX04,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01062009,NCT01062009_EG003,No,All,Child,Phase 1 | Phase 2,6,"Inclusion Criteria:

Admission to pediatric intensive care unit
Age between 1 month and 10 years
Pediatric Risk of Mortality III score > 5, OR presence of at least 1 new organ failure
Anticipated pediatric intensive care unit length of stay > 3 days
Ability of parent or legal guardian to provide informed consent

Exclusion Criteria:

Known zinc deficiency
Pre-existing bone marrow failure
New or existing diagnosis of diabetes mellitus
Limitation of care orders in place
New diagnosis of brain injury, encephalopathy
Clinical contraindication for zinc supplementation","750 mcg/kg/day supplemental IV zinc sulfate q8 hrs for 7 days

Zinc sulfate: Zinc sulfate 200 mcg/ml in Normal Saline",ChEMBL:CHEMBL1200929 | DrugBank:DB09322 | PubChem:24424,ZINC SULFATE,O=S(=O)([O-])[O-].[Zn+2],A12CB01 | B05XA18 | C05AX04,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01062230,NCT01062230_EG000,No,All,Adult | Older Adult,Phase 2,6,"Inclusion Criteria:

History of histologically documented MM with relapsed or progressive disease after at least one line of prior therapy.

Patient has measurable disease in which to capture response, defined as one or more of the following:

Serum M-protein level > 1.0 gm/dl (10.0 g/L) measured by serum protein electrophoresis or immunoglobulin electrophoresis; or
Urinary M-protein excretion > 200 mg/24 hrs; or
Bone marrow plasmacytosis of > 30% by bone marrow aspirate and/or biopsy; or
Serum Free Light Chains (By the Freelite test) > 2X ULN, in the absence of renal failure
Radiographic evidence of disease
Performance status of < 2 as per ECOG scale, unless PS of 3-4 based solely on bone pain.
Patients must have a platelet count > 100,000/L and an ANC of at least 1,000/μl.
Patients must have adequate renal function defined as serum creatinine ≤2.5 mg/dL.
Patients must have adequate hepatic function defined as serum transaminases and direct bilirubin < 3 x the upper limit of normal.
Male or female adults of at least 18 years of age.
Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study.
Growth factors are allowed during the study
Male subject agrees to use an acceptable method for contraception for the duration of the study.

Exclusion Criteria:

Platelet count of <100x 10(9)/L within 14 days before enrollment.
Absolute neutrophil count (ANC) <1.0 x 10(9)/L
Serum creatinine ≥ 2.5 mg/dL within 14 days before enrollment.
Patient has >Grade 2 peripheral neuropathy within 14 days before enrollment.
Myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure (see section 1.4), uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at Screening has to be documented by the investigator as not medically relevant.
Patients with a history of treatment for clinically significant ventricular cardiac arrhythmias.
Patient has hypersensitivity to bortezomib, boron or mannitol.
Chemotherapy or radiotherapy received within the previous 4 weeks of study enrollment.
Female subject is pregnant or breast-feeding. Confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test result obtained during screening. Pregnancy testing is not required for post-menopausal or surgically sterilized women.
Patient has received other investigational drugs with 14 days before enrollment
Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
Diagnosed or treated for another malignancy within 3 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy.
POEMS Syndrome
Clinically significant hepatic dysfunction as noted by bilirubin or AST > 3 times the upper normal limit or clinically significant concurrent hepatitis.
Uncontrolled, active infection
Patients that have taken bisphosphonates within 30 days of screening will not be eligible for this trial.
Must not have received VELCADE 90 days prior to enrolling in this trial.","All participants enrolled.

Bortezomib (Velcade): Bortezomib will be administered as a 3-5 second bolus IV injection at the dose of 0.7 mg/m2 on days 1, 4, 8, and 11 q. 21 days times three cycles.

Patients will undergo three 21-day cycles.",ChEMBL:CHEMBL325041 | DrugBank:DB00188 | PubChem:387447,Bortezomib,CC(C)C[C@H](NC(=O)[C@H](Cc1ccccc1)NC(=O)c1cnccn1)B(O)O,L01XG01 | L01XX32,1.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01062763,NCT01062763_EG000,No,All,Adult | Older Adult,Phase 3,61,"Inclusion Criteria:

Age < 75 years
Type-2 diabetes
Therapy resistant hypertension (by ABPM)
Treatment with at least 3 antihypertensives

Exclusion Criteria:

HbA1c > 10.0
BP > 180/110 mmHg
Secondary hypertension
Intolerance to spironolactone
Permanent treatment with nonsteroidal antiinflammatory drugs or systemic glucocorticoids
Total cholesterol 10 mmol/l
New York Heart Association class III and IV
Pregnancy or planned pregnancy
Psychiatric disease
Malignant disease
Insufficient adherence","spironolactone is added to previous antihypertensive treatment

spironolactone : 25 uptrated if necessary to 50 mg once daily",ChEMBL:CHEMBL1393 | DrugBank:DB00421 | PubChem:5833,Spironolactone,[H][C@]12CC[C@]3(C)[C@]4(CCC(=O)O4)CC[C@@]3([H])[C@]1([H])[C@]([H])(SC(C)=O)CC1=CC(=O)CC[C@@]12C,C03DA01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01069510,NCT01069510_EG001,No,All,Adult | Older Adult,Phase 2,40,"Inclusion Criteria:

Fibrosis index ≥29%, or

Evidence of cardiovascular dysfunction including any of the following:

Systemic ejection fraction <55%,
NYHA 2-3
6-minute walk distance <500 m.
Completion of Visit 1 of the study Heart Failure in Congenital Heart Disease: the role of myocardial fibrosis"" (eIRB # 3665) including meeting all inclusion for that study (Aged 18-80, Known congenital heart disease).
Tetralogy of Fallot, cyanotic congenital heart disease, or a systemic right ventricle.

Exclusion Criteria:

Patient currently taking spironolactone or previously taking spironolactone within the last 6 months.
Serum potassium ≥5.0 mmol/L at the initial visit, if not taking potassium supplements. Patients will be eligible if a repeat potassium is <5.0 mmol/L after potassium supplements have been discontinued.
Moderate/severe systemic atrioventricular valve regurgitation,
Likely to undergo cardiac surgery, pacemaker implantation, or possible transplantation within one year (all self-reported),
Unwilling to commit to return visits including mandatory blood draws for potassium,
Renal insufficiency (estimated creatinine clearance < 30 ml/min/1.73m2),
Positive urine pregnancy test.
Any contraindication to MRI.","Spironolactone 25 mg daily

Spironolactone 25mg: Spironolactone 25 mg daily for 12 months",ChEMBL:CHEMBL1393 | DrugBank:DB00421 | PubChem:5833,Spironolactone,[H][C@]12CC[C@]3(C)[C@]4(CCC(=O)O4)CC[C@@]3([H])[C@]1([H])[C@]([H])(SC(C)=O)CC1=CC(=O)CC[C@@]12C,C03DA01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01072201,NCT01072201_EG000,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 3,60,"Inclusion Criteria:

Male and female subjects, ages 30-70.
Availability for the six-month duration of the clinical research study.
Good general health.
Subjects who have lost teeth for periodontal disease reasons and who have been restored with implants.
Minimum of 5 remaining teeth and a minimum of 2 implants.
Initial evaluation of the gingival and peri-implant mucosal tissues by determining full mouth bleeding on probing.
Initial plaque evaluation by determining full mouth presence/absence of plaque.
Signed Informed Consent Form.

Exclusion Criteria:

Tumor(s) of the soft or hard tissues of the oral cavity.
Untreated periodontal disease (purulent exudate, tooth mobility, and/or extensive loss or periodontal attachment or alveolar bone).
Carious lesions requiring immediate restorative treatment.
Uncontrolled Diabetes
Use of antibiotics any time during the one month prior to entry into the study.
Untreated peri-implantitis.
Participation in any other clinical research study or test panel within the three months prior to entry into the study.
Pregnant women or women who are breast feeding.
History of allergies to personal care/consumer products or their ingredients.
Medical condition which prohibits not eating/drinking for up to 2 hours.
Current alcohol or drug abuse.
Systemic or local disease conditions that would compromise post-operative healing.
Regular use of anti-inflammatory drugs.",Triclosan/copolymer/Fluoride,PubChem:24848164,Sodium fluoride and triclosan,Oc1cc(Cl)ccc1Oc1ccc(Cl)cc1Cl.[F-].[Na+],,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01076088,NCT01076088_EG002,No,All,Adult | Older Adult,Phase 3,126,"Inclusion Criteria:

has type 2 diabetes mellitus
is male, a female who cannot have children, or a female who agrees to use birth control during the study
is not on an antihyperglycemic agent (AHA) (hemoglobin A1c [A1C] 7.5-11.0%) or on oral single AHA (A1C 7.0-10.5%) or low-dose AHA combination therapy (A1C 7.0-10.0%)

Exclusion Criteria:

Patient has type 1 diabetes mellitus or ketoacidosis
Patient is taking a dipeptidyl peptidase-4 (DPP-4) inhibitor (such as sitagliptin)
Patient is on a weight loss program not in the maintenance phase or on a weight loss medication
Patient has a history of liver disease, heart failure, heart disease, stroke, high blood pressure, blood disorders, or cancer
Patient is HIV positive
Patient is pregnant",Metformin 500 mg twice daily,ChEMBL:CHEMBL1431 | DrugBank:DB00331 | PubChem:4091,Metformin,CN(C)C(=N)NC(=N)N,A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01079988,NCT01079988_EG003,No,All,Child | Adult | Older Adult,Phase 4,20,"Inclusion Criteria:

Participation in Genentech study ACD2601g, Genentech study HUPA 600 or Serono study IMP24011.
Inflammatory psoriasis disease recurrence occurring up to 2 months after discontinuation of efalizumab that required immediate therapeutic control in the opinion of the Investigator. Psoriasis had to be rapidly developing, symptomatic and inflammatory in nature.
Written informed consent, given prior to any study-related procedure not part of the subject's normal medical care, with the understanding that the subject could withdraw consent at any time without prejudice to his or her future medical care.

Female subjects had to be neither pregnant nor breast-feeding, and had to lack childbearing potential, as defined by either:

Being post-menopausal or surgically sterile, or
Using an accepted form of contraception.
Confirmation that the subject was not pregnant had to be established by a negative urinary hCG test at SD1. A pregnancy test was not required if the subject was post-menopausal or surgically sterile.
Outpatient status at the time of enrolment.

Exclusion Criteria:

Disease recurrence that was part of the natural disease progression, was not inflammatory in nature, and was not related to efalizumab study medication in the previous study.","Starting dose 20 - 25 mg per week until clinical improvement. Upon clinical improvement, dose to be reduced by 25%. Thereafter, methotrexate dose to be reduced by 25% every two weeks.",ChEMBL:CHEMBL34259 | DrugBank:DB00563 | PubChem:126941,Methotrexate,CN(Cc1cnc2nc(N)nc(N)c2n1)c1ccc(C(=O)N[C@@H](CCC(=O)O)C(=O)O)cc1,L01BA01 | L04AX03,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,1.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT01081795,NCT01081795_EG001,No,All,Adult,Phase 2,130,"Inclusion Criteria:

Participants who meet the Second Edition of the International Classification of Headache Disorders (ICHD-II), 1.1 Migraine without aura or 1.2 Migraine with aura over at least 6 months before the time of informed consent
Participants who had an average of no more than 8 migraine attacks per month during 3 months before informed consent and an average of no more than 14 headache (migraine and non-migraine) days
Participants whose number of migraine attacks during the baseline determination period (28 days) is 3 to 12 according to the 24-hour rule and number of headache days (migraine and non-migraine) is no more than 14
Participants who took no migraine preventive medications over 2 weeks before informed consent, or who can take at least 2-week washout period before baseline determination period if they are taking migraine preventive medications
Female participants must be postmenopausal, surgically sterile, abstinent, or can take adequate contraceptive measures after informed consent and continue it to the completion of investigational treatment

Exclusion Criteria:

Participants who cannot distinguish between migraine and non-migraine headache
Participants with headache other than those described in the ICHD-II, 1.1 Migraine without aura, 1.2 Migraine with aura, 2. Tension headache or 11.5 Sinus headache
If the participant has received drug therapies for prevention of migraine, the discontinued preventive therapies due to insufficient efficacy should be at least three types
Participants who excessively took medications for migraine attacks such as analgesics (drug used to control pain) as medications to be taken as needed within 3 months before informed consent
Participants who have taken topiramate (test drug in this study) in the past","In titration period, topiramate 25 mg tablet once daily in the evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; then 2 topiramate 25 mg tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period",ChEMBL:CHEMBL220492 | DrugBank:DB00273 | PubChem:5284627,Topiramate,[H][C@@]12OC(C)(C)O[C@]1([H])CO[C@@]1(COS(N)(=O)=O)OC(C)(C)O[C@]12[H],A08AA51 | N03AX11,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT01087814,NCT01087814_EG000,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 4,16,"Inclusion Criteria:

HIV-negative, proven by ELISA
Age: ≥ 18 years old

Exclusion Criteria:

Psychiatric or psychological illness that would make adherence to protocol procedures unlikely.",Both arms received both versions of the drug during the course of the study.,ChEMBL:CHEMBL223228 | DrugBank:DB00625 | PubChem:64139,Efavirenz,O=C1Nc2ccc(Cl)cc2[C@@](C#CC2CC2)(C(F)(F)F)O1,J05AG03 | J05AR06 | J05AR11,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01088997,NCT01088997_EG000,No,All,Child,Not Applicable,7,"Inclusion Criteria:

Gestational age > 34 weeks
Post-natal age < 10 days
Hypoxemia defined by: Oxygenation Index (OI) >15 (Mean Airway Pressure x Fraction of Inspired Oxygen (FiO2) x 100 /PaO2) as drawn from two post-ductal arterial blood gas samples (in-dwelling arterial catheter) taken at least 15 minutes apart. OR mechanically ventilated and with >75% FiO2 for >6 hours while on iNO
Absence of congenital heart disease based on a two-dimensional echocardiogram and/or clinical assessment
An in-dwelling arterial catheter to facilitate painless sampling
Currently on iNO or plan to start iNO before enrollment

Exclusion Criteria:

Lethal non-cardiac congenital anomalies including diaphragmatic hernia
Clinically apparent bleeding; thrombocytopenia <30,000 or other laboratory evidence of coagulopathy
Currently on extracorporeal membrane oxygenation (ECMO)or plan to initiate ECMO within 2 hours of enrollment",Subjects received a bolus intravenous (IV) infusion of 50 mcg/kg/min of milrinone lactate over 1 hour followed by a continuous IV infusion of 0.5 mcg/kg/min milrinone lactate over 24 hours.,ChEMBL:CHEMBL189 | DrugBank:DB00235 | PubChem:4197,Milrinone,Cc1[nH]c(=O)c(C#N)cc1-c1ccncc1,C01CE02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT01088997,NCT01088997_EG001,No,All,Child,Not Applicable,5,"Inclusion Criteria:

Gestational age > 34 weeks
Post-natal age < 10 days
Hypoxemia defined by: Oxygenation Index (OI) >15 (Mean Airway Pressure x Fraction of Inspired Oxygen (FiO2) x 100 /PaO2) as drawn from two post-ductal arterial blood gas samples (in-dwelling arterial catheter) taken at least 15 minutes apart. OR mechanically ventilated and with >75% FiO2 for >6 hours while on iNO
Absence of congenital heart disease based on a two-dimensional echocardiogram and/or clinical assessment
An in-dwelling arterial catheter to facilitate painless sampling
Currently on iNO or plan to start iNO before enrollment

Exclusion Criteria:

Lethal non-cardiac congenital anomalies including diaphragmatic hernia
Clinically apparent bleeding; thrombocytopenia <30,000 or other laboratory evidence of coagulopathy
Currently on extracorporeal membrane oxygenation (ECMO)or plan to initiate ECMO within 2 hours of enrollment",Subjects received a bolus intravenous (IV) infusion of 20 mcg/kg/min of milrinone lactate over 1 hour followed by a continuous IV infusion of 0.2 mcg/kg/min milrinone lactate over 24 hours.,ChEMBL:CHEMBL189 | DrugBank:DB00235 | PubChem:4197,Milrinone,Cc1[nH]c(=O)c(C#N)cc1-c1ccncc1,C01CE02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT01089543,NCT01089543_EG000,No,All,Adult | Older Adult,Phase 2,85,"Inclusion criteria:

-Participants diagnosed as Functional Dyspepsia according to Rome III criteria.

Exclusion criteria:

Participants with neuropsychiatric disorder.
Participants diagnosed with irritable bowel syndrome, inflammatory bowel disease and serious constipation.",Rabeprazole 10 mg tablet taken orally once daily after breakfast for 8 weeks.,ChEMBL:CHEMBL1219 | DrugBank:DB01129 | PubChem:5029,Rabeprazole,COCCCOc1ccnc(CS(=O)c2nc3ccccc3[nH]2)c1C,A02BC04 | A02BC54 | A02BD12 | A02BD13 | M01AA05 | M02AA03,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01089543,NCT01089543_EG001,No,All,Adult | Older Adult,Phase 2,85,"Inclusion criteria:

-Participants diagnosed as Functional Dyspepsia according to Rome III criteria.

Exclusion criteria:

Participants with neuropsychiatric disorder.
Participants diagnosed with irritable bowel syndrome, inflammatory bowel disease and serious constipation.",Rabeprazole 20 mg tablet taken orally once daily after breakfast for 8 weeks.,ChEMBL:CHEMBL1219 | DrugBank:DB01129 | PubChem:5029,Rabeprazole,COCCCOc1ccnc(CS(=O)c2nc3ccccc3[nH]2)c1C,A02BC04 | A02BC54 | A02BD12 | A02BD13 | M01AA05 | M02AA03,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01089543,NCT01089543_EG002,No,All,Adult | Older Adult,Phase 2,83,"Inclusion criteria:

-Participants diagnosed as Functional Dyspepsia according to Rome III criteria.

Exclusion criteria:

Participants with neuropsychiatric disorder.
Participants diagnosed with irritable bowel syndrome, inflammatory bowel disease and serious constipation.",Rabeprazole 40 mg tablet taken orally once daily after breakfast for 8 weeks.,ChEMBL:CHEMBL1219 | DrugBank:DB01129 | PubChem:5029,Rabeprazole,COCCCOc1ccnc(CS(=O)c2nc3ccccc3[nH]2)c1C,A02BC04 | A02BC54 | A02BD12 | A02BD13 | M01AA05 | M02AA03,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01090921,NCT01090921_EG000,No,All,Adult | Older Adult,Phase 2,50,"Inclusion Criteria:

Diagnosis of multiple myeloma based on standard criteria.
Measurable disease, defined as a monoclonal immunoglobulin spike on serum electrophoresis of > 1Gm/dL and/or urine monoclonal immunoglobulin spike of > 200mg/24 hours.
Non-secretors must have measurable protein by Freelite or measurable disease such as plasmacytoma to be eligible.
Patient must not have been previously treated with chemotherapy. Prior treatment of hypercalcemia with corticosteroids, or bisphosphonates does not disqualify the patient.

Patient must be ineligible for autologous stem cell transplant due to one or more of the following reasons:

Age>65
Impaired renal function (creatinine≥2.0 mg/dL)
Impaired pulmonary function (DLCO≤50%)
Poor performance status (KPS≤80)

Other prohibitive comorbid disorder

5b. Patients≥60 who decline autologous stem cell transplant are eligible for this study.
5c. Patients who are eligible but wish to postpone autologous stem cell transplant are eligible for this study.
Karnofsky performance status>50
Patients treated with local radiotherapy with or without a brief exposure to steroids are eligible. Patients who require concurrent radiotherapy should have entry to the protocol deferred until the radiotherapy is completed, followed by a four week wash out period Spot RT to ≤3 vertebrae acceptable prior to entry.

Meets the following pretreatment laboratory criteria at Baseline (Within 14 days prior to study drug administration):

Platelet count>50x10^9/L or, if the bone marrow is extensively infiltrated,>30x10^9/L
Hemoglobin>8.0G/dL
Absolute neutrophil count >1.0x10^9/L or, if the bone marrow is extensively infiltrated, >0.5x10^9/L

Meets the following pretreatment laboratory criteria for liver function tests at the screening visit conducted within 14 days of registration

AST (SGOT): <3 times the upper limit of institutional laboratory normal
ALT (SGPT): <3 times the upper limit of institutional laboratory normal
Total bilirubin: <2 times the upper limit of institutional laboratory normal, unless clearly related to the disease
Women with child-bearing potential should be practicing an adequate form of contraception, as judged by the investigator (i.e. birth control pills, double barrier method, abstinence, etc.) or be surgically sterile or 12 months post-menopausal. Male subject agrees to use an acceptable method for contraception for the duration of the study.
Age 18 years or older
Has given voluntary written informed consent.

Exclusion Criteria:

POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein (M-protein) and skin changes)
Plasma cell leukemia
Impaired kidney function requiring dialysis, patients on hemodialysis are excluded
Receiving steroids >the equivalent of 10mg prednisone daily for other medical conditions, e.g., asthma, systemic lupus erythematosis, rheumatoid arthritis
Infection not controlled by antibiotics
HIV infection. Patients should provide consent for HIV testing according to the institution's standard practice
Known active hepatitis B or C
Myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure (Appendix D), uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
Second malignancy requiring concurrent treatment
Other serious medical or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol
Positive pregnancy test in women of childbearing potential
Patient has hypersensitivity to boron or mannitol.
Patient has ≥Grade 2 peripheral neuropathy within 14 days before enrollment.
Patient has received other investigational drugs with 14 days before enrollment","Bortezomib is administered at a dose of 1.6mg/m2 IV push over 3 to 5 seconds. Treatment is administered once a week for four weeks followed by one week off. This 5 week period is considered a treatment cycle. Dexamethasone is also administered at a dose of 40mg daily on day of and day after each dose of Bortezomib, with a dose reduction to 20mg on the same schedule if the patient cannot tolerate the higher dose of dexamethasone. The study duration for a given subject will be approximately 30 weeks.

Bortezomib: Bortezomib will be administered at a dose of 1.6 mg/m2 IV push. Treatment will be administered once a week for four weeks followed by one week off. This 5 week period is considered a treatment cycle.

Dexamethasone will also be administered at a dose of 40mg on the day of and day after each dose of bortezomib, with a dose reduction to 20mg on the same schedule if the patient cannot tolerate the higher dose of dexamethasone.",ChEMBL:CHEMBL325041 | DrugBank:DB00188 | PubChem:387447,Bortezomib,CC(C)C[C@H](NC(=O)[C@H](Cc1ccccc1)NC(=O)c1cnccn1)B(O)O,L01XG01 | L01XX32,1.0,0.0,0.0,0.0,1.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01097330,NCT01097330_EG001,No,All,Adult | Older Adult,Phase 3,5,"Inclusion Criteria - Patients must meet all of the following criteria:

> 18 and < 85 years of age
ICD implanted for primary prophylaxis against sudden cardiac death or ICD implanted for secondary prophylaxis against spontaneous or inducible sustained VT without any reversible causes
Coronary artery disease (CAD) with prior myocardial infarction (MI)
ICD or electrocardiogram (ECG) documentation of ventricular arrhythmia responsible for appropriate ICD therapy [antitachycardia pacing (ATP) & shocks].

Exclusion Criteria - Patients should not have any of the following criteria:

Contraindication or allergy to contrast media, routine procedural medications or catheter materials
Contraindication to an interventional procedure
Current or previous (within 3 months) amiodarone therapy
Atrial Fibrillation requiring antiarrhythmic drug therapy
Contraindication to amiodarone therapy
New York Heart Association (NYHA) functional class IV
Myocardial infarction within the past 60 days
Stroke within the past 90 days
Unstable angina
Hypertrophic cardiomyopathy, Non-ischemic dilated cardiomyopathy, Arrhythmogenic Right Ventricular Dysplasia, Brugada Syndrome, Catecholamine sensitive polymorphic VT or long QT syndrome
Patients with active ischemia that are eligible for revascularization
Life expectancy less than 6 months
Incessant or multiple episodes of VT requiring immediate therapy with medications or ablation
Untreated hypothyroidism or hyperthyroidism. Patients who are euthyroid on thyroid hormone replacement therapy are acceptable.
Current enrollment in another investigational drug or device study.
Presence of any other condition that the investigator feels would be problematic or would restrict or limit the participation of the patient for the entire study period.
Absolute contra-indication to the use of heparin and or warfarin.
Documented intra-atrial thrombus, ventricular thrombus (< 6 months after detection of thrombus), tumor, or another abnormality which precludes catheter introduction.
Females of childbearing potential who are not practicing protocol acceptable method of birth control.","amiodarone titrated to therapeutic levels as per standard of care and maintained on a dose of at least 200 mg (300 mg recommended) once a day for the duration of the study.

Amiodarone: Amiodarone titrated to therapeutic levels as per standard of care and maintained on a dose of at least 200 mg (300 mg recommended) once a day for the duration of the study",ChEMBL:CHEMBL633 | DrugBank:DB01118 | PubChem:2157,Amiodarone,CCCCc1oc2ccccc2c1C(=O)c1cc(I)c(OCCN(CC)CC)c(I)c1,C01BD01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01097395,NCT01097395_EG000,No,All,Adult | Older Adult,Phase 4,17,"Inclusion Criteria:

Chronic HCV-infected men and women
18-70 years
HCV genotype 1
Deemed ready for HCV treatment by hepatology provider and patient
Allowed medications: all those not specifically listed in the exclusion criteria below including medications for peginterferon / ribavirin - related adverse effects: acetaminophen, ibuprofen, diphenhydramine, selective serotonin reuptake inhibitors, darbepoeitin, erythropoietin, GCSF

Exclusion Criteria:

previous treatment with interferon, peginterferon, investigational HCV drugs, boceprevir, or ribavirin;
baseline absolute neutrophil count (ANC) < 1000/mm3,
platelets < 100,000/mm3,
hemoglobin < 12 g/dL for women and < 13 g/dL for men;
HIV positive serostatus;
HBV positive serostatus;
decompensated liver disease (i.e., ascites, history of esophageal variceal bleeding, hepatic encephalopathy);
autoimmune hepatitis
hemoglobinopathy (e.g., sickle cell anemia, thalassemia)
Cockcroft and Gault estimated creatinine clearance < 50 mL/min;
alcohol or illicit drug use that in the opinion of the investigator would interfere with study participation and/or impact study results
for females, active pregnancy or any intent to become pregnant during study period or for up to 6 months after completing treatment
for males, a pregnant female partner or intent to impregnate a female during study period or for up to 6 months after completing treatment
for both sexes an unwillingness to use two forms of contraception during the study period and for 6 months after completing treatment. While on telaprevir and for 2 weeks following discontinuation of telaprevir, females must use two non-hormonal forms of contraception;
history of significant or unstable cardiac disease including severe coronary artery disease (unstable angina, recent myocardial infarction, chest pain with exertion) or congestive heart failure;
receipt of an organ transplant;
malignant neoplastic disease;
chronic pulmonary disease that in the opinion of the study hepatologists would preclude treatment with peginterferon and ribavirin (e.g., pulmonary function tests ≤70% within the previous 2 years);
history of admission to a psychiatric facility within the previous year;
suicide attempt within the previous 3 years;
concomitant medications including: amantadine, mycophenolate mofetil, and investigational HCV compounds, alfuzosin, alfentanil, ergot derivatives (dihydroergotamine/ergotamine/ergonovine/methylergonovine), meperidine, anti-arrhythmics (quinidine, flecainide, propafenone, amiodarone, bepridil), astemizole, terfenadine, buspirone, diazepam, estazolam, oral midazolam, triazolam, budesonide, domperidone, eletriptan, eplerenone, fluticasone, pimozide, salmeterol, calcium channel blockers (diltiazem, felodipine, nifedipine, nisoldipine, verapamil), cisapride, cyclosporine, sirolimus, systemic tacrolimus, atorvastatin, lovastatin, simvistatin, sildenafil, tadalafil, verdenafil, antibiotics (clarithromycin, erythromycin, telithromycin, troleandomycin), carbamazepine, Phenobarbital, phenytoin, nefazodone, St. Johns Wort, antifungals (fluconazole, itraconazole, ketoconazole, posaconazole, voriconazole), rifampin, rifabutin, aprepitant, cholestyramine, fluvoxamine, mifepreistone, modafinil, systemic dexamethasone. With the exception of St. Johns Wort, investigators may use their discretion on use of herbal and dietary supplements.
Evidence of severe retinopathy or clinically relevant ophthalmologic disorders","1000 mg daily in patients weighing <75 kg and 1200 mg daily in patients weighing ≥ 75 kg

ribavirin: Randomization to standard weight based ribavirin dosing (1000 or 1200 mg daily) or concentration-guided dosing based on first dose AUC0-12",ChEMBL:CHEMBL1643 | DrugBank:DB00811 | PubChem:37542,Ribavirin,NC(=O)c1ncn([C@@H]2O[C@H](CO)[C@@H](O)[C@H]2O)n1,J05AP01,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT01097395,NCT01097395_EG001,No,All,Adult | Older Adult,Phase 4,18,"Inclusion Criteria:

Chronic HCV-infected men and women
18-70 years
HCV genotype 1
Deemed ready for HCV treatment by hepatology provider and patient
Allowed medications: all those not specifically listed in the exclusion criteria below including medications for peginterferon / ribavirin - related adverse effects: acetaminophen, ibuprofen, diphenhydramine, selective serotonin reuptake inhibitors, darbepoeitin, erythropoietin, GCSF

Exclusion Criteria:

previous treatment with interferon, peginterferon, investigational HCV drugs, boceprevir, or ribavirin;
baseline absolute neutrophil count (ANC) < 1000/mm3,
platelets < 100,000/mm3,
hemoglobin < 12 g/dL for women and < 13 g/dL for men;
HIV positive serostatus;
HBV positive serostatus;
decompensated liver disease (i.e., ascites, history of esophageal variceal bleeding, hepatic encephalopathy);
autoimmune hepatitis
hemoglobinopathy (e.g., sickle cell anemia, thalassemia)
Cockcroft and Gault estimated creatinine clearance < 50 mL/min;
alcohol or illicit drug use that in the opinion of the investigator would interfere with study participation and/or impact study results
for females, active pregnancy or any intent to become pregnant during study period or for up to 6 months after completing treatment
for males, a pregnant female partner or intent to impregnate a female during study period or for up to 6 months after completing treatment
for both sexes an unwillingness to use two forms of contraception during the study period and for 6 months after completing treatment. While on telaprevir and for 2 weeks following discontinuation of telaprevir, females must use two non-hormonal forms of contraception;
history of significant or unstable cardiac disease including severe coronary artery disease (unstable angina, recent myocardial infarction, chest pain with exertion) or congestive heart failure;
receipt of an organ transplant;
malignant neoplastic disease;
chronic pulmonary disease that in the opinion of the study hepatologists would preclude treatment with peginterferon and ribavirin (e.g., pulmonary function tests ≤70% within the previous 2 years);
history of admission to a psychiatric facility within the previous year;
suicide attempt within the previous 3 years;
concomitant medications including: amantadine, mycophenolate mofetil, and investigational HCV compounds, alfuzosin, alfentanil, ergot derivatives (dihydroergotamine/ergotamine/ergonovine/methylergonovine), meperidine, anti-arrhythmics (quinidine, flecainide, propafenone, amiodarone, bepridil), astemizole, terfenadine, buspirone, diazepam, estazolam, oral midazolam, triazolam, budesonide, domperidone, eletriptan, eplerenone, fluticasone, pimozide, salmeterol, calcium channel blockers (diltiazem, felodipine, nifedipine, nisoldipine, verapamil), cisapride, cyclosporine, sirolimus, systemic tacrolimus, atorvastatin, lovastatin, simvistatin, sildenafil, tadalafil, verdenafil, antibiotics (clarithromycin, erythromycin, telithromycin, troleandomycin), carbamazepine, Phenobarbital, phenytoin, nefazodone, St. Johns Wort, antifungals (fluconazole, itraconazole, ketoconazole, posaconazole, voriconazole), rifampin, rifabutin, aprepitant, cholestyramine, fluvoxamine, mifepreistone, modafinil, systemic dexamethasone. With the exception of St. Johns Wort, investigators may use their discretion on use of herbal and dietary supplements.
Evidence of severe retinopathy or clinically relevant ophthalmologic disorders","Dose adjusted based on first dose AUC0-12

ribavirin: Randomization to standard weight based ribavirin dosing (1000 or 1200 mg daily) or concentration-guided dosing based on first dose AUC0-12",ChEMBL:CHEMBL1643 | DrugBank:DB00811 | PubChem:37542,Ribavirin,NC(=O)c1ncn([C@@H]2O[C@H](CO)[C@@H](O)[C@H]2O)n1,J05AP01,1.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT01099618,NCT01099618_EG000,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 4,17,"Inclusion Criteria:

All newly diagnosed overweight/obese (BMI >/=28 kg/m2) African-American patients with new-onset DKA and/or severe hyperglycemia and without apparent precipitating cause will be considered for inclusion into the study. The diagnosis of DKA will be established by standard criteria (blood glucose > 250 mg/dL, pH < 7.3, HCO3 < 18 mmol/L, increased anion gap).
The hyperglycemic group will include patients with an admission plasma glucose > 400 mg/dL but without the presence of metabolic acidosis or ketosis.

Exclusion Criteria:

significant medical or surgical illness, including but not limited to myocardial ischemia, congestive heart failure, chronic renal insufficiency, liver failure, and infectious processes;
recognized or suspected endocrine disorders associated with increased insulin resistance, such as hypercortisolism, acromegaly, or hyperthyroidism;
bleeding disorders, thrombocytopenia, or abnormalities in coagulation studies;
pregnancy,
have an allergy to any component of metformin or sitagliptin.","All newly diagnosed subjects with KPDM that are able to discontinue insulin after 12 weeks or less will be randomized in double-blind fashion to receive either metformin 1000mg, sitagliptin 100mg or placebo once daily. Subjects that do not achieve remission will continue to receive insulin therapy and will discontinue the protocol. A total of 48 obese subjects with DKA and without ketoacidosis will be randomized to receive metformin (MET) 1000 mg (n=16), sitagliptin (SIT) 100mg (n=16) or placebo (n=16).

metformin: The study subject will receive metformin (MET) 1000 mg tablet once a day as long as the patient maintains near-normoglycemic remission (BG < 130mg/dL and A1c <7%) during the 3-year follow-up period.",ChEMBL:CHEMBL1431 | DrugBank:DB00331 | PubChem:4091,Metformin,CN(C)C(=N)NC(=N)N,A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01103362,NCT01103362_EG000,No,Female,Adult | Older Adult,Phase 3,596,"Inclusion criteria:

Women with primary diagnosis of Hypoactive Sexual Desire Disorder (HSDD) who completed a prior trial of flibanserin. Such completion requires compliance with trial medication and the trial visit schedule including any post-treatment visits required in that clinical trial. Early discontinuation for any reason disqualifies the patient from entry into this trial. Patients must enroll in this study within 7 days after completing the final visit of the parent trial.
The premenopausal patient must use a medically acceptable method of contraception for at least two months before baseline and continue to use medically acceptable method of contraception during the trial.
Postmenopausal patients must be a naturally postmenopausal woman of any age with at least one ovary. Natural menopause is defined as greater than 12 months of spontaneous amenorrhea.
In the investigator's opinion, patients must be willing to adhere to trial requirements as well as to be able to perform them.
Patients must be able and willing to give meaningful, written informed consent prior to participation in the trial, in accordance with regulatory requirements. Patients must have sufficient understanding to communicate effectively with the investigator, and be willing to discuss sexual functioning with study staff.

Exclusion criteria:

Patients with history of Major Depressive Disorder (MDD) within six months prior to the Screen Visit, or a score of greater than or equal to 14 on the Beck Depression Inventory II (BDI-II), or a history of suicidal behavior or suicidal ideation according to the Columbia-Suicide Severity Rating Scale (C-SSRS®). If a psychiatrist or psychologist, using clinical judgment, believes a patient who scored between 14 and 19 on the BDI®-II is not depressed, the patient may be entered into the trial. NOTE: If a patient reports positive response to BDI®-II Question 9 and/or a Yes response to either C-SSRS® Suicide Ideation section Question 1 and/or 2 and/or any question in the Suicide Behavior section, please refer to Section 5.2.5 for immediate actions required.
At the Screen Visit, serum alanine aminotransferase, serum aspartate aminotransferase, alkaline phosphatase, or total bilirubin greater than or equal to three times upper limit of normal; blood urea nitrogen greater than or equal to 30 mg/deciliter (dL), plasma creatinine greater than or equal to 2 mg/dL, hemoglobin <9.5 grams/dL, leukopenia (<2.5 x 103/microliter [µL]), neutropenia (<1.5 x 103/µL), lymphopenia (<0.8 x 103/µL), thrombocytopenia (<100 x 103/µL) or thrombocytosis (>500 x 103/µL); or random glucose > upper limit of normal.
Patients with newly developed, self-reported symptoms after the End of Treatment parent trial visit and at this trial Screen Visit of pelvic inflammatory disease, urinary tract or vaginal infection / vaginitis, cervicitis, interstitial cystitis, vulvodynia, or significant vaginal atrophy.
Patients with history of any cancer within the last ten years, other than non-invasive, previously resected basal cell carcinoma of the skin.
Patients whose sexual function was affected by hysterectomy, oophorectomy, or any other pelvic or vaginal surgery.
Patients who are pregnant (by urine pregnancy test at the Screen Visit) or have been pregnant within the month prior to the Screen Visit or who are breast-feeding or have breast-fed within the last six months prior to the Baseline Visit.
Patients receiving medication excluded in their prior safety and efficacy trial of flibanserin causing sexual dysfunction or safety-relevant interactions (i.e., antidepressants, anxiolytics, antipsychotics, anticonvulsants, anticoagulants).
Patients with clinically relevant conditions which might interfere with their ability to participate in the trial.
Participation in a trial of an investigational medication other than flibanserin within one month prior to the Screen Visit.","flibanserin 100mg po qd

flibanserin: all patients will receive open-label flibanserin 100mg",ChEMBL:CHEMBL231068 | DrugBank:DB04908 | PubChem:6918248,Flibanserin,O=c1[nH]c2ccccc2n1CCN1CCN(c2cccc(C(F)(F)F)c2)CC1,G02CX02,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01103778,NCT01103778_EG000,No,All,Adult | Older Adult,Phase 4,8,"Inclusion Criteria:

Male or female, 18 years of age or older.
Must have IgA nephropathy documented by kidney biopsy.
Must have greater than 1gm of proteinuria a day.
Must be on a stable dose of Angiotensin Converting Enzyme Inhibitor (ACEI) and/or Angiotensin Receptor Blocking agent (ARB) for at least 4 weeks prior to screening.

Exclusion Criteria:

Low platelet count and neutrophil count within certain limits defined for enrollment.
Underlying peripheral neuropathy.
Having cardiac problems, such as myocardial infarction, heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
Allergic to VELCADE®, boron or mannitol.
Female subjects who are pregnant or breast-feeding.
Recent use of investigational drug within 14 days before enrollment.
Having serious medical conditions and infections (including HIV,or hepatitis B or C) or psychiatric illness likely to interfere with participation in the study.
Diagnosed or treated for cancer within 3 years of participation in the study, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, and in situ malignancy, or low-risk prostate cancer after curative therapy.","Patients with greater than 1gm of proteinuria per day will receive Velcade®.

Bortezomib (Velcade®): Velcade® at 1.3 mg/m2, on days 1, 4, 8 and 11 (=1 cycle).",ChEMBL:CHEMBL325041 | DrugBank:DB00188 | PubChem:387447,Bortezomib,CC(C)C[C@H](NC(=O)[C@H](Cc1ccccc1)NC(=O)c1cnccn1)B(O)O,L01XG01 | L01XX32,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01109004,NCT01109004_EG000,No,All,Child | Adult | Older Adult,Phase 3,247,"Inclusion Criteria:

Patients meeting the criteria for symptomatic multiple myeloma (MM).
Patients who are 70 years of age, or younger, at time of enrollment.
Patients who have received at least two cycles of any regimen as initial systemic therapy and are within 2 - 12 months of the first dose of initial therapy.
Cardiac function: left ventricular ejection fraction at rest greater than 40 percent.
Hepatic: bilirubin less than 1.5x the upper limit of normal and alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than 2.5x the upper limit of normal. (Patients who have been diagnosed with Gilbert's Disease are allowed to exceed the defined bilirubin value of 1.5x the upper limit of normal.)
Renal: Creatinine clearance of grater than or equal to 40 mL/min, estimated or calculated.
Pulmonary: Diffusing capacity of the lung for carbon monoxide (DLCO), forced expiratory volume in one second (FEV1), or forced vital capacity (FVC) greater than 50 percent of predicted value (corrected for hemoglobin).
Patients with an adequate autologous graft defined as a cryopreserved PBSC graft containing greater than or equal to 4 x 10^6 CD34+ cells/kg patient weight. The graft may not be CD34+ selected or otherwise manipulated to remove tumor or other cells. The graft can be collected at the transplanting institution or by a referring center. The autograft must be stored so that there are two products each containing at least 2 x 10^6 CD34+ cells/kg patient weight.
Signed informed consent form.

Exclusion Criteria:

Patients who never fulfill the criteria for symptomatic MM.
Patients with purely non-secretory MM [absence of a monoclonal protein (M protein) in serum as measured by electrophoresis and immunofixation and the absence of Bence Jones protein in the urine defined by use of conventional electrophoresis and immunofixation techniques]. Patients with light chain MM detected in the serum by free light chain assay are eligible.
Patients with plasma cell leukemia.
Karnofsky performance score less than 70 percent.
Patients with greater than grade 2 sensory neuropathy (CTCAE).
Patients with uncontrolled bacterial, viral or fungal infections (currently taking medication and progression of clinical symptoms).
Patients seropositive for the human immunodeficiency virus (HIV).
Myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at Screening has to be documented by the investigator as not medically relevant.
Patient has hypersensitivity to bortezomib, boron or mannitol.
Patient has received other investigational drugs with 14 days before enrollment.
Patients with prior malignancies except resected basal cell carcinoma or treated cervical carcinoma in situ. Cancer treated with curative intent less than 5 years previously will not be allowed unless approved by the Protocol Officer or one of the Protocol Chairs. Cancer treated with curative intent greater than 5 years previously is allowed.
Female patients who are pregnant (positive B-HCG) or breastfeeding.
Females of childbearing potential (FCBP) or men who have sexual contact with FCBP unwilling to use contraceptive techniques during the length of lenalidomide maintenance therapy.
Prior allograft or prior autograft.
Patients who have received mid-intensity melphalan (greater than 50 mg IV) as part of prior therapy.
Patients unable or unwilling to provide informed consent.
Prior organ transplant requiring immunosuppressive therapy.
Patients with disease progression prior to enrollment.
Patients who have received lenalidomide as initial therapy for MM and have experienced toxicities resulting in treatment discontinuation.
Patients who experienced thromboembolic events while on full anticoagulation during prior therapy with lenalidomide or thalidomide.
Patients unwilling to take deep vein thrombosis (DVT) prophylaxis.
Patients who cannot undergo an intervention in any treatment arm due to a priori denial of medical costs coverage by third party payers.
Patients unable to unwilling to return to the transplant center for their assigned treatments.","Initial autologous transplant followed by a second autologous transplant and lenalidomide maintenance

Lenalidomide: All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive a second autologous PBSC transplant with the same conditioning regimen as the first transplant. All patients will also receive maintenance lenalidomide which will start after the second transplant. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms.",ChEMBL:CHEMBL848 | DrugBank:DB00480 | PubChem:216326,Lenalidomide,Nc1cccc2c1CN(C1CCC(=O)NC1=O)C2=O,L04AX04,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01109004,NCT01109004_EG002,No,All,Child | Adult | Older Adult,Phase 3,257,"Inclusion Criteria:

Patients meeting the criteria for symptomatic multiple myeloma (MM).
Patients who are 70 years of age, or younger, at time of enrollment.
Patients who have received at least two cycles of any regimen as initial systemic therapy and are within 2 - 12 months of the first dose of initial therapy.
Cardiac function: left ventricular ejection fraction at rest greater than 40 percent.
Hepatic: bilirubin less than 1.5x the upper limit of normal and alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than 2.5x the upper limit of normal. (Patients who have been diagnosed with Gilbert's Disease are allowed to exceed the defined bilirubin value of 1.5x the upper limit of normal.)
Renal: Creatinine clearance of grater than or equal to 40 mL/min, estimated or calculated.
Pulmonary: Diffusing capacity of the lung for carbon monoxide (DLCO), forced expiratory volume in one second (FEV1), or forced vital capacity (FVC) greater than 50 percent of predicted value (corrected for hemoglobin).
Patients with an adequate autologous graft defined as a cryopreserved PBSC graft containing greater than or equal to 4 x 10^6 CD34+ cells/kg patient weight. The graft may not be CD34+ selected or otherwise manipulated to remove tumor or other cells. The graft can be collected at the transplanting institution or by a referring center. The autograft must be stored so that there are two products each containing at least 2 x 10^6 CD34+ cells/kg patient weight.
Signed informed consent form.

Exclusion Criteria:

Patients who never fulfill the criteria for symptomatic MM.
Patients with purely non-secretory MM [absence of a monoclonal protein (M protein) in serum as measured by electrophoresis and immunofixation and the absence of Bence Jones protein in the urine defined by use of conventional electrophoresis and immunofixation techniques]. Patients with light chain MM detected in the serum by free light chain assay are eligible.
Patients with plasma cell leukemia.
Karnofsky performance score less than 70 percent.
Patients with greater than grade 2 sensory neuropathy (CTCAE).
Patients with uncontrolled bacterial, viral or fungal infections (currently taking medication and progression of clinical symptoms).
Patients seropositive for the human immunodeficiency virus (HIV).
Myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at Screening has to be documented by the investigator as not medically relevant.
Patient has hypersensitivity to bortezomib, boron or mannitol.
Patient has received other investigational drugs with 14 days before enrollment.
Patients with prior malignancies except resected basal cell carcinoma or treated cervical carcinoma in situ. Cancer treated with curative intent less than 5 years previously will not be allowed unless approved by the Protocol Officer or one of the Protocol Chairs. Cancer treated with curative intent greater than 5 years previously is allowed.
Female patients who are pregnant (positive B-HCG) or breastfeeding.
Females of childbearing potential (FCBP) or men who have sexual contact with FCBP unwilling to use contraceptive techniques during the length of lenalidomide maintenance therapy.
Prior allograft or prior autograft.
Patients who have received mid-intensity melphalan (greater than 50 mg IV) as part of prior therapy.
Patients unable or unwilling to provide informed consent.
Prior organ transplant requiring immunosuppressive therapy.
Patients with disease progression prior to enrollment.
Patients who have received lenalidomide as initial therapy for MM and have experienced toxicities resulting in treatment discontinuation.
Patients who experienced thromboembolic events while on full anticoagulation during prior therapy with lenalidomide or thalidomide.
Patients unwilling to take deep vein thrombosis (DVT) prophylaxis.
Patients who cannot undergo an intervention in any treatment arm due to a priori denial of medical costs coverage by third party payers.
Patients unable to unwilling to return to the transplant center for their assigned treatments.","Initial autologous transplant followed by lenalidomide maintenance

Lenalidomide: All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive maintenance with lenalidomide (15 mg daily). Maintenance lenalidomide will start after the first autologous transplant. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms.",ChEMBL:CHEMBL848 | DrugBank:DB00480 | PubChem:216326,Lenalidomide,Nc1cccc2c1CN(C1CCC(=O)NC1=O)C2=O,L04AX04,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01115101,NCT01115101_EG000,No,Female,Adult | Older Adult,Phase 4,239,"Study participation was offered to all pts. aged > 18 years in labor and delivery for elective or unplanned secondary cesarean in the 37th or higher week of gestation.

Inclusion Criteria:

cesarean in spinal anesthesia,
no history of opioid or metamizol treatment
written consent
ability to use a Patient-controlled analgesia device

Exclusion Criteria:

cesarean in general anaesthesia
use of peridural catheter for pre-, peri- or post cesarean analgesia
additional post cesarean metamizol use
allergy/hypersensitivity to morphine, oxycodon, acetaminophen or ibuprofen
chronic use of general anaesthesia
history of known pain syndrome",Patients randomized to the oral analgesia group received 20mg oxycodone at fixed intervals at 2 and 12 hours after CS.,ChEMBL:CHEMBL656 | DrugBank:DB00497 | PubChem:5284603,Oxycodone,COc1ccc2c3c1O[C@H]1C(=O)CC[C@@]4(O)[C@@H](C2)N(C)CC[C@]314,N02AA05 | N02AA55 | N02AA56 | N02AJ17 | N02AJ18 | N02AJ19,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01115673,NCT01115673_EG000,No,All,Child | Adult,Phase 3,239,"Inclusion Criteria:

Must be at least 16 and less than 51 years of age
Must weigh at least 100 lbs with a body mass index of at least 18 and less than 30
Must have up to four of their back teeth (third-molars) pulled

Exclusion Criteria:

Cannot be allergic to acetaminophen (Tylenol)
Cannot be pregnant (or planning to be pregnant) or nursing a baby
Cannot have any other medical conditions that the investigator determines might compromise your safety or the study results",1000 mg Acetaminophen Caplet,ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01115673,NCT01115673_EG001,No,All,Child | Adult,Phase 3,241,"Inclusion Criteria:

Must be at least 16 and less than 51 years of age
Must weigh at least 100 lbs with a body mass index of at least 18 and less than 30
Must have up to four of their back teeth (third-molars) pulled

Exclusion Criteria:

Cannot be allergic to acetaminophen (Tylenol)
Cannot be pregnant (or planning to be pregnant) or nursing a baby
Cannot have any other medical conditions that the investigator determines might compromise your safety or the study results",650 mg Acetaminophen Caplet,ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01121913,NCT01121913_EG002,Accepts Healthy Volunteers,All,Adult,Phase 1,23,"Inclusion Criteria:

Healthy male and female subjects 18 to 45 years of age (inclusive).
Body mass within 10% of the ideal mass in relation to height and age, according to the BMI.
Body mass not less than 70 kg. The normal total circulating blood volume in males and in females is about 71 mL/kg and 65 mL/kg of the body mass, respectively (Meyer, 1988). No subject will have more than 13% of estimated blood volume taken during the study (Standards for the Practice of Blood Transfusion in South Africa, 1999).
Findings within the range of clinical acceptability in medical history and physical examination, and laboratory results within the ""normal ranges"" for the relevant laboratory tests (unless the clinical investigator considers the deviation to be irrelevant for the purpose of the study).
Normal ECG and vital signs, or abnormalities which the clinical investigator does not consider a disqualification for participation in the study.
Willingness to undergo pre- and post-study physical examinations, and pre- and post study laboratory investigations.
Ability to comprehend and willingness to sign both statements of informed consent (for screening and phase-related procedures).
Non-smoker or past smoker who stopped smoking at least 3 months before entering the study.

For females, the following conditions are to be met:

has been surgically sterilized, or

is of childbearing potential, and all of the following conditions are met:

had a normal menstrual flow within 1 month before study entry, and
has a negative urine pregnancy test at screening. If this test is positive, the subject will be excluded from the study before receiving study medication. In the rare circumstance that a pregnancy is discovered after the subjects received the study drug, every attempt must be made to follow such subjects to term, and
must agree to use an accepted method of contraception (i.e., spermicide and barrier methods or spermicide and intrauterine contraceptive device). The subject must agree to continue with the same method throughout the study. Hormonal contraceptives will be allowed, with a stable dose for at least one month prior to the first intake of study medication.

Exclusion Criteria:

Evidence of psychiatric disorder, antagonistic personality, poor motivation, emotional or intellectual problems likely to limit the validity of consent to participate in the study or limit the ability to comply with protocol requirements.
History of, or current compulsive alcohol abuse (> 10 drinks weekly), or regular exposure to other substances of abuse.
Use of any medication, prescribed or over-the-counter, within 2 weeks prior to the first administration of study medication except if this will not affect the outcome of the study in the opinion of the clinical investigator. Use of hormonal contraceptive agents by females is allowed.
Participation in another study with an experimental drug within 8 weeks before the first administration of study medication.
Treatment within the previous 3 months with any drug with a well-defined potential for adversely affecting a major organ or system with evidence to this effect.
A major illness during the 3 months before commencement of the screening period.
History of hypersensitivity to the study drug or any related drugs.
History of bronchial asthma.
History of epilepsy.
Relevant history or laboratory or clinical findings indicative of acute or chronic disease, likely to influence study outcome.
Donation or loss of blood equal to or exceeding 500 mL during the 8 weeks before the first administration of study medication.
Diagnosis of hypotension made during the screening period.
Diagnosis of hypertension made during the screening period or current diagnosis of hypertension.
Resting pulse rate of > 100 beats per minute or < 45 beats per minute during the screening period, either supine or standing.
Positive testing for HIV, hepatitis B surface antigen and/or Hepatitis C antibodies.
Positive urine screen for drugs of abuse.
A urine pregnancy test (ß-HCG) either positive or not performed or lactation.
Positive urine screen for tobacco use (SureStepTM Smoke Check Tests and One-Step Cotinine (COT) Tests).
History of marijuana, barbiturate, amphetamine or narcotic abuse within 12 months prior to study start.
Significant liver disease, defined as active hepatitis or elevated liver enzymes (e.g. aspartate aminotransferase, alanine aminotransferase) >2 times the upper boundary of the normal range.",2 * 150 mg Triticco® tablets (at 07:30 and 19:30) reference product dosed in either treatment phase.,PubChem:62935,Trazodone Hydrochloride,Cl.O=c1n(CCCN2CCN(c3cccc(Cl)c3)CC2)nc2ccccn12,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT01121913,NCT01121913_EG003,Accepts Healthy Volunteers,All,Adult,Phase 1,21,"Inclusion Criteria:

Healthy male and female subjects 18 to 45 years of age (inclusive).
Body mass within 10% of the ideal mass in relation to height and age, according to the BMI.
Body mass not less than 70 kg. The normal total circulating blood volume in males and in females is about 71 mL/kg and 65 mL/kg of the body mass, respectively (Meyer, 1988). No subject will have more than 13% of estimated blood volume taken during the study (Standards for the Practice of Blood Transfusion in South Africa, 1999).
Findings within the range of clinical acceptability in medical history and physical examination, and laboratory results within the ""normal ranges"" for the relevant laboratory tests (unless the clinical investigator considers the deviation to be irrelevant for the purpose of the study).
Normal ECG and vital signs, or abnormalities which the clinical investigator does not consider a disqualification for participation in the study.
Willingness to undergo pre- and post-study physical examinations, and pre- and post study laboratory investigations.
Ability to comprehend and willingness to sign both statements of informed consent (for screening and phase-related procedures).
Non-smoker or past smoker who stopped smoking at least 3 months before entering the study.

For females, the following conditions are to be met:

has been surgically sterilized, or

is of childbearing potential, and all of the following conditions are met:

had a normal menstrual flow within 1 month before study entry, and
has a negative urine pregnancy test at screening. If this test is positive, the subject will be excluded from the study before receiving study medication. In the rare circumstance that a pregnancy is discovered after the subjects received the study drug, every attempt must be made to follow such subjects to term, and
must agree to use an accepted method of contraception (i.e., spermicide and barrier methods or spermicide and intrauterine contraceptive device). The subject must agree to continue with the same method throughout the study. Hormonal contraceptives will be allowed, with a stable dose for at least one month prior to the first intake of study medication.

Exclusion Criteria:

Evidence of psychiatric disorder, antagonistic personality, poor motivation, emotional or intellectual problems likely to limit the validity of consent to participate in the study or limit the ability to comply with protocol requirements.
History of, or current compulsive alcohol abuse (> 10 drinks weekly), or regular exposure to other substances of abuse.
Use of any medication, prescribed or over-the-counter, within 2 weeks prior to the first administration of study medication except if this will not affect the outcome of the study in the opinion of the clinical investigator. Use of hormonal contraceptive agents by females is allowed.
Participation in another study with an experimental drug within 8 weeks before the first administration of study medication.
Treatment within the previous 3 months with any drug with a well-defined potential for adversely affecting a major organ or system with evidence to this effect.
A major illness during the 3 months before commencement of the screening period.
History of hypersensitivity to the study drug or any related drugs.
History of bronchial asthma.
History of epilepsy.
Relevant history or laboratory or clinical findings indicative of acute or chronic disease, likely to influence study outcome.
Donation or loss of blood equal to or exceeding 500 mL during the 8 weeks before the first administration of study medication.
Diagnosis of hypotension made during the screening period.
Diagnosis of hypertension made during the screening period or current diagnosis of hypertension.
Resting pulse rate of > 100 beats per minute or < 45 beats per minute during the screening period, either supine or standing.
Positive testing for HIV, hepatitis B surface antigen and/or Hepatitis C antibodies.
Positive urine screen for drugs of abuse.
A urine pregnancy test (ß-HCG) either positive or not performed or lactation.
Positive urine screen for tobacco use (SureStepTM Smoke Check Tests and One-Step Cotinine (COT) Tests).
History of marijuana, barbiturate, amphetamine or narcotic abuse within 12 months prior to study start.
Significant liver disease, defined as active hepatitis or elevated liver enzymes (e.g. aspartate aminotransferase, alanine aminotransferase) >2 times the upper boundary of the normal range.","3 * 100 mg Desyrel® tablets (at 07:30, 15:30 and 23:30) reference product dosed in either treatment phase.",PubChem:62935,Trazodone Hydrochloride,Cl.O=c1n(CCCN2CCN(c3cccc(Cl)c3)CC2)nc2ccccn12,,0.0,0.0,0.0,0.0,0.0,1.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0
NCT01121926,NCT01121926_EG001,Accepts Healthy Volunteers,All,Adult,Phase 1,29,"Inclusion Criteria:

Healthy male and female subjects 18 to <56 years of age.
Body mass within 10% of ideal mass in relation to height and age, according to Body Mass Index.
Body mass not less than 60 kg.
Findings within the range of clinical acceptability in medical history and physical examination, and laboratory results within the reference ranges for the relevant laboratory tests (unless the investigator considered the deviation to be irrelevant for the purpose of the study).
Normal electrocardiogram (ECG) and vital signs, or abnormalities which the investigator did not consider a disqualification for participation in the study.
Willingness to undergo pre- and post-study physical examinations and laboratory investigations.
Ability to comprehend and willingness to sign both statements of informed consent (for screening and phase-related procedures).
Non-smoker or past smoker who stopped the use of any form of tobacco, including snuff or similar products, at least 3 months before entering the study.

For females, the following conditions had to be met:

had been surgically sterilized or undergone a hysterectomy, or

was of childbearing potential, and all of the following conditions were met:

Had a negative pregnancy test at screening. If this test was positive, the subject was to be excluded from the study before receiving study medication. In the circumstance that a pregnancy was discovered after the subjects received the study medication, every attempt had to be made to follow such subjects to term.
Had to agree to use an accepted method of contraception (i.e., spermicide and barrier methods or spermicide and non-hormonal intrauterine contraceptive device). The subject had to agree to continue with the same method throughout the study. Hormonal contraceptives were not allowed.
females not of childbearing potential could also have been included if they had no menstrual period for one year and were considered as post-menopausal.

Exclusion Criteria:

Evidence of psychiatric disorder, antagonistic personality, poor motivation, emotional or intellectual problems likely to limit the validity of consent to participate in the study or limit the ability to comply with protocol requirements.
History of, or current compulsive alcohol abuse (>10 drinks weekly), or regular exposure to other substances of abuse.
Use of any medication, prescribed or over-the-counter, within 2 weeks prior to the first administration of study medication except if this would not affect the outcome of the study in the opinion of the investigator.
Participation in another study with an experimental drug, where the last administration (of previous study medication) was within 8 weeks before the first administration of study medication.
Treatment within the previous 3 months with any drug with a well-defined potential for adversely affecting a major organ or system with evidence to this effect.
A major illness during the 3 months before commencement of the screening period.
History of hypersensitivity to the study medication or any related medication.
History of bronchial asthma.
History of epilepsy.
History of porphyria.
Relevant history or laboratory or clinical findings indicative of acute or chronic disease, likely to influence study outcome.
Donation or loss of blood equal to or exceeding 500 mL during the 8 weeks before the first administration of study medication.
Diagnosis of hypotension made during the screening period.
Diagnosis of hypertension made during the screening period or current diagnosis of hypertension.
Resting pulse of > 100 beats per minute or < 40 beats per minute during the screening period, either supine or standing.
Positive testing for HIV and/or Hepatitis B and/or Hepatitis C.
Positive urine screen for drugs of abuse.
Positive urine screen for tobacco use.
A serum pregnancy test (beta human chorionic gonadotropin [β-HCG]) either positive or not performed or lactation.",Trazodone HCl (Apotex Corp.) reference product (100 mg tablet administered thrice daily) dosed in either period. A drug-free period of 7 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.,PubChem:62935,Trazodone Hydrochloride,Cl.O=c1n(CCCN2CCN(c3cccc(Cl)c3)CC2)nc2ccccn12,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT01122264,NCT01122264_EG000,No,Male,Adult | Older Adult,Phase 4,250,"Inclusion Criteria:

History of Erectile Dysfunction (ED) of at least 3 months duration.
Anticipate having the same adult female sexual partner during the study.
Agree not to use any other treatment for ED and to participate in recording responses to questionnaires and other instruments used in this study.

Exclusion Criteria:

Previous or current treatment with tadalafil or any other phosphodiesterase type 5 (PDE5) inhibitor.
ED caused by other primary sexual disorders, history of radical prostatectomy or other pelvic surgery with subsequent failure to achieve any erection, or history of penile implant or clinically significant penile deformity.
ED caused by untreated or inadequately treated endocrine disease.
Current treatment with doxazosin, nitrates, cancer chemotherapy, or anti-androgens.
Severe renal or hepatic impairment, history of malignant hypertension.
Presence or history of specific heart conditions.","Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.",ChEMBL:CHEMBL779 | DrugBank:DB00820 | PubChem:110635,Tadalafil,[H][C@]12Cc3c([nH]c4ccccc34)[C@@H](c3ccc4c(c3)OCO4)N1C(=O)CN(C)C2=O,C02KX52 | C02KX54 | G04BE08 | G04CA54 | G04CB51,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT01122264,NCT01122264_EG001,No,Male,Adult | Older Adult,Phase 4,257,"Inclusion Criteria:

History of Erectile Dysfunction (ED) of at least 3 months duration.
Anticipate having the same adult female sexual partner during the study.
Agree not to use any other treatment for ED and to participate in recording responses to questionnaires and other instruments used in this study.

Exclusion Criteria:

Previous or current treatment with tadalafil or any other phosphodiesterase type 5 (PDE5) inhibitor.
ED caused by other primary sexual disorders, history of radical prostatectomy or other pelvic surgery with subsequent failure to achieve any erection, or history of penile implant or clinically significant penile deformity.
ED caused by untreated or inadequately treated endocrine disease.
Current treatment with doxazosin, nitrates, cancer chemotherapy, or anti-androgens.
Severe renal or hepatic impairment, history of malignant hypertension.
Presence or history of specific heart conditions.",Participants were instructed to take a 5-mg or 2.5-mg tablet of tadalafil orally once a day for 24 weeks.,ChEMBL:CHEMBL779 | DrugBank:DB00820 | PubChem:110635,Tadalafil,[H][C@]12Cc3c([nH]c4ccccc34)[C@@H](c3ccc4c(c3)OCO4)N1C(=O)CN(C)C2=O,C02KX52 | C02KX54 | G04BE08 | G04CA54 | G04CB51,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01122316,NCT01122316_EG000,No,All,Adult | Older Adult,Not Applicable,10,"Inclusion Criteria:

Systolic HF of any etiology (left ventricular ejection fraction ≤ 40%)
Previously-diagnosed, inadequately controlled DM (HbA1c≥7.5%)
On any combination of anti-diabetic medications excluding metformin

Exclusion Criteria:

Current metformin therapy
Previous intolerance to metformin therapy
Renal dysfunction (creatinine clearance < 60 ml/minute)
History of lactic acidosis.",Metformin at 500 mg PO BID and pending lab values may have been titrated to 1000 mg PO BID at 1 month.,ChEMBL:CHEMBL1431 | DrugBank:DB00331 | PubChem:4091,Metformin,CN(C)C(=N)NC(=N)N,A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01122381,NCT01122381_EG000,No,All,Adult | Older Adult,Phase 1 | Phase 2,1,"Inclusion Criteria:

Must be a veteran.
The number of migraine days per 4-week period is to be 4-14 for a period of 3 months prior to screening for entry into the trial.
Migraine must have been occurring for 6 months preceding entry into the trial and age of onset should be before age 60 years.
Migraine must be at least moderate severity and interrupt daily activities in some respect at least 3 times per month.
As long as the veteran can easily distinguish nonmigraine headaches from migraine, there is no limit on the number of non migraine headache days allowed. ""Transformed migraine"" headaches due to medication over usage will be excluded according to exclusion criteria #4.
Migraine diagnosis:

Veterans with headache must have migraine categorized using the International Headache Society (I.H.S.) criteria as illustrated below for the two main types with and without aura.

Criteria for migraine without aura (I.H.S. 1.1)

> 5 attacks
headache lasting 4-72 hours when untreated or not successfully treated.

headache with two of the following characteristics

unilateral,
pulsating,
moderate to severe intensity,
aggravation by exertion.

one of the following occurs with headache

nausea and/or vomiting
photophobia and phonophobia

Criteria for migraine with aura (I.H.S. 1.2)

at least 2 attacks

at least three of the following characteristics:

One or more fully reversible aura symptoms indicating focal cerebral cortical - and/or brain stem dysfunction.

One or more aura symptoms of the following types:

Homonymous visual disturbance
Unilateral parenthesis and/or numbness
Unilateral weakness

Aphasia or unclassifiable speech difficulty

At least one aura symptom develops gradually over more than 4 minutes or, 2 or more symptoms occur in succession.
No aura symptom lasts more than 60 minutes. If more than one aura symptom is present, accepted duration is proportionally increased.
Headache follows aura with a free interval of less than 60 minutes. (It may also begin before or simultaneously with the aura). Headache, nausea and/or photophobia usually follow neurological aura symptoms directly or after a free interval of less than an hour. The headache usually lasts 4-72 hours, but may be completely absent (1.2.5, acephalgic migraine).

Exclusion Criteria:

Veterans with migraine plus other systemic disorder will be excluded if migraine onset was temporally related to onset of the systemic disorder.
Blood pressure elevations (must be < borderline values 135/85 for 4 weeks before enrollment into the study). Current treatment for hypertension with beta-blockers, calcium channel blockers, or ace inhibitors not allowed.
Use of other prophylactic migraine drugs (requires a washout phase) and cannot have failed more than two other prophylactic drugs for migraine.
Excessive use of acute pain medicines, including narcotics (>10 days month). Those using non-narcotics could be tapered off over 4-8 weeks.
Receiving disability or seeking disability for headache or chronic pain.
Significant neck pain or cervicogenic contributors to chronic headache.
Significant depression, anxiety, post-traumatic stress disorder, or other disabling psychiatric condition.
Known allergies or serious side effects with ESX or succinimides in the past.
Known liver or significant renal disease.
Women veterans of child-bearing age who do not have adequate birth control.
Chronic bone marrow suppression.
Using psychogenic or other sedating maintenance drugs.
History of porphyria.
History of cluster headache. 15.History of other CNS disease.
Age younger than 18 years and greater than 65.
Women veterans who are breastfeeding.
Veterans with familial hemiplegic migraine (FHM).

Ongoing exclusions during the study:

The addition of other migraine prophylactic headache medicines is not allowed. 2. New drugs cannot be added that aggravate headache (nitrates, dipyridamole, niacin).",ethosuximide blinded capsules of 250mg ESX; subject was titrated up to 4 capsules qd,ChEMBL:CHEMBL696 | DrugBank:DB00593 | PubChem:3291,Ethosuximide,CCC1(C)CC(=O)NC1=O,N03AD01 | N03AD51,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT01124045,NCT01124045_EG000,No,All,Child,Phase 3,39,"Inclusion Criteria:

0 to 3 years of age.
Undergoing uncomplicated cataract extraction in 1 eye with or without intraocular lens.
Informed consent signed by a parent or legal guardian.
Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

Presence of any active or suspected viral, bacterial, or fungal disease in the study eye.
Use of any topical medication in the study within 7 days prior to surgery, except for drops that are needed to examine the eye or to prepare for surgery.
Patients with posttraumatic cataract.
Active uveitis in the study eye.
Ocular neoplasm in the study eye.
Human immunodeficiency virus (HIV); acquired immunodeficiency syndrome (AIDS).
Suspected permanent low vision or blindness in the fellow nonstudy eye. The study eye must not be the patient's only good eye.
Patients on systemic steroids or nonsteroidal anti-inflammatory drugs.
History of steroid-induced intraocular pressure (IOP) rise.
Currently on medication for ocular hypertension or glaucoma in the study eye.
Diabetes.
Other protocol-defined exclusion criteria may apply.","Difluprednate ophthalmic emulsion, 0.05%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment",ChEMBL:CHEMBL1201749 | DrugBank:DB06781 | PubChem:443936,Difluprednate,[H][C@@]12CC[C@](OC(=O)CCC)(C(=O)COC(C)=O)[C@@]1(C)C[C@H](O)[C@@]1(F)[C@@]2([H])C[C@H](F)C2=CC(=O)C=C[C@@]21C,D07AC19,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0
NCT01125930,NCT01125930_EG001,No,All,Adult | Older Adult,Phase 3,46,"Inclusion Criteria:

Subjects 18 years of age and older of any race.
Clinical diagnosis of mild to moderate erythematotelangiectatic facial rosacea based on physician evaluation.
Willing and able to understand and sign informed consent.
Able to complete study and comply with study procedures.

Exclusion Criteria:

Severe self reported facial sensitivity
History of allergy to fish
Severe sun sensitivity
Severe erythematotelangiectatic rosacea requiring systemic treatment
Papulopustular, Ocular-only, Phymatous rosacea, Steroid rosacea, pyoderma faciale
Unwilling to undergo facial biopsies
Concomitant use of medications that are reported to exacerbate rosacea, such as topical and systemic steroids
Use of topical rosacea treatments in the past 2 weeks.
Use of systemic antibiotics in the past 4 weeks.
Use of systemic retinoids within the past 6 months.
Use of topical retinoids within the past 3 months
Use of laser or light based rosacea treatments within the past 2 months.
Cosmetic procedures (e.g., superficial chemical peels, exfoliation or microdermabrasion of the face) within the past two months
Use of topical anti-aging medications including alpha hydroxy acids, salicylic acid, beta-hydroxy acid, vitamin A, vitamin E, ascorbic acid
Other dermatologic conditions that require the use of interfering topical or systemic therapy or that might interfere with study assessments.
Clinically significant abnormal findings or conditions (other than rosacea), which might, in the opinion of the Investigator, interfere with study evaluations or pose a risk to subject safety during the study.
If female, Subjects who are either of non-child bearing potential (defined as postmenopausal -absence of menstrual bleeding for 1 year - or as having undergone bilateral tubal ligation, hysterectomy or bilateral ovariectomy) or, if of childbearing potential, Subjects who have had a negative urine pregnancy test at the beginning of the study, and have agreed to practice appropriate birth-control to prevent pregnancy during the study.(The type and dose of birth control must have been stable for at least 2 months prior to study entry and not be expected to change during the study).
Subjects who are lactating.
Use of any investigational therapy within the past 4 weeks.
Known hypersensitivity or previous allergic reaction to retinoids
Carcinoid, Pheochromocytoma or other systemic flushing causes","Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.",ChEMBL:CHEMBL38 | ChEMBL:CHEMBL547 | ChEMBL:CHEMBL705 | DrugBank:DB00523 | DrugBank:DB00755 | DrugBank:DB00982 | PubChem:444795 | PubChem:449171 | PubChem:5282379,Tretinoin,CC(C=CC1=C(C)CCCC1(C)C)=CC=CC(C)=CC(=O)O,D10AD01 | D10AD04 | D10AD51 | D10AD54 | D10BA01 | D11AH04 | L01XF01 | L01XF02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT01127503,NCT01127503_EG000,No,All,Child | Adult | Older Adult,Phase 2,2,"Key Inclusion Criteria:

Females of childbearing potential cannot be at risk of pregnancy during the study.
Genetically confirmed diagnosis of VCFS at the time of screening.
Must have one of the following Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition Text Revision (DSM-IV TR) diagnoses (applicable based upon clinical assessments): schizophrenia, schizoaffective disorder, psychosis not otherwise specified (NOS), bipolar disorder, or mood disorder with psychotic features.
A total PANSS composite score >65.
Willing to discontinue psychotropic medications. -

Key Exclusion Criteria:

Evidence of acute suicidality.
Known or observed clinically significant cardiovascular, pulmonary, renal, hepatic, or gastrointestinal disorders; other clinically significant psychiatric/neurological and sleep disorders by DSM-IV-TR criteria; endocrine, or hematological or metabolic diseases.
Full scale IQ of less than 50.
Pregnancy.
Not using a reliable means of contraception.
Systolic blood pressure of ≤110 mm/Hg or ≥160 mm/Hg, diastolic blood pressure ≤60 mm/Hg or ≥90 mm/Hg, or has clinically symptomatic orthostatic changes.
QTcF > 450 msec, or PR > 250 msec, or QRS > 110 msec on ECG.
History of seizure disorder. -","Metyrosine: Metyrosine (250 mg capsules) were to be used at all dose levels (administered as multiples of that dosing unit). The starting dose was 250 mg/day of metyrosine. Dose escalation was to be carried out weekly for 8 weeks (up to a maximum of 8 capsules/day [2000 mg/day if metyrosine]) with dosage increments of 1 capsule/day per week. Weekly dose escalation was to stop based upon the investigator's assessment of safety, but not efficacy (i.e., dose escalation was to be forced to the maximum of 8 capsules/day assuming acceptable safety and tolerability).",ChEMBL:CHEMBL1200862 | ChEMBL:CHEMBL1330596 | DrugBank:DB00765 | DrugBank:DB16306 | PubChem:3125 | PubChem:441350,Metyrosine,CC(N)(Cc1ccc(O)cc1)C(=O)O,C02KB01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01128972,NCT01128972_EG004,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 2,36,"Inclusion Criteria:

An intact maxillary dental arch suitable for the retention of the palatal appliance and an intact mandibular dental arch - subjects may have fixed bridges replacing missing teeth
No current active caries or periodontal disease that may compromise the study or the health of the subjects
A gum base stimulated whole saliva flow rate greater than or equal to 0.8 mL/minute and an unstimulated whole saliva flow rate greater than or equal to 0.2 mL/minute

Exclusion Criteria:

Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients","Participants were administered with treatment regimen comprising of placebo dentifrice (0ppmF) and placebo sterile water MR. The treatment regimen included application of 1.5g placebo dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.",ChEMBL:CHEMBL1098659 | DrugBank:DB09145 | PubChem:10129877 | PubChem:24602 | PubChem:962,Water,O,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01130532,NCT01130532_EG001,No,Male,Adult | Older Adult,Phase 4,205,"Inclusion Criteria:

At least a 3-month history of erectile dysfunction (ED).
Are able to read, understand and provide signed informed consent.
Have an International Index of Erectile Function-Erectile Function (IIEF-EF) domain score that is greater than or equal to 17 and less than 26 at screening.
Have been taking a maximum dose of sildenafil citrate (100 milligram [mg]), vardenafil (20 mg), or tadalafil (20 mg) on as needed basis for at least one month prior to screening.
Anticipate having the same female sexual partner during the study who is willing to participate in the required number of sexual intercourse attempts and complete study measures during the study.
Agree to make at least four sexual intercourse attempts during both the 4-week as needed run-in period and the 4-week non-drug run-in period.
Agree not to use any other erectile dysfunction (ED) treatment, including herbal therapy during the 4-week non-drug, run-in, the double-blind treatment period, the open label period and for 96 hours after the end of the study.

Partner Inclusion Criteria:

Are female and at least 18 years of age at screening.
Anticipate having the same male study subject as her sexual partner during the study.
Able to read, understand and provide signed informed consent.
Agree to make the required number of sexual intercourse attempts with the male sexual study partner during the study.
Willing to participate in recording responses to the treatment satisfaction scale.

Exclusion Criteria:

Have an IIEF-EF domain score of greater than or equal to 26 at screening.
Prior ineffective treatment with (or nonresponder to) any PDE5 Inhibitor
Have previously used or are currently using any PDE5 inhibitor once daily.
Present with ED caused by other primary disorders or ED caused by untreated/inadequately treated endocrine disease.
Partner unwilling to complete all study requirements.
History of radical prostatectomy or other pelvic surgery or penile implant, or a clinically significant penile deformity, in the opinion of the investigator
Exhibit evidence of clinically significant renal insufficiency or hepatobiliary disease, or significant cardiac history as determined by the investigator
Currently receive treatment with nitrates, cancer chemotherapy, or antiandrogens
Have previously completed or withdrawn from this study or any other study investigating tadalafil for once-daily use.",5.0 mg Tadalafil for 12 weeks during double-blind treatment period.,ChEMBL:CHEMBL779 | DrugBank:DB00820 | PubChem:110635,Tadalafil,[H][C@]12Cc3c([nH]c4ccccc34)[C@@H](c3ccc4c(c3)OCO4)N1C(=O)CN(C)C2=O,C02KX52 | C02KX54 | G04BE08 | G04CA54 | G04CB51,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01132846,NCT01132846_EG000,No,All,Adult | Older Adult,Phase 2,122,"Inclusion Criteria:

A diagnosis of heart failure as defined by the presence of at least 1 symptom (dyspnea, orthopnea, or edema) AND 1 sign (rales on auscultation, peripheral edema, ascites, pulmonary vascular congestion on chest radiography)
Prior clinical diagnosis of heart failure Must be identified within 24 hours of hospital admission (24 hour clock begins when the admission orders are placed)
Estimated GFR of > 15 but < 60 mL/min/1.73m2 determined by the MDRD equation
Male or female patient ≥18 years old
Willingness to provide informed consent
Ability to have a PICC or central line placed (if needed) within 12 hours of randomization and study drug infusion started
Anticipated hospitalization of at least 72 hours

Exclusion Criteria:

Received IV vasoactive treatment or ultra-filtration therapy for heart failure since initial presentation
Anticipated need for IV vasoactive treatment or ultra-filtration for heart failure during this hospitalization
Systolic BP <90 mmHg
Hemoglobin (Hgb) < 9 g/dl
Renal replacement therapy
History of renal artery stenosis > 50%
Hemodynamically significant arrhythmias including ventricular tachycardia or defibrillator shock within 4 weeks
Acute coronary syndrome within 4 weeks as defined by electrocardiographic (ECG) ST-segment depression or prominent T-wave inversion and/or positive biomarkers of necrosis (e.g., troponin) in the absence of ST-segment elevation and in an appropriate clinical setting (chest discomfort or anginal equivalent)
Active myocarditis
Hypertrophic obstructive cardiomyopathy
Greater than moderate stenotic valvular disease
Restrictive or constrictive cardiomyopathy
Complex congenital heart disease
Constrictive pericarditis
Non-cardiac pulmonary edema
Clinical evidence of digoxin toxicity
Need for mechanical hemodynamic support
Sepsis
Terminal illness (other than HF) with expected survival of less than 1 year
Previous adverse reaction to the study drugs
Use of IV iodinated radiocontrast material in last 72 hours or planned during hospitalization
Enrollment or planned enrollment in another randomized clinical trial during this hospitalization
Inability to comply with planned study procedures
Pregnancy or nursing mothers","Drug: Dopamine

Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study

Dopamine: Participants randomized to the low dose dopamine arm will receive dopamine of 2ug/kg/min or placebo during the first 72 hours in the trial.",DrugBank:DB00988 | PubChem:681,Dopamine,NCCc1ccc(O)c(O)c1,C01CA04,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01135069,NCT01135069_EG001,Accepts Healthy Volunteers,All,Child | Adult,Phase 3,209,"Inclusion Criteria:

Normal, healthy male and female children and adult
Written and verbal informed consent must be obtained. Patients age 12 to 17 (inclusive) must sign an assent for the study and a parent or a legal guardian must sign the informed consent.
Women of child-bearing potential must be non-pregnant and non-nursing, and must be willing to avoid pregnancy during the course of the study and during the menstrual cycle following completion of their participation in the study.
Able to refrain from the use of all other topical acne medications or antibiotics during the treatment period.
Considered reliable and capable of understanding their responsibility and role in the study.

Exclusion Criteria:

Significant history or clinical evidence of auto-immune, cardiovascular, gastrointestinal, hematological, hepatic, neurological, pancreatic, or renal disease.
Abnormal pre-existing skin condition which might affect the normal course of acne vulgaris (e.g., eczema, psoriasis, albinism, or chronic vesiculobullous disorders).
Use topical acne therapy during the two week period prior to study initiation.
Use of systemic retinoid treatment within six months prior to study initiation.
Pregnant or breast-feeding.
Serious psychological illness.
Participation in any clinical research study during the 30 day period preceding study initiation.",Retin-A Micro 0.1%,ChEMBL:CHEMBL38 | ChEMBL:CHEMBL547 | ChEMBL:CHEMBL705 | DrugBank:DB00523 | DrugBank:DB00755 | DrugBank:DB00982 | PubChem:444795 | PubChem:449171 | PubChem:5282379,Tretinoin,CC(C=CC1=C(C)CCCC1(C)C)=CC=CC(C)=CC(=O)O,D10AD01 | D10AD04 | D10AD51 | D10AD54 | D10BA01 | D11AH04 | L01XF01 | L01XF02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT01142193,NCT01142193_EG000,No,All,Adult | Older Adult,Phase 3,124,"Inclusion Criteria:

Subject has a confirmed diagnosis of partial-onset seizures with or without secondary generalization for at least 12 months prior to Visit 1.
Currently on a stable dosing regimen of 1 to 3 AEDs for at least 4-weeks prior to Visit 1 (12 weeks for phenobarbital and primidone).
Have a minimum of 8 partial-onset seizures and no more than 21 consecutive seizure free days, during the 8-week baseline.

Exclusion Criteria:

Have a history of seizure episodes lasting less than 30 minutes in which several seizures occur with such frequency that the initiation and completion of each individual seizure cannot be distinguished, within 3 months prior to Visit 1.
Have a history of pseudoseizures, or status epilepticus, within 3 months prior to Visit 1.
Have a history of metabolic acidosis, nephrolithiasis, ureterolithiasis, or narrow angle glaucoma.
Have a history of suicidal attempts, suicidal ideation, or uncontrolled psychiatric illness within 2 years of Visit 1.
Currently taking, or have taken felbamate within the past 18 months, or have taken vigabatrin in the past.
Have taken topiramate within the past 6 months.",Titration of 50 mg in weekly increments over 3 weeks to 200 mg,ChEMBL:CHEMBL220492 | DrugBank:DB00273 | PubChem:5284627,Topiramate,[H][C@@]12OC(C)(C)O[C@]1([H])CO[C@@]1(COS(N)(=O)=O)OC(C)(C)O[C@]12[H],A08AA51 | N03AX11,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01144286,NCT01144286_EG000,No,Female,Adult | Older Adult,Phase 2,57,"Inclusion Criteria:

Women aged between 18 to 65 years of age who have signed the informed consent.
Not pregnant, not nursing.
No indication of other vulvovaginitis or genital infections
Positive 10% potassium hydroxide (KOH) preparation for budding yeast and/or pseudohyphae.
Negative wet mount results for T. vaginalis and clue cells.
Exclusion Criteria:
Subjects with another vaginal or vulvar condition that would confound the interpretation of clinical response.
Hypersensitivity to imidazole products administered topically.
Any other medical condition which in the opinion of the investigator could interfere with study conduct.","placebo pessary, single dose",PubChem:9806019,Arasertaconazole mononitrate,Clc1ccc(C(Cn2ccnc2)OCc2csc3c(Cl)cccc23)c(Cl)c1.O=[N+]([O-])O,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01146873,NCT01146873_EG001,No,All,Child | Adult | Older Adult,Phase 3,150,"Inclusion Criteria:

HIV-infected child 3 to 5 years of age at time of screening for this trial if enrolled from outside or any age if enrolled from control arm of Neverest II.
Reliable history or documented exposure to NVP used as part of PMTCT
Initiated antiretroviral therapy with LPV/r at age less than 36 months
Receiving LPV/r-based ART for at least 12 months
At least one viral load measurement less than 50 copies/ml conducted as part of screening for the study
ALT measurement grade I or less (DAIDS Toxicity Tables 2004) (Appendix A). These may be repeated until ALTs normalize if necessary.

Exclusion criteria:

Prior treatment with any NNRTI drug as part of a therapeutic regimen
Substitution of other NRTI drugs (instead of 3TC and D4T which are the standard first line regimen) will be allowed.","Participants are assigned to switch to an EFV-based antiretroviral regimen. Efavirenz was prescribed once daily in the evening at 200 mg for weights of 10 kg to 13.9 kg (22-30 lb) and 300mg for weights of 14 kg to 24.9 kg (31-55 lb). Efavirenz was available in 50-mg and 200-mg capsules. If children were unable to swallow capsules, caregivers were shown how to open the capsules and dissolve the contents in water.",ChEMBL:CHEMBL223228 | DrugBank:DB00625 | PubChem:64139,Efavirenz,O=C1Nc2ccc(Cl)cc2[C@@](C#CC2CC2)(C(F)(F)F)O1,J05AG03 | J05AR06 | J05AR11,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01147107,NCT01147107_EG001,No,All,Adult | Older Adult,Phase 4,41,"Inclusion Criteria:

HIV infected patients, age >18 years, meet Vietnam guideline to begin ART (CD4 count < 350 cells/mm3 and/or WHO stage III or IV disease)
Hepatitis C infection as documented by positive HCV antibodies and a detectable serum HCV RNA level
AST and ALT ≤ 2 x ULN (≤ 80 U/L)
Estimated creatinine clearance ≥ 60 mL/min

Exclusion Criteria:

Any prior ART
Positive Hepatitis B surface antigen
Clinical evidence of de-compensated cirrhosis (ascites, encephalopathy, esophageal bleeding)
Requirement for acute therapy for other AIDS-defining illness within 14 days prior to study entry
Currently on rifampicin therapy
In the first trimester of pregnancy, intent to become pregnant, or breast feeding during the study period","Emtricitabine/tenofovir DF* 200 mg/300 mg po daily + Efavirenz 600 mg po daily

Efavirenz: Emtricitabine/tenofovir DF* 200 mg/300 mg po daily + Efavirenz 600 mg po daily",ChEMBL:CHEMBL223228 | DrugBank:DB00625 | PubChem:64139,Efavirenz,O=C1Nc2ccc(Cl)cc2[C@@](C#CC2CC2)(C(F)(F)F)O1,J05AG03 | J05AR06 | J05AR11,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT01152190,NCT01152190_EG001,No,Male,Adult | Older Adult,Phase 3,47,"Inclusion Criteria

Present with benign prostatic hyperplasia
Provide signed informed consent at the screening
Agree not to use other treatment for Benign Prostatic Hyperplasia, Erectile Dysfunction or Overactive Bladder (including herbal treatments) during the study

Exclusion Criteria

Have prostatic cancer or are being treated for cancer.
Any condition that may negatively influence the transrectal ultrasound.
Are being treated for heart disease with any drug that is called a nitrate (for example, nitroglycerin).
Any evidence of moderate to severe cardiac disease
Have had any of the following in the past 90 days: chest pain (called unstable angina or angina) that requires treatment, heart attack also known as myocardial infarction, heart bypass surgery (called coronary artery bypass graft surgery), had a procedure to open up blood vessels in the heart know as angioplasty or stent placement (percutaneous coronary intervention), positive cardiac stress test without effective cardiac intervention.
Have very high or very low blood pressure.
Have uncontrolled diabetes.
Have certain problems with your kidneys, liver, or nervous system.","Tadalafil: 5-milligram (mg) tablet administered orally, once daily for 8 weeks.",ChEMBL:CHEMBL779 | DrugBank:DB00820 | PubChem:110635,Tadalafil,[H][C@]12Cc3c([nH]c4ccccc34)[C@@H](c3ccc4c(c3)OCO4)N1C(=O)CN(C)C2=O,C02KX52 | C02KX54 | G04BE08 | G04CA54 | G04CB51,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01152788,NCT01152788_EG001,No,All,Adult | Older Adult,Phase 2,28,"Inclusion Criteria:

Histologically documented cutaneous malignant melanoma which is recurrent or metastatic and is not curable by surgical or other means.
Patients must have tumour tissue from their primary and/or metastatic tumour available to assess putative molecular markers of response (paraffin block or 12 unstained slides).
Presence of clinically and/or radiologically documented disease. At least one site of disease must be unidimensionally measurable as follows:

Chest X-ray > 20 mm, CT scan (with slice thickness of < 5 mm) >10 mm (longest diameter), Physical exam (using calipers) > 10 mm, Lymph nodes by CT scan > 15 mm measured in short axis.

All radiology studies must be performed within 21 days prior to randomization (Exception: Within 28 days if negative).

Patients must have either maximum tumour lesion size of ≤ 50 mm OR if tumour lesion is > 50 mm, LDH must be ≤ 2.5 x ULN.
Patients must have a life expectancy of at least 12 weeks.
Age > 18 years.
ECOG performance status of 0-1.
Previous Therapy:

Immunotherapy: Prior adjuvant immunotherapy for melanoma is permitted if completed ≥ 1 month prior to study entry. No immunotherapy for metastatic disease is permitted. rIL-21 or dacarbazine must be the first systemic therapy for metastatic disease.

Chemotherapy: Patients must not have received any prior chemotherapy (including regional therapy). rIL-21 or dacarbazine must be the first systemic therapy for metastatic disease (except for RAF and MEK-Inhibitors).

Surgery: Previous surgery is permissible. Patient must be > 4 weeks since any major surgery.

Radiation Therapy: Previous radiation therapy is permitted with exception of radiation therapy for brain metastases. Patients must be > 4 weeks since the last treatment with radiation. Exceptions may be made, however, for low dose, non-myelosuppressive radiotherapy. Patients must have recovered from the toxic effects of radiation.

Laboratory Requirements: (must be done within 7 days prior to randomization) Hematology: Absolute granulocytes (AGC) ≥ 1.5 x 109/L, Platelets ≥ 100 x 109/L Chemistry: Serum creatinine ≤ 1.5 x UNL, Bilirubin ≤ UNL AST and ALT ≤ 2.5 x UNL, LDH ≤ 2.5 x UNL.
Female patients of child-bearing potential must have a negative serum or urine pregnancy test within 7 days of enrollment.
Sexually active patients must agree to use a medically accepted form of contraception while receiving study therapy.
Patient consent must be obtained according to local Institutional and/or University Human Experimentation Committee requirements. It will be the responsibility of the local participating investigators to obtain the necessary local clearance, and to indicate in writing to the NCIC CTG Study Coordinator that such clearance has been obtained, before the trial can commence in that centre. Because of differing requirements, a standard consent form for the trial will not be provided but a sample form is given in Appendix VII. A copy of the initial REB approval and approved consent form must be sent to the central office. The patient must sign the consent form prior to randomization. Please note that the consent form for this study must contain a statement which gives permission for qualified representatives of the NCIC CTG, BMS, ZymoGenetics, the company collaborator, and regulatory authorities to review patient records (see section 16 for further details) and a statement which gives permission for NCIC CTG to access and study tissue for biomarker assessments.
Patients must be accessible for treatment and follow-up. Patients randomized on this trial must be treated and followed at the participating centre. This implies there must be reasonable geographical limits (for example: 2 hour's driving distance) placed on patients being considered for this trial.
In accordance with NCIC CTG policy, protocol treatment is to begin within 5 working days of patient randomization.

Exclusion Criteria:

Patients with known HIV, Hepatitis B or Hepatitis C infection.
History of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for > 5 years.
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, myocardial infarction, other interventional cardiac procedure within the past 12 months, autoimmune conditions requiring chronic immunosuppressive therapy, or psychiatric illness/social situations that would limit compliance with study requirements.
Patients may not have received any other investigational agents within 28 days of study entry, and may not receive concurrent treatment with other anti-cancer therapy or investigational agents while on protocol therapy.
Patients with known brain metastases or history of CNS metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. A head CT or MRI is required on all patients to rule out brain metastases.
Pregnant or lactating women. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with rIL-21 or dacarbazine, breastfeeding should be discontinued if the mother is treated with protocol therapy.
Prohibited Medications: Long Term (> 7 days) Systemic Corticosteroids (e.g. prednisone, dexamethasone, etc.) because these may counteract the stimulatory effects of rIL-21 on lymphocytes. (Note: Topical steroids are allowed).","Dacarbazine: 1000 mg/m2 IV Day 1, every 3 weeks",ChEMBL:CHEMBL476 | DrugBank:DB00851 | PubChem:135398738 | PubChem:2942,Dacarbazine,CN(C)/N=N/c1[nH]cnc1C(N)=O,L01AX04,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01152996,NCT01152996_EG000,No,All,Adult | Older Adult,Phase 3,1073,"Inclusion Criteria:

Has completed either study LuAA21004_315 ( NCT01153009), LuAA21004_316 (NCT01163266), or LuAA21004_317 (NCT01179516) immediately prior to enrollment in the extension study (ie, the baseline visit is the same visit as the Week 8 [Lu AA21004_317] or Week 10 [Lu AA21004_315 or Lu AA21004_316] assessment of the preceding protocol).
Suffers from a recurrent major depressive episode) as the primary diagnosis according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria (classification code 296.3x) at entry into the prior study.
Twelve-month continuation treatment with Lu AA21004 is indicated for the treatment of this participant according to the opinion of the investigator.
Females of childbearing potential who are sexually active with a nonsterilized male partner agree to routinely use adequate contraception throughout the duration of the study.

Exclusion Criteria:

Has Major Depressive Disorder for whom other psychiatric disorders (mania, bipolar disorder, schizophrenia, or any psychotic disorder) have been diagnosed during the prior study.
In the investigator's clinical judgment, has a significant risk of suicide and/or a score of ≥5 points on item 10 (suicidal thoughts) of the Montgomery Åsberg Depression Rating Scale (MADRS).
In the opinion of the investigator, is unlikely to comply with the clinical study protocol or is unsuitable for any reason.
Has a clinically significant moderate or severe ongoing adverse event related to study medication from the prior study.
Has used/uses disallowed concomitant medication.","Vortioxetine 10 mg, capsules, orally, once daily for the first week of treatment; then vortioxetine up-titrated to 15 mg or 20 mg, capsules, orally, once daily for up to 51 weeks.",ChEMBL:CHEMBL2104993 | DrugBank:DB09068 | PubChem:9966051,Vortioxetine,Cc1ccc(Sc2ccccc2N2CCNCC2)c(C)c1,N06AX26,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01153009,NCT01153009_EG001,No,All,Adult | Older Adult,Phase 3,147,"Inclusion Criteria:

Man or a woman who suffers from a major depressive episode (MDE) recurrent as the primary diagnosis according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria (classification code 296.3x) as confirmed by the Structured Clinical Interview for DSM Disorders (SCID).
The reported duration of the current MDE is at least 3 months.
Has a Montgomery Åsberg Depression Rating Scale (MADRS) total score of 26 or greater at Screening and Baseline Visits.
Has a Clinical Global Impression - Severity of Illness (CGI-S) score of 4 or greater at Screening and Baseline Visits.

Exclusion Criteria:

Has previously participated in a Lu AA21004 clinical study.

Has 1 or more the following:

Any current psychiatric disorder other than major depressive disorder (MDD) as defined in the DSM-IV-TR (as assessed by the SCID).
Current or past history of: manic or hypomanic episode, schizophrenia or any other psychotic disorder, including major depression with psychotic features, mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in the DSM-IV-TR.
Diagnosis of any substance abuse or dependence (except nicotine and caffeine) as defined in the DSM-IV-TR that has not been in sustained full remission for at least 2 years prior to screening (subject must also have negative urine drug screen prior to Baseline).
Presence or history of a clinically significant neurological disorder (including epilepsy).
Neurodegenerative disorder (Alzheimer disease, Parkinson disease, multiple sclerosis, Huntington disease, etc).
Any Axis II disorder that might compromise the study.
The current depressive symptoms are considered by the investigator to have been resistant to 2 adequate antidepressant treatments of at least 6 weeks duration each. Has 1 or more laboratory values outside the normal range, based on the blood or urine samples taken at the Screening Visit, that are considered by the investigator to be clinically significant.
Has a thyroid stimulating hormone value outside the normal range at the Screening Visit that is deemed clinically significant by the investigator.
Has clinically significant abnormal vital signs as determined by the investigator.
Has an abnormal electrocardiogram as determined by the central reader and confirmed as clinically significant by the investigator.
Has an alanine aminotransferase, aspartate aminotransferase or total bilirubin level greater than 1.5 times the upper limits of normal.
Has a previous history of cancer that had been in remission for less than 5 years prior to the first dose of study medication. This criterion does not include those patients with basal cell or Stage I squamous cell carcinoma of the skin.
Has a disease or takes medication that, in the opinion of the investigator, could interfere with the assessments of safety, tolerability, or efficacy.
Has a known history of or currently has increased intraocular pressure or is at risk of acute narrow-angle glaucoma.
Has a clinically significant unstable illness, for example, hepatic impairment or renal insufficiency, or a cardiovascular, pulmonary, gastrointestinal, endocrine, neurological, rheumatologic, immunologic, infectious, skin and subcutaneous tissue disorders, or metabolic disturbance. The following are also considered unstable due to the potential impact on assessment of MDD response: pain disorder, chronic fatigue syndrome, fibromyalgia, and obstructive sleep apnea.
Has a significant risk of suicide according to the investigator's opinion or has a score greater than or equal to 5 on item 10 (suicidal thoughts) of the Montgomery Åsberg Depression Rating Scale or has made a suicide attempt in the previous 6 months.","Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 15 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week.",ChEMBL:CHEMBL2104993 | DrugBank:DB09068 | PubChem:9966051,Vortioxetine,Cc1ccc(Sc2ccccc2N2CCNCC2)c(C)c1,N06AX26,0.0,0.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01153009,NCT01153009_EG002,No,All,Adult | Older Adult,Phase 3,154,"Inclusion Criteria:

Man or a woman who suffers from a major depressive episode (MDE) recurrent as the primary diagnosis according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria (classification code 296.3x) as confirmed by the Structured Clinical Interview for DSM Disorders (SCID).
The reported duration of the current MDE is at least 3 months.
Has a Montgomery Åsberg Depression Rating Scale (MADRS) total score of 26 or greater at Screening and Baseline Visits.
Has a Clinical Global Impression - Severity of Illness (CGI-S) score of 4 or greater at Screening and Baseline Visits.

Exclusion Criteria:

Has previously participated in a Lu AA21004 clinical study.

Has 1 or more the following:

Any current psychiatric disorder other than major depressive disorder (MDD) as defined in the DSM-IV-TR (as assessed by the SCID).
Current or past history of: manic or hypomanic episode, schizophrenia or any other psychotic disorder, including major depression with psychotic features, mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in the DSM-IV-TR.
Diagnosis of any substance abuse or dependence (except nicotine and caffeine) as defined in the DSM-IV-TR that has not been in sustained full remission for at least 2 years prior to screening (subject must also have negative urine drug screen prior to Baseline).
Presence or history of a clinically significant neurological disorder (including epilepsy).
Neurodegenerative disorder (Alzheimer disease, Parkinson disease, multiple sclerosis, Huntington disease, etc).
Any Axis II disorder that might compromise the study.
The current depressive symptoms are considered by the investigator to have been resistant to 2 adequate antidepressant treatments of at least 6 weeks duration each. Has 1 or more laboratory values outside the normal range, based on the blood or urine samples taken at the Screening Visit, that are considered by the investigator to be clinically significant.
Has a thyroid stimulating hormone value outside the normal range at the Screening Visit that is deemed clinically significant by the investigator.
Has clinically significant abnormal vital signs as determined by the investigator.
Has an abnormal electrocardiogram as determined by the central reader and confirmed as clinically significant by the investigator.
Has an alanine aminotransferase, aspartate aminotransferase or total bilirubin level greater than 1.5 times the upper limits of normal.
Has a previous history of cancer that had been in remission for less than 5 years prior to the first dose of study medication. This criterion does not include those patients with basal cell or Stage I squamous cell carcinoma of the skin.
Has a disease or takes medication that, in the opinion of the investigator, could interfere with the assessments of safety, tolerability, or efficacy.
Has a known history of or currently has increased intraocular pressure or is at risk of acute narrow-angle glaucoma.
Has a clinically significant unstable illness, for example, hepatic impairment or renal insufficiency, or a cardiovascular, pulmonary, gastrointestinal, endocrine, neurological, rheumatologic, immunologic, infectious, skin and subcutaneous tissue disorders, or metabolic disturbance. The following are also considered unstable due to the potential impact on assessment of MDD response: pain disorder, chronic fatigue syndrome, fibromyalgia, and obstructive sleep apnea.
Has a significant risk of suicide according to the investigator's opinion or has a score greater than or equal to 5 on item 10 (suicidal thoughts) of the Montgomery Åsberg Depression Rating Scale or has made a suicide attempt in the previous 6 months.","Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 20 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week.",ChEMBL:CHEMBL2104993 | DrugBank:DB09068 | PubChem:9966051,Vortioxetine,Cc1ccc(Sc2ccccc2N2CCNCC2)c(C)c1,N06AX26,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT01155219,NCT01155219_EG001,No,All,Adult | Older Adult,Phase 4,150,"Inclusion Criteria:

Written informed consent.

Association of the 4 following criteria:

- Bilateral primary open angle glaucoma or bilateral ocular hypertension already treated and controlled by mono-therapy of Xalatan® (1drop per day),
- With local intolerance signs.

Exclusion Criteria:

Presence of severe objective ocular sign.
Any ocular hypertension other than primary ocular hypertension or primary chronic open angle glaucoma (such as congenital, angle closure glaucoma, secondary glaucoma).
Absolute defect in the ten degrees central point of the visual field.
Best far corrected visual acuity ≤ 1/10.","Latanoprost

One drop in the conjunctival sac of each eye in the evening",ChEMBL:CHEMBL1051 | DrugBank:DB00654 | PubChem:5311221,Latanoprost,CC(C)OC(=O)CCC/C=C\C[C@@H]1[C@@H](CC[C@@H](O)CCc2ccccc2)[C@H](O)C[C@@H]1O,S01EE01 | S01EE51,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01155999,NCT01155999_EG001,No,All,Child | Adult,Phase 3,286,"Inclusion Criteria:

Age ≥ one day of life and ≤ 18 years
Purulent bacterial conjunctivitis","Tobramycin: 1 to 2 drops every two hours while awake on Days 0-1, up to 8×/day, then 1 to 2 drops 4 times daily on Days 2-6",ChEMBL:CHEMBL1747 | DrugBank:DB00684 | PubChem:36294,Tobramycin,NC[C@H]1O[C@H](O[C@H]2[C@H](O)[C@@H](O[C@H]3O[C@H](CO)[C@@H](O)[C@H](N)[C@H]3O)[C@H](N)C[C@@H]2N)[C@H](N)C[C@@H]1O,J01GB01 | S01AA12,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01156012,NCT01156012_EG000,No,All,Adult | Older Adult,Phase 3,213,"Inclusion Criteria:

Adult patients diagnosed with glaucoma

Exclusion Criteria:

Under 18.","One drop of T2345

T2345: One drop of T2345 at 9.00pm.",ChEMBL:CHEMBL1051 | DrugBank:DB00654 | PubChem:5311221,Latanoprost,CC(C)OC(=O)CCC/C=C\C[C@@H]1[C@@H](CC[C@@H](O)CCc2ccccc2)[C@H](O)C[C@@H]1O,S01EE01 | S01EE51,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01156480,NCT01156480_EG000,No,All,Child,Not Applicable,2,"Inclusion Criteria:

Infant born at gestational age less than 34 weeks
Birth weight less than 2500 grams
Diagnosis of stage II or III NEC made by attending neonatologist, neonatology fellow, or pediatric hospitalist
Legally authorized representative is able to provide written informed consent prior to the performance of an protocol-specified evaluations or procedures
Consent can be obtained and study drug can be administered within 6 hours of diagnosis

Exclusion Criteria:

congenital gastrointestinal anomaly
subject is already receiving parenteral steroid therapy or subject has received parenteral steroids within one week prior to study entry
subject has received indomethacin therapy within 48 hours prior to being diagnosed with NEC","Subjects in hydrocortisone group will receive 3mg/kg/day divided every 8 hours via intravenous (IV) route for 3 days, followed by 2mg/kg/day divided every 8 hours IV for 1 day, followed by 1.5mg/kg/day divided every 8 hours IV for 1 day, followed by 1mg/kg/day divided every 12 hours for 1 day, followed by 0.5mg/kg/day in single dose for one day. Subjects in placebo group will receive equal volume of placebo on the same dosing schedule. The first dose of study drug will be given within 6 hours of diagnosis of NEC, once informed consent is obtained, and subjects will continue to receive study drug until all doses have been given (total of 18 doses) or consent is withdrawn.",ChEMBL:CHEMBL389621 | DrugBank:DB00741 | PubChem:5754,Hydrocortisone,[H][C@@]12CC[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)CC[C@@]21C,A01AC03 | A07EA02 | C05AA01 | D07AA02 | D07BA04 | D07CA01 | D07XA01 | H02AB09 | R01AD60 | S01BA02 | S01BB01 | S01CA03 | S01CB03 | S02BA01 | S02CA03 | S03CA04,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01162551,NCT01162551_EG000,No,All,Child | Adult,Phase 2,3,"Inclusion Criteria:

Patients </= 25 years of age, at time of enrollment, with second or greater relapse of ALL or NHL. For ALL must have histologic diagnosis with >10% blasts in the marrow and for lymphoblastic lymphoma or peripheral T-cell lymphoma must have radiologic or physical evidence of recurrence.
Lansky > 50% or Karnofsky > 50%
Negative Pregnancy Test
Creatinine clearance or radioisotope GFR > 70ml/min/m2 OR serum creatinine based on age /gender
Pulse ox >94%
Total Bilirubin <1.5 x normal for age
ALT < 5 x normal for age
Albumin > 2g/dL
Shortening fraction by echo > 28% OR ejection fraction > 50% by gated radionuclide study

Exclusion Criteria:

Patient has known allergies to sirolimus,FK-506 or mTOR inhibitors
Patient is taking other investigational anti-neoplastic drugs
Patient received no myelosuppressive chemo within 14 days
< 14 days have elapsed since local palliative XRT (small port) < 28 days since prior craniospinal XRT or 50% radiation of pelvis <28 days if other substantial BM radiation
Hematopoietic growth factors within 7 days of entry (except erythropoietin.)
Patient has taken any biologic agents within 14 days
Post BMT/SCT - evidence of active GVHD, at least > 3 months must have elapsed
Patient has uncontrolled infection (if patients with fungal disease, stable for < 14 days and patients with bacteremia without negative blood culture
Existing non-hematologic toxicities > grade 2

Use of steroids or hydroxyurea is permitted upto 14 days prior to entry.","Sirolimus: Oral bolus on day 1, then daily oral dose days 2-28. Dose will be altered to maintain a sirolimus trough level between ≥ 8 and ≤ 13. Trough levels will be checked weekly.

Methotrexate: Oral 20 mg/m2/week on Days 2, 9, 16, 23.

One cycle is 28 days

Sirolimus and Methotrexate: Single Arm Efficacy Trial:

Sirolimus: Oral bolus on day 1, then daily oral dose days 2-28. Dose will be altered to maintain a sirolimus trough level between ≥ 8 and ≤ 13. Trough levels will be checked weekly.

Methotrexate: Oral 20 mg/m2/week on Days 2, 9, 16, 23.

One cycle is 28 days.",ChEMBL:CHEMBL34259 | DrugBank:DB00563 | PubChem:126941,Methotrexate,CN(Cc1cnc2nc(N)nc(N)c2n1)c1ccc(C(=O)N[C@@H](CCC(=O)O)C(=O)O)cc1,L01BA01 | L04AX03,1.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT01163266,NCT01163266_EG001,No,All,Adult | Older Adult,Phase 3,155,"Inclusion Criteria:

Suffers from a major depressive episode recurrent as the primary diagnosis according to the American Psychiatric Association Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria.
Has a Montgomery Åsberg Depression Rating Scale (MADRS) total score of 26 or greater at Screening and Baseline Visits.
Has a Clinical Global Impression - Severity of Illness (CGI-S) score of 4 or greater at Screening and Baseline Visits.

Exclusion Criteria:

Has previously participated in a Lu AA21004 clinical study.

Has 1 or more the following:

Any current psychiatric disorder other than Major Depressive Disorder as defined in the DSM-IV
Current or past history of: manic or hypomanic episode, schizophrenia or any other psychotic disorder defined in the DSM-IV-TR.
Diagnosis of alcohol or other substance disorder (except nicotine and caffeine) as defined in the DSM-IV-TR that has not been in sustained full remission for at least years prior to screening (participant must also have negative urine drug screen prior to Baseline).
Presence or history of a clinically significant neurological disorder (including epilepsy)
Neurodegenerative disorder.
Any Axis II disorder that might compromise the study.
Has a thyroid stimulating hormone value outside the normal range at the Screening Visit that is deemed clinically significant by the investigator.
Has clinically significant abnormal vital signs as determined by the investigator.
Has an abnormal Electrocardiogram.
Has an alanine aminotransferase, aspartate aminotransferase or total bilirubin level greater than 1.5 times the upper limits of normal.
Has a previous history of cancer that had been in remission for less than 5 years prior to the first dose of study medication.
Has a disease or takes medication that, in the opinion of the investigator, could interfere with the assessments of safety, tolerability, or efficacy.
Has a known history of or currently has increased intraocular pressure or is at risk of acute narrow-angle glaucoma.
Has a clinically significant unstable illness, for example, hepatic impairment or renal insufficiency, or a cardiovascular, pulmonary, gastrointestinal, endocrine, neurological, rheumatologic, immunologic, infectious, skin and subcutaneous tissue disorders, or metabolic disturbance. For the purposes of this protocol the following conditions are considered unstable due to the potential impact on assessment of MDD response: pain disorder, chronic fatigue syndrome, fibromyalgia, and obstructive sleep apnea.
Has a significant risk of suicide according to the investigator's opinion.","Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up to 8 weeks.",ChEMBL:CHEMBL2104993 | DrugBank:DB09068 | PubChem:9966051,Vortioxetine,Cc1ccc(Sc2ccccc2N2CCNCC2)c(C)c1,N06AX26,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT01163266,NCT01163266_EG002,No,All,Adult | Older Adult,Phase 3,150,"Inclusion Criteria:

Suffers from a major depressive episode recurrent as the primary diagnosis according to the American Psychiatric Association Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria.
Has a Montgomery Åsberg Depression Rating Scale (MADRS) total score of 26 or greater at Screening and Baseline Visits.
Has a Clinical Global Impression - Severity of Illness (CGI-S) score of 4 or greater at Screening and Baseline Visits.

Exclusion Criteria:

Has previously participated in a Lu AA21004 clinical study.

Has 1 or more the following:

Any current psychiatric disorder other than Major Depressive Disorder as defined in the DSM-IV
Current or past history of: manic or hypomanic episode, schizophrenia or any other psychotic disorder defined in the DSM-IV-TR.
Diagnosis of alcohol or other substance disorder (except nicotine and caffeine) as defined in the DSM-IV-TR that has not been in sustained full remission for at least years prior to screening (participant must also have negative urine drug screen prior to Baseline).
Presence or history of a clinically significant neurological disorder (including epilepsy)
Neurodegenerative disorder.
Any Axis II disorder that might compromise the study.
Has a thyroid stimulating hormone value outside the normal range at the Screening Visit that is deemed clinically significant by the investigator.
Has clinically significant abnormal vital signs as determined by the investigator.
Has an abnormal Electrocardiogram.
Has an alanine aminotransferase, aspartate aminotransferase or total bilirubin level greater than 1.5 times the upper limits of normal.
Has a previous history of cancer that had been in remission for less than 5 years prior to the first dose of study medication.
Has a disease or takes medication that, in the opinion of the investigator, could interfere with the assessments of safety, tolerability, or efficacy.
Has a known history of or currently has increased intraocular pressure or is at risk of acute narrow-angle glaucoma.
Has a clinically significant unstable illness, for example, hepatic impairment or renal insufficiency, or a cardiovascular, pulmonary, gastrointestinal, endocrine, neurological, rheumatologic, immunologic, infectious, skin and subcutaneous tissue disorders, or metabolic disturbance. For the purposes of this protocol the following conditions are considered unstable due to the potential impact on assessment of MDD response: pain disorder, chronic fatigue syndrome, fibromyalgia, and obstructive sleep apnea.
Has a significant risk of suicide according to the investigator's opinion.","Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week then vortioxetine 20 mg, encapsulated tablets, orally, once daily for up to 7 weeks.",ChEMBL:CHEMBL2104993 | DrugBank:DB09068 | PubChem:9966051,Vortioxetine,Cc1ccc(Sc2ccccc2N2CCNCC2)c(C)c1,N06AX26,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0
NCT01170884,NCT01170884_EG000,No,All,Adult | Older Adult,Phase 4,59,"Inclusion Criteria:

Diagnosed with glaucoma or ocular hypertension.
Visual Acuity 20/100 or better in both eyes

Exclusion Criteria:

Any active ocular disease
History of any intraocular surgery or glaucoma laser surgery within 3 months
Contraindication to pupil dilation
Use of topical, periorbital, intravitreal, or systemic steroid within 3 months",COMBIGAN® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution) adjunctive to LUMIGAN® (bimatoprost 0.03% ophthalmic solution),PubChem:11387895,Combigan,Brc1c(NC2=NCCN2)ccc2nccnc12.CC(C)(C)NCC(O)COc1nsnc1N1CCOCC1,,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01175135,NCT01175135_EG000,No,All,Adult | Older Adult,Phase 2,74,"Inclusion Criteria:

Diagnosis of schizophrenia with acute exacerbation of illness
The current acute exacerbation of schizophrenia must be less than 4 weeks duration prior to the initial evaluation.

Exclusion Criteria:

Subjects with evidence or history of clinically significant uncontrolled medical illness
Subjects with a current diagnosis of schizoaffective disorder, major depression, bipolar disorder, or obsessive compulsive disorder.
Subjects who meet Diagnostic and Statistical Manual-IV (DSM-IV)defined diagnostic criteria for psychoactive substance dependence (excluding nicotine dependence) within 12 months of screening or DSM-IV defined substance abuse within 3 months prior to screening.","Participants received PF-02545920 5 milligram (mg) tablet, orally every 12 hours for 28 days.",ChEMBL:CHEMBL562318 | DrugBank:DB08387 | PubChem:11581936,Mardepodect,Cn1cc(-c2ccncc2)c(-c2ccc(OCc3ccc4ccccc4n3)cc2)n1,,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT01175135,NCT01175135_EG001,No,All,Adult | Older Adult,Phase 2,74,"Inclusion Criteria:

Diagnosis of schizophrenia with acute exacerbation of illness
The current acute exacerbation of schizophrenia must be less than 4 weeks duration prior to the initial evaluation.

Exclusion Criteria:

Subjects with evidence or history of clinically significant uncontrolled medical illness
Subjects with a current diagnosis of schizoaffective disorder, major depression, bipolar disorder, or obsessive compulsive disorder.
Subjects who meet Diagnostic and Statistical Manual-IV (DSM-IV)defined diagnostic criteria for psychoactive substance dependence (excluding nicotine dependence) within 12 months of screening or DSM-IV defined substance abuse within 3 months prior to screening.","Participants received PF-02545920 tablet, dose was titrated with a starting dose of 5 mg up to 15 mg, orally every 12 hours for 28 days.",ChEMBL:CHEMBL562318 | DrugBank:DB08387 | PubChem:11581936,Mardepodect,Cn1cc(-c2ccncc2)c(-c2ccc(OCc3ccc4ccccc4n3)cc2)n1,,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01177709,NCT01177709_EG000,No,All,Adult | Older Adult,Not Applicable,12,"Inclusion Criteria:

Patients will be 18-70 years of age;
Currently hospitalized or an outpatient at MPC;
BMI ≥ 35 or excessive recent weight gain ( > than 10 lb weight gain in the past 3 months);
Patients will have a diagnosis of schizophrenia or schizoaffective disorder or bipolar disorder.

Exclusion Criteria:

Age below 18 or over 70;
Patient is currently already treated with metformin.",Metformin: metformin 500- 2500 mg/day.,ChEMBL:CHEMBL1431 | DrugBank:DB00331 | PubChem:4091,Metformin,CN(C)C(=N)NC(=N)N,A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT01178528,NCT01178528_EG000,No,All,Adult | Older Adult,Phase 3,121,"Inclusion Criteria:

heart failure II-III
ischemic origin
stable medications from at least 3 months
> 3 months from an acute ischemic syndrome or revascularization procedure
naive on heart rate reducing agents

Exclusion Criteria:

bradycardia
hypersensitivity or contraindications to study drugs
exercise tolerance at 6 minute walking test <100 m or >400 m",up to 7.5 mg b.i.d.,ChEMBL:CHEMBL471737 | DrugBank:DB09083 | PubChem:132999,Ivabradine,COc1cc2c(cc1OC)CC(=O)N(CCCN(C)C[C@H]1Cc3cc(OC)c(OC)cc31)CC2,C01EB17 | C07FX05 | C07FX06,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01179516,NCT01179516_EG001,No,All,Adult | Older Adult,Phase 3,154,"Inclusion Criteria:

Suffers from a major depressive episode (MDE) recurrent as the primary diagnosis according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria.
The reported duration of the current MDE is at least 3 months.
Has a Montgomery Åsberg Depression Rating Scale (MADRS) total score of 26 or greater at Screening and Baseline Visits.
Has a Clinical Global Impression - Severity of Illness (CGI-S) score of 4 or greater at Screening and Baseline Visits.

Exclusion Criteria:

Has received any investigational compound <30 days before Screening or 5 half-lives prior to Screening.
Has received Lu AA21004 in a previous clinical study.

Has 1 or more the following:

Any current psychiatric disorder other than MDD as defined in the DSM-IV-TR .
Current or history of: manic or hypomanic episode, schizophrenia or any other psychotic disorder, including major depression with psychotic features, mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in the DSM-IV-TR.
Diagnosis of alcohol or other substance abuse or dependence (excluding nicotine or caffeine) as defined in the DSM-IV-TR that had not been in sustained full remission for at least 2 years prior to Screening.
Presence or history of a clinically significant neurological disorder (including epilepsy).
Neurodegenerative disorder (Alzheimer disease, Parkinson disease, multiple sclerosis, Huntington disease, etc).
Any Axis II disorder that might compromise the study.
The current depressive symptoms of the patient were considered by the investigator to have been resistant to 2 adequate antidepressant treatments of at least 6 weeks duration each.
Has received electroconvulsive therapy, vagal nerve stimulation, or repetitive transcranial magnetic stimulation within 6 months prior to Screening.
Was currently receiving formal cognitive or behavioral therapy, systematic psychotherapy, or planned to initiate such therapy during the study.
Has a significant risk of suicide according to the investigator's clinical judgment or had a score ≥5 on item 10 (suicidal thoughts) of the MADRS or had made a suicide attempt in the previous 6 months.
Was required to take excluded medications or it was anticipated that would require treatment with at least 1 of the disallowed concomitant medications during the study.
Has a clinically significant unstable illness, for example hepatic impairment or renal insufficiency, or a cardiovascular, pulmonary, gastrointestinal, endocrine, neurological, rheumatologic, immunologic, hematological, infectious, dermatological disorder or metabolic disturbance. NOTE: For the purposes of this study, the following conditions were considered unstable due to the potential impact on assessment of MDD response: pain disorder, chronic fatigue syndrome, fibromyalgia, and obstructive sleep apnea.

Has 1 or more laboratory value outside the normal range, based on the blood or urine samples taken at the Screening Visit, that were considered by the investigator to be clinically significant; or the patient has any of the following values at the Screening Visit:

A serum creatinine value >1.5 times the upper limits of normal (× ULN).
A total serum total bilirubin value >1.5 × ULN.
A serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value >2 × ULN.
Has a thyroid stimulating hormone value outside the normal range.
Has clinically significant abnormal vital signs.
Has an abnormal electrocardiogram.","Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up to 8 weeks.",ChEMBL:CHEMBL2104993 | DrugBank:DB09068 | PubChem:9966051,Vortioxetine,Cc1ccc(Sc2ccccc2N2CCNCC2)c(C)c1,N06AX26,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01179516,NCT01179516_EG002,No,All,Adult | Older Adult,Phase 3,151,"Inclusion Criteria:

Suffers from a major depressive episode (MDE) recurrent as the primary diagnosis according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria.
The reported duration of the current MDE is at least 3 months.
Has a Montgomery Åsberg Depression Rating Scale (MADRS) total score of 26 or greater at Screening and Baseline Visits.
Has a Clinical Global Impression - Severity of Illness (CGI-S) score of 4 or greater at Screening and Baseline Visits.

Exclusion Criteria:

Has received any investigational compound <30 days before Screening or 5 half-lives prior to Screening.
Has received Lu AA21004 in a previous clinical study.

Has 1 or more the following:

Any current psychiatric disorder other than MDD as defined in the DSM-IV-TR .
Current or history of: manic or hypomanic episode, schizophrenia or any other psychotic disorder, including major depression with psychotic features, mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in the DSM-IV-TR.
Diagnosis of alcohol or other substance abuse or dependence (excluding nicotine or caffeine) as defined in the DSM-IV-TR that had not been in sustained full remission for at least 2 years prior to Screening.
Presence or history of a clinically significant neurological disorder (including epilepsy).
Neurodegenerative disorder (Alzheimer disease, Parkinson disease, multiple sclerosis, Huntington disease, etc).
Any Axis II disorder that might compromise the study.
The current depressive symptoms of the patient were considered by the investigator to have been resistant to 2 adequate antidepressant treatments of at least 6 weeks duration each.
Has received electroconvulsive therapy, vagal nerve stimulation, or repetitive transcranial magnetic stimulation within 6 months prior to Screening.
Was currently receiving formal cognitive or behavioral therapy, systematic psychotherapy, or planned to initiate such therapy during the study.
Has a significant risk of suicide according to the investigator's clinical judgment or had a score ≥5 on item 10 (suicidal thoughts) of the MADRS or had made a suicide attempt in the previous 6 months.
Was required to take excluded medications or it was anticipated that would require treatment with at least 1 of the disallowed concomitant medications during the study.
Has a clinically significant unstable illness, for example hepatic impairment or renal insufficiency, or a cardiovascular, pulmonary, gastrointestinal, endocrine, neurological, rheumatologic, immunologic, hematological, infectious, dermatological disorder or metabolic disturbance. NOTE: For the purposes of this study, the following conditions were considered unstable due to the potential impact on assessment of MDD response: pain disorder, chronic fatigue syndrome, fibromyalgia, and obstructive sleep apnea.

Has 1 or more laboratory value outside the normal range, based on the blood or urine samples taken at the Screening Visit, that were considered by the investigator to be clinically significant; or the patient has any of the following values at the Screening Visit:

A serum creatinine value >1.5 times the upper limits of normal (× ULN).
A total serum total bilirubin value >1.5 × ULN.
A serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value >2 × ULN.
Has a thyroid stimulating hormone value outside the normal range.
Has clinically significant abnormal vital signs.
Has an abnormal electrocardiogram.","Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 15 mg, encapsulated tablets, orally, once daily for up to 7 weeks.",ChEMBL:CHEMBL2104993 | DrugBank:DB09068 | PubChem:9966051,Vortioxetine,Cc1ccc(Sc2ccccc2N2CCNCC2)c(C)c1,N06AX26,0.0,0.0,0.0,0.0,0.0,1.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT01181128,NCT01181128_EG001,No,Male,Child | Adult | Older Adult,Phase 3,24,"Inclusion Criteria:

Male, ≥12 years of age with weight at least 40 kg
Diagnosed with severe hemophilia A, defined as <1 IU/dL (<1%) endogenous Factor VIII)
History of at least 150 documented prior exposure days to any Factor VIII product
Platelet count ≥100,000 cells/μL

Exclusion Criteria:

History of Factor VIII inhibitors
Kidney and liver dysfunction
Diagnosed with other coagulation disorder(s) in addition to hemophilia A
Prior history of hypersensitivity or anaphylaxis associated with any FVIII or IV immunoglobulin administration",65 IU/kg of rFVIIIFc via IV injection every 7 days,PubChem:104815,Cuprous ion,[Cu+],,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01181128,NCT01181128_EG002,No,Male,Child | Adult | Older Adult,Phase 3,23,"Inclusion Criteria:

Male, ≥12 years of age with weight at least 40 kg
Diagnosed with severe hemophilia A, defined as <1 IU/dL (<1%) endogenous Factor VIII)
History of at least 150 documented prior exposure days to any Factor VIII product
Platelet count ≥100,000 cells/μL

Exclusion Criteria:

History of Factor VIII inhibitors
Kidney and liver dysfunction
Diagnosed with other coagulation disorder(s) in addition to hemophilia A
Prior history of hypersensitivity or anaphylaxis associated with any FVIII or IV immunoglobulin administration","Initial single dose of 50 IU/kg of rFVIIIFc via IV injection followed by 10 to 50 IU/kg rFVIIIFc, as required to treat a bleeding episode",PubChem:104815,Cuprous ion,[Cu+],,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01181921,NCT01181921_EG000,No,All,Adult | Older Adult,Phase 4,1,"Inclusion Criteria:

Diagnosis of Alzheimer-type dementia according to the definition of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM IV-TR) and a diagnosis of possible or probable Alzheimer-type dementia, according to NINCDS-ADRDA classification (American Psychiatric Association, 2000
McKhann, G. et al, 1984)
should have moderate dementia, evidenced by a Mini-Mental Status examination (MMSE) score between 12 and 20, including these limits
At inclusion, a recent CT or MRI must be available
Physical examination and the electrocardiogram (ECG) performed at the screening visit must be normal or consistent with the underlying illness in the study population
History of sleep behavior changes (eg: insomnia, daytime sleepiness, changes in sleep/wakefulness cycle) 2 or more weeks before, reported by the caregiver
Patients should have a caregiver sufficiently informed of their condition and, if possible, living with them
Patients (or their legally-acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study

Exclusion Criteria:

History of other neurodegenerative disorders, such as Parkinson's disease, Pick disease or Huntington's chorea, Down syndrome, Creutzfeldt-Jakob disease (patients with mild extrapyramidal signs for which no treatment is required are not excluded from the trial)
Clinically significant cardiovascular disease expected to limit the ability of the patient to participate and complete the study
Any history of epilepsy or seizures (except for febrile seizures in childhood)
Clinically significant psychiatric condition, according to the DSM-IV criteria, particularly major depression or schizophrenia currently
Active peptic ulcer (treatment of the disease started < 3 months or treatment is not successful
Clinically significant liver, renal, pulmonary, metabolic, or endocrine disorders
Clinically significant urinary flow obstruction
History of or suspected alcoholism or drug abuse in accordance to the DSM-IV criteria, in the past year, or previous history of prolonged abuse
Previous therapy with memantine or an acetylcholinesterase inhibitor (including galantamine)
Patients receiving antipsychotics, hypnotic or sedative agents (those patients who need this kind of medication during the study would be withdrawn from the study and replaced)
Bedridden patients","Galantamine (capsules/oral use). Starting dose: 8 mg/day for 4 weeks; initial maintenance dose: 16 mg/day for 4 weeks; then, an increase to the maintenance dose of 24 mg/day should be considered on an individual basis after appropriate assessment.",ChEMBL:CHEMBL659 | DrugBank:DB00674 | PubChem:9651,Galantamine,[H][C@]12C[C@@H](O)C=C[C@]13CCN(C)Cc1ccc(OC)c(c13)O2,N06DA04,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01188551,NCT01188551_EG003,No,All,Child | Adult | Older Adult,Phase 2 | Phase 3,100,"Inclusion Criteria:

functional status as assigned by the American Society of Anesthesiology (ASA) classification of I or II (no or minimal co-morbid disease)
patients scheduled for placement of bilateral myringotomy tubes

Exclusion Criteria:

history of allergy to either dexmedetomidine or fentanyl
concomitant use of medications which may exaggerate the HR response of dexmedetomidine including digoxin or β-adrenergic antagonists.",Fentanyl given intranasally in the OR without any pre-medication.,ChEMBL:CHEMBL596 | DrugBank:DB00813 | PubChem:3345,Fentanyl,CCC(=O)N(c1ccccc1)C1CCN(CCc2ccccc2)CC1,N01AH01 | N01AH51 | N02AB03,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01188811,NCT01188811_EG000,No,All,Adult | Older Adult,Phase 2 | Phase 3,28,"Inclusion Criteria:

Diagnosis of SPMS
Age 40-70 years
Able to understand English and able to give informed consent

Exclusion Criteria:

Unable to undergo MRI testing
For ambulatory subjects only, a self-reported medical or neurological condition other than MS that is a cause of progressive or fluctuating problems that affect walking(e.g. worsening neuropathy, uncontrolled lower extremity arthritis, uncontrolled heart or lung disease)
For ambulatory subjects only, fixed and/or stable conditions of less than 1 years duration that affect walking (e.g. joint replacement, lumbar stenosis, alcoholism, stroke, etc.)
Pregnant or breast-feeding.
Current major disease or disorder other than MS (such as cancer, kidney, heart or lung disease, post-traumatic stress disorder) that may interfere with study procedures
Natalizumab, mitoxantrone, azathioprine taken in the last 12 months
Other immunosuppressants or chemotherapies taken in the last 12 months
Scheduled (every 3 months or more frequently) IV steroids used in the last 12 months
IV or oral steroids taken in the past 60 days.
Lipoic acid taken in the past 60 days.
Subject has insulin-dependent diabetes or is not controlled on oral diabetes medications","28 subjects receive oral lipoic acid 1200mg daily

lipoic acid: 1200 mg taken by mouth daily starting on day one of the study and ending on the last day of study participation.",ChEMBL:CHEMBL33864 | DrugBank:DB00166 | PubChem:6112 | PubChem:864,Lipoic acid,O=C(O)CCCCC1CCSS1,A16AX01,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT01188928,NCT01188928_EG002,No,All,Adult | Older Adult,Phase 3,96,"Inclusion Criteria:

Signed and dated informed consent obtained prior to any trial related activities (including any washout period).
Aged 18 years or above
Either sex
Any race or ethnicity
Attending a hospital outpatient clinic or the private practice of a board certified dermatologist.
Clinical diagnosis of stable plaque psoriasis vulgaris of at least 6 months duration involving the non-scalp regions of the body (trunk and/or limbs) amenable to treatment with a maximum of 100 g of topical medication per week.
An investigator's global assessment of disease severity (IGA) of mild or moderate on the body (trunk and/or limbs) at Day 0 (Visit 1).
A minimum modified Psoriasis Area and Severity Index (PASI) score for extent of 2 in at least one body region (i.e. psoriasis affecting at least 10% of arms, and/or 10% of trunk, and/or 10% of legs)
Females of childbearing potential must have a negative pregnancy test at Day 0 (Visit 1).
Females of childbearing potential must agree to use a highly effective method of birth control during the study. A highly effective method of birth control is defined as one which results in a low failure rate (less than 1% per year) such as implants, injectables, combined oral contraceptives, some intrauterine devices, sexual abstinence or vasectomised partner. The patients must have used the contraceptive method continually for at least 1 month prior to the pregnancy test, and must continue using the contraceptive method for at least 1 week after the last application of study medication. A female is defined as not of child-bearing potential if she is postmenopausal (12 months with no menses without an alternative medical cause), or surgically sterile (tubal ligation/section, hysterectomy or bilateral ovariectomy).
Able to communicate with the investigator and understand and comply with the requirements of the study.

Exclusion Criteria:

Systemic treatment with biological therapies, whether marketed or not, with a possible effect on psoriasis vulgaris within the following time periods prior to randomisation:

etanercept - within 4 weeks prior to randomisation
adalimumab, alefacept, infliximab - within 2 months prior to randomisation
ustekinumab - within 4 months prior to randomisation
experimental products - within 4 weeks/5 half-lives (whichever is longer) prior to randomisation
Systemic treatment with all other therapies with a possible effect on psoriasis vulgaris (e.g., corticosteroids, retinoids, methotrexate, cyclosporine and other immunosuppressants) within 4 weeks prior to randomisation.
PUVA or Grenz ray therapy within 4 weeks prior to randomisation.
UVB therapy within 2 weeks prior to randomisation.
Any topical treatment of the trunk and/or limbs (except for emollients) within 2 weeks prior to randomisation.
Topical treatment for other relevant skin disorders on the face and flexures (e.g., facial and flexural psoriasis, eczema) with class 1- 5 corticosteroids or vitamin D analogues within 2 weeks prior to randomisation.
Topical treatment for other relevant skin disorders on the scalp (e.g. scalp psoriasis) with class 1-5 corticosteroids, vitamin D analogues or prescription shampoos within 2 weeks prior to randomisation.
Planned initiation of, or changes to, concomitant medication that could affect psoriasis vulgaris (e.g. beta blockers, anti-malarials, lithium, ACE inhibitors) during the study.
Current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis.
Subjects with any of the following conditions present on the treatment area: viral (e.g. herpes or varicella) lesions of the skin, fungal and bacterial skin infections, parasitic infections, skin manifestations in relation to syphilis or tuberculosis, rosacea, perioral dermatitis, acne vulgaris, atrophic skin, striae atrophicae, fragility of skin veins, icthyosis, acne rosacea, ulcers and wounds.
Known or suspected disorders of calcium metabolism associated with hypercalcaemia.
Known or suspected severe renal insufficiency or severe hepatic disorders.
Known or suspected hypersensitivity to component(s) of the investigational products.
Current participation in any other interventional clinical study.
Subjects who have received treatment with any non-marketed drug substance (i.e. an agent which has not yet been made available for clinical use following registration) within the 4-week period prior to randomisation or longer, if the class of substance required a longer washout as defined above (e.g. biological treatments).
Planned excessive exposure to the sun during the study that may affect the psoriasis vulgaris.
Previously randomised in this study.
Females who are pregnant, have a positive pregnancy test at Day 0 (Visit 1), or are breast-feeding. Females of child-bearing potential wishing to become pregnant during the study, or not using an adequate method of contraception during the study.",Calcipotriol 50 mcg/g in the topical suspension vehicle,ChEMBL:CHEMBL1200666 | PubChem:5288783,CALCIPOTRIENE,C=C1/C(=C\C=C2/CCC[C@]3(C)[C@@H]([C@H](C)/C=C/[C@@H](O)C4CC4)CC[C@@H]23)C[C@@H](O)C[C@@H]1O,D05AX02 | D05AX52,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01190306,NCT01190306_EG001,No,All,Child | Adult | Older Adult,Phase 3,127,"Inclusion Criteria:

12 years of age or older
Having a diagnosis of keratoconus
Presence of central or inferior steepening
Topography consistent with keratoconus
Presence of one or more slit lamp or retinoscopy findings associated with keratoconus
Contact lens wearers only:Removal of contact lenses for the required period of time
Signed written informed consent
Willingness and ability to comply with schedule for follow-up visits

Exclusion Criteria:

For keratoconus, a history of previous corneal surgery or the insertion of Intacs in the eye to be treated
Corneal pachymetry ≤ 400 microns
Previous ocular condition that may predispose the eye for future complications or prevent the possibility of improved vision
A history of chemical injury or delayed epithelial healing in the eye(s) to be treated.
Pregnancy (including plan to become pregnant) or lactation during the course of the study
A known sensitivity to study medications
Nystagmus or any other condition that would prevent a steady gaze during the cross-linking treatment or other diagnostic tests
A condition that, in the investigator's opinion, would interfere with or prolong epithelial healing.
Presence or history of any other condition or finding that, in the investigator's opinion, makes the patient unsuitable as a candidate for cross-linking or study participation or may confound the outcome of the study.",Eyes in the control group will be treated with riboflavin only.,ChEMBL:CHEMBL1534 | DrugBank:DB00140 | PubChem:493570,Riboflavin,Cc1cc2nc3c(=O)[nH]c(=O)nc-3n(C[C@H](O)[C@H](O)[C@H](O)CO)c2cc1C,A11HA04 | S01XA26,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01191086,NCT01191086_EG000,No,All,Adult | Older Adult,Phase 3,210,"Inclusion Criteria:

Have completed the maintenance period of the P09-004 study.
Continue to be treated with a stable dose of 1 to a maximum of 3 approved concomitant AEDs.","Topiramate extended-release capsules (USL255) up to a maximum of 400 mg per day

USL255",ChEMBL:CHEMBL220492 | DrugBank:DB00273 | PubChem:5284627,Topiramate,[H][C@@]12OC(C)(C)O[C@]1([H])CO[C@@]1(COS(N)(=O)=O)OC(C)(C)O[C@]12[H],A08AA51 | N03AX11,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01194856,NCT01194856_EG000,No,All,Adult | Older Adult,Phase 4,1,"Inclusion Criteria:

HIV infection
Age > or = 18 years old.
Signed informed consent.
Clinical lipoatrophy of at least moderate severity and in at least two different areas of the following: face, arms, legs, or buttocks (as self reported by the patient and confirmed by the physician).
Women of childbearing potential must be using an adequate method of contraception to avoid pregnancy throughout the study in such a manner that the risk of pregnancy is minimized.

All subjects must not participate in a conception process (e.g. active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization), and if participating in sexual activity that could lead to pregnancy, the female subject/ male partner must use condoms (male or female) in addition to one of the following forms of contraception while on study: either a spermicidal agent, diaphragm, cervical cap, IUD, or hormonal-based contraception.

Prior to study enrollment, women of childbearing potential (WOCBP) must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy. In addition, men enrolled on this study should understand the risks to any sexual partner of childbearing potential and should practice an effective method of birth control.

Receiving EFV-containing antiretroviral regimen for at least the last 48 weeks prior to study entry. Backbone NRTI regimens can include tenofovir, abacavir, emtricitabine, and/ or lamivudine. Backbone NRTI regimens cannot include zidovudine, stavudine, or didanosine. Breaks in therapy for a maximum of 5 consecutive days will be allowed during these 48 weeks, including the period immediately preceding study entry.
Patient willing and able to stop aspirin/ NSAIDS for 7 days before study entry and the scheduled skin biopsy procedures.
HIV-1 RNA < 400 copies/mL for at least 90 days prior to study entry.

Laboratory values obtained within 60 days prior to study entry:

Absolute neutrophil count (ANC) ≥ 500 / mm3
Hemoglobin ≥ 9.0 g/dL
Platelet count ≥ 75,000/ mm3
Creatinine clearance > 50 mL / min
PT/PTT < 1.2 ULN

Exclusion Criteria:

Receipt of AZT, d4T, ddI, or ddC at study entry or within 24 weeks of entry
Life expectancy < 12 months
Women who are pregnant or breastfeeding
WOCBP unwilling to use contraception WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period
Women with a positive pregnancy test.
Sexually active fertile men not using effective birth control if their partners are WOCBP.

Other Exclusion Criteria

Prisoners or subjects who are involuntarily incarcerated.
Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.
Clinically important illness within 14 days prior to study entry
Inability to communicate effectively with the study personnel.
Bleeding diathesis
Supplementation with recombinant growth hormone, growth hormone releasing factor, anabolic steroids, estrogen or testosterone, unless it is for replacement purposes.
Have no plans to alter any vitamin supplementation that subjects are receiving at study entry. This includes all vitamin supplementation, coenzyme Q, N acetyl cysteine, L-acetyl carnitine, and uridine.","Serving as the Control Arm - patients will maintain EFV-containing antiretroviral regimen

Efavirenz: Maintain dosage - 600 mg orally QHS for 96 weeks",ChEMBL:CHEMBL223228 | DrugBank:DB00625 | PubChem:64139,Efavirenz,O=C1Nc2ccc(Cl)cc2[C@@](C#CC2CC2)(C(F)(F)F)O1,J05AG03 | J05AR06 | J05AR11,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01195922,NCT01195922_EG000,No,All,Adult | Older Adult,Phase 1 | Phase 2,16,"ELIGIBILITY CRITERIA:

Males and females and members of any race or ethnic group who meet the eligibility criteria may participate in this trial.

INCLUSION CRITERIA:

Participants must meet all of the following inclusion criteria:

Age 18 years and older
Histologically confirmed previously untreated squamous cell carcinoma o f the oral cavity or oropharynx accessible for biopsy
Clinical stage II, III, or IVA disease without distant metastasis, as defined by the American Joint Committee on Cancer Staging System, Seventh edition.
Definitive therapy to include surgical resection or chemoradiation for curative purposes
Life expectancy o f greater than 6 months
Eastern Cooperative Oncology Group ( ECOG) performance status of 0 or 1
Willing and able to provide written informed consent

EXCLUSION CRITERIA:

Participants who meet any of the following criteria are not eligible for enrollment:

Surgical resection or chemoradiation of the HNSCC is contraindicated
Prior head or neck squamous cell carcinoma within 5 years, except for previously treated skin cancer
Received chemotherapy targeted monoclonal antibody therapy or investigational therapy within 30 days prior to enrollment
Previous radiation therapy to the head or neck
No measurable tumor remaining after prior biopsy or negative margins from prior biopsy

Inadequate hematologic, renal or liver function within l4 days prior to the first rapamycin dosing visit, as defined by:

Absolute neutrophil count less than 1.5 times 10 (9)/L
CD4 count < 400 (to account for natural fluctuations in CD4 levels, participants with at least one CD4 count (Bullet) 400 within 14 days prior to dosing will not be excluded)
Platelet count less than 100 times 10(9)/L
Hemoglobin less than l0 g/dL (eligibility level for hemoglobin may be reached by transfusion)
AST, ALT or bilirubin greater than 1.5 times the upper limit of local lab normal values
Total cholesterol level greater than 350 mg/dL
Triglyceride level greater than 400 mg/dL
International Normalized Ratio (INR) greater than 1.5
Serum creatinine greater than 1.5mg/dL
Active hepatitis or HBV or HCV infection
Women who are pregnant or lactating (female of child-bearing age must be abstinent or use a barrier type birth control method throughout the study)
Presence of any contraindications to rapamycin therapy, including HlV-protease inhibitors and drugs or agents that are modulators of cytochrome P-450 3A4 (CYP3A4) and p-glycoprotein(P-gp)
Hypersensitivity to rapamycin

11 .Has received live vaccine (such as influenza nasal vaccine measles mumps, rubella, oral polio, B CG, yellow fever, varicella, or TY2la typhoid) in the past 30 days or has plans to take a live vaccine in the next 3 months

12. Any cognitive impairment that limits the subject s or the subject s legally authorized representative s ability to understand the protocol, provide informed consent or assent, or to comply with the protocol procedures

13.Unable or unwilling to comply with the requirements of the protocol","Rapamycin (sirolimus), which will be dispensed as either tablets or an oral solution for patients with dysphagia (see Section 0), will be administered orally as a single loading dose of 15 mg on the first day and 5 mg once a day for the next 20 days. Serum rapamycin levels will be obtained on Days 8, 15, 22, and 28 (if rapamycin is > 3 ng/ml at Day 28, the subject will return daily, or as is convenient, for testing until rapamycin is ≤ 3 ng/ml). Dose reduction to 3 mg by mouth once per day will occur if trough levels of rapamycin > 20 ng/ml occur on Days 8 or 15 (see Appendix A, Study Calendar for visit windows). If a dose is decreased at Day 8, it will not be increased at Day 15 regardless of serum rapamycin levels. If subjects receiving 3 mg have levels > 20 ng/ml at Day 15, rapamycin will be reduced to 2 mg once per day. Rapamycin will cease on Day 21 regardless of level.",ChEMBL:CHEMBL413 | DrugBank:DB00877 | PubChem:134760597 | PubChem:138404388 | PubChem:21944094 | PubChem:5284616,Sirolimus,COC1CC2CCC(C)C(O)(O2)C(=O)C(=O)N2CCCCC2C(=O)OC(C(C)CC2CCC(O)C(OC)C2)CC(=O)C(C)C=C(C)C(O)C(OC)C(=O)C(C)CC(C)C=CC=CC=C1C,L01EG04 | L04AA10 | S01XA23,1.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,1.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT01198145,NCT01198145_EG000,No,All,Adult | Older Adult,Phase 3,43,"DISEASE CHARACTERISTICS:

Diagnosis of cancer that supports the use of radiotherapy to the pelvis
No current or prior metastases beyond pelvic regional lymph nodes
Planning to receive a course of continuous definitive or adjuvant external-beam radiotherapy to a minimum dose of 4500 cGy with or without fluorouracil, capecitabine, or oxaliplatin

Planned course of pelvic radiotherapy must fall within the following parameters:

Pelvis must be encompassed by the planned radiotherapy fields

Superior border may not lie superior to the L4-5 interspace and may not be inferior to the most inferior aspect of the sacroiliac joints
Portions of the rectum may have special blocking, depending upon disease site

Total planned dose to the central axis midplane (for AP-PA parallel opposed fields) or isocenter (for 3- or 4-field techniques) for the pelvic field must lie between 4500-5300 cGy (inclusive)*

Subsequent to completion of treatment to the pelvic field, a boost to primary tumor or tumor bed may be planned

Planned treatment is to be given 4-5 times per week on a one-treatment-per-day basis

Daily dose (specified at central axis midplane or at isocenter for multi-field techniques) must lie between 170-210 cGy (inclusive) per day*
NOTE: *For institutions that do not use midplane or isocenter as the point for specification of dose, it will be necessary to determine the dose according to the methods specified above in order to determine patient eligibility.
No perineal irradiation planned (e.g., anal cancer patients, patients who have had an abdominal-perineal resection)
No brachytherapy planned before the completion of all external-beam radiotherapy
No planned split-course radiotherapy

PATIENT CHARACTERISTICS:

ECOG performance status 0-2
Life expectancy ≥ 6 months
Hemoglobin ≥ 10.0 g/dL
Leukocytes ≥ 3,500/mm^3
ANC ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3
Creatinine ≤ 1.5 times upper limit of normal (ULN)
AST ≤ 1.5 times ULN
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
Willing to provide blood specimens as required by the study (Mayo Clinic Rochester patients only)
Able to complete questionnaires alone or with assistance
No history of inflammatory bowel disease
No history of gastrointestinal or genitourinary obstruction or porphyria
No history of G6PD deficiency
No history of irritable bowel syndrome
No history of blood dyscrasia
No history of severe allergies or asthma
No history of hepatic or renal disease
No diarrhea ≥ grade 3, rectal bleeding, abdominal cramping, or incontinence of stool within the past week
No medical condition that may interfere with the ability to receive study treatment
No known allergy to sulfasalazine, sulfa medications, salicylates, or any known component of drug formulation

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
No prior pelvic radiotherapy
No prior abdominal-perineal resection, Hartmann procedure, or other surgical procedure leaving the patient without a functioning rectum
No planned use of leucovorin or cytotoxic chemotherapeutic agents concurrent with radiotherapy (except for fluorouracil, capecitabine, or oxaliplatin)
No other concurrent sulfasalazine
No concurrent digoxin",Patients receive two 500 mg oral sulfasalazine tablets twice daily during radiotherapy and for 4 weeks after completion of radiotherapy.,ChEMBL:CHEMBL421 | DrugBank:DB00795 | PubChem:5339,Sulfasalazine,O=C(O)c1cc(/N=N/c2ccc(S(=O)(=O)Nc3ccccn3)cc2)ccc1O,A07EC01 | G01AE10,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01198587,NCT01198587_EG000,No,All,Child,Not Applicable,23,"Inclusion Criteria:

Healthy Children with non-bloody diarrhea illness defined as loose or watery stools
Symptoms must be present for greater than 24 hours but less than 72 hours.
Comorbid conditions including; Asthma, Gastroesophageal reflux (unless followed by a Gastroenterologist), Mild speech, language, motor delays, Benign heart murmurs, Isolated atrial septal defect (ASD) or ventricular septal defect (VSD), Epilepsy (unless developmentally delayed), Children born Prematurely between 33-37 weeks without long term sequelae, Repaired tetralogy of fallot (no cardiac issues for >6 months), Diabetes may be enrolled in the study.

Exclusion Criteria:

Children with symptoms less than 24 hours
Children with symptoms greater than 24 hours
Failure to thrive
G or J tube
Major surgery within last 3 months
Minor surgery (tonsillectomy, ear tubes, skin lesion removals etc) within last 1 month
Followed by GI service for any reason (crohns, ulcerative colitis, constipation)
Developmental delay, patient >1 year behind milestones
Current brain tumor
Currently being treated for cancer or in remission < 6 months
Intussuception
Antibiotics in the last 14 days or currently taking antibiotics for any reason
Autism
Children born premature <33 weeks
Cystic Fibrosis
Major congenital Heart Disease (any disease where child's baseline oxygen saturations <93%)
Short Gut
Liver disease
History of bowel resection","Outpatients with diarrhea will be randomized to zinc sulfate

Zinc Sulfate: For children ages 6month to 1 year, 12.5mg orally daily for 14 days mixed in 60 mL of fluid.

For children aged 1 year and above 25mg orally daily for 14 days mixed in 60 mL of fluid.",ChEMBL:CHEMBL1200929 | DrugBank:DB09322 | PubChem:24424,ZINC SULFATE,O=S(=O)([O-])[O-].[Zn+2],A12CB01 | B05XA18 | C05AX04,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01198587,NCT01198587_EG001,No,All,Child,Not Applicable,5,"Inclusion Criteria:

Healthy Children with non-bloody diarrhea illness defined as loose or watery stools
Symptoms must be present for greater than 24 hours but less than 72 hours.
Comorbid conditions including; Asthma, Gastroesophageal reflux (unless followed by a Gastroenterologist), Mild speech, language, motor delays, Benign heart murmurs, Isolated atrial septal defect (ASD) or ventricular septal defect (VSD), Epilepsy (unless developmentally delayed), Children born Prematurely between 33-37 weeks without long term sequelae, Repaired tetralogy of fallot (no cardiac issues for >6 months), Diabetes may be enrolled in the study.

Exclusion Criteria:

Children with symptoms less than 24 hours
Children with symptoms greater than 24 hours
Failure to thrive
G or J tube
Major surgery within last 3 months
Minor surgery (tonsillectomy, ear tubes, skin lesion removals etc) within last 1 month
Followed by GI service for any reason (crohns, ulcerative colitis, constipation)
Developmental delay, patient >1 year behind milestones
Current brain tumor
Currently being treated for cancer or in remission < 6 months
Intussuception
Antibiotics in the last 14 days or currently taking antibiotics for any reason
Autism
Children born premature <33 weeks
Cystic Fibrosis
Major congenital Heart Disease (any disease where child's baseline oxygen saturations <93%)
Short Gut
Liver disease
History of bowel resection","Patients admitted to the hospital with diarrhea and dehydration will be randomized to zinc sulfate

Zinc Sulfate: For children ages 6month to 1 year, 12.5mg orally daily for 14 days mixed in 60 mL of fluid.

For children aged 1 year and above 25mg orally daily for 14 days mixed in 60 mL of fluid.",ChEMBL:CHEMBL1200929 | DrugBank:DB09322 | PubChem:24424,ZINC SULFATE,O=S(=O)([O-])[O-].[Zn+2],A12CB01 | B05XA18 | C05AX04,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01199861,NCT01199861_EG000,No,All,Adult,Phase 3,95,"Inclusion Criteria:

Must have relapsing MS
Must have lifetime tetanus vaccination
Agree to receive 2010/2011 seasonal influenza vaccine and tetanus toxoid booster injection

Exclusion Criteria:

Patients with a type of MS that is not relapsing
Patients with history of chronic immune disease
Certain cancers
Diabetic patients with certain eye disorders
Patients who are on certain immunosuppressive medications or heart medications
Patients with certain heart conditions
Patients with certain lung conditions
Patients who have already received the 2010/2011 seasonal influenza vaccine

Other protocol-defined inclusion/exclusion criteria may apply",Participants received Fingolimod 0.5 mg capsules orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.,ChEMBL:CHEMBL314854 | DrugBank:DB08868 | PubChem:107970,Fingolimod,CCCCCCCCc1ccc(CCC(N)(CO)CO)cc1,L04AA27,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT01201356,NCT01201356_EG000,No,All,Adult | Older Adult,Phase 3,4083,"Key Inclusion Criteria:

- Patients who have completed selected ongoing or planned trials with FTY720.

Key Exclusion Criteria:

Premature permanent discontinuation of a previous fingolimod study.
Pregnant or nursing (lactating) women.
Women of child-bearing potential, UNLESS they are using two birth control methods, at least 1 of which must be hormonal contraception, tubal sterilization, partner's vasectomy or intrauterine device.
Chronic disease of the immune system, other than multiple sclerosis, which may require immunosuppressive treatment.
Diabetic patients with moderate or severe non-proliferative diabetic retinopathy or proliferative diabetic retinopathy and uncontrolled diabetic patients with HbA1c > 8%.
Active systemic bacterial, viral or fungal infections, or known to have AIDS, Hepatitis B, Hepatitis C infection or have positive HIV antibody, Hepatitis B surface antigen or Hepatitis C antibody tests.
Previous treatment with cladribine, cyclophosphamide or mitoxantrone.
Treatment with immunoglobulins and/or monoclonal antibodies (including Natalizumab) in the past 3 months during the previous fingolimod study:

Any of the following cardiovascular conditions that have developed during the previous fingolimod study:

Myocardial infarction within the past 6 months prior to entry in the extension study or with current unstable ischemic heart disease;
Cardiac failure (Class III, according to New York Heart Association Classification) or any severe cardiac disease as determined by the investigator;
Arrhythmia requiring current treatment with Class III antiarrhythmic drugs (e.g., amiodarone, bretylium, sotalol, ibutilide, azimilide, dofetilide)
History or presence of a third degree AV block
Proven history of sick sinus syndrome or sino-atrial heart block
Known history of angina pectoris due to coronary spasm or Raynaud's phenomenon

Any of the following pulmonary conditions during the previous fingolimod study:

Severe respiratory disease or pulmonary fibrosis diagnosed (during the previous fingolimod study)
Active tuberculosis
Alcohol abuse, chronic liver disease during the previous fingolimod study.

The patient must have participated in a previous fingolimod trial to be eligible to participate in this trial.","Open-label fingolimod 0.5 mg, taken orally once daily",ChEMBL:CHEMBL314854 | DrugBank:DB08868 | PubChem:107970,Fingolimod,CCCCCCCCc1ccc(CCC(N)(CO)CO)cc1,L04AA27,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT01201798,NCT01201798_EG000,No,All,Child | Adult | Older Adult,Phase 3,56,"Inclusion Criteria:

Diagnosis of endogenous anterior uveitis in at least 1 eye.
The presence of > 10 cells in the anterior chamber of at least one eye, and a flare score of > 2 in that same eye.
Age 2 years or older on day of consent.
Negative urine pregnancy test on Day 0 for females of childbearing potential who are not at least 1 year post-menopausal or surgically sterilized.
Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

Presence of endogenous anterior uveitis diagnosed for > 2 weeks prior to enrollment in the study.
Presence of intermediate uveitis, posterior uveitis or panuveitis in either eye.
Instillation of any topical corticosteroid or NSAID in the study eye within 7 days of instillation of study drug.
History of glaucoma or clinically significant ocular hypertension in the opinion of the Investigator involving an IOP ≥ 21 millimeters mercury in either eye.
History of steroid-induced elevation of intraocular pressure.
Any confirmed or suspected active viral, bacterial or fungal keratoconjunctival disease in either eye.
History of glaucoma or clinically significant ocular hypertension in the opinion of the Investigator involving an intraocular pressure (IOP) > 21 mmHg in either eye.
Corneal abrasion or ulceration in either eye.
Pregnancy or lactation.
Other protocol-defined exclusion criteria may apply.","Difluprednate 0.05% ophthalmic emulsion, 1 drop in study eye, 4 times a day for 14 days, followed by a 14-day tapering period",ChEMBL:CHEMBL1201749 | DrugBank:DB06781 | PubChem:443936,Difluprednate,[H][C@@]12CC[C@](OC(=O)CCC)(C(=O)COC(C)=O)[C@@]1(C)C[C@H](O)[C@@]1(F)[C@@]2([H])C[C@H](F)C2=CC(=O)C=C[C@@]21C,D07AC19,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01202188,NCT01202188_EG002,No,All,Adult | Older Adult,Phase 3,473,"Inclusion Criteria:

Male or female adults aged ≥40 yrs
Smoking history of at least 10 pack years
Diagnosis of COPD (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2008)
Post-bronchodilator FEV1 < 80% and ≥ 30% of the predicted normal value and post-bronchodilator FEV1/FVC (forced vital capacity) <70%

Exclusion Criteria:

Patients who have had a respiratory tract infection within 4 weeks prior to Visit 1
Patients with concomitant pulmonary disease
Patients with a history of asthma
Any patient with lung cancer or a history of lung cancer
Patients with a history of certain cardiovascular co-morbid conditions
Patients with a known history and diagnosis of alpha-1 antitrypsin deficiency
Patients in the active phase of a supervised pulmonary rehabilitation program
Patients contraindicated for inhaled anticholinergic agents and β2 agonists
Other protocol-defined inclusion/exclusion criteria may apply",NVA237 50 μg capsules for inhalation delivered once daily via a single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.,ChEMBL:CHEMBL1201335 | DrugBank:DB00986 | PubChem:3494,GLYCOPYRRONIUM,C[N+]1(C)CCC(OC(=O)C(O)(c2ccccc2)C2CCCC2)C1,A03AB02 | A03CA05 | D11AA01 | R03AL04 | R03AL07 | R03AL09 | R03AL11 | R03AL12 | R03BB06,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT01203878,NCT01203878_EG001,No,All,Adult | Older Adult,Phase 4,9,"Inclusion Criteria:

Male and female adults; 18 and over
At least 10 and no more than 30 clinically typical actinic keratoses on the face

Exclusion Criteria:

Hypertrophic actinic keratoses or other skin lesions on the head that might required excluded treatment during the study
Known contraindication to treatment with imiquimod or photodynamic therapy
Condition that would limit compliance, be a potential safety risk, or require therapy with an excluded treatment
Systemically immunocompromised
Pregnant or nursing
Dermatologic disease and/or condition in treatment area that might exacerbated by treatment with imiquimod, cause difficulty with examination, or require therapy with an excluded treatment
Participation in another clinical study

Treatment within the past 60 days with:

Ultraviolet therapy
Systemic immunomodulators
Chemotherapeutic or cytotoxic agents
Investigational agents

Treatment on the head within the past 60 days with:

Imiquimod
Photodynamic therapy
Red or blue light source therapy
Cryotherapy or chemotherapy
Surgical excision or curettage
Topical corticosteroids
Laser
Dermabrasion
Chemical peel
Topical retinoids
Topical 5-fluorouracil
Topical pimecrolimus or tacrolimus
Topical diclofenac
Treatment for actinic keratoses on the head within the past 60 days","Imiquimod 3.75% applied to the entire face daily for 2 2-week cycles separated by a 2-week no treatment period, followed by observation",ChEMBL:CHEMBL1282 | DrugBank:DB00724 | PubChem:57469,Imiquimod,CC(C)Cn1cnc2c(N)nc3ccccc3c21,D06BB10,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT01204294,NCT01204294_EG005,No,All,Adult | Older Adult,Phase 3,63,"Inclusion criteria:

Diagnosis of type 2 diabetes mellitus
Male and female patients on diet and exercise regimen who are treated with one antidiabetic drug

Exclusion criteria:

Myocardial infarction, stroke, transient ischemic attack, or pulmonary embolism
Impaired hepatic function
Glitazone, glinide, and sulfonylurea group: renal failure or renal impairment defined as estimated glomerular filtration rate <30 ml/min (severe renal impairment) at Visit 1, Biguanide group: renal failure or renal impairment defined as estimated glomerular filtration rate <60 ml/min (moderate renal impairment) at Visit 1
Treatment with anti-obesity drugs",sulfonylurea plus metformin,ChEMBL:CHEMBL1431 | DrugBank:DB00331 | PubChem:4091,Metformin,CN(C)C(=N)NC(=N)N,A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT01204294,NCT01204294_EG006,No,All,Adult | Older Adult,Phase 3,61,"Inclusion criteria:

Diagnosis of type 2 diabetes mellitus
Male and female patients on diet and exercise regimen who are treated with one antidiabetic drug

Exclusion criteria:

Myocardial infarction, stroke, transient ischemic attack, or pulmonary embolism
Impaired hepatic function
Glitazone, glinide, and sulfonylurea group: renal failure or renal impairment defined as estimated glomerular filtration rate <30 ml/min (severe renal impairment) at Visit 1, Biguanide group: renal failure or renal impairment defined as estimated glomerular filtration rate <60 ml/min (moderate renal impairment) at Visit 1
Treatment with anti-obesity drugs",alpha-glucosidase inhibitor plus metformin,ChEMBL:CHEMBL1431 | DrugBank:DB00331 | PubChem:4091,Metformin,CN(C)C(=N)NC(=N)N,A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT01210443,NCT01210443_EG000,No,All,Child | Adult | Older Adult,Phase 3,2,"Inclusion Criteria:

Subject who completed the B1321052 study as planned.

Exclusion Criteria:

Has uncontrolled systemic hypertension as evidenced by sitting systolic blood pressure >160 mm Hg or sitting diastolic blood pressure >100 mm Hg at Screening.
Has hypotension defined as systolic arterial pressure <90 mm Hg after sitting for 5 minutes at Screening.",All participants received one 100 mg film-coated tablet of sitaxentan daily. The intended treatment period was until sitaxentan was launched in Japan. Participants could receive additional PAH-specific drug treatment (beraprost or sildenafil) at the discretion of the investigator.,ChEMBL:CHEMBL282724 | DrugBank:DB06268 | PubChem:216235,Sitaxentan,Cc1cc2c(cc1CC(=O)c1sccc1S(=O)(=O)Nc1onc(C)c1Cl)OCO2,C02KX03,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01211522,NCT01211522_EG000,No,All,Adult | Older Adult,Phase 3,192,"Inclusion Criteria:

adult patients (≥18 years old)
in a medical and/or surgical ICU
on mechanical ventilation or non-invasive positive pressure ventilation (NIPPV), and/or requiring vasopressors due to shock
delirious (according to the CAM-ICU)

Exclusion Criteria:

Rapidly resolving organ failure criteria, indicated by planned immediate discontinuation of mechanical ventilation, NIPPV, and/or vasopressors at the time of screening for study enrollment
Pregnancy or breastfeeding (negative pregnancy test required prior to enrollment of female patients of childbearing age)
Severe dementia or neurodegenerative disease, defined as either impairment that prevents the patient from living independently at baseline or IQCODE >4.5, measured using a patient's qualified surrogate, mental illness requiring long-term institutionalization, acquired or congenital mental retardation, Parkinson's disease, Huntington's disease, and/or coma or another severe deficit due to structural brain disease such as stroke, intracranial hemorrhage, cranial trauma, intracranial malignancy, anoxic brain injury, or cerebral edema.
History of torsades de pointes, documented baseline QT prolongation (congenital long QT syndrome), or QTc >500 ms at screening due to refractory electrolyte abnormalities, other drugs, or thyroid disease
Ongoing maintenance therapy with typical or atypical antipsychotics
History of neuroleptic malignant syndrome (NMS), haloperidol allergy, or ziprasidone allergy
Expected death within 24 hours of enrollment or lack of commitment to aggressive treatment by family or the medical team (e.g., likely withdrawal of life support measures within 24 hours of screening)
Inability to obtain informed consent from an authorized representative within 72 hours of meeting all inclusion criteria, i.e., developing qualifying organ dysfunction criteria.","Haloperidol

Haloperidol: Haloperidol, up to 10mg q12 hours, will be administered intravenously (IV) by bolus over up to 5 minutes at concentrations of 5mg/mL. Patient will only receive IV while in the ICU.",ChEMBL:CHEMBL54 | DrugBank:DB00502 | PubChem:3559,Haloperidol,O=C(CCCN1CCC(O)(c2ccc(Cl)cc2)CC1)c1ccc(F)cc1,N05AD01,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01216072,NCT01216072_EG000,No,All,Adult | Older Adult,Phase 4,783,"Inclusion Criteria:

Relapsing forms of MS
Expanded Disability Status Scale (EDSS) 0-5.5
Continuous treatment with MS DMT for a minimum of 6 months
Fingolimod naive

Exclusion Criteria:

Immune system diseases other than MS
Active macular edema
History of selected prior infections and criteria for immunizations
History of selected immune system treatments and/or medications
Selected cardiovascular, pulmonary, or hepatic conditions
Selected abnormal laboratory values
Pregnant or nursing women

Other protocol-defined inclusion/exclusion criteria applied",Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.,ChEMBL:CHEMBL314854 | DrugBank:DB08868 | PubChem:107970,Fingolimod,CCCCCCCCc1ccc(CCC(N)(CO)CO)cc1,L04AA27,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT01217229,NCT01217229_EG000,No,All,Adult | Older Adult,Phase 2,20,"Inclusion Criteria:

Male or female patients ≥18 years old
Pathologic confirmation of relapsed or refractory classical Hodgkin lymphoma, with archival or fresh tissue available for retrospective analysis.
Patients must have progressed after-or been ineligible for-autologous stem cell transplantation. Patients who received a prior allogeneic stem cell transplantation are eligible if they have no evidence of graft versus host disease (GVHD) and have been off immunosuppression for at least 3 months prior to Cycle 1 Day 1 (C1D1).
Documented disease that is radiographically measurable (≥2 cm in the largest transverse dimension).
Patients must have discontinued any previous monoclonal antibody, radioimmunotherapy, or cytotoxic chemotherapy at least 28 days prior to C1D1 and must have recovered fully from the side effects of that treatment prior to beginning study treatment.
Women of child-bearing potential must have a negative pregnancy test within 7 days of initiation of dosing and must agree to use an acceptable method of birth control while on study drug and for 3 months after the last dose. Women of non-childbearing potential may be included if they are either surgically sterile or have been postmenopausal for ≥1 year. Men of child-bearing potential must also agree to use an acceptable method of birth control while on study drug.
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Adequate hematologic, hepatic, and renal function (absolute neutrophil count ≥1.0 x 109/L, Hgb >9 g/dL, platelet count ≥50 x 109/L, Aspartate Transaminase (AST) / Alanine Transaminase (ALT) ≤2.5x Upper limit of normal (ULN), creatinine ≤1.5x ULN)
Willing and able to provide written informed consent prior to any study related procedures and to comply with all study requirements

Exclusion Criteria:

Investigational drug use within 28 days of the first dose of PLX3397
History or clinical evidence of central nervous system, meningeal, or epidural disease including brain metastasis
Patients with another active cancer [excluding basal cell carcinoma or cervical intraepithelial neoplasia (cervical carcinoma in situ) or melanoma in situ]. Prior history of other cancer is allowed, as long as there was no active disease within the prior 5 years.
Patients with uncontrolled intercurrent illness, an active or uncontrolled infection, or a fever >38.5˚C (not due to tumor fever) on C1D1
Refractory nausea and vomiting, malabsorption, biliary shunt, or significant bowel resection that would preclude adequate absorption
Patients with serious illnesses, medical conditions, or other medical history including abnormal laboratory results, which in the investigator's opinion would be likely to interfere with a patient's participation in the study, or with the interpretation of the results
Women of child-bearing potential who are pregnant or breast feeding
Corrected QT interval (QTc) ≥450 msec.",Participants received PLX3397 administered once or twice daily with continuous dosing at 900 mg/day.,ChEMBL:CHEMBL3813873 | DrugBank:DB12978 | PubChem:25151352,Pexidartinib,FC(F)(F)c1ccc(CNc2ccc(Cc3c[nH]c4ncc(Cl)cc34)cn2)cn1,L01EX15,1.0,0.0,0.0,1.0,0.0,1.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,1.0,1.0,1.0,1.0,0.0,1.0,0.0,1.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT01217307,NCT01217307_EG000,No,All,Adult | Older Adult,Phase 2 | Phase 3,191,"Inclusion Criteria:

The diagnosis acute MI defined by chest pain suggestive for myocardial ischemia for at least 30 minutes, the time from onset of the symptoms less than 12 hours before hospital admission, and an ECG recording with ST- segment elevation of more than 0.1 mV in 2 or more leads.
Successful primary PCI (post-procedural TIMI 2/3);
At least one stent sized ≥ 3.0 mm;
Eligible for 3T CMR imaging;
Verbal followed by written informed consent.

Exclusion Criteria:

rescue PCI after thrombolytic therapy;
need for emergency coronary artery bypass grafting;
creatinin >177 μmol/L measured pre-PCI;
Younger than 18 years;
Mechanical ventilation;
Diabetes;
Prior myocardial infarction;
Contra-indication to metformin (see safety);
The existence of a life-threatening disease with a life-expectancy of less than 6 months.","metformin 500mg twice daily during 4 months

Metformin: Metformin 500mg twice daily during 4 months",ChEMBL:CHEMBL1431 | DrugBank:DB00331 | PubChem:4091,Metformin,CN(C)C(=N)NC(=N)N,A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01217606,NCT01217606_EG001,No,All,Adult | Older Adult,Phase 3,95,"Inclusion Criteria:

Ocular hypertension or primary open-angle glaucoma in each eye
Requires treatment with IOP-lowering medication in both eyes

Exclusion Criteria:

Required chronic use of ocular medications during the study other than study medication
Use of any corticosteroids within 30 days
History of any traumatic eye surgeries
Cataract surgery in the past 6 months
Anticipated wearing of contact lenses during the study","Fixed Combination brimonidine tartrate/timolol ophthalmic solution (Combigan®). One drop of Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution administered to each eye, twice daily for up to 12 months.",PubChem:11387895,Combigan,Brc1c(NC2=NCCN2)ccc2nccnc12.CC(C)(C)NCC(O)COc1nsnc1N1CCOCC1,,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01218477,NCT01218477_EG000,No,All,Adult | Older Adult,Phase 1 | Phase 2,3,"Key Inclusion Criteria

Age ≥18 years
Diagnosis of chronic myeloid leukemia (CML) and cytogenetic positive for the Philadelphia chromosome (Ph+), documented Ph+ cells on bone marrow assessment (BMA) ≤6 weeks prior to treatment
Either chronic-phase CML, with <15% blasts in peripheral blood and bone marrow, or advanced-phase CML, including Ph+ acute lymphoblastic leukemia (ALL) (> 5% blasts) or hematologic progression with ≥15% blasts not in complete cytogenetic remission
Resistance or suboptimal response to imatinib, dasatinib, or nilotinib and no known T315I/A Abl-kinase mutation.

Key Exclusion Criteria

Known Abl-kinase T315I or T315A mutation
CCyR at baseline
Any serious or uncontrolled medical disorder or active infection that would impair the ability of the subject to receive protocol therapy
Uncontrolled or significant cardiovascular disease
Grade 3 or higher peripheral blood counts
Serum calcium or phosphate below the lower limit of normal
Baseline hypomagnesemia and amylase or lipase at least Grade 1 or higher
Reduced renal function, defined as serum creatinine level >3*upper limit of normal

Prior therapies for CML or Ph+ ALL permitted, with the following restriction:

Therapy permitted with corticosteroids, hydroxyurea, or anagrelide prior to starting treatment and during the first 4 weeks on study
6 months or longer after stem cell transplantation
28 days or longer after any investigational agent
7 days or longer after any standard chemotherapy agent
Concomitant use of medications with a known risk of causing Torsades de Pointes
Concomitant use of strong inhibitors of the CYP3A4 isoenzyme","Participants received dasatinib, 100/140 mg once daily (QD) (100 mg for those with CML-chronic phase; 140 mg for those with CML-advanced phase)",ChEMBL:CHEMBL1421 | DrugBank:DB01254 | PubChem:3062316,Dasatinib,Cc1nc(Nc2ncc(C(=O)Nc3c(C)cccc3Cl)s2)cc(N2CCN(CCO)CC2)n1,L01EA02 | L01XE06,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01227993,NCT01227993_EG000,No,All,Adult | Older Adult,Phase 1 | Phase 2,3,"INCLUSION CRITERIA:

Participant previously participated in NCT00837252 (NIH protocol 09-EI-0075), Pilot Study for the Evaluation of Finasteride in the Treatment of Chronic Central Serous Chorioretinopathy, and demonstrated clinical improvement, as indicated by a reduction in subretinal fluid as measured on OCT.

Participant has subretinal fluid present in the macula that has a volume of at least 0.1 microliter causing visual change (such as reduced acuity, metamorphopsia or microperimetry deficits) and warrants treatment.

Participant must understand and sign the protocol's informed consent document.

Participant agrees to take the appropriate precautions to ensure that persons who are pregnant, nursing or of childbearing potential do not handle the finasteride tablets. [All of the NCT00837252 (NIH protocol 09-EI-0075) participants were male given the male predilection of this disease.]

EXCLUSION CRITERIA:

Participant has abnormal liver function testing (LFT) as defined by elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels that are greater than twice the respective upper limits of normal (ULN) (i.e., ALT greater than 82 U/L and/or AST greater than 68 U/L). If a participant has ALT or AST levels greater than twice the ULN, the participant can be enrolled only if cleared by hepatology.

Participant is on steroid medication (oral, topical or inhaled).","Participants are treated with 5 mg oral finasteride daily when they have clinically significant subretinal fluid accumulation, defined as any subretinal fluid in the macula with a volume of at least 0.1 microliter and causing visual change such as reduced acuity, metamorphopsia, or microperimetry deficits.",ChEMBL:CHEMBL710 | DrugBank:DB01216 | PubChem:57363,Finasteride,[H][C@@]12CC[C@@]3([H])NC(=O)C=C[C@]3(C)[C@@]1([H])CC[C@]1(C)[C@@H](C(=O)NC(C)(C)C)CC[C@@]21[H],D11AX10 | G04CA51 | G04CA55 | G04CB01 | G04CB51,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01229735,NCT01229735_EG001,No,All,Child | Adult | Older Adult,Phase 4,166,"Inclusion Criteria:

Male or female subjects from 16 to 80 years, inclusive. Subjects under 20 years may only be included where legally permitted and ethically accepted
Subjects with refractory epilepsy with partial onset seizure classifiable according to the International League Against Epilepsy (ILAE).
Subjects having at least 2 partial onset seizures whether or not secondarily generalized during the 8 weeks historical baseline preceding V1 according to ILAE classification
Subjects having at least 1 partial onset seizures whether or not secondarily generalized per 4 weeks preceding V2 according to ILAE classification
Subjects with each interval of partial onset seizures less than 6 weeks during entire 12 weeks (8 weeks preceding V1 and 4 weeks preceding V2)
Subjects being uncontrolled while treated by 1 to 3 permitted concomitant AEDs.
Permitted concomitant AEDs having been stable and at optimal dosage for the subject from at least 4 week before V1 and during 4 weeks preceding V2 and expected to be kept stable during the Treatment Period.

Exclusion Criteria:

Subjects presenting any generalized epilepsies classified as type II according to the ILAE classification (ref to publication from 1981)
Subjects suffering from epilepsies and syndromes undetermined whether focal or generalized (classification III according to the ILAE classification)
Subjects suffering from special syndromes (classification IV according to the ILAE classification)
History or occurring only in clusters (too frequently or indistinctly separated to be reliably counted) before V2.
Presence of exclusively type IA non-motor seizures.
History or presence of status epilepticus within last 3 months preceding V1 or during Baseline
History or presence of known pseudo-seizures
Subjects who are currently on vigabatrin. (Subjects who received vigabatrin in the past and have a normal visual field test are allowed.)
Subject taking 1 or more of the following medications on a regular basis within 28 days prior to Visit 1: antipsychotics drugs, and psychostimulant (amphetamine derivatives)",25 mg and 100 mg topiramate tablet; titration from 100 mg/day (50 mg bid) to 400 mg/day (200 mg bid) topiramate with treatment duration up to 52 weeks,ChEMBL:CHEMBL220492 | DrugBank:DB00273 | PubChem:5284627,Topiramate,[H][C@@]12OC(C)(C)O[C@]1([H])CO[C@@]1(COS(N)(=O)=O)OC(C)(C)O[C@]12[H],A08AA51 | N03AX11,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01232920,NCT01232920_EG000,No,All,Child | Adult | Older Adult,Phase 3,41,"Inclusion Criteria:

Non-infectious anterior, intermediate, posterior or panuveitis
Active uveitis within the last 60 days (defined by the presence of any of the following according to SUN criteria: ≥ 1+ anterior chamber cells, anterior vitreous cells, vitreous haze, active retinal or choroidal lesions)
Prednisone dose ≥ 15 mg/day
History of corticosteroid taper failure (inability to taper to prednisone 10 mg or less) or obvious chronic disease necessitating corticosteroid-sparing immunosuppressive treatment

Exclusion Criteria:

Any infectious cause of uveitis
Tuberculosis: Evidence of active TB (PPD and CXR required - latent TB patients are still eligible)
Positive for Hepatitis: HBsAg and/or Hep C antibody
Positive for Syphilis: RPR/VDRL and/or FTA-ABS
Abnormal CBC (<2500 WBC or <75,000 Plts or <10 Hgb)
Abnormal liver and/or kidney tests (ALT/AST >2x normal or CR>1.5)
Pregnancy or breast-feeding (blood or urine pregnancy test for all females, excluding those who are post-menopausal)
Chronic hypotony (IOP < 5 mm Hg for > 3 months)
Prior use of any immunosuppressive drug for the treatment of uveitis in the past 6 months
Prior failed treatment with methotrexate or mycophenolate mofetil
Periocular or intravitreal corticosteroid injection in the past 3 months
Fluocinolone acetonide implant surgery in either eye in < 3 years
Intraocular surgery in < 30 days, or any ocular surgery scheduled during the 6-month study period
VA of hand motions or worse in better eye
< 16 years of age at enrollment","Methotrexate: All methotrexate doses will be taken orally once per week in a divided dose (half in the morning, half in the evening), and should be taken with food. For the first two weeks, a loading dose of 15 mg/week orally will be administered to assess tolerability. After two weeks, the dose will be ramped up to 25 mg/week until the end of follow-up or until treatment failure due to intolerability, adverse events, or of lack of efficacy. If the study ophthalmologist decides to reduce the study treatment dose due to intolerability, the dose will be reduced to 20 mg per week while maintaining masking. If side effects persist and the study ophthalmologist wishes to reduce the dose a second time, the dose will be reduced to 15 mg per week.",ChEMBL:CHEMBL34259 | DrugBank:DB00563 | PubChem:126941,Methotrexate,CN(Cc1cnc2nc(N)nc(N)c2n1)c1ccc(C(=O)N[C@@H](CCC(=O)O)C(=O)O)cc1,L01BA01 | L04AX03,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01236378,NCT01236378_EG000,No,All,Adult | Older Adult,Phase 1,24,"Inclusion Criteria:

Male or female, above 18 years of age and Body Mass Index (BMI) of 18.0 to 25.0 kg/m2, inclusive;
Subjects must have received a primary or secondary renal allograft for at least 2 months prior to Screening;
Subjects must be currently taking Rapamune tablets for prophylaxis of renal rejection. The dosages of any medications must be stable for at least 2 weeks prior to screening and continue with no change until completion of the last PK sample collection.

Exclusion Criteria:

Acute rejection or vascular rejection episode in the 4 weeks prior to Screening; or patients dependent on dialysis; or inadequate renal function (in the opinion of the investigator);
Recipients of multiple organ transplants (i.e., prior or concurrent transplantation of any organs other than renal transplant);
Current use of strong inducers or inhibitors of CYP3A4 within 2 weeks prior to collection of the first PK sample and until collection of the final PK sample;
Any clinically significant medical or psychiatric condition or laboratory abnormality, in the judgment of the investigator.","Sirolimus, 1 mg tablet formulation; total daily dosage could have varied from participant to participant, dosage must have been stable for at least 2 weeks prior to screening and continued with no change until completion of the last PK sample collection.",ChEMBL:CHEMBL413 | DrugBank:DB00877 | PubChem:134760597 | PubChem:138404388 | PubChem:21944094 | PubChem:5284616,Sirolimus,COC1CC2CCC(C)C(O)(O2)C(=O)C(=O)N2CCCCC2C(=O)OC(C(C)CC2CCC(O)C(OC)C2)CC(=O)C(C)C=C(C)C(O)C(OC)C(=O)C(C)CC(C)C=CC=CC=C1C,L01EG04 | L04AA10 | S01XA23,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01237353,NCT01237353_EG000,Accepts Healthy Volunteers,All,Adult,Not Applicable,6,"Inclusion Criteria:

Healthy adult with no active medical problems or significant chronic diseases as determined by the study doctor based on history, physical exam;
BMI between 18.5 - 35 kg/m2;
Taking no medications 2 weeks before and during the study enrollment, including drugs of abuse, prescription or OTC medications (except acetaminophen);
Subjects must be able to maintain adequate birth control during the study independent of hormonal contraceptive use;
Be able to provide written informed consent and comply with requirements of the study;
Avoid eating grapefruit and drinking grapefruit juice from 7 days before the first study day until completion of the entire study;
Abstinence from alcoholic beverages, caffeinated beverages and orange juice from 6pm the night before a study day until completion of that study day;
Fast from food and beverages at least 8 hours prior to the study day;
Be able to read, speak and understand English

Exclusion Criteria:

Subjects with a history of gastrointestinal disease including gastroesophageal reflux disease, gastritis, peptic ulcer disease or dyspepsia.
Subjects with a fasting gastric pH of > 4 (i.e. hypochlorhydria)
Subjects with history of dysphagia, achalasia, or difficulty swallowing capsules, tablets or pills.
Subjects on prescription or chronic over-the counter medications (including hormonal contraceptives);
Subjects with known allergy to study interventions;
Subjects who smoke tobacco;
Subjects with ongoing alcohol or illegal drug use;
Subjects who are pregnant, lactating or attempting to conceive;
Subjects unable to maintain adequate birth control during the study;
Subjects unable to follow protocol instructions or protocol criteria.","betaine hydrochloride : betaine hydrochloride 1500mg po x 1 on day 5

Rabeprazole : rabeprazole po daily x 5 days",ChEMBL:CHEMBL1219 | DrugBank:DB01129 | PubChem:5029,Rabeprazole,COCCCOc1ccnc(CS(=O)c2nc3ccccc3[nH]2)c1C,A02BC04 | A02BC54 | A02BD12 | A02BD13 | M01AA05 | M02AA03,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01237899,NCT01237899_EG002,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 1,8,"Inclusion Criteria:

Are healthy men and women of non-childbearing potential as determined by medical history and physical examination.

Male subjects: Non-vasectomized male subjects must agree to use 2 medically accepted methods of contraception with all sexual partners during the study and for 90 days following the final dosing.
Female subjects: Female subjects must be of non-childbearing potential due to surgical sterilization (hysterectomy, bilateral oophorectomy or tubal ligation) or menopause. They should be a minimum of 12 months without a menstrual period. Peri-menopausal women who are 6 months without a menstrual period.
Have given written informed consent prior to any study-specific procedures.
Are reliable and willing to make themselves available for the duration of the study and are willing to follow site-specific study procedures.
Have a body mass index (BMI) of between 19 and 32.5 kilograms per square meter (kg/m^2).
Have clinical laboratory test results within the normal reference range for the population or study site, or test results with acceptable deviations that are judged by the Investigator not to be clinically significant.
Have venous access sufficient to allow blood sampling per the protocol.
Have serum potassium levels within the normal range.
Are nonsmokers or smokers of less than or equal to 10 cigarettes per day.

Exclusion Criteria:

Are currently enrolled in, or have discontinued, within 60 days inclusive, a clinical trial involving an investigational drug, device or an off-label use of an approved drug, or are concurrently enrolled in any other type of medical research judged to be scientifically or medically incompatible with this study. Subjects who meet any of these criteria may be enrolled in this study but they cannot be dosed until at least 60 days following the last day of the previous investigational trial.
Have previously completed or withdrawn from this study or any other study investigating LY2623091.
Have a history or presence of medical illness including but not limited to any cardiovascular, hepatic, respiratory, hematological, endocrine or neurological disease, or any clinically significant laboratory abnormality that is of a serious medical problem that would preclude study participation.
Have an abnormality in the 12-lead electrocardiogram (ECG), which increases the risks associated with participation in the study.
Are unwilling or unable to comply with the use of an electronic data capture system.
Show evidence of human immunodeficiency virus (HIV) and/or positive human HIV antibodies, hepatitis C and/or positive hepatitis C antibody or hepatitis B and/or positive hepatitis B surface antigen.

Use and/or intend to use any medication for a medical condition that is not compatible with Inclusion Criterion. For medications that may be used in ""healthy"" subjects (example given: preventative and/or naturopathic agents, temporary symptom-relieving medications, and so forth) the following constraints must be observed:

No use of vasoactive drugs (example given: diuretics, antihypertensive agents, phosphodiesterase inhibitors, erectile dysfunction medications, nasal decongestants, et cetera) or systemic glucocorticoids within 7 days of first dosing and/or anticipated use during the study.
No use of acetaminophen/paracetamol or non-steroidal anti-inflammatory drugs (NSAIDs) within 24 hours of first dosing and/or anticipated use during the study. Aspirin may not be used at doses greater than 100 milligrams per day (mg/day) within 7days of first dosing and/or anticipated use during the study.
No use of herbal or nutritional products within 7 days of first dosing and/or anticipated use during the study.
Have donated blood of more than 50 milliliters (mL) within the last 60 days.
Have an average weekly alcohol intake that exceeds 21 units per week and/or subjects unwilling to stop alcohol within 48 hours of study enrollment and for the duration of the study.
Have an abnormally high blood pressure (supine or standing) defined as diastolic blood pressure greater than 95 millimeters of mercury (mmHg) and /or systolic blood pressure greater than 150 mmHg, confirmed by at least 1 repeat measurement.
Have serum potassium greater than the upper limit of normal.
Regularly use known drugs of abuse or show positive findings for such use on urinary drug screening.
Consumption of natural licorice and/or natural licorice-containing products and/or grapefruit and/or grapefruit juice within 7 days of first dosing and/or anticipated consumption during the study.
Consumption of methylxanthine-containing beverages and/or foods (example: coffee, tea, caffeinated soft drinks, chocolate) within 4 days of first dosing and/or anticipated consumption during the study.
Are unwilling to abstain from salt-substitutes containing potassium for the duration of the study.",Daily by mouth for 7 days.,PubChem:42636651,"(E)-1-(5-((E)-(3-Fluorodibenzo(b,E)oxepin-11(6H)-ylidene)methyl)-1-((R)-1-morpholinopropan-2-yl)-1H-benzo(d)imidazol-2(3H)-ylidene)urea",CC(CN1CCOCC1)n1c(NC(N)=O)nc2cc(C=C3c4ccccc4COc4cc(F)ccc43)ccc21,,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01237899,NCT01237899_EG003,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 1,8,"Inclusion Criteria:

Are healthy men and women of non-childbearing potential as determined by medical history and physical examination.

Male subjects: Non-vasectomized male subjects must agree to use 2 medically accepted methods of contraception with all sexual partners during the study and for 90 days following the final dosing.
Female subjects: Female subjects must be of non-childbearing potential due to surgical sterilization (hysterectomy, bilateral oophorectomy or tubal ligation) or menopause. They should be a minimum of 12 months without a menstrual period. Peri-menopausal women who are 6 months without a menstrual period.
Have given written informed consent prior to any study-specific procedures.
Are reliable and willing to make themselves available for the duration of the study and are willing to follow site-specific study procedures.
Have a body mass index (BMI) of between 19 and 32.5 kilograms per square meter (kg/m^2).
Have clinical laboratory test results within the normal reference range for the population or study site, or test results with acceptable deviations that are judged by the Investigator not to be clinically significant.
Have venous access sufficient to allow blood sampling per the protocol.
Have serum potassium levels within the normal range.
Are nonsmokers or smokers of less than or equal to 10 cigarettes per day.

Exclusion Criteria:

Are currently enrolled in, or have discontinued, within 60 days inclusive, a clinical trial involving an investigational drug, device or an off-label use of an approved drug, or are concurrently enrolled in any other type of medical research judged to be scientifically or medically incompatible with this study. Subjects who meet any of these criteria may be enrolled in this study but they cannot be dosed until at least 60 days following the last day of the previous investigational trial.
Have previously completed or withdrawn from this study or any other study investigating LY2623091.
Have a history or presence of medical illness including but not limited to any cardiovascular, hepatic, respiratory, hematological, endocrine or neurological disease, or any clinically significant laboratory abnormality that is of a serious medical problem that would preclude study participation.
Have an abnormality in the 12-lead electrocardiogram (ECG), which increases the risks associated with participation in the study.
Are unwilling or unable to comply with the use of an electronic data capture system.
Show evidence of human immunodeficiency virus (HIV) and/or positive human HIV antibodies, hepatitis C and/or positive hepatitis C antibody or hepatitis B and/or positive hepatitis B surface antigen.

Use and/or intend to use any medication for a medical condition that is not compatible with Inclusion Criterion. For medications that may be used in ""healthy"" subjects (example given: preventative and/or naturopathic agents, temporary symptom-relieving medications, and so forth) the following constraints must be observed:

No use of vasoactive drugs (example given: diuretics, antihypertensive agents, phosphodiesterase inhibitors, erectile dysfunction medications, nasal decongestants, et cetera) or systemic glucocorticoids within 7 days of first dosing and/or anticipated use during the study.
No use of acetaminophen/paracetamol or non-steroidal anti-inflammatory drugs (NSAIDs) within 24 hours of first dosing and/or anticipated use during the study. Aspirin may not be used at doses greater than 100 milligrams per day (mg/day) within 7days of first dosing and/or anticipated use during the study.
No use of herbal or nutritional products within 7 days of first dosing and/or anticipated use during the study.
Have donated blood of more than 50 milliliters (mL) within the last 60 days.
Have an average weekly alcohol intake that exceeds 21 units per week and/or subjects unwilling to stop alcohol within 48 hours of study enrollment and for the duration of the study.
Have an abnormally high blood pressure (supine or standing) defined as diastolic blood pressure greater than 95 millimeters of mercury (mmHg) and /or systolic blood pressure greater than 150 mmHg, confirmed by at least 1 repeat measurement.
Have serum potassium greater than the upper limit of normal.
Regularly use known drugs of abuse or show positive findings for such use on urinary drug screening.
Consumption of natural licorice and/or natural licorice-containing products and/or grapefruit and/or grapefruit juice within 7 days of first dosing and/or anticipated consumption during the study.
Consumption of methylxanthine-containing beverages and/or foods (example: coffee, tea, caffeinated soft drinks, chocolate) within 4 days of first dosing and/or anticipated consumption during the study.
Are unwilling to abstain from salt-substitutes containing potassium for the duration of the study.",Daily by mouth for 7 days.,PubChem:42636651,"(E)-1-(5-((E)-(3-Fluorodibenzo(b,E)oxepin-11(6H)-ylidene)methyl)-1-((R)-1-morpholinopropan-2-yl)-1H-benzo(d)imidazol-2(3H)-ylidene)urea",CC(CN1CCOCC1)n1c(NC(N)=O)nc2cc(C=C3c4ccccc4COc4cc(F)ccc43)ccc21,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT01240785,NCT01240785_EG000,No,Female,Child | Adult | Older Adult,Phase 4,110,"Inclusion Criteria:

Mothers with gestational diabetes who had at least twice plasma glucose at fasting > 5.4 mmol/L and/or 1 hour postprandial value > 7.7 mmol/L at 24 to 32 gestational weeks

Exclusion Criteria:

Fasting glucose > 7.0 mmol/L or 1 hour postprandial plasma glucose > 11.0 mmol/L or Glycosylated hemoglobin A1c (HbA1c) > 7.0%
Renal, hepatic or cardiac failure
Pregestational use of metformin
Pregnancy with multiple fetuses",metformin: metformin 1 g twice daily or maximum tolerated dose less than 2 g daily,ChEMBL:CHEMBL1431 | DrugBank:DB00331 | PubChem:4091,Metformin,CN(C)C(=N)NC(=N)N,A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01241240,NCT01241240_EG001,No,All,Adult | Older Adult,Phase 3,98,"Inclusion Criteria:

Ocular hypertension or primary open-angle glaucoma in each eye
Requires treatment with IOP-lowering medication in both eyes

Exclusion Criteria:

Required chronic use of ocular medications during the study other than study medication
Use of any corticosteroids within 30 days
History of any prior eye surgery, except for uncomplicated eye surgery performed more than 6 months before the Screening visit
Anticipated wearing of contact lenses during the study","Fixed Combination brimonidine tartrate/timolol ophthalmic solution (Combigan®). One drop of Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution administered to each eye, twice daily for 12 weeks.",PubChem:11387895,Combigan,Brc1c(NC2=NCCN2)ccc2nccnc12.CC(C)(C)NCC(O)COc1nsnc1N1CCOCC1,,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01243450,NCT01243450_EG000,Accepts Healthy Volunteers,All,Child | Adult,Phase 3,401,"A subject will be eligible to participate if they meet all of the following inclusion criteria:

Normal, healthy male and female children and adults.
Age 12 to 40 years.
Written and verbal informed consent must be obtained. Subjects age 12 to 17 (inclusive) must sign an assent for the study and a parent or a legal guardian must sign the informed consent (per FDA letter 8.21.07).
Women of child-bearing potential must be non-pregnant and non-nursing, and must be willing to avoid pregnancy during the course of the study and during the menstrual cycle following completion of their participation in the study, adequate contraception is defined as regular use of any two of the following: oral, injectable contraceptives, condoms, spermicides, diaphragm, IUD, implantable and contraceptive patches. (oral contraceptives if used for at least three months and injectable contraceptives if used for at least 6 months)- prior to enrollment in the study, or abstinence.
Have at least 20 inflammatory (papules and pustules) and 25 non-inflammatory (open and closed comedones) lesions with a maximum of 2 nodulocystic lesions on the face (per FDA letter 8.21.07).
Global severity score from 2-4
Able to refrain from the use of all other topical acne medications or antibiotics during the treatment period.
Considered reliable and capable of understanding their responsibility and role in the study.

Exclusion Criteria

A subject will be eligible to participate if they meet none of the following exclusion criteria:

Subjects with active cystic acne as evidenced by more than 2 facial nodules.
More than 40 papules and/or pustules (inflammatory lesions)
More than 60 open and or closed comedones/milia (non-inflammatory lesions)
Overall severity grade of less than 2 or greater than 4,
History of allergy or hypersensitivity to tretinoin.
Significant history or clinical evidence of auto-immune, cardiovascular, gastrointestinal, hematological, hepatic, neurological, pancreatic, or renal disease
Use of systemic retinoid treatment within six months prior to study initiation.
Oral contraceptives should not be started or changed within 3 months prior to study initiation or planned to change during the study.
Pregnant or breast-feeding.
Participation in a clinical study for acne within 4 months preceding study initiation.","active cream

Tretinoin: Topical skin",ChEMBL:CHEMBL38 | ChEMBL:CHEMBL547 | ChEMBL:CHEMBL705 | DrugBank:DB00523 | DrugBank:DB00755 | DrugBank:DB00982 | PubChem:444795 | PubChem:449171 | PubChem:5282379,Tretinoin,CC(C=CC1=C(C)CCCC1(C)C)=CC=CC(C)=CC(=O)O,D10AD01 | D10AD04 | D10AD51 | D10AD54 | D10BA01 | D11AH04 | L01XF01 | L01XF02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01243450,NCT01243450_EG002,Accepts Healthy Volunteers,All,Child | Adult,Phase 3,404,"A subject will be eligible to participate if they meet all of the following inclusion criteria:

Normal, healthy male and female children and adults.
Age 12 to 40 years.
Written and verbal informed consent must be obtained. Subjects age 12 to 17 (inclusive) must sign an assent for the study and a parent or a legal guardian must sign the informed consent (per FDA letter 8.21.07).
Women of child-bearing potential must be non-pregnant and non-nursing, and must be willing to avoid pregnancy during the course of the study and during the menstrual cycle following completion of their participation in the study, adequate contraception is defined as regular use of any two of the following: oral, injectable contraceptives, condoms, spermicides, diaphragm, IUD, implantable and contraceptive patches. (oral contraceptives if used for at least three months and injectable contraceptives if used for at least 6 months)- prior to enrollment in the study, or abstinence.
Have at least 20 inflammatory (papules and pustules) and 25 non-inflammatory (open and closed comedones) lesions with a maximum of 2 nodulocystic lesions on the face (per FDA letter 8.21.07).
Global severity score from 2-4
Able to refrain from the use of all other topical acne medications or antibiotics during the treatment period.
Considered reliable and capable of understanding their responsibility and role in the study.

Exclusion Criteria

A subject will be eligible to participate if they meet none of the following exclusion criteria:

Subjects with active cystic acne as evidenced by more than 2 facial nodules.
More than 40 papules and/or pustules (inflammatory lesions)
More than 60 open and or closed comedones/milia (non-inflammatory lesions)
Overall severity grade of less than 2 or greater than 4,
History of allergy or hypersensitivity to tretinoin.
Significant history or clinical evidence of auto-immune, cardiovascular, gastrointestinal, hematological, hepatic, neurological, pancreatic, or renal disease
Use of systemic retinoid treatment within six months prior to study initiation.
Oral contraceptives should not be started or changed within 3 months prior to study initiation or planned to change during the study.
Pregnant or breast-feeding.
Participation in a clinical study for acne within 4 months preceding study initiation.",Tretinoin: Topical skin,ChEMBL:CHEMBL38 | ChEMBL:CHEMBL547 | ChEMBL:CHEMBL705 | DrugBank:DB00523 | DrugBank:DB00755 | DrugBank:DB00982 | PubChem:444795 | PubChem:449171 | PubChem:5282379,Tretinoin,CC(C=CC1=C(C)CCCC1(C)C)=CC=CC(C)=CC(=O)O,D10AD01 | D10AD04 | D10AD51 | D10AD54 | D10BA01 | D11AH04 | L01XF01 | L01XF02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01243567,NCT01243567_EG001,No,All,Adult | Older Adult,Phase 4,38,"Inclusion Criteria:

Diagnosis of primary open-angle glaucoma that has never been treated
Visual Acuity 20/60 or better in each eye

Exclusion Criteria:

Eye surgery within 3 months
Any refractive eye surgery
Contraindication to beta-adrenoceptor antagonist therapy (eg, chronic obstructive pulmonary disease [COPD], bronchial asthma, sinus bradycardia, heart block, history of severe myocardial infarction [heart attack])
Eye inflammation or eye infection within 3 months
Eye trauma within 6 months
Oral, injectable, or topical ophthalmic steroids within 21 days or anticipated use during study","Latanoprost 0.005% ophthalmic solution (Xalatan®) administered to each eye requiring treatment, once daily in the evening for 3 months.",ChEMBL:CHEMBL1051 | DrugBank:DB00654 | PubChem:5311221,Latanoprost,CC(C)OC(=O)CCC/C=C\C[C@@H]1[C@@H](CC[C@@H](O)CCc2ccccc2)[C@H](O)C[C@@H]1O,S01EE01 | S01EE51,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01244126,NCT01244126_EG000,No,All,Child,Phase 4,171,"Inclusion Criteria:

bilateral myringotomy

Exclusion Criteria:

ASA greater than 2
history of bleeding disorder/thrombocytopenia
history of allergy to morphine or fentanyl",0.1 mg/kg morphine IM,PubChem:6321225,Morphine sulfate pentahydrate,CN1CCC23c4c5ccc(O)c4OC2C(O)C=CC3C1C5.CN1CCC23c4c5ccc(O)c4OC2C(O)C=CC3C1C5.O.O.O.O.O.O=S(=O)(O)O,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01245140,NCT01245140_EG001,No,All,Adult | Older Adult,Phase 2,24,"Inclusion Criteria:

A female subject is eligible to participate if she is of:

Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea and a follicle stimulating hormone concentration of ≥40 international units (IU)/L.
Child-bearing potential with negative pregnancy test as determined by human chorionic gonadotropin (hCG) test at screening or prior to dosing and either 1) agrees to use a medically acceptable contraception method for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point and continue contraception until the end of the study, or 2) has only same-sex partners, when this is her preferred and usual lifestyle.
Capable of understanding and willing to provide signed and dated written voluntary informed consent (and any local or national authorization requirements) before any protocol specific procedures are performed.
Male or female aged at least 18 years at time of consent and at time of first dose.
Have PPP for at least 6 months, with or without psoriasis lesions on other areas of the skin
A PPPASI score of at least 8 with involvement of at least 10% of the palms and/or the soles
Refractory to standard topical corticosteroid therapy

Exclusion Criteria:

Unable to comply with the requirement of the study
Female subjects who are pregnant or who plan to become pregnant or who are breast feeding
Subjects whose disease is adequately controlled by standard non-medicated therapy (skin moisturizing and protection)
Known hypersensitivity to other retinoids or vitamin A derivatives, or to any study medication component, especially soybean oil and partly hydrogenated soybean oil

Treated with any of the following treatments 4 weeks before the start of study treatment:

systemic drugs: corticosteroids, immunosuppressants, methotrexate
phototherapy: ultraviolet B light therapy [UVB], psoralen with ultraviolet A combination therapy [PUVA], Grenz rays, X-rays
Treated with biologic treatments within 6 weeks prior to start of study treatment.
Abnormal hematology
Treated with any systemic or topical retinoids within 3 months or 1 month, respectively, before start of study treatment
Treated with high-potency topical corticosteroids within 2 weeks before the start of study treatment
Severe generalized pustular psoriasis
A skin condition of palms and/or soles that interferes with the diagnosis of PPP by the investigator
Any condition that, in the judgment of the investigator, would put the subject at unacceptable risk for participation in the study.

Hepatic insufficiency, severe renal failure, uncontrolled hypercholesterolemia as characterized by:

AST/ ALT >2.5 x upper limit of normal (ULN)
Creatinine clearance <60 mL/min (calculated, Cockcroft-Gault)
Fasting triglyceridemia >1.5 x upper limit of normal (ULN)
Fasting cholesterol >1.5 x ULN
Fasting low-density lipoprotein (LDL) cholesterol >1.5x ULN
Subjects with hypothyroidism as indicated by thyroid stimulating hormone (TSH) above ULN and thyroxine (T4) test below LLN or hypervitaminosis A

Subjects with unstable cardiac disease or poorly controlled cardiovascular risk factors, for example:

Acute coronary syndrome or coronary revascularization (percutaneous coronary intervention [PCI], coronary artery bypass graft [CABG]) within 3 months before start of study treatment
Poorly controlled diabetes mellitus (HbA1c >8.5%)
Systolic blood pressure ≥160 mm Hg and/or diastolic blood pressure ≥100 mm Hg at the screening examination
Subjects receiving drugs with a potential for drug-drug interaction, such as systemic tetracyclines, ketoconazole, or St. John's Wort within 1 week, or receiving systemic itraconazole within 2 weeks, before start of study treatment
Subjects included in the study of an investigational drug within 2 months before start of study treatment (3 months for biologics)
Subjects with a score of 20 or more on the Center for Epidemiologic Studies Depression scale (CES-D), or with active major psychiatric disorder (eg, Major Depressive Disorder, Generalized Anxiety Disorder, Bipolar Disorder [I or II], or schizophrenia)
Subjects who score a 4 or 5 for the previous 30 days on the Columbia Suicide Severity Rating Scale (CSSRS) at Screening or Baseline
Subjects who have made a suicide attempt within the 6 months preceding the Screening or Baseline visits",Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.,ChEMBL:CHEMBL38 | ChEMBL:CHEMBL547 | ChEMBL:CHEMBL705 | DrugBank:DB00523 | DrugBank:DB00755 | DrugBank:DB00982 | PubChem:444795 | PubChem:449171 | PubChem:5282379,Tretinoin,CC(C=CC1=C(C)CCCC1(C)C)=CC=CC(C)=CC(=O)O,D10AD01 | D10AD04 | D10AD51 | D10AD54 | D10BA01 | D11AH04 | L01XF01 | L01XF02,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,1.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01246076,NCT01246076_EG000,No,All,Adult | Older Adult,Phase 2,24,"Inclusion Criteria:

Patient must be able to understand and voluntarily sign an informed consent form.
Patient must be ≥ 18 years old.
Patient must be able to adhere to the study visit schedule and other protocol requirements.

Patient must have histologically confirmed Myelodysplastic Syndrome as defined by FAB Classification including CMML and secondary MDS which has either:

progressed at any time during treatment with hypomethylating agents
failed to achieve a response after 6 cycles
progressed after treatment with hypomethylating agents had been discontinued Criteria for response and for progression as defined by revised IWG criteria
Patient must have discontinued all previous cancer therapy, including radiation, hormonal therapy and surgery at least 4 weeks prior to treatment in this study.
Patient must have an ECOG performance status of ≤ 2 at study entry

Patient must have laboratory test results within these ranges:

calculated creatinine clearance ≥ 30ml/min by Cockcroft-Gault formula
total bilirubin ≤ 1.5 x ULN
AST (SGOT) and ALT (SGPT) ≤ 3 x ULN
Patient must be disease free of prior malignancies for at least 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma ""in situ"" of the cervix or breast.
Patient must be registered into the mandatory Revlimid REMS® program and be willing and able to comply with the requirements of Revlimid REMS®.
If a female of childbearing potential (FCBP), patient must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 to 14 days prior to initiation of therapy and again within 24 hours prior to prescribing lenalidomide for Cycle 1 (prescriptions must be filled within 7 days).

Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS® program. A FCBP is defined as a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).

-If a FCBP, patient must agree to use two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual intercourse during the following time periods related to this study: 1) for at least 28 days before starting study drug; 2) while participating in the study; and 3) for at least 28 days after discontinuation from the study. The two methods of reliable contraception must include one highly effective method (i.e. intrauterine device (IUD), hormonal [birth control pills, injections, or implants], tubal ligation, partner's vasectomy) and one additional effective (barrier) method (i.e. latex condom, diaphragm, cervical cap). FCBP must be referred to a qualified provider of contraceptive methods if needed

Exclusion Criteria:

Patient must not have any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
Patient must not be pregnant or breastfeeding.
Patient must not have any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
Patient must not use any other experimental drug or therapy within 28 days of baseline.
Patient must not have a known hypersensitivity to thalidomide.
Patient must not have developed of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
Patient must not have any prior use of lenalidomide.
Patient must not be concurrently using other anti-cancer agents or treatments.
Patient must not have known seropositivity for or active viral infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV). Patients who are seropositive because of hepatitis B virus vaccine are eligible.","Lenalidomide 50 mg/day for two 28 day cycles.

Patients who have bone marrow aplasia as defined by a cellularity of <10% will be observed till counts recover. If patients do not progress following 2 cycles of HD lenalidomide, they will receive low dose lenalidomide 10 mg daily for 12 cycles.",ChEMBL:CHEMBL848 | DrugBank:DB00480 | PubChem:216326,Lenalidomide,Nc1cccc2c1CN(C1CCC(=O)NC1=O)C2=O,L04AX04,1.0,1.0,0.0,0.0,0.0,1.0,1.0,1.0,0.0,1.0,1.0,1.0,1.0,1.0,1.0,0.0,1.0,0.0,1.0,1.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0
NCT01253902,NCT01253902_EG002,No,All,Adult | Older Adult,Phase 4,55,"Inclusion Criteria:

Diagnosis of ocular hypertension or open-angle glaucoma in at least 1 eye requiring treatment with an anti-glaucoma/ocular hypertensive medication
Best corrected visual acuity score of 20/100 or better in both eyes
Females on birth control pills must be on same type of pill and dose for at least 3 month

Exclusion Criteria:

Use of Lumigan® 0.01%/Lumigan® RC, Lumigan®, Travatan® or Travatan Z® within 6 months
History of or active ocular infection/inflammation (eg, uveitis)
Punctal plug use
Required use of ocular medications during the study other than study medication (intermittent use of certain types artificial tears acceptable)
Intraocular surgery or glaucoma laser surgery in study eye(s) within 3 months
History of corneal refractive laser surgery (eg, LASIK, LASEK) in study eye(s)
Planned contact lens wear during study","One drop of latanoprost ophthalmic solution 0.005% (Xalatan®) administered to affected eye(s), once daily in the evening for 12 weeks.",ChEMBL:CHEMBL1051 | DrugBank:DB00654 | PubChem:5311221,Latanoprost,CC(C)OC(=O)CCC/C=C\C[C@@H]1[C@@H](CC[C@@H](O)CCc2ccccc2)[C@H](O)C[C@@H]1O,S01EE01 | S01EE51,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01254604,NCT01254604_EG000,No,All,Adult | Older Adult,Phase 3,93,"Inclusion Criteria:

Participant has been diagnosed with primary open-angle glaucoma, pigmentary glaucoma, capsular glaucoma/pseudoexfoliation, or ocular hypertension
Has been using ocular hypotensive medication on a stable treatment regimen for at least 30 days prior to screening, or is treatment-naive (has never used or has not used ocular hypotensive medication for the last 4 weeks prior to screening)
Able to discontinue all topical and/or systemic ocular hypotensive medication during the washout period (up to 4 weeks pre-study)
Best-corrected early treatment of diabetic retinopathy study (ETDRS) visual acuity of 20/80 or better in each eye
Willing and able to avoid wearing contact lenses from 4 weeks prior to dosing with study medication through 24 hours after final dosing
Willing and able to self-administer or has an able person available on a daily basis to assist with administration of study medications
Participant with reproductive potential must agree to remain abstinent (unless abstinence is not a locally acceptable method of contraception) or use highly effective methods of birth control (hormonal contraceptives, intrauterine device, diaphragm, condoms and vasectomy) within the projected duration of the study
Able to refrigerate study drug at home.

Exclusion Criteria:

Mean IOP >36 mmHg in either eye at screening
Unable to use study medication in the affected eye(s)
History of any inflammatory ocular surface disease or a history of anterior or posterior uveitis in either eye within 6 months prior to screening
History of retinal detachment, proliferative diabetic retinopathy, or any progressive retinal disease
Significant visual field loss or evidence of progressive visual loss within the last year
Intraocular surgery in either eye in the last 4 months
Any glaucoma surgery, refractive surgery, or penetrating keratoplasty in either eye
Currently on two or more anti-glaucoma medications (except Cosopt™ or its generic formulation)
Previously used tafluprost
History of cardiovascular disorder within 6 months of screening
History of bronchial asthma, wheezing, chronic obstructive pulmonary disease (COPD) or other pulmonary disease, abnormal chest x-ray, or has current active pneumonia.","One drop of preservative-free vehicle (contains no active drug) per eye in the morning, and one drop of preservative-free tafluprost (0.0015%) per eye in the evening for four weeks.",ChEMBL:CHEMBL1963683 | DrugBank:DB08819 | PubChem:9868491,Tafluprost,CC(C)OC(=O)CCC/C=C\C[C@@H]1[C@@H](/C=C/C(F)(F)COc2ccccc2)[C@H](O)C[C@@H]1O,S01EE05,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01255722,NCT01255722_EG001,No,All,Adult | Older Adult,Phase 4,159,"Inclusion Criteria:

Male or female adult patient (having reached legal majority age)
Symptomatic patient suspected for coronary artery disease scheduled for a coronary CT angiography

Exclusion Criteria:

Patient with a heart rate > 65 beats per minute (bpm) and contraindication or intolerance to b-blocker administration
Patient with arrhythmia or non-sinus rhythm
Patient with decompensated heart failure
Patient with evidence of ongoing or active clinical instability (suspected or known acute myocardial infarction, cardiac shock, acute pulmonary oedema)
Patient who has previously undergone coronary artery bypass graft
Patient who has previously undergone percutaneous transluminal coronary stent placement
Patient with artificial heart valve
Patient with known moderate to severe aortic stenosis","Patients were IV injected with a single dose of iopromide before a coronary CT angiography

iopromide: Single IV injection",ChEMBL:CHEMBL1725 | DrugBank:DB09156 | PubChem:3736,Iopromide,COCC(=O)Nc1c(I)c(C(=O)NCC(O)CO)c(I)c(C(=O)N(C)CC(O)CO)c1I,V08AB05,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01258153,NCT01258153_EG000,No,All,Child,Phase 2,40,"Inclusion Criteria:

Healthy infants with diagnosis of infant colic according to the following modified Wessel criterion ""paroxysm of irritability, fussing or crying that start and stop without obvious cause for >3h/day, >3 days/week for one week""
Age > 4 weeks and < 20 weeks
Infants breast-fed mixed fed or formula fed with a stable dietary regimen
Normal growth
History of no adequate response to conventional treatment alternatives which make the infants in need of medical treatment
Willingness to refrain from use of antimuscarinic drugs, simethicone, dimethicone or antiacids during the study period.

Exclusion Criteria:

Clinical evidence of allergies or other diseases which may cause crying and/or fussiness or may interfere with absorption or clearance of the drug.
Suspect of gastroesophageal reflux disease (GERD)
Suspect of cow milk allergy.",Nepadutant oral solution: Oral administration once daily for 7 days,ChEMBL:CHEMBL1908318 | DrugBank:DB12538 | PubChem:166639582 | PubChem:44208970 | PubChem:9876321,Nepadutant,CC(=O)NC1C(NC(=O)CC2NC(=O)C(CC(C)C)NC(=O)C3CNC(=O)CC(NC2=O)C(=O)NC(Cc2c[nH]c4ccccc24)C(=O)NC(Cc2ccccc2)C(=O)N3)OC(CO)C(O)C1O,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01258153,NCT01258153_EG001,No,All,Child,Phase 2,38,"Inclusion Criteria:

Healthy infants with diagnosis of infant colic according to the following modified Wessel criterion ""paroxysm of irritability, fussing or crying that start and stop without obvious cause for >3h/day, >3 days/week for one week""
Age > 4 weeks and < 20 weeks
Infants breast-fed mixed fed or formula fed with a stable dietary regimen
Normal growth
History of no adequate response to conventional treatment alternatives which make the infants in need of medical treatment
Willingness to refrain from use of antimuscarinic drugs, simethicone, dimethicone or antiacids during the study period.

Exclusion Criteria:

Clinical evidence of allergies or other diseases which may cause crying and/or fussiness or may interfere with absorption or clearance of the drug.
Suspect of gastroesophageal reflux disease (GERD)
Suspect of cow milk allergy.",Nepadutant oral solution: Oral administration once daily for 7 days,ChEMBL:CHEMBL1908318 | DrugBank:DB12538 | PubChem:166639582 | PubChem:44208970 | PubChem:9876321,Nepadutant,CC(=O)NC1C(NC(=O)CC2NC(=O)C(CC(C)C)NC(=O)C3CNC(=O)CC(NC2=O)C(=O)NC(Cc2c[nH]c4ccccc24)C(=O)NC(Cc2ccccc2)C(=O)N3)OC(CO)C(O)C1O,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01262352,NCT01262352_EG001,No,All,Child | Adult | Older Adult,Phase 2,18,"Inclusion Criteria:

Male or female subjects with confirmed diagnosis of CF
Must have the G551D-CFTR mutation in at least 1 allele
FEV1 >90% of predicted normal for age, gender, and height

Exclusion Criteria:

Ongoing participation in another therapeutic clinical study or prior participation in an investigational drug study within the 30 days prior to screening
Use of inhaled hypertonic saline treatment within 2 weeks of the Period 1, Day 1 visit",Oral tablet of 150 mg of ivacaftor q12h for up to 28 days.,ChEMBL:CHEMBL2010601 | DrugBank:DB08820 | DrugBank:DB15141 | PubChem:16220172 | PubChem:71470491,Ivacaftor,CC(C)(C)c1cc(C(C)(C)C)c(NC(=O)c2c[nH]c3ccccc3c2=O)cc1O,R07AX02 | R07AX30 | R07AX31 | R07AX32,0.0,0.0,1.0,0.0,0.0,0.0,1.0,1.0,0.0,1.0,1.0,1.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,1.0,1.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT01265030,NCT01265030_EG000,No,All,Child | Adult,Phase 1 | Phase 2,9,"Inclusion Criteria:

Must be less than 30 years of age at time of original diagnosis
Must have biopsy-proven desmoid tumor (or aggressive fibromatosis). For patients with recurrent disease, a biopsy is not required at the time of recurrence
Patients known to have germ-line adenomatous polyposis coli (APC) mutations or clinical manifestations of Familial Adenomatous Polyposis(FAP)/Gardner's syndrome can be included

Patients must have surgery planned to remove the desmoid tumor and either:

the desmoid tumor has already recurred after a prior surgery or
the newly diagnosed and/or previously unresected disease is judged to be at high risk for recurrence due to its size (>5 centimeters) or location at an anatomic site making it unlikely to be resected with negative margins (eg. adjacent to neurovascular structures)
There must be a commitment by the surgical team to resect the primary tumor within 3 days following the 4 weeks of sirolimus unless the clinical situation at the time of resection suggests that these interventions are not in the patient's best interest

Concomitant medication restrictions:

Patients may have received prior chemotherapy (excluding prior mTOR inhibitors)
Use of steroids for non-tumor indications (for example: asthma or severe allergic reaction) is permitted
Patients must have a Karnofsky performance status of greater than or equal to 50 for patients older than 16 years of age or Lansky performance status of greater than or equal to 50 for patients less than or equal to 16 years of age.
Patients must have a life expectancy of greater than or equal to 8 weeks.

Patients must have recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study

Myelosuppressive chemotherapy: Must not have received within 2 weeks of entry onto this study (4 weeks if prior nitrosourea)
Biologic (anti-neoplastic agent): at least 7 days since the completion of therapy with a biological agent
Stem Cell Transplant (SCT): No evidence of active graft versus host disease. For allogeneic SCT, greater than or equal to 6 months must have elapsed.
Patients must be able to consume oral medication in the form of tablets or solution

Patients must have normal laboratory values as defined below:

Creatinine clearance or radioisotope Glomerular Filtration Rate ≥ 70millileters/minute/1.73 meters2 or a normal serum creatinine based on age/gender

Hepatic: Adequate liver function is defined as:

Total bilirubin less than or equal to 1.5 x upper limit of normal (ULN)for age, and
Serum glutamic pyruvic transaminase (SGPT) less than or equal to 2.5 x upper limit normal (ULN) for age

Hematologic function: Adequate bone marrow function is defined as:

Absolute Neutrophil Count (ANC) greater than or equal to 1 x 10 to the ninth/Liter
Hemoglobin greater than or equal to 10 gram/deciliter
Platelet count greater than or equal to 100 x 10 to the ninth/Liter
Female patients must have a negative pregnancy test
Female patients who are lactating must agree to stop breast-feeding
Sexually active patients of childbearing potential must agree to use effective contraception
Patients must be able to cooperate fully with all planned protocol therapy
Signed informed consent MUST be obtained from patient or parent/legal guardian (if patient is less than 18 years of age). Consent must be signed prior to any study procedures and study entry

Exclusion Criteria:

Patients with other fibroblastic lesions or other fibromatoses are NOT eligible.

Concomitant medication restrictions

Patients may NOT have received prior mTor inhibitors
Growth factor(s): Must not have received within 1 week of entry onto this study.
Patients must not be known to be Human Immunodeficiency Virus positive. Testing for Human Immunodeficiency Virus is not mandatory.
Patients must not be taking medicines known to influence sirolimus metabolism","Preoperative sirolimus:

loading dose of 12 milligrams/meter2; Per Os (PO), by mouth day 1 (Max dose 12 milligram)
starting 24 hours after the initial loading dose, subjects will receive a dose of 4 milligram/meters2 daily; Per Os (PO), by mouth days 2 through 28

Sirolimus: -Loading dose of 12 milligrams/meter2; Per Os (PO), by mouth day 1 (Max dose 12 milligrams)

-Starting 24 hours after the initial loading dose, patients will receive a dose of 4 milligrams/meter2 daily; Per Os (PO), by mouth days 2 through 28 (Max dose 4 milligram/day)",ChEMBL:CHEMBL413 | DrugBank:DB00877 | PubChem:134760597 | PubChem:138404388 | PubChem:21944094 | PubChem:5284616,Sirolimus,COC1CC2CCC(C)C(O)(O2)C(=O)C(=O)N2CCCCC2C(=O)OC(C(C)CC2CCC(O)C(OC)C2)CC(=O)C(C)C=C(C)C(O)C(OC)C(=O)C(C)CC(C)C=CC=CC=C1C,L01EG04 | L04AA10 | S01XA23,1.0,1.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,1.0,1.0,1.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0
NCT01268579,NCT01268579_EG000,No,All,Adult | Older Adult,Not Applicable,9,"Inclusion Criteria:

Prior diagnostic surgical or core needle biopsy, with confirmation of tonsil and/or base of tongue squamous cell carcinoma that is positive for expression of p16 and phosphorylated eIF4E, as determined by the Department of Pathology at MSKCC. The biopsy may be either of the tonsil base of tongue and/or an involved neck node. 2 unstained slides and/or tissue block must be available from the initial diagnostic biopsy
Positive expression p16 and phosphorylated eIF4E is defined as >=30% of tumor cells with cytological and/or nuclear staining
Age ≥ 18 and ≤ 65 years of age
Karnofsky Performance Status ≥ 80
Adequate organ function, as follows:

Adequate bone marrow reserve: absolute neutrophil count (ANC) ≥ 1.5 X 109/L, platelets ≥ 160 X 109/L, hemoglobin ≥ 12 g/dL Hepatic: total bilirubin within 1.5 X upper limit of normal (ULN) ; alkaline phosphatase (AP), aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 X ULN (Patients with Gilbert's syndrome as the cause of hyperbilirubinemia may be eligible if total bilirubin ≤ 2.5 X UNL) Renal: Serum creatinine ≤ 1.3 mg/dL. Patients with serum creatinine > 1.3 mg/dL may be eligible if creatinine clearance (CrCl) ≥ 55 mL/min based on the standard Cockroft and Gault formula.

Patients of childbearing potential must have a negative serum pregnancy test within 14 days of treatment. Patients must agree to use a reliable method of birth control during and for 6 months following the last dose of study drug.
Ability to swallow oral medication.
Non-surgical patients: If primary radiation +/- chemotherapy (concurrent or sequential) is planned, patients must agree to undergo research biopsy after completion of ribavirin treatment.

Exclusion Criteria:

Prior chemotherapy or radiation for tonsillar or base of tongue squamous cell cancer
More than 10 pack-years of tobacco use
History of hemolytic anemia or thalassemia
Active infection or serious underlying medical condition that would impair the patient's ability to receive protocol treatment.
Current therapeutic anticoagulation with Coumadin (warfarin)
Current or prior treatment with ribavirin
Known active Hepatitis B or C
Any prior documented history of transient ischemic attack (TIA) or cerebrovascular accident (CVA)
New York Heart Association (NYHA) Grade II or greater congestive heart failure
Clinically significant peripheral vascular disease
History of unstable angina or myocardial infarction (MI) within the last 3 years","This will be a single institution non-randomized study for patients with tonsil and/or base of tongue squamous cell cancer. This is a pilot study to obtain pharmacodynamic data regarding the effects of ribavirin on tonsil squamous cell cancer.

ribavirin: The clinical intervention in this study is ribavirin therapy for approximately 14 days. Ribavirin 800 mg/day is administered in divided doses, 400 mg PO qAM and 400 mg PO qPM.",ChEMBL:CHEMBL1643 | DrugBank:DB00811 | PubChem:37542,Ribavirin,NC(=O)c1ncn([C@@H]2O[C@H](CO)[C@@H](O)[C@H]2O)n1,J05AP01,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT01270464,NCT01270464_EG001,No,All,Child | Adult | Older Adult,Phase 3,103,"Inclusion Criteria:

The patient is male or female, 12 through 75 years of age, with a previous diagnosis of asthma. Patients 12 through 17 years of age are excluded from participating in Argentina.
The patient has an ACQ score of at least 1.5.
The patient has airway reversibility of at least 12% to beta-agonist administration at screening.
The patient is currently taking fluticasone at a dosage of at least 440 μg daily (or equivalent). Patients' baseline asthma therapy regimens (including but not limited to inhaled corticosteroids, leukotriene antagonists, 5-lipoxygenase inhibitors, cromolyn) must be stable for 30 days before screening, and continue without dosage changes throughout study.
The patient has a blood eosinophil count of at least 400/μL.
Female patients must be surgically sterile, 2 years postmenopausal, or must have a negative pregnancy test ßHCG at screening (serum) and baseline (urine).
Female patients of childbearing potential (not surgically sterile or 2 years postmenopausal), must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the study and for 30 days after the end-of-treatment visit. Acceptable methods of contraception include barrier method with spermicide, abstinence, intrauterine device (IUD), or steroidal contraceptive (oral, transdermal, implanted, and injected).
Written informed consent is obtained. Patients 12 through 17 years old, where participating, need to provide assent in accordance with local standards.
Other inclusion criteria apply.

Exclusion Criteria:

The patient has a clinically meaningful comorbidity that would interfere with the study schedule or procedures, or compromise the patient's safety.
The patient has known hypereosinophilic syndrome (HES).
The patient has another confounding underlying lung disorder (eg, chronic obstructive pulmonary disease, pulmonary fibrosis, or lung cancer). The patient has other pulmonary conditions with symptoms of asthma and blood eosinophilia (eg, Churg-Strauss syndrome, allergic bronchopulmonary aspergillosis).
The patient is a current smoker (ie, has smoked within the last 6 months prior to screening).
The patient has a history of use of systemic immunosuppressive or immunomodulating agents (anti-IgE mAb, methotrexate, cyclosporin, interferon-α, or anti-tumor necrosis factor mAb) within 6 months prior to study entry (screening).
The patient is currently using systemic corticosteroids (includes use of oral corticosteroids).
The patient has a current infection or disease that may preclude assessment of asthma.
The patient is expected to be poorly compliant with study drug administration, study procedures, or visits.
The patient has any aggravating factors that are inadequately controlled (eg, gastroesophageal reflux disease).
The patient has participated in any investigative drug or device study within 30 days prior to screening.
The patient has participated in any investigative biologics study within 90 days prior to screening.
The patient has previously received anti-hIL-5 monoclonal antibody (eg, mepolizumab).
Female patients who are pregnant, or nursing, or, if of childbearing potential and not using a medically accepted, effective method of birth control (e.g. spermicide, abstinence, IUD, or steroidal contraceptive [oral, transdermal, implanted, and injected]) are excluded from this study.
The patient has a current infection or disease that may preclude assessment of asthma.
The patient has a history of concurrent immunodeficiency (human immunodeficiency, acquired immunodeficiency syndrome, or congenital immunodeficiency). Patients in Argentina must have documented serology testing for HIV performed during screening.
Other exclusion criteria apply.","0.3 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses",ChEMBL:CHEMBL417 | ChEMBL:CHEMBL53463 | DrugBank:DB00445 | DrugBank:DB00997 | PubChem:1691 | PubChem:31703 | PubChem:41867,Epirubicin,COc1cccc2c1C(=O)c1c(O)c3c(c(O)c1C2=O)CC(O)(C(=O)CO)CC3OC1CC(N)C(O)C(C)O1,L01DB01 | L01DB03,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT01270464,NCT01270464_EG002,No,All,Child | Adult | Older Adult,Phase 3,103,"Inclusion Criteria:

The patient is male or female, 12 through 75 years of age, with a previous diagnosis of asthma. Patients 12 through 17 years of age are excluded from participating in Argentina.
The patient has an ACQ score of at least 1.5.
The patient has airway reversibility of at least 12% to beta-agonist administration at screening.
The patient is currently taking fluticasone at a dosage of at least 440 μg daily (or equivalent). Patients' baseline asthma therapy regimens (including but not limited to inhaled corticosteroids, leukotriene antagonists, 5-lipoxygenase inhibitors, cromolyn) must be stable for 30 days before screening, and continue without dosage changes throughout study.
The patient has a blood eosinophil count of at least 400/μL.
Female patients must be surgically sterile, 2 years postmenopausal, or must have a negative pregnancy test ßHCG at screening (serum) and baseline (urine).
Female patients of childbearing potential (not surgically sterile or 2 years postmenopausal), must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the study and for 30 days after the end-of-treatment visit. Acceptable methods of contraception include barrier method with spermicide, abstinence, intrauterine device (IUD), or steroidal contraceptive (oral, transdermal, implanted, and injected).
Written informed consent is obtained. Patients 12 through 17 years old, where participating, need to provide assent in accordance with local standards.
Other inclusion criteria apply.

Exclusion Criteria:

The patient has a clinically meaningful comorbidity that would interfere with the study schedule or procedures, or compromise the patient's safety.
The patient has known hypereosinophilic syndrome (HES).
The patient has another confounding underlying lung disorder (eg, chronic obstructive pulmonary disease, pulmonary fibrosis, or lung cancer). The patient has other pulmonary conditions with symptoms of asthma and blood eosinophilia (eg, Churg-Strauss syndrome, allergic bronchopulmonary aspergillosis).
The patient is a current smoker (ie, has smoked within the last 6 months prior to screening).
The patient has a history of use of systemic immunosuppressive or immunomodulating agents (anti-IgE mAb, methotrexate, cyclosporin, interferon-α, or anti-tumor necrosis factor mAb) within 6 months prior to study entry (screening).
The patient is currently using systemic corticosteroids (includes use of oral corticosteroids).
The patient has a current infection or disease that may preclude assessment of asthma.
The patient is expected to be poorly compliant with study drug administration, study procedures, or visits.
The patient has any aggravating factors that are inadequately controlled (eg, gastroesophageal reflux disease).
The patient has participated in any investigative drug or device study within 30 days prior to screening.
The patient has participated in any investigative biologics study within 90 days prior to screening.
The patient has previously received anti-hIL-5 monoclonal antibody (eg, mepolizumab).
Female patients who are pregnant, or nursing, or, if of childbearing potential and not using a medically accepted, effective method of birth control (e.g. spermicide, abstinence, IUD, or steroidal contraceptive [oral, transdermal, implanted, and injected]) are excluded from this study.
The patient has a current infection or disease that may preclude assessment of asthma.
The patient has a history of concurrent immunodeficiency (human immunodeficiency, acquired immunodeficiency syndrome, or congenital immunodeficiency). Patients in Argentina must have documented serology testing for HIV performed during screening.
Other exclusion criteria apply.","3.0 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses.",ChEMBL:CHEMBL417 | ChEMBL:CHEMBL53463 | DrugBank:DB00445 | DrugBank:DB00997 | PubChem:1691 | PubChem:31703 | PubChem:41867,Epirubicin,COc1cccc2c1C(=O)c1c(O)c3c(c(O)c1C2=O)CC(O)(C(=O)CO)CC3OC1CC(N)C(O)C(C)O1,L01DB01 | L01DB03,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT01270659,NCT01270659_EG000,No,All,Adult,Phase 3,6,"Inclusion Criteria:

pain sufficient to warrant medication stronger than acetaminophen (Tylenol) or aspirin
only if Emergency Department provider approves
a negative pregnancy test is required for participation for women of childbearing age

Exclusion Criteria:

If treating provider determines intravenous analgesia is required
allergy to acetaminophen or any opiate/opioid, or lansoprazole patients currently taking phenothiazines, CNS depressants (including alcohol), or if they have taken an monoamine oxidase inhibitor (MAOI) or selective serotonin reuptake inhibitor (SSRI) in the past two weeks
if patient has already been administered an opioid analgesic for their current injury
patients on chronic opioids therapy or a history of opioid abuse
breastfeeding mothers
patients who plan to drive home after their emergency department visit
history of phenylketonuria (due to phenylalanine in the formulation of the lansoprazole solutab)","Subject will receive FBT and placebo at a low dose

Fentanyl: Fentanyl buccal tablet 100 mcg once",ChEMBL:CHEMBL596 | DrugBank:DB00813 | PubChem:3345,Fentanyl,CCC(=O)N(c1ccccc1)C1CCN(CCc2ccccc2)CC1,N01AH01 | N01AH51 | N02AB03,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT01270659,NCT01270659_EG001,No,All,Adult,Phase 3,25,"Inclusion Criteria:

pain sufficient to warrant medication stronger than acetaminophen (Tylenol) or aspirin
only if Emergency Department provider approves
a negative pregnancy test is required for participation for women of childbearing age

Exclusion Criteria:

If treating provider determines intravenous analgesia is required
allergy to acetaminophen or any opiate/opioid, or lansoprazole patients currently taking phenothiazines, CNS depressants (including alcohol), or if they have taken an monoamine oxidase inhibitor (MAOI) or selective serotonin reuptake inhibitor (SSRI) in the past two weeks
if patient has already been administered an opioid analgesic for their current injury
patients on chronic opioids therapy or a history of opioid abuse
breastfeeding mothers
patients who plan to drive home after their emergency department visit
history of phenylketonuria (due to phenylalanine in the formulation of the lansoprazole solutab)","Subject will receive the high dose regimen of FBT and a high dose placebo

Fentanyl: Fentanyl buccal tablet 200 mcg once",ChEMBL:CHEMBL596 | DrugBank:DB00813 | PubChem:3345,Fentanyl,CCC(=O)N(c1ccccc1)C1CCN(CCc2ccccc2)CC1,N01AH01 | N01AH51 | N02AB03,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01272388,NCT01272388_EG000,No,All,Adult | Older Adult,Phase 4,1,"Inclusion Criteria:

Patients with severe aortic stenosis (AVA < 1.0 cm2)
Left ventricular hypertrophy
EF ≥ 45%
NYHA functional class ≥ 2
Ambulatory (able to perform a 6 minute walk test)
Normal sinus rhythm
18 years of age and older
Able and willing to comply with all the requirements for the study

Exclusion Criteria:

Need for ongoing nitrate medications
SBP < 110mmHg or MAP < 75mmHg
Moderately severe or severe mitral regurgitation
Moderately severe or severe aortic regurgitation
Creatinine clearance < 30 mL/min
Increased risk of priapism
Retinal or optic nerve problems or unexplained visual disturbance
If a subject requires ongoing use of an alpha antagonist typically used for benign prostatic hyperplasia (BPH) (prazosin, terazosin, doxazosin, or tamsulosin), SBP < 120 mmHg or MAP < 80 mmHg is excluded
Need for ongoing use of a potent CYP3A inhibitor or inducer (ritonavir, ketoconazole, itraconazole, rifampin)
Cirrhosis
Pulmonary fibrosis
Current or recent (≤ 30 days) acute coronary syndrome
O2 sat < 90% on room air
Females that are pregnant or believe they may be pregnant
Any condition which the PI determines will place the subject at increased risk or is likely to yield unreliable data
Unwilling to provide informed consent","Tadalafil: Active drug will be encapsulated to look identical to the placebo pill. Subjects will take a single oral dose of tadalafil once daily from the time of randomization until the surgical date (~4 weeks). Subjects will begin by taking 20 mg (1 pill) daily for 3 days before having the dose increased to 40 mg (2 pills) once daily. If the increase to 40mg daily is not tolerated, then the dose will be decreased back to 20mg daily.",ChEMBL:CHEMBL779 | DrugBank:DB00820 | PubChem:110635,Tadalafil,[H][C@]12Cc3c([nH]c4ccccc34)[C@@H](c3ccc4c(c3)OCO4)N1C(=O)CN(C)C2=O,C02KX52 | C02KX54 | G04BE08 | G04CA54 | G04CB51,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01274533,NCT01274533_EG000,No,All,Adult | Older Adult,Phase 2,4,"Inclusion Criteria:

Age ≥18 years at the time of signing the informed consent form.
Able to adhere to the study visit schedule and other protocol requirements.
Relapsed or refractory HTLV-1 associated Adult T-cell Leukemia/Lymphoma (Acute and lymphoma subtypes)
All previous cancer therapy, including radiation, hormonal therapy and surgery, must have been discontinued at least 4 weeks prior to treatment in this study.
ECOG performance status of ≤ 2 at study entry (see Appendix C).

Laboratory test results within these ranges:

Absolute neutrophil count ≥ 1000/mm³
Platelet count ≥ 50,000 /mm³
Calculated creatinine clearance of ≥ 30 mL/min by Cockcroft-Gault formula (Appendix J). Patients with calculated creatinine clearance ≥ 30 mL/min and < 60 mL/min will have a reduced starting dose of lenalidomide (see Section 5.4.2).
Total bilirubin ≤ 1.5 x ULN
AST (SGOT) and ALT (SGPT) ≤ 3 x ULN.
Disease free of prior malignancies for ≥ 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma ""insitu"" of the cervix or breast.
Females of childbearing potential (FCBP)† must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days prior to and again within 24 hours of starting lenalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy. All patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure. See Appendix A: Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable Birth Control Methods, AND also Appendix B: Education and Counseling Guidance Document.
Patients at high risk for DVT/PE must be able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to ASA may use warfarin or low molecular weight heparin).

Exclusion Criteria:

Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide).
Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
Evidence of laboratory TLS by Cairo-Bishop Definition of Tumor Lysis Syndrome (see Appendix H). Subjects may be enrolled upon correction of electrolyte abnormalities.
Use of any other experimental drug or therapy within 28 days of baseline.
Known hypersensitivity to thalidomide.
The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
Any prior use of lenalidomide.
Concurrent use of other anti-cancer agents or treatments.
Known positive for HIV or infectious hepatitis, type B or C.
Recent DVT/PE requiring dose adjustments of anticoagulation within past 90 days","Oral lenalidomide is initiated on Day 1 of Cycle 1 and continues once daily days 1-21 of a 28 day cycle. Subjects may continue participation in the Treatment Phase of the study for 24 months unless disease progression or drug is discontinued for safety reasons.

Lenalidomide: 25mg or 10mg (based on creatinine clearance) once daily for days 1-21 of a 28 day cycle",ChEMBL:CHEMBL848 | DrugBank:DB00480 | PubChem:216326,Lenalidomide,Nc1cccc2c1CN(C1CCC(=O)NC1=O)C2=O,L04AX04,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01275339,NCT01275339_EG000,No,All,Adult | Older Adult,Phase 4,2,"Inclusion Criteria:

Patients with moderate to severe aortic stenosis (AVA < 1.5 cm2)
Left ventricular hypertrophy
Diastolic dysfunction as evidenced by tissue Doppler e' (average of septal and lateral) ≤ 7 cm/s
EF ≥ 50%
None or minimal symptoms related to aortic stenosis (NYHA ≤ 2)
The subject and treating physician are not planning on a valve replacement procedure to occur during the next 6 months
Ambulatory
Normal sinus rhythm
18 years of age and older
Able and willing to comply with all the requirements for the study

Exclusion Criteria:

Need for ongoing nitrate medications
SBP < 110mmHg or MAP < 75mmHg
Moderately severe or severe mitral regurgitation
Moderately severe or severe aortic regurgitation
Contraindication to MRI
Creatinine clearance < 30 mL/min
Cirrhosis
Pulmonary fibrosis
Increased risk of priapism
Retinal or optic nerve problems or unexplained visual disturbance
If a subject requires ongoing use of an alpha antagonist typically used for benign prostatic hyperplasia (BPH) (prazosin, terazosin, doxazosin, or tamsulosin), SBP < 120 mmHg or MAP < 80 mmHg is excluded
Need for ongoing use of a potent CYP3A inhibitor or inducer (ritonavir, ketoconazole, itraconazole, rifampin)
Current or recent (≤ 30 days) acute coronary syndrome
O2 sat < 90% on room air
Females that are pregnant or believe they may be pregnant
Any condition which the PI determines will place the subject at increased risk or is likely to yield unreliable data
Unwilling to provide informed consent","Tadalafil: Active drug will be encapsulated to look identical to the placebo pill. Subjects will take a single oral dose of tadalafil once daily from the time of randomization until study completion (6 months). Subjects will begin by taking 20 mg (1 pill) daily for 3 days before having the dose increased to 40 mg (2 pills) once daily. If the increase to 40mg daily is not tolerated, then the dose will be decreased back to 20mg daily.",ChEMBL:CHEMBL779 | DrugBank:DB00820 | PubChem:110635,Tadalafil,[H][C@]12Cc3c([nH]c4ccccc34)[C@@H](c3ccc4c(c3)OCO4)N1C(=O)CN(C)C2=O,C02KX52 | C02KX54 | G04BE08 | G04CA54 | G04CB51,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT01275339,NCT01275339_EG002,No,All,Adult | Older Adult,Phase 4,4,"Inclusion Criteria:

Patients with moderate to severe aortic stenosis (AVA < 1.5 cm2)
Left ventricular hypertrophy
Diastolic dysfunction as evidenced by tissue Doppler e' (average of septal and lateral) ≤ 7 cm/s
EF ≥ 50%
None or minimal symptoms related to aortic stenosis (NYHA ≤ 2)
The subject and treating physician are not planning on a valve replacement procedure to occur during the next 6 months
Ambulatory
Normal sinus rhythm
18 years of age and older
Able and willing to comply with all the requirements for the study

Exclusion Criteria:

Need for ongoing nitrate medications
SBP < 110mmHg or MAP < 75mmHg
Moderately severe or severe mitral regurgitation
Moderately severe or severe aortic regurgitation
Contraindication to MRI
Creatinine clearance < 30 mL/min
Cirrhosis
Pulmonary fibrosis
Increased risk of priapism
Retinal or optic nerve problems or unexplained visual disturbance
If a subject requires ongoing use of an alpha antagonist typically used for benign prostatic hyperplasia (BPH) (prazosin, terazosin, doxazosin, or tamsulosin), SBP < 120 mmHg or MAP < 80 mmHg is excluded
Need for ongoing use of a potent CYP3A inhibitor or inducer (ritonavir, ketoconazole, itraconazole, rifampin)
Current or recent (≤ 30 days) acute coronary syndrome
O2 sat < 90% on room air
Females that are pregnant or believe they may be pregnant
Any condition which the PI determines will place the subject at increased risk or is likely to yield unreliable data
Unwilling to provide informed consent","Tadalafil: Active drug will be encapsulated to look identical to the placebo pill. Subjects will take a single oral dose of tadalafil once daily from the time of randomization until study completion (6 months). Subjects will begin by taking 20 mg (1 pill) daily for 3 days before having the dose increased to 40 mg (2 pills) once daily. If the increase to 40mg daily is not tolerated, then the dose will be decreased back to 20mg daily.",ChEMBL:CHEMBL779 | DrugBank:DB00820 | PubChem:110635,Tadalafil,[H][C@]12Cc3c([nH]c4ccccc34)[C@@H](c3ccc4c(c3)OCO4)N1C(=O)CN(C)C2=O,C02KX52 | C02KX54 | G04BE08 | G04CA54 | G04CB51,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01276223,NCT01276223_EG001,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 2,107,"Inclusion Criteria:

Normal subjects:

No known history of dry eye disease.
Non-contact lens wearer.
No current use of artificial tears or any other dry eye treatment.

OR

Dry eye patients:

At least a 6 month history of dry eye.
Non-contact lens wearer.
Uses artificial tears.
Experiences persistent ocular discomfort.
Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

The presence of any acute infectious or non-infectious ocular conditions in either eye within 1 month of Visit 1.
Severe Sjogren's Syndrome.
Lid function abnormalities.
Use of steroids, tetracycline, doxycycline, etc., within 30 days of Visit 1.
History of corneal surgery including refractive surgeries.
History of glaucoma or ocular hypertension
Other protocol-defined exclusion criteria may apply.",Difluprednate 0.05% ophthalmic emulsion,ChEMBL:CHEMBL1201749 | DrugBank:DB06781 | PubChem:443936,Difluprednate,[H][C@@]12CC[C@](OC(=O)CCC)(C(=O)COC(C)=O)[C@@]1(C)C[C@H](O)[C@@]1(F)[C@@]2([H])C[C@H](F)C2=CC(=O)C=C[C@@]21C,D07AC19,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01277211,NCT01277211_EG000,Accepts Healthy Volunteers,Female,Adult,Phase 3,714,"Key Inclusion Criteria:

Sexually active Chinese women, at risk for pregnancy and not planning to use condoms during trial medication use
Women in need for contraception and willing to use a hormonal contraceptive method for 13 cycles
Body mass index ≥18 and ≤29 kg/m^2

Key Exclusion Criteria:

Contraindications for contraceptive steroids
Abnormal cervical smear corresponding to indeterminate changes at screening
Clinically relevant abnormal laboratory result at screening as judged by the investigator.","Participants were to complete 13 cycles of etonogestrel (ENG) and ethinylestradiol (EE) use. Each cycle was 28 days, with a 21-day active treatment period followed by a 7-day ring-free period. Participants used one ring per cycle. Each ring contained 11.7 mg ENG and 2.7 mg EE, and released on average 120 mcg/day of ENG and 15 mcg/day of EE.",PubChem:9960701,Nuvaring,C#CC1(O)CCC2C3CCC4=CC(=O)CCC4C3C(=C)CC21CC.C#CC1(O)CCC2C3CCc4cc(O)ccc4C3CCC21C,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01277744,NCT01277744_EG000,No,All,Child | Adult | Older Adult,Phase 2,20,"Inclusion Criteria:

Age greater than or equal to 1 years
Histologically or genetically proven diffuse peritoneal or retroperitoneal tumor from desmoplastic round cell tumor, ovarian germ cell, sarcoma, Wilms' tumor, or other non-carcinoma tumors.
Radiologic workup must demonstrate that the disease is confined to the abdominal cavity
Radiologic workup or prior abdominal exploration must be consistent with disease which can be debulked to a residual size of less than or equal to 1 cm thickness per tumor deposit
Patients must have a minimum expected duration of survival of greater than 6 weeks as determined and documented by the attending surgeon or medical oncologist.
Patients must not have any systemic illness which precludes them from being an operative candidate as determined by anesthesia preoperative evaluation. This includes but is not limited to, sepsis, liver failure, pregnant or lactating females.
Patients must have fully intact mental status and normal neurologic abilities. Intact mental status is defined by 'the capacity to identify and recall one's identity and place in time and space.' Assessment of mental status and documentation of fully intact mental status will be completed using physical and mental exam by the referring doctor or oncologist.
Patients must have adequate renal function (serum creatinine </= 1.5 mg/dl without history dialysis or renal failure or creatinine clearance less than 50 mL/min/1.73M^2 if less than 5 years of age)
Patients will be eligible if the white blood cell count (WBC) is >/=2000/microliter or absolute neutrophil count (ANC) is >/=1,500 and platelets are >/= 100,000/mm^3
Patients will be eligible if serum total bilirubin and liver enzymes are </=2 times the upper limit of normal
Patients must be recovered from any toxicity from all prior chemotherapy, immunotherapy, or radiotherapy and be at least 14 days past the date of their last treatment

Exclusion Criteria:

Patients will be ineligible if they have any concomitant cardiopulmonary disease which would place them at unacceptable risk for a major surgical procedure
Patients will be ineligible if they have disease outside of the abdominal cavity which is uncontrolled
Patients will be ineligible if they have a baseline neurologic toxicity of Grade 3 or greater (because of the potential neurotoxicity associated with platinum)
Patients who have failed previous intraperitoneal platinum therapy will be ineligible
Patients with Retroperitoneal Liposarcoma will be ineligible.",HIPEC with Cisplatin,DrugBank:DB00515 | PubChem:5460033 | PubChem:5702198,Cisplatin,Cl[Pt]Cl.N.N,L01XA01,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01277861,NCT01277861_EG000,No,All,Adult,Phase 4,100,"Inclusion Criteria:

18-64 years of age
Subjects scheduled for elective superficial and peripheral surgery of less than 2 h duration (e.g., hernia surgery, breast surgery, upper or lower limb surgery, superficial abdominal/chest wall surgery [i.e., lipoma], minor gynecological procedures [i.e., hysteroscopy])

Exclusion Criteria:

obesity (body mass index >30)
pregnancy
history of gastroesophageal reflux, hiatal hernia, significant cardiovascular, pulmonary (e.g., reactive airway disease), hepatic, renal, neurologic, metabolic, and endocrine disease
history of alcohol and drug abuse
requiring tracheal intubation.",FENTANYL,ChEMBL:CHEMBL596 | DrugBank:DB00813 | PubChem:3345,Fentanyl,CCC(=O)N(c1ccccc1)C1CCN(CCc2ccccc2)CC1,N01AH01 | N01AH51 | N02AB03,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01277861,NCT01277861_EG001,No,All,Adult,Phase 4,100,"Inclusion Criteria:

18-64 years of age
Subjects scheduled for elective superficial and peripheral surgery of less than 2 h duration (e.g., hernia surgery, breast surgery, upper or lower limb surgery, superficial abdominal/chest wall surgery [i.e., lipoma], minor gynecological procedures [i.e., hysteroscopy])

Exclusion Criteria:

obesity (body mass index >30)
pregnancy
history of gastroesophageal reflux, hiatal hernia, significant cardiovascular, pulmonary (e.g., reactive airway disease), hepatic, renal, neurologic, metabolic, and endocrine disease
history of alcohol and drug abuse
requiring tracheal intubation.",SALINE,ChEMBL:CHEMBL596 | DrugBank:DB00813 | PubChem:3345,Fentanyl,CCC(=O)N(c1ccccc1)C1CCN(CCc2ccccc2)CC1,N01AH01 | N01AH51 | N02AB03,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01280110,NCT01280110_EG000,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 4,44,"Inclusion Criteria:

Pseudophakic eyes that underwent cataract surgery at least 6 months before.

Exclusion Criteria:

Use of any eyedrop.
Other conditions associated with a break in the blood-aqueous or blood retina barrier (ie diabetes, ARMD, vasculitis, uveitis)
Previous history of cystoid macular edema.
Previous ocular surgery other than cataract surgery.",One group will receive preserved lubricating drops 4 times a day for 1 month.,PubChem:57503849,Hydroxypropylmethylcellulose,CC(O)COCC1OC(OC2C(COCC(C)O)OC(OCC(C)O)C(OCC(C)O)C2OCC(C)O)C(OCC(C)O)C(OCC(C)O)C1OCC(C)O.COCC1OC(OC2C(COC)OC(OC)C(OC)C2OC)C(OC)C(OC)C1OC,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01280110,NCT01280110_EG001,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 4,44,"Inclusion Criteria:

Pseudophakic eyes that underwent cataract surgery at least 6 months before.

Exclusion Criteria:

Use of any eyedrop.
Other conditions associated with a break in the blood-aqueous or blood retina barrier (ie diabetes, ARMD, vasculitis, uveitis)
Previous history of cystoid macular edema.
Previous ocular surgery other than cataract surgery.",The second group will receive preservative-free lubricating drops 4 times a day for 1 month.,PubChem:24748,7H,CC(=O)O.O=CC(O)C(O)C(O)C(O)CO,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01281475,NCT01281475_EG000,No,All,Child,Phase 2 | Phase 3,33,"Inclusion Criteria:

Age between 4 years and 12 years (i.e., before the 13th birthday)
Molecular confirmation of the diagnosis of AS, which may include abnormal methylation studies or UBE3A mutation analyses - only subjects with a molecular diagnosis will be allowed to enroll
Not on LD, CD, or any dopamine agonists in the 2 weeks prior to participation

Exclusion Criteria:

Co-morbid disorders that may be associated with developmental or cognitive delays
Poorly controlled seizures - An average of more than 2 clinical seizures per month in the 12 months prior to enrollment.
Use of medications that may interact with LD/CD including atypical antipsychotics (aripiprazole, asenapine, iloperidone, olanzapine, paliperidone, risperidone, ziprasidone), monoamine oxidase inhibitors (isocarboxazid, phenelzine, selegiline, tranylcypromine), or phenytoin within the last 14 days, or other investigational interventions within the past 3 months
Presence of cardiovascular disease or instability, respiratory disease, liver disease, peptic ulcer disease, renal impairment, or hematological disorders
Pregnancy","Levodopa is a prodrug that ""delivers"" dopamine to the brain. It is usually given with carbidopa, a peripheral decarboxylase inhibitor, to increase the bioavailability of levodopa.

Levodopa/carbidopa: Levodopa/Carbidopa (4:1)

Dosages are based on levodopa.

Subjects randomized to the levodopa arm will receive a levodopa dose of 5 mg/kg/day in the first 2 weeks of the study, a levodopa dose of 10 mg/kg/day in the second 2 weeks of the study, and a levodopa dose of 15 mg/kg/day (up to a maximum of 800 mg per day) for the remaining duration of the study.

Levodopa/Carbidopa is a combined formulation that will be dispensed as capsules. It should be taken 3 times a day.",DrugBank:DB00988 | PubChem:681,Dopamine,NCCc1ccc(O)c(O)c1,C01CA04,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01283464,NCT01283464_EG001,No,All,Adult | Older Adult,Phase 2,12,"Inclusion Criteria:

Age 35 or over
Moderate to severe photodamage

Exclusion Criteria:

History of facial cosmetic surgery, facial resurfacing procedures, deep peels, or facial fillers
History of keloids or hypertrophic scars
Use of oral steroids or oral retinoids (such as Accutane) in past 6 months",Tretinoin 0.02% cream,ChEMBL:CHEMBL38 | ChEMBL:CHEMBL547 | ChEMBL:CHEMBL705 | DrugBank:DB00523 | DrugBank:DB00755 | DrugBank:DB00982 | PubChem:444795 | PubChem:449171 | PubChem:5282379,Tretinoin,CC(C=CC1=C(C)CCCC1(C)C)=CC=CC(C)=CC(=O)O,D10AD01 | D10AD04 | D10AD51 | D10AD54 | D10BA01 | D11AH04 | L01XF01 | L01XF02,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0
NCT01285323,NCT01285323_EG001,No,All,Child | Adult | Older Adult,Phase 3,232,"Inclusion Criteria:

The patient is male or female, 12 through 75 years of age, with a previous diagnosis of asthma. Patients 12 through 17 years of age are excluded from participating in Germany, India, Argentina, and Korea; patients 66 through 75 years of age are excluded from participating in India and Korea.
The patient has had at least 1 asthma exacerbation requiring oral, intramuscular (im), or intravenous (iv) corticosteroid use for at least 3 days over the past 12 months before screening.
The patient has a current blood eosinophil level of at least 400/μL.
The patient has airway reversibility of at least 12% to beta-agonist administration.
The patient has an ACQ score of at least 1.5 5 at the screening and baseline (before the 1st dose of study drug) visits.
The patient is taking inhaled fluticasone at a dosage of at least 440 μg, or equivalent, daily. Chronic oral corticosteroid use (no more than 10 mg/day prednisone or equivalent) is allowed. If a patient is on a stable dose, eg, 2 weeks or more of oral corticosteroid treatment at the time of study enrollment, the patient must remain on this dose throughout the study. The patient's baseline asthma therapy regimen (including, but not limited to, inhaled corticosteroids, oral corticosteroids up to a maximum dose of 10 mg prednisone daily or equivalent, leukotriene antagonists, 5-lipoxygenase inhibitors, or cromolyn) must be stable for 30 days prior to screening and baseline and must continue without dosage changes throughout the study.
All female patients must be surgically sterile, 2 years postmenopausal, or must have a negative pregnancy test (ß-human chorionic gonadotropin [ß-HCG]) at screening (serum) and baseline (urine).
Female patients of childbearing potential (not surgically sterile or 2 years postmenopausal), must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the study and for 30 days after participation in the study. Acceptable methods of contraception include barrier method with spermicide, abstinence, intrauterine device (IUD), or steroidal contraceptive (oral, transdermal, implanted, and injected). NOTE: Partner sterility alone is not acceptable for inclusion in the study.
Written informed consent is obtained. Patients 12 through 17 years old, where participating, must provide assent.
The patient is in reasonable health (except for diagnosis of asthma) as judged by the investigator, and as determined by a medical history, medical examination, ECG evaluation (at screening), serum chemistry, hematology, and urinalysis.
The patient must be willing and able to understand and comply with study restrictions, requirements, and procedures, as specified by the study center, and to remain at the study center for the required duration during the study period, and willing to return to the study center for the follow-up evaluation as specified in this protocol.
Patients who experience an asthma exacerbation during the screening period will be considered to have failed screening and cannot be randomly assigned to study drug. Patients may be rescreened 1 time only.

Exclusion Criteria:

The patient has a clinically meaningful co-morbidity that would interfere with the study schedule or procedures, or compromise the patient's safety.
The patient has known hypereosinophilic syndrome.
The patient has another confounding underlying lung disorder (eg, chronic obstructive pulmonary disease, pulmonary fibrosis, or lung cancer). Patients with pulmonary conditions with symptoms of asthma and blood eosinophilia (eg, Churg-Strauss syndrome, allergic bronchopulmonary aspergillosis) will also be excluded.
The patient is a current smoker (ie, has smoked within the last 6 months prior to screening).
The patient is using systemic immunosuppressive, immunomodulating, or other biologic agents (including, but not limited to, anti-immunoglobulin E (IgE) mAb, methotrexate, cyclosporin, interferon-α, or anti-tumor necrosis factor [anti-TNF] mAb) within 6 months prior to screening.
The patient has previously received an anti-hIL-5 monoclonal antibody (eg, reslizumab, mepolizumab, or benralizumab).
The patient has any aggravating medical factors that are inadequately controlled (eg, rhinitis, gastroesophageal reflux disease, and uncontrolled diabetes).
The patient has participated in any investigative drug or device study within 30 days prior to screening.
The patient has participated in any investigative biologics study within 6 months prior to screening.
Other exclusion criteria apply.",Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.,ChEMBL:CHEMBL417 | ChEMBL:CHEMBL53463 | DrugBank:DB00445 | DrugBank:DB00997 | PubChem:1691 | PubChem:31703 | PubChem:41867,Epirubicin,COc1cccc2c1C(=O)c1c(O)c3c(c(O)c1C2=O)CC(O)(C(=O)CO)CC3OC1CC(N)C(O)C(C)O1,L01DB01 | L01DB03,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT01286077,NCT01286077_EG000,No,All,Adult | Older Adult,Phase 2,51,"Inclusion Criteria:

Adult Multiple Myeloma patients in partial response or better after high dose chemotherapy and autologous stem cell transplantation
Patient fulfills defined laboratory requirements within 14 days before enrolment
If female, is either postmenopausal for more than 24 consecutive months or surgically sterilized or willing to use an acceptable method of birth control for defined period
If male, agree to use an acceptable barrier method of contraception and to not donate sperm up to 3 months following treatment

Exclusion Criteria:

Patient received another antimyeloma or experimental therapy following autologous stem cell transplantation
Patient has a peripheral neuropathy or neuropathic pain of grade 2 or greater intensity as defined by the NCI common terminology criteria of adverse event (NCI CTCAE) version 3.0
Patient has an uncontrolled or severe cardiovascular disease within 6 months of enrolment
Patient has any conditions that would compromise his/her well-being or the completion of the study requirements","bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles",ChEMBL:CHEMBL325041 | DrugBank:DB00188 | PubChem:387447,Bortezomib,CC(C)C[C@H](NC(=O)[C@H](Cc1ccccc1)NC(=O)c1cnccn1)B(O)O,L01XG01 | L01XX32,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT01287039,NCT01287039_EG001,No,All,Child | Adult | Older Adult,Phase 3,245,"Inclusion Criteria:

The patient is male or female, 12 through 75 years of age, with a previous diagnosis of asthma.
The patient has had at least 1 asthma exacerbation requiring oral, intramuscular (im), or intravenous (iv) corticosteroid use for at least 3 days over the past 12 months before screening.
The patient has a current blood eosinophil level of at least 400/μl.
The patient has airway reversibility of at least 12% to beta-agonist administration.
The patient has an ACQ score of at least 1.5 at the screening and baseline (before the 1st dose of study drug) visits.
The patient is taking inhaled fluticasone at a dosage of at least 440 μg, or equivalent, daily. Chronic oral corticosteroid use (no more than 10 mg/day prednisone or equivalent) is allowed. If a patient is on a stable dose, eg, 2 weeks or more of oral corticosteroid treatment at the time of study enrollment, the patient must remain on this dose throughout the study. The patient's baseline asthma therapy regimen (including but not limited to inhaled corticosteroids, oral corticosteroids up to a maximum of 10 mg of prednisone daily or equivalent, leukotriene antagonists, 5-lipooxygenase inhibitors, or cromolyn) must be stable for 30 days prior to screening and baseline, and must continue without dosage changes throughout study.
All female patients must be surgically sterile, 2 years postmenopausal, or must have a negative pregnancy test ß-human chorionic gonadotropin [ß-HCG]) at screening (serum) and baseline (urine).
Female patients of childbearing potential (not surgically sterile or 2 years postmenopausal), must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the study and for 30 days after participation in the study.
Written informed consent is obtained. Patients 12 through 17 years old must provide assent.

The patient is in reasonable health (except for diagnosis of asthma) as judged by the investigator, and as determined by a medical history, medical examination, ECG evaluation (at screening), serum chemistry, hematology, and urinalysis.

Other criteria apply; please contact the investigator for more information.

Exclusion Criteria:

The patient has a clinically meaningful co-morbidity that would interfere with the study schedule or procedures, or compromise the patient's safety.
The patient has known hypereosinophilic syndrome.
The patient has another confounding underlying lung disorder (eg, chronic obstructive pulmonary disease, pulmonary fibrosis, or lung cancer). Patients with pulmonary conditions with symptoms of asthma and blood eosinophilia (eg, Churg-Strauss syndrome, allergic bronchopulmonary aspergillosis) will also be excluded.
The patient is a current smoker (ie, has smoked within the last 6 months prior to screening).
The patient is using systemic immunosuppressive or immunomodulating or other biologic agents (including, but not limited to, anti-IgE mAb, methotrexate, cyclosporin, interferon-α, or anti-tumor necrosis factor [anti TNF] mAb) within 6 months prior to screening.
The patient has previously received an anti-hIL-5 monoclonal antibody (eg, reslizumab, mepolizumab, or benralizumab).
The patient has any aggravating medical factors that are inadequately controlled (eg, rhinitis, gastroesophageal reflux disease, and uncontrolled diabetes).
The patient has participated in any investigative drug or device study within 30 days prior to screening.
The patient has participated in any investigative biologics study within 6 months prior to screening.

Female patients who are pregnant, nursing, or, if of childbearing potential, and not using a medically accepted, effective method of birth control (eg, barrier method with spermicide, abstinence, IUD, or steroidal contraceptive [oral, transdermal, implanted, and injected]) are excluded from this study. NOTE: Partner sterility alone is not considered an acceptable form of birth control.

Other criteria apply; please contact the investigator for more information.",Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.,ChEMBL:CHEMBL417 | ChEMBL:CHEMBL53463 | DrugBank:DB00445 | DrugBank:DB00997 | PubChem:1691 | PubChem:31703 | PubChem:41867,Epirubicin,COc1cccc2c1C(=O)c1c(O)c3c(c(O)c1C2=O)CC(O)(C(=O)CO)CC3OC1CC(N)C(O)C(C)O1,L01DB01 | L01DB03,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT01290601,NCT01290601_EG000,No,All,Adult,Phase 2,46,"Inclusion Criteria:

Positive smear for P. vivax.
Parasite density > 500 and < 200,000/μl
Age: 20-60 years old
Willing to sign consent form
Willing to be hospitalized for 29 days and remain in a malaria free region for 60 days thereafter for follow-up.
A female is eligible to enter and participate in this study if she is of:

a non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including any female who is post-menopausal or, b child-bearing potential, has a negative pregnancy (urine or serum) test at screen, and agrees to comply with recognized contraceptive methods during the treatment stage of the study and for a period of 12 weeks after stopping study drug. Recognized contraceptive methods include, abstinence, implants of levonorgestrel, injectable progestogen, or appropriate double barrier methods using licensed contraceptives such as diaphragm and condom (by the partner) or intrauterine device and condom. The use of oral/patch contraceptives during the study is not considered sufficient contraceptive protection.

Exclusion Criteria:

Mixed malaria infections by Field's stain.
Female subjects who are pregnant, lactating or unwilling/unable to comply with recognized contraceptive methods during the treatment stage of the study and for a period of 12 weeks after stopping study drug.
Symptoms of severe vomiting (no food or inability to take food during the previous 8 hours).
Demonstrated glucose-6-phosphate dehydrogenase deficiency.
Subject has taken other anti-malarials (mefloquine, primaquine, chloroquine) within the past 30 days by history
Clinically significant illness (intercurrent illness e.g. pneumonia, pre-existing condition e.g. renal disease, malignancy or conditions that may affect absorption of study medication e.g. severe diarrhea or any signs of malnutrition as defined clinically).
Clinically significant abnormal laboratory values as determined by history, physical examination or routine blood chemistries and hematology values (laboratory guideline values for exclusion are hemoglobin <7 gm/dL, platelets < 50,000/μl, White Blood Cell count (WBC) < 2000/μl, serum creatinine >2.0mg/dL, or ALT or AST more than 3 times the upper limit of normal for age.
History of allergy to chloroquine, mefloquine, tafenoquine, primaquine or any other 8-aminoquinolines.
Subject has taken another investigational drug within 30 days or 5 half lives (whichever is longer), of study start.
History of previous eye surgery or have evidence of corneal or retinal abnormalities identified in baseline ophthalmological examination.
Subjects taking concomitant medications likely to affect renal or ophthalmic function or that are known to be metabolized primarily by the cytochrome P450 isoforms 3A4/5 and 2C9 and whose therapeutic effect occurs within a narrow plasma concentration range (e.g. warfarin, ketoconazole).
Subjects whom, after examination by the study ophthalmologist, are judged to be at risk for acute angle closure glaucoma.
Females who are pre-menarchal.","Tafenoquine: 2 capsules (200mg base/capsule for a total of 400mg base) and 4 chloroquine placebo capsules for 2 days, followed by 2 tafenoquine capsules and 2 chloroquine placebo capsules for 1 day, followed by 1 primaquine placebo capsule/day for 14 days.

Tafenoquine: Tafenoquine: 2 capsules (200mg base/capsule for a total of 400mg base) and 4 chloroquine placebo capsules for 2 days, followed by 2 tafenoquine capsules and 2 chloroquine placebo capsules for 1 day, followed by 1 primaquine placebo capsule/day for 14 days.",ChEMBL:CHEMBL298470 | DrugBank:DB06608 | PubChem:115358,Tafenoquine,COc1cc(C)c2c(Oc3cccc(C(F)(F)F)c3)c(OC)cc(NC(C)CCCN)c2n1,P01BA07,1.0,0.0,0.0,0.0,0.0,1.0,1.0,1.0,1.0,0.0,1.0,0.0,1.0,1.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT01290887,NCT01290887_EG000,No,All,Child | Adult | Older Adult,Phase 3,1051,"Inclusion Criteria:

Written informed consent is obtained.
Patient must have completed treatment in a previous Cephalon-sponsored double-blind asthma exacerbation study or received at least 2 doses of study drug treatment in a pulmonary function study.
The patient must be willing and able to comply with study restrictions and to remain at the clinic for the required duration during the study period, and willing to return to the clinic for the follow-up evaluation as specified in this protocol.
other criteria may apply; please contact the investigator for more information.

Exclusion Criteria:

The patient has a clinically meaningful comorbidity that would interfere with the study schedule or procedures, or compromise the patient's safety.
The patient has another confounding underlying lung disorder (eg, chronic obstructive pulmonary disease, pulmonary fibrosis, or lung cancer).
The patient is a current smoker.
The patient is expected to be poorly compliant with study drug administration, study procedures, or visits.
The patient has any aggravating factors that are inadequately controlled (e.g., gastroesophageal reflux disease [GERD]).
Female patients who are pregnant, or nursing, or, if of childbearing potential and not using a medically accepted, effective method of birth control (eg, spermicide, abstinence, intrauterine device [IUD], or steroidal contraceptive [oral, transdermal, implanted, and injected] in conjunction with a barrier method) are excluded from this study.
The patient has a current infection or disease that may preclude assessment of asthma.
other criteria may apply; please contact the investigator for more information.",Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for up to 24 months.,ChEMBL:CHEMBL417 | ChEMBL:CHEMBL53463 | DrugBank:DB00445 | DrugBank:DB00997 | PubChem:1691 | PubChem:31703 | PubChem:41867,Epirubicin,COc1cccc2c1C(=O)c1c(O)c3c(c(O)c1C2=O)CC(O)(C(=O)CO)CC3OC1CC(N)C(O)C(C)O1,L01DB01 | L01DB03,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT01293123,NCT01293123_EG001,No,All,Adult | Older Adult,Not Applicable,2,"Inclusion Criteria:

Men and women aged 18-65 years;
Integrase inhibitor-naive subjects with clinical indication to initiate RAL under the supervision of their HIV care provider;
Baseline detectable HIV-1 RNA levels ≥ 5000 copies/mL in plasma and ≥ 500 copies/mL in CSF;
Absolute T-cell CD4+ subset between 200-500/mm3
Individual willing to undergo serial lumbar punctures as outlined in study evaluations;
Subject able to give informed consent to all study procedures (if cognitively impaired, the individual must pass an evaluation to ensure adequate comprehension of the consent document and procedures);
Susceptibility to all study drugs on Monogram Biosciences PhenoSense GT assay.

Exclusion Criteria:

Contraindication to lumbar puncture, such as current coagulopathy, thrombocytopenia (platelets below 50,000/µL), or use of anticoagulants;
Cognitive, psychiatric, or substance use disorders or any other medical conditions that would interfere with study participation, in the opinion of the investigator;
Major opportunistic infections (e.g., pneumonia, tuberculosis) within 30 days;
Use of prescribed drugs with known substantial interactions with the study drugs;
Positive HCV serology;
HIV-associated dementia/Global Deterioration Scale ≥4;
Pregnancy;
Serum creatinine higher than 2.0 mg/dL;
Total bilirubin or alanine or aspartate transaminases more than 3 times the upper limit of normal",Efavirenz: efavirenz 600 mg PO once daily,ChEMBL:CHEMBL223228 | DrugBank:DB00625 | PubChem:64139,Efavirenz,O=C1Nc2ccc(Cl)cc2[C@@](C#CC2CC2)(C(F)(F)F)O1,J05AG03 | J05AR06 | J05AR11,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01296672,NCT01296672_EG000,No,Male,Adult | Older Adult,Phase 4,306,"Inclusion Criteria:

Risk of prostate cancer 20-60% calculated with the on-line Prostate Cancer Prevention Trial (PCPT) prostate cancer risk calculator. (www.prostate-cancer-risk-calculator.com). PSA value must be obtained within 3 months prior to study entry. A description of the frequency of these individuals in the population is provided in Specific Aim 2
Patient has been recommended to undergo and plans to have a prostate biopsy.
Patient is willing to delay prostate biopsy for a 3-month finasteride vs placebo treatment.
No allergy to finasteride or other five alpha reductase inhibitors.
Patient is willing to take finasteride vs placebo 5 mg orally daily for 3-month treatment period.
Age 55 or older. (This age is selected as the PCPT risk calculator is only valid for this age range.)

Exclusion Criteria:

Risk of cancer greater than 60% or less than 20%.
Prior history of prostate cancer.
Prior treatment with finasteride or dutasteride in the past 6 months
Younger than age 55.",Finasteride 5mg every day by mouth for 3 months,ChEMBL:CHEMBL710 | DrugBank:DB01216 | PubChem:57363,Finasteride,[H][C@@]12CC[C@@]3([H])NC(=O)C=C[C@]3(C)[C@@]1([H])CC[C@]1(C)[C@@H](C(=O)NC(C)(C)C)CC[C@@]21[H],D11AX10 | G04CA51 | G04CA55 | G04CB01 | G04CB51,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01298128,NCT01298128_EG000,No,Female,Adult,Not Applicable,70,"Inclusion Criteria:

Patients less than 38 years of age.
Healthy women starting their first IVF/ICSI cycle.
No contraindication to Combined Oral Contraceptive (COC) use. Appendix 1
Consent to randomization.

Exclusion Criteria:

Any contraindication to COC use.
Hypersensitivity to Nuva ring or any of its components.
Language barrier to consent.",NuvaRing for IVF pre-treatment,PubChem:9960701,Nuvaring,C#CC1(O)CCC2C3CCC4=CC(=O)CCC4C3C(=C)CC21CC.C#CC1(O)CCC2C3CCc4cc(O)ccc4C3CCC21C,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01302444,NCT01302444_EG000,No,All,Adult | Older Adult,Phase 4,1,"Inclusion Criteria:

Adult patients 18-80 years of age

World Health Organization Group 1 PAH

Idiopathic PAH
Heritable PAH
PAH associated with connective tissue disease
PAH associated with surgical repair of congenital left to right shunt
PAH associated with anorectic drug use
WHO functional Class III-IV
6 minute walking distance > 150-meters and < 450 meters
Right heart catheterization showing mean PAP (pulmonary arterial pressure)> 25 mmHg and PCWP (pulmonary capillary wedge pressure) < 15 mmHg within 6 months of study entry.

Exclusion Criteria:

Pulmonary hypertension associated with

a. Portal hypertension b. HIV infection c. Pulmonary venous hypertension defined as PCWP > 15 mmHg d. Chronic lung disease defined as i. FEV1(forced expiratory volume at one second

)/FVC (forced vital capacity) less than 0.65 ii. TLC < 0.70 iii. Untreated Sleep Apnea with AHI (apnea-hypopnea index )> 20 or hemoglobin oxygen saturation nadir < 87% e. Chronic Thromboembolic Disease f. Sarcoidosis g. Pulmonary veno occlusive disease (PVOD)

Concomitant use of nitrates (any form) either regularly or intermittently.
Concomitant use of potent CYP3A inhibitors (e.g., ritonavir, ketoconazole, itraconazole)
Vascular disease of the retina including retinitis pigmentosa, any sudden vision loss, including any damage to the optic nerve or NAION
low blood pressure or high blood pressure that is not controlled
Postural hypotension
Inability to manage home infusion therapy
Pulmonary vasodilator therapy with any phosphodiesterase inhibitor or endothelin receptor antagonist within 30 days of study entry
Participation in a clinical investigational study within previous 30 days

Renal failure defined as:

estimated creatinine clearance < 30 ml/min
serum creatinine > 2.5 mg/dl
Subjects with liver function abnormalities (ALT [Alanine Aminotransferase or AST (Alanine Aminotransferase ) > 3 times the upper limit of normal at screening or at baseline) or chronic liver disease
History of hypersensitivity reaction or adverse effect related to tadalafil
Life expectancy < 12 months
History of deformed penis shape, an erection that lasted more than 4 hours, or Peyronie's disease.
Blood cell problems such as sickle cell anemia, multiple myeloma, or leukemia
Pregnant or planning to become pregnant or breast feed.","first 4 weeks are for adjusting treprostinil dose, then Tadalafil 40mg daily for 12 weeks, Group is randomly chosen from entire cohort",ChEMBL:CHEMBL779 | DrugBank:DB00820 | PubChem:110635,Tadalafil,[H][C@]12Cc3c([nH]c4ccccc34)[C@@H](c3ccc4c(c3)OCO4)N1C(=O)CN(C)C2=O,C02KX52 | C02KX54 | G04BE08 | G04CA54 | G04CB51,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01303406,NCT01303406_EG001,No,All,Child | Adult | Older Adult,Phase 3,16,"Inclusion Criteria:

Completion of V5 (Month 12), V6 (Month 18), or V7 (Month 24) in the MICONOS extension study
Patients who in the opinion of the investigator are able to comply with the requirements of the study
Body weight ≥ 25kg
Negative urine pregnancy test

Exclusion Criteria:

AE during the course of the MICONOS extension study which in the opinion of the investigator is attributable to idebenone and precludes further treatment with idebenone
Clinically significant abnormalities of clinical haematology or biochemistry including, but not limited to, elevations greater than 1.5 times the upper limit of normal SGOT, SGPT or creatinine
Parallel participation in another clinical drug trial
Pregnancy or breast-feeding
Abuse of drugs or alcohol
Any change of concomitant medication within the last 30 days that in the opinion of the investigator the intake could negatively impact the study","Following the body weight, patients will be allocated to one of the following regimen:

Idebenone Patients < 45 kg - 3 tablets 3 times a day with meals

Idebenone Patients > 45 kg - 5 tablets 3 times a day with meals

Idebenone: All PROTI patients randomised to idebenone treatment will receive high dose idebenone. This is defined according to body weight. In patients weighing 45 kg or less, it is 1350 mg/day (3 x 150 mg tablets three times per day with meals). In patients weighing more than 45 kg, it is 2250 mg/day (5 x 150 mg tablets three times per day with meals).",ChEMBL:CHEMBL252556 | DrugBank:DB09081 | PubChem:3686,Idebenone,COC1=C(OC)C(=O)C(CCCCCCCCCCO)=C(C)C1=O,N06BX13,0.0,1.0,0.0,0.0,1.0,0.0,1.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01309243,NCT01309243_EG001,No,All,Adult | Older Adult,Phase 3,392,"Inclusion Criteria:

Ability to understand and sign a written informed consent form
Plasma HIV-1 RNA levels ≥ 2,500 copies/mL at screening
No prior use of any approved or experimental anti-HIV drug for any length of time
Screening genotype report showing sensitivity to EFV, FTC, TDF, and lack of the RPV mutations K101E/P, E138A/G/K/Q/R, Y181C/I/V, and H221Y
Normal ECG
Hepatic transaminases (alanine aminotransferase [ALT] and aspartate aminotransferase [AST]) ≤ 5 x the upper limit of the normal range (ULN)
Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin
Adequate hematologic function
Serum amylase ≤ 5 x ULN (participants with serum amylase > 5 x ULN remained eligible if serum lipase was ≤ 5 x ULN)
Adequate renal function
Males and Females of childbearing potential must have agreed to utilize highly effective contraception methods (two separate forms of contraception, one of which must be an effective barrier method, or be non-heterosexually active, practice sexual abstinence or have a vasectomized partner) from screening throughout the duration of study period and for 12 weeks following the last dose of study drug.
Adult (≥ 18 years) males or non-pregnant females

Exclusion Criteria:

A new AIDS-defining condition diagnosed within the 30 days prior to screening
Females who were breastfeeding
Positive serum pregnancy test (female of childbearing potential)
Proven or suspected acute hepatitis in the 30 days prior to study entry
Subjects receiving drug treatment for hepatitis C, or subjects who were anticipated to receive treatment for hepatitis C during the course of the study
Subjects experiencing decompensated cirrhosis
Had an implanted defibrillator or pacemaker
Current alcohol or substance abuse
A history of malignancy within the past 5 years or ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous carcinoma
Active, serious infections requiring parenteral antibiotic or antifungal therapy within 30 days prior to baseline
Receiving ongoing therapy or anticipated to need to initiate drugs or herbal/natural supplements during the study that are contraindicated or not recommended for use, including drugs not to be used with FTC, EFV, RPV, or TDF; or subjects with known allergies to the excipients of the FTC/RPV/TDF or EFV/FTC/TDF single-tablet regimens
Participation in any other clinical trial without prior approval from the sponsor was prohibited while participating in this trial.
Had been treated with immunosuppressant therapies or chemotherapeutic agents within 3 months of study screening, or expected to receive these agents or systemic steroids for immunosuppression during the study (eg, corticosteroids, immunoglobulins, and other immune-based or cytokine-based therapies)
Had any other clinical condition or prior therapy that, in the opinion of the Investigator, would have made the participant unsuitable for the study or unable to comply with the dosing requirements",EFV 600 mg/FTC 200 mg/TDF 300 mg STR administered orally once daily,ChEMBL:CHEMBL223228 | DrugBank:DB00625 | PubChem:64139,Efavirenz,O=C1Nc2ccc(Cl)cc2[C@@](C#CC2CC2)(C(F)(F)F)O1,J05AG03 | J05AR06 | J05AR11,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT01313117,NCT01313117_EG000,No,Female,Adult | Older Adult,Phase 1 | Phase 2,9,"Inclusion Criteria

Diagnosis of Breast cancer.

Breast cancer must meet the following criteria:

Early stage breast cancer (stages I, IIA) must be estrogen receptor (ER) positive AND low tumor grade (histopathologic grade 1 or 2)
Locally advanced breast cancer (LABC) (stages IIB, IIIA, IIB as defined by the Union for International Cancer Control and American Joint Committee on Cancer) must be ER positive, HER2 positive or HER2 negative, AND satisfy the following requirements: high endocrine responsiveness (defined as greater than 50% of tumor cells staining for hormone receptors), Grade 1 or 2 histological grade, less than 4 nodes positive, absence of extensive peritumoral vascular invasion, AND pathological tumor size less than 5 cm.
Inflammatory breast cancer (IBC) (stage IIIC)
Metastatic breast cancer (stage IV)
Must be receiving single agent paclitaxel in their prescribed chemotherapy regimen.
Age > 18 years. There is no upper age limit for participation in this study.
Required lab values: AST, ALT, creatinine
Women of childbearing potential and sexually active males must agree to use contraception while on study.
ECOG performance status 0,1,2
All patients must have given signed, informed consent.

Exclusion Criteria

Breast cancer meeting the following criteria:

Breast cancer stage 0
Early stage breast cancer (stages I, IIA) that is ER negative OR higher tumor grade (histopathologic grade greater than 2)
Stages I, II, and IIIA triple negative breast cancer (negative for estrogen receptors, progesterone receptors, and HER2)
LABC (stages IIB, IIIA, IIB) if they have low endocrine responsiveness (defined as less than 50% of tumor cells staining for hormone receptors), Grade 3 histological grade, 4 or more nodes positive, presence of extensive peritumoral vascular invasion, OR pathological tumor size greater than 5 cm
LABC (stages IIB, IIIA, IIB) that are ER negative
Evidence of pre-existing peripheral neuropathy as determined by baseline Michigan neuropathy screening instrument score > 2.
Previous chemotherapy treatment of any kind.
AST and ALT >2 times upper limit of normal; Creatinine > 2.0 mg/dL.
Current use of medications or substances known to be associated with peripheral neuropathy.
Use of ALA or other anti-oxidant supplements during the prior three months.
Diabetes mellitus or use of medications known to lower blood sugar.
Participation in any other experimental trial.","Oral administration three times daily (morning, mid-day, night)

Alpha lipoic acid: The baseline dose is 100 mg three times daily for four months. Dose escalation will occur until a maximum tolerated dose is found.",ChEMBL:CHEMBL33864 | DrugBank:DB00166 | PubChem:6112 | PubChem:864,Lipoic acid,O=C(O)CCCCC1CCSS1,A16AX01,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT01313923,NCT01313923_EG000,No,All,Adult | Older Adult,Early Phase 1,3,"Inclusion Criteria:

Subject must be 18 years of age or older.
Subject must have an established diagnosis of pemphigus disorder via biopsy and/or serologic titer, as determined appropriate by the lead researcher.
Subject must have active disease at the time of enrollment, as defined by a positive Nikolsky sign.
Subject must not be taking any immunosuppressive medication or therapy other than corticosteroids.
Subject must be able to understand and follow directions.
If female, subject is not currently breast feeding and/or pregnant as confirmed via negative pregnancy test, no potential for pregnancy, or if of child-bearing age, agrees to using birth control for entire duration of study and 12 weeks after end of study.

Exclusion Criteria:

Subject may not be under 18 years old.
Subject cannot understand or follow directions.
Subject may not have any condition that could, in the opinion of the investigator, compromise the subject's ability to give written consent and/or comply with the study procedures, such as a history of substance abuse or a psychiatric condition.
If female and of child bearing age, is pregnant or unwilling to use birth control during the study period.

Subject may not have any of the following laboratory abnormalities at baseline:

total white blood cell count < 2,000/mm3 or platelet count < 100,000/mm3
creatinine >1.5mg/dL
urine analysis protein of 2+ or greater
fasting triglycerides > 400 mg/dL, fasting total cholesterol > 300 mg/dL, or fasting LDLcholesterol > 160 mg/dL
transaminases > 2 times the upper limit of normal
Subjects may not be using any of the following medications: systemic antifungals, antiepileptics, HIV protease inhibitors, cimetidine, cisapride, clarithromycin, danazol, diltiazem, erythromycin, metoclopramide, rifabutin, rifampin, rifapentine, troleandomycin, or verapamil
Subject may not consume grapefruit juice and/or St. John's Wort (hypericum perforatum) throughout the duration of the study.

Subject may not have other significant concurrent medical conditions, including

Active malignancy, including evidence of cutaneous basal or squamous cell carcinoma or melanoma, or history of cancer (other than fully resected and surgically cured cutaneous basal cell and squamous cell carcinoma) within 5 years before the first 13 of 25 sirolimus dose. If malignancy occurred more than 5 years ago, documentation of disease-free state since treatment is required.
Known immunodeficiency syndromes, including HIV
Renal failure or insufficiency, as defined by laboratory parameters above
Significant proteinuria, as defined by laboratory parameters above
History of high cholesterol, lipids, or liver disease, as defined by laboratory parameters above
Uncontrolled hypertension, as defined by a blood pressure > 140/90 despite optimal medical therapy, as prescribed by primary care doctor
Any condition that, in the opinion of the investigator, might cause this study to be detrimental to the subject
Any active Common Terminology Criteria (CTC) grade 2 (localized infection; requiring local intervention) or higher infection (including chronic or localized infections) within 30 days prior to screening, at screening, or during screening period prior to first dose of sirolimus",No results as study has been terminated early by the investigator.,ChEMBL:CHEMBL413 | DrugBank:DB00877 | PubChem:134760597 | PubChem:138404388 | PubChem:21944094 | PubChem:5284616,Sirolimus,COC1CC2CCC(C)C(O)(O2)C(=O)C(=O)N2CCCCC2C(=O)OC(C(C)CC2CCC(O)C(OC)C2)CC(=O)C(C)C=C(C)C(O)C(OC)C(=O)C(C)CC(C)C=CC=CC=C1C,L01EG04 | L04AA10 | S01XA23,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01314417,NCT01314417_EG000,No,All,Adult | Older Adult,Phase 1 | Phase 2,2,"INCLUSION CRITERIA:

Participant must be 18 years of age or older.
Participant must understand and sign the protocol's informed consent document.
Participant is willing to comply with the study procedures and return for all study visits.

Participant has chronic macular edema secondary to non-infectious panuveitis, posterior or intermediate uveitis in at least one eye (the study eye) that has:

not been responsive to conventional immunosuppressive therapy in the past 3 months; OR
recurred while on conventional immunosuppressive therapy.
Participant has central macular thickness of ≥ 270 microns in the study eye.
Participant has visual acuity of 20/400 or better (≥ 19 ETDRS letters) in the study eye.
Female participants of childbearing potential must not be pregnant or breast-feeding, must have a negative serum pregnancy test at screening and must be willing to undergo serum pregnancy tests throughout the study.

Both female participants of childbearing potential (see Appendix 1 for definition) and male participants able to father children must have (or have a partner who has) had a hysterectomy or vasectomy, be completely abstinent from intercourse or must agree to practice two acceptable methods of contraception throughout the course of the study and for six months after the last study medication injection. Acceptable methods of contraception include:

hormonal contraception (i.e., birth control pills, injected hormones, dermal patch or vaginal ring),
intrauterine device,
barrier methods (diaphragm, condom) with spermicide, or
surgical sterilization (tubal ligation).

EXCLUSION CRITERIA:

Participant is in another investigational study and actively receiving investigational therapy for macular edema.
Participant has evidence of infectious panuveitis, posterior or intermediate uveitis in either eye.
Participant is expected to need ocular surgery in the study eye during the course of the trial.
Participant had intraocular surgery in the study eye within the past 90 days.
Participant had an injection of bevacizumab or ranibizumab within the past four weeks in the study eye.
Participant had an injection of triamcinolone within the past six weeks in the study eye.
Participant has a systemic condition that, in the opinion of the investigator, would preclude participation in the study.
Participant has significant cataract or media opacity in the study eye that makes posterior segment visualization difficult as determined by investigator.
Participant has a confirmed positive serologic and/or molecular test for HIV-1/2.","Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.",ChEMBL:CHEMBL34259 | DrugBank:DB00563 | PubChem:126941,Methotrexate,CN(Cc1cnc2nc(N)nc(N)c2n1)c1ccc(C(=O)N[C@@H](CCC(=O)O)C(=O)O)cc1,L01BA01 | L04AX03,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT01315574,NCT01315574_EG000,No,All,Adult | Older Adult,Phase 4,14,"Inclusion Criteria:

Subjects must be 18 years of age and may be of any race and either gender;

Subjects must not have ever used topical prostaglandin anti-glaucomatous therapy;

Subject has not used anti-glaucomatous treatment in the past 30 days and has not been using prescribed anti-glaucomatous medication for more than 6 months.
Subject is using other topical anti-glaucomatous topical treatment and wants to switch to a prostaglandin (must have undergone 30 day washout period)
The IRB Approved informed consent and the privacy document must be read, signed, and dated by the subject or legally authorized representative before enrollment. Additionally, the informed consent document must be signed and dated by the individual consenting the subject, as well as signed and dated by a witness, if applicable;
Subjects must be generally healthy and have normal ocular health; and
Subjects must be willing to follow the study procedures and visit schedule.

Exclusion Criteria:

Subjects must not have known sensitivities to any ingredient in any of the test articles

Subjects must not have any systemic or ocular disease or disorder (exc refractive error), complicating factors or structural abnormality that would negatively affect the conduct or outcome of the study:

No prior (within 30 days of enrollment) or current ocular infections (bacterial, viral or fungal), active ocular inflammation (i.e., follicular conjunctivitis, allergic conjunctivitis, iritis), glaucoma, or preauricular lymphadenopathy.
No clinically significant lash or lid abnormality (e.g., trichiasis, entropion or ectropion).
No uncontrolled systemic disease or debilitating disease (e.g. cardiovascular disease, hypertension, diabetes, or cystic fibrosis.).
No prior (within 7 days of enrollment) or current, unstable active illness (e.g., upper respiratory infection).
Pregnant woman
Subjects must not have history of ocular surgery/trauma within the last 6 months
Subjects must not have used any topical ocular or systemic antibiotics within 30 days of enrollment continuing throughout the study
Subjects must not have used any topical ocular or systemic corticosteroids within 30 days of enrollment continuing throughout the study
Subjects must not have used immunomodulator medications within 30 days of enrollment continuing throughout the study
Subjects must not have a immune cell density of >60/fame present at their baseline confocal scan
Subjects must not have participated in any other ophthalmic drug or device clinical trial within 30 days of enrollment.
Inability to cooperate with the confocal exam","7 Patients were randomized to receive BAK-containing Xalatan for treatment of their glaucoma.

Latanoprost: One drop Xalatan (0.005% ophthalmic solution) in affected eye once daily.",ChEMBL:CHEMBL1051 | DrugBank:DB00654 | PubChem:5311221,Latanoprost,CC(C)OC(=O)CCC/C=C\C[C@@H]1[C@@H](CC[C@@H](O)CCc2ccccc2)[C@H](O)C[C@@H]1O,S01EE01 | S01EE51,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01316042,NCT01316042_EG001,No,Female,Child,Not Applicable,2,"Inclusion Criteria:

Girls aged 4-10 with pubic hair prior to 8 years of age
Elevated DHEAS level above age normal levels
Informed consent from parents and assent from the girl

Exclusion Criteria:

Diagnosis of incomplete precocious puberty, peripheral precocious puberty, or evidence of any abnormal pituitary, hypothalamic, adrenal, thyroid, and gonadal function other than premature secretion of adrenal androgens.
Chronic illness requiring treatment that may interfere with growth and development, i.e. chronic steroid use, renal failure, etc.
21-hydroxylase deficiency or other enzyme deficiency leading to the phenotype of congenital adrenal hyperplasia. 21-hydroxylase deficiency will be excluded in all patients by a fasting 17-hydroxyprogesterone (17-OHP) level < 2 ng/mL. In the case of elevated fasting 17-OHP levels, an ACTH stimulation test will be performed. A 1-hour stimulated value > 10 ng/mL will be an exclusion 82. As 21 hydroxylase deficiency is a congenital condition, any normal level in the past of 17-hydroxyprogesterone allows entry into this study.
Uncorrected thyroid disease (defined as TSH < 0.2 mIU/ML or > 5.5 mIU/mL). A normal level within the last year is adequate for entry.
Type I or Type II diabetes (defined as a fasting serum glucose > 125mg/dL on two occasions 83), or patients receiving anti-diabetic medications such as insulin, thiazolidinediones, acarbose, or sulfonylureas; patients currently receiving metformin XR for a diagnosis of Type I or Type II diabetes or for PCOS are also specifically excluded.
Liver disease defined as AST or ALT > 2 times normal or total bilirubin > 2.5 mg/dL.
Renal disease defined as BUN > 30 mg/dL or serum creatinine > 1.4 mg/dL.
Significant anemia (Hemoglobin < 10 mg/dL).
History of deep venous thrombosis, pulmonary embolus, or cerebrovascular accident.
Known heart disease (New York Heart Association Class II or higher).
Enrolled simultaneously into other investigative studies that require medications, proscribe the study medications, or otherwise prevent compliance with the protocol. Patients who anticipate taking longer than a one month break during the protocol should not be enrolled.
Concomitant use other medications known to affect reproductive function or metabolism. These medications include growth hormone, IGF-1, medroxyprogesterone acetate, oral contraceptives, GnRH agonists and antagonists, anti-androgens, gonadotropins, anti-obesity drugs, somatostatin, diazoxide, ACE inhibitors, and calcium channel blockers. The washout period on all these medications will be three months.
Suspected adrenal or ovarian tumor secreting androgens or other ectopic steroid secreting tumor.
Suspected Cushing's syndrome.
Lactose intolerance (the placebo filler is lactose).
Known hypersensitivity to study medication, including ACTH and GnRH, or their excipients.
Any concomitant medical condition that in the opinion of the investigator, may expose a subject to unacceptable level of safety risk, or that affects subject compliance.
Subjects who anticipate having any surgery associated with restricted intake of fluids or radiological studies with contrast dye during the study period.
Any concomitant medical condition that in the opinion of the investigator, may expose a subject to unacceptable level of safety risk, or that affects subject compliance.",2 212.5mg pill/day for 12 months,ChEMBL:CHEMBL1431 | DrugBank:DB00331 | PubChem:4091,Metformin,CN(C)C(=N)NC(=N)N,A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01317004,NCT01317004_EG000,No,All,Adult | Older Adult,Phase 4,50,"Inclusion Criteria:

Patients must be diagnosed with relapsing remitting MS (RRMS) as defined by 2005 revised McDonald criteria.
Patients who explicitly agree to be assigned to a treatment group that may receive fingolimod or DMT after having been informed about their respective benefits and possible adverse events by the investigator.
An Expanded Disability Status Scale (EDSS) score of 0-5.5 inclusive.
Must have received continuous treatment with a single approved and indicated MS DMT for a minimum of 6 months prior to the screening visit. Patients must continue with this MS DMT until the randomization visit.
Naïve to treatment with fingolimod.

Exclusion Criteria:

A manifestation of MS other than those defined in the inclusion criteria.
A history of chronic disease of the immune system other than MS or a known immunodeficiency syndrome.
History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
Patients with uncontrolled diabetes mellitus (HbA1c > 7%).
Diagnosis of macular edema during Screening Phase.

Other protocol-defined inclusion/exclusion criteria may apply",Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.,ChEMBL:CHEMBL314854 | DrugBank:DB08868 | PubChem:107970,Fingolimod,CCCCCCCCc1ccc(CCC(N)(CO)CO)cc1,L04AA27,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01318109,NCT01318109_EG000,No,All,Adult,Phase 2 | Phase 3,92,"Inclusion Criteria:

Had been taking metformin at a stable dose regimen (500 mg/day twice daily after meal or 750 mg/day three times daily after meal) for at least 12 weeks prior to the initiation of the treatment period (Week 0).
Had an glycosylated hemoglobin (HbA1c) of 6.5% or more and below 10.0% at 8 weeks after the initiation of the observation period (Week -4).
Had an HbA1c difference between 4 weeks after the initiation of the observation period (Week -8) and 8 weeks after the initiation of the observation period (Week -4) being within 10.0%* of the value at 4 weeks after the initiation of the observation period (Week -8) (*rounded off to the first decimal place).
Was receiving specific diet and exercise (if any) therapies during the observation period.

Exclusion Criteria:

Had taken other diabetic medications than metformin within 12 weeks before the initiation of the treatment period (Week 0).
With a history or symptoms of lactic acidosis.","Alogliptin 12.5 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.",PubChem:66563540,Alogliptin/metformin,CN(C)C(=N)N=C(N)N.Cn1c(=O)cc(N2CCCC(N)C2)n(Cc2ccccc2C#N)c1=O,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01318109,NCT01318109_EG001,No,All,Adult,Phase 2 | Phase 3,96,"Inclusion Criteria:

Had been taking metformin at a stable dose regimen (500 mg/day twice daily after meal or 750 mg/day three times daily after meal) for at least 12 weeks prior to the initiation of the treatment period (Week 0).
Had an glycosylated hemoglobin (HbA1c) of 6.5% or more and below 10.0% at 8 weeks after the initiation of the observation period (Week -4).
Had an HbA1c difference between 4 weeks after the initiation of the observation period (Week -8) and 8 weeks after the initiation of the observation period (Week -4) being within 10.0%* of the value at 4 weeks after the initiation of the observation period (Week -8) (*rounded off to the first decimal place).
Was receiving specific diet and exercise (if any) therapies during the observation period.

Exclusion Criteria:

Had taken other diabetic medications than metformin within 12 weeks before the initiation of the treatment period (Week 0).
With a history or symptoms of lactic acidosis.","Alogliptin 25 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.",PubChem:66563540,Alogliptin/metformin,CN(C)C(=N)N=C(N)N.Cn1c(=O)cc(N2CCCC(N)C2)n(Cc2ccccc2C#N)c1=O,,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01318109,NCT01318109_EG002,No,All,Adult,Phase 2 | Phase 3,100,"Inclusion Criteria:

Had been taking metformin at a stable dose regimen (500 mg/day twice daily after meal or 750 mg/day three times daily after meal) for at least 12 weeks prior to the initiation of the treatment period (Week 0).
Had an glycosylated hemoglobin (HbA1c) of 6.5% or more and below 10.0% at 8 weeks after the initiation of the observation period (Week -4).
Had an HbA1c difference between 4 weeks after the initiation of the observation period (Week -8) and 8 weeks after the initiation of the observation period (Week -4) being within 10.0%* of the value at 4 weeks after the initiation of the observation period (Week -8) (*rounded off to the first decimal place).
Was receiving specific diet and exercise (if any) therapies during the observation period.

Exclusion Criteria:

Had taken other diabetic medications than metformin within 12 weeks before the initiation of the treatment period (Week 0).
With a history or symptoms of lactic acidosis.","Metformin 250 mg, tablets, orally, twice or three times daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.",ChEMBL:CHEMBL1431 | DrugBank:DB00331 | PubChem:4091,Metformin,CN(C)C(=N)NC(=N)N,A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01318135,NCT01318135_EG002,No,All,Adult,Phase 2 | Phase 3,142,"Inclusion Criteria:

Common criteria that applied to participants completing both the core phase 2/3 sulfonylurea add-on study and those completing the core phase 2/3 metformin add-on study:

Had completed the core phase 2/3 sulfonylurea add-on study or the core phase 2/3 metformin add-on study.
Was capable of understanding and complying with protocol requirements.
Signed a written informed consent form prior to the initiation of any study procedure.

Exclusion Criteria:

Common criteria that applied to participants completing both the core phase 2/3 sulfonylurea add-on study and those completing the core phase 2/3 metformin add-on study:

With clinical manifestation of hepatic impairment (eg, an aspartate aminotransferase or alanine aminotransferase value of 2.5 times or more of the upper reference limit at Week 8 of the core phase 2/3 sulfonylurea add-on study or the core phase 2/3 metformin add-on study).
With clinical manifestation of renal impairment (eg, a creatinine value of 1.5 times or more of the upper reference limit at Week 8 of the core phase 2/3 sulfonylurea add-on study or the core phase 2/3 metformin add-on study).
With serious cardiac disease, cerebrovascular disorder, or serious pancreatic or hematological disease (eg, a subject who requires hospital admission).

Criteria that applied only to participants completing the core phase 2/3 metformin add-on study:

1. With history or symptoms of lactic acidosis.","Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.",PubChem:66563540,Alogliptin/metformin,CN(C)C(=N)N=C(N)N.Cn1c(=O)cc(N2CCCC(N)C2)n(Cc2ccccc2C#N)c1=O,,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0
NCT01318135,NCT01318135_EG003,No,All,Adult,Phase 2 | Phase 3,145,"Inclusion Criteria:

Common criteria that applied to participants completing both the core phase 2/3 sulfonylurea add-on study and those completing the core phase 2/3 metformin add-on study:

Had completed the core phase 2/3 sulfonylurea add-on study or the core phase 2/3 metformin add-on study.
Was capable of understanding and complying with protocol requirements.
Signed a written informed consent form prior to the initiation of any study procedure.

Exclusion Criteria:

Common criteria that applied to participants completing both the core phase 2/3 sulfonylurea add-on study and those completing the core phase 2/3 metformin add-on study:

With clinical manifestation of hepatic impairment (eg, an aspartate aminotransferase or alanine aminotransferase value of 2.5 times or more of the upper reference limit at Week 8 of the core phase 2/3 sulfonylurea add-on study or the core phase 2/3 metformin add-on study).
With clinical manifestation of renal impairment (eg, a creatinine value of 1.5 times or more of the upper reference limit at Week 8 of the core phase 2/3 sulfonylurea add-on study or the core phase 2/3 metformin add-on study).
With serious cardiac disease, cerebrovascular disorder, or serious pancreatic or hematological disease (eg, a subject who requires hospital admission).

Criteria that applied only to participants completing the core phase 2/3 metformin add-on study:

1. With history or symptoms of lactic acidosis.","Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.",PubChem:66563540,Alogliptin/metformin,CN(C)C(=N)N=C(N)N.Cn1c(=O)cc(N2CCCC(N)C2)n(Cc2ccccc2C#N)c1=O,,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0
NCT01318278,NCT01318278_EG000,No,All,Child,Not Applicable,10,"Inclusion Criteria:

Infants less than 24 hours of age
Infants with birth weight of <1001 grams and/or gestational age of <29 weeks
Not initiated on any continuous pressor therapy prior to enrollment
Intravenous line in place
Outborn infants meeting eligibility criteria

Exclusion Criteria:

Infants not meeting eligibility criteria
Infants with life-threatening congenital defects
Infants with congenital hydrops
Infants with frank hypovolemia (perinatal history consistent with decreased circulating blood volume plus clinical signs of hypovolemia)
Infants with other unresolved causes of hypotension (air leaks, lung overdistention, or metabolic abnormalities).","Dopamine treatment beginning at 5 mcg/kg/min and titrated by 5 mcg/kg/min to effect up to maximum of 20 mcg/kg/min

Dopamine: dopamine at low/medium/and high dose (5, 10, 15, and 20 mcg/kg/min) given IV as a continuous infusion, titrated up for efficacy",DrugBank:DB00988 | PubChem:681,Dopamine,NCCc1ccc(O)c(O)c1,C01CA04,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01322360,NCT01322360_EG000,No,All,Child,Phase 4,50,"Inclusion Criteria:

parent or guardian provided written parental permission/informed consent, with subject assent (if required by local IRB).
The child is 2 years old through 17 years old, inclusive (at the time of informed consent signing).
A routine pediatric procedure is expected to require inpatient hospitalization postoperatively.
Must be an inpatient for the study treatment period.
Is expected by the investigator to require use of oral opioid for the treatment of postoperative pain.
Has the ability to read and understand the study procedures and has the ability to communicate meaningfully with the study investigator and staff (if the subject is of preverbal age or cannot read or communicate meaningfully, then the subject's parent or guardian must meet this criterion).
Child is expected to experience moderate to severe postoperative pain, in the investigator's opinion, during the immediate postoperative period after discontinuation of intermittent administration of IV opioid (preferably morphine) and is able to tolerate oral medications.
If female subject is of childbearing potential, she must have a negative pregnancy test result at screening (serum) and on the day of surgery prior to surgery (urine).
Must have vascular access to facilitate blood draws.

Exclusion Criteria:

Has significant medical disease(s), laboratory abnormalities, or conditions(s) that in the investigator's judgment could compromise the subject's welfare, ability to communicate with study staff, complete study activities, or would otherwise contraindicate study participation. There is no minimum value for SpO2 for inclusion in the study; this should be based on the investigator's judgment.
Has used opioids chronically (e.g., codeine, morphine, oxycodone, or hydromorphone, for >7 calendar days) within the previous 30 days.
Has known hypersensitivity or contraindication to receiving oral opioid(s).
Has a current active enteral malabsorption disorder.
Has impaired liver function (e.g., alanine aminotransferase [ALT] ≥3 times the upper limit of normal [ULN], or bilirubin ≥3 times ULN), known active hepatic disease (e.g., hepatitis), evidence of clinically significant chronic liver disease or other condition affecting the liver (e.g., chronic hepatitis) that may suggest the potential for an increased susceptibility to hepatic toxicity with oral morphine exposure. Subjects with no previous history of liver function impairment may be enrolled prior to receipt of screening laboratory testing results.
Has significantly impaired renal function or disease, as evidenced by an estimated glomerular filtration rate (i.e., from creatinine levels using the Schwartz formula) calculated to be less than one-third of normal for the applicable age of this study population. Subjects with no previous history of kidney function impairment may be enrolled prior to receipt of screening laboratory testing results.
Has a history of substance abuse or there is evidence of current substance abuse, in the investigator's opinion.
Has received epidural or regional anesthesia within 12 hours prior to the first dose of oral morphine sulfate.
Has participated in an interventional clinical study (investigational or marketed product) within 30 days before screening, or plans to participate in another clinical trial in the next 30 days.",Morphine sulfate oral solution and Morphine sulfate tablets,PubChem:16051935,Morphine Sulfate,CN1CCC23c4c5ccc(O)c4OC2C(O)C=CC3C1C5.CN1CCC23c4c5ccc(O)c4OC2C(O)C=CC3C1C5.O=S(=O)(O)O,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT01323153,NCT01323153_EG000,No,All,Adult | Older Adult,Phase 3,148,"Inclusion Criteria:

Adult patients, >/=45 years of age
Patients admitted to the hospital for acute coronary syndrome (ACS)
Patients receiving guideline-based medical and dietary management of dyslipidemia

Exclusion Criteria:

Symptomatic congestive heart failure (NYHA Class III or IV)
Clinically significant heart disease requiring coronary artery bypass grafting, cardiac transplantation, surgical valve repair/replacement during the study
Uncontrolled hypertension
Uncontrolled diabetes
Severe anemia
Concomitant treatment with any other drug raising high-density lipoprotein C (HDL-C; eg niacin, fibrates)",dalcetrapib: Oral doses of 600 mg once daily for 20 weeks,ChEMBL:CHEMBL313006 | DrugBank:DB12181 | PubChem:6918540,Dalcetrapib,CCC(CC)CC1(C(=O)Nc2ccccc2SC(=O)C(C)C)CCCCC1,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01324999,NCT01324999_EG000,No,All,Adult | Older Adult,Phase 2 | Phase 3,12,"Inclusion Criteria:

Biopsy proven sarcoidosis
Mean pulmonary artery pressure > 25 mmHg at rest or greater than 30 mmHg with exercise by right heart catheterization within 1 year prior to entry into study
Pulmonary capillary wedge pressure ≤ 15 mmHg
PVR values ≥ 3.0 Woods units
Forced vital capacity (FVC) > 40% predicted
Forced expiratory volume in 1 second (FEV1) > 40% predicted
WHO functional class II or III
Stable sarcoidosis treatment regimen for three months prior to entry into study
6 minute walk distance between 150-450 meters
Stable dose of antihypertensive medications
On no other medication to treat PAH (sildenafil, vardenafil, treprostinil, epoprostenol, iloprost, bosentan, ambrisentan) within one month prior to enrollment and during duration of the study
Non-pregnant females

Exclusion Criteria:

Exercise limitation related to a non-cardiopulmonary reason (e.g. arthritis)
Severe systemic hypertension > 170/95
Severe systemic hypotension < 90/50
History of priapism
Patients with congestive heart failure (left ventricular dysfunction) LVEF < 45% by echocardiogram
Anticipation by the investigator for escalation in sarcoidosis treatment during the course of the study
Pulmonary hypertension related to etiology other than sarcoidosis (i.e. HIV, scleroderma, chronic thromboemboli)
Use within 1 month of an sildenafil or vardenafil
WHO functional class IV status
Patients with severe other organ disease felt by investigators to impact on survival during the course of the study
Subjects with liver function abnormalities (ALT or AST > 3 times the upper limit of normal at screening or at baseline) or chronic liver disease
Advanced kidney failure (GFR < 30 ml/min at screening or at baseline)
History of hypersensitivity reaction or adverse effect related to tadalafil
Pregnant or lactating women
Concomitant use of nitrates (any form) either regularly or intermittently
Concomitant use of potent CYP3A inhibitors (eg, ritonavir, ketoconazole, itraconazole)
Any additional contraindications and precautions specified in the package inserts for Tadalafil (Adcirca) not listed above",40 mg daily,ChEMBL:CHEMBL779 | DrugBank:DB00820 | PubChem:110635,Tadalafil,[H][C@]12Cc3c([nH]c4ccccc34)[C@@H](c3ccc4c(c3)OCO4)N1C(=O)CN(C)C2=O,C02KX52 | C02KX54 | G04BE08 | G04CA54 | G04CB51,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT01328782,NCT01328782_EG000,No,All,Child,Not Applicable,124,"Inclusion Criteria:

ASA class I, II or III
Patients 4-12 years old requiring general anesthesia for closed reduction and percutaneous pinning (CRPP) of supracondylar type elbow fractures (SCEFx).
Patients able to understand and report their pain with the Faces Pain Scale Revised

Exclusion Criteria:

Medical contraindications to analgesic therapy.
Known allergy or sensitivity to analgesic agent.
Clinical evidence of skin inflammation precluding the 'clean' area at the site of injection.
Patients lacking the cognitive understanding to report their pain with the FSP-R (unable to complete seriation task).
Patients necessitating open reduction due to inability to obtain an acceptable closed reduction.
Comorbid diagnosis of other traumatic injury that causes any local and or global pain.
Patients presenting to ER with neurovascular injury or compartment syndrome due to fracture.
For patients in either of the two intervention arms, if after three attempts, the intraarticular injection is not successful, the patient will be dropped from the study.
Patients admitted for complications directly related to the surgery will be dropped from analysis. Any such event will be immediately reported to COMIRB with in five business days. However, patients admitted due to a late afternoon/evening surgery and patients admitted for standard observational purposes unrelated to surgical complications, will not be dropped from the study.
Known drug allergy to oxycodone and or acetaminophen.
Children 4-7 years old weighing less than 14 kg (Weight exclusion criteria is based on a 4 year old female that is below the fifth percentile for weight, per the Center for Disease Control Growth Charts).
Children 8-12 years old weighing less than 20 kg (Weight exclusion criteria based on an 8 year old female that is below the fifth percentile for weight, per the Center for Disease Control Growth Charts).",This group will receive Oxycodone with Acetaminophen orally,ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01328782,NCT01328782_EG002,No,All,Child,Not Applicable,124,"Inclusion Criteria:

ASA class I, II or III
Patients 4-12 years old requiring general anesthesia for closed reduction and percutaneous pinning (CRPP) of supracondylar type elbow fractures (SCEFx).
Patients able to understand and report their pain with the Faces Pain Scale Revised

Exclusion Criteria:

Medical contraindications to analgesic therapy.
Known allergy or sensitivity to analgesic agent.
Clinical evidence of skin inflammation precluding the 'clean' area at the site of injection.
Patients lacking the cognitive understanding to report their pain with the FSP-R (unable to complete seriation task).
Patients necessitating open reduction due to inability to obtain an acceptable closed reduction.
Comorbid diagnosis of other traumatic injury that causes any local and or global pain.
Patients presenting to ER with neurovascular injury or compartment syndrome due to fracture.
For patients in either of the two intervention arms, if after three attempts, the intraarticular injection is not successful, the patient will be dropped from the study.
Patients admitted for complications directly related to the surgery will be dropped from analysis. Any such event will be immediately reported to COMIRB with in five business days. However, patients admitted due to a late afternoon/evening surgery and patients admitted for standard observational purposes unrelated to surgical complications, will not be dropped from the study.
Known drug allergy to oxycodone and or acetaminophen.
Children 4-7 years old weighing less than 14 kg (Weight exclusion criteria is based on a 4 year old female that is below the fifth percentile for weight, per the Center for Disease Control Growth Charts).
Children 8-12 years old weighing less than 20 kg (Weight exclusion criteria based on an 8 year old female that is below the fifth percentile for weight, per the Center for Disease Control Growth Charts).",This group will receive an intra-articular shot of ropivacaine during surgery and will be sent to the recovery room to receive pain medicine as needed.,PubChem:53262281,Naropin,CCC[NH+]1CCCCC1C(=O)Nc1c(C)cccc1C.O.[Cl-],,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01333501,NCT01333501_EG000,No,All,Adult,Phase 4,104,"Inclusion Criteria:

Patients with relapsing-remitting forms of MS defined by 2005 revised McDonald criteria.
Patients with active disease, defined as at least one clinical relapse in the last year, or two clinical relapses in the last two years if there are signs of disease activity at one brain MRI scan performed in the last six months.
Patients with cognitive impairment at screening, defined as at least one test of the Rao's Brief Repeatable Battery with scores falling outside the 90th percentile of the normative data.

Exclusion Criteria:

Patients who had already been treated with multiweekly interferon (interferon beta 1b, or beta 1a multiweekly) and had an unsatisfactory response according to the judgment of the investigator.
Patients with hyperactive forms of the MS disease according to the judgment of the investigator.
Patients with an EDSS score higher than 5.
Patients with a prior or current diagnosis of Major Depression according to DSM-IV.
Patients with a history of chronic disease of the immune system other than MS such as known immunodeficiency syndrome.

Other protocol-defined inclusion/exclusion criteria may apply",0.5 mg in capsules for oral administration once daily,ChEMBL:CHEMBL314854 | DrugBank:DB08868 | PubChem:107970,Fingolimod,CCCCCCCCc1ccc(CCC(N)(CO)CO)cc1,L04AA27,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,1.0,1.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01334125,NCT01334125_EG000,No,All,Child | Adult,Phase 3,15,"Inclusion Criteria:

A. General inclusion criteria

Ten to 20 years of age.
Pubertal (Tanner stages 2-5, by examination).
Hemoglobin A1c level of > 8.0% in the 6 months prior to enrollment.
All subjects must have access to a computer.

B. Specific inclusion criteria: [Subjects could have either #1, or #2].

Subjects with clinical and biochemical features of T2DM of > 6mo duration who also have positive T1DM antibodies

Clinical features: acanthosis nigricans, BMI >85%
Biochemical: evidence of insulin resistance at diagnosis
fasting insulin >27 uIU/mL(normal range 6-27) at a fasting blood glucose of ≥ 126 mg/dL, or
fasting c-peptide level of > 7.1 ng/mL (normal range 0.9 - 7.1), or
Homeostasis model of insulin resistance of >3.16

Patients with T1DM of > one yr duration with BMI >85%

Presentation with ketoacidosis at diagnosis
C-peptide <0.9 ng/mL (normal range 0.9 - 7.1),or (insulin < 6 uIU/mL) (NR 6-27) at diagnosis (when blood glucose is ≥ 126 mg/dL)
Can be antibody positive or negative
Increased insulin requirement (>2 Units/kg/day)

Exclusion Criteria:

Subjects on weight altering medications, such as orlistat.
Subjects with eating disorder
Subjects on medications other than insulin and or metformin that may affect blood glucose level.
Subjects with abnormal hepatic function tests.
Subjects with nephropathy, defined in this case as an overnight albumin excretion rate of >200 mcg/min using a first morning urine sample collection.
Subjects with recurrent diabetes ketoacidosis (more than 2 episodes in the past 12 months), or recurrent severe hypoglycemia (more than 2 episodes of hypoglycemia with altered level of consciousness, requiring assistance to treat in the past year).
Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures.
Known or suspected allergy to metformin.
The receipt of any investigational drug within 6 months prior to this trial.
Active malignant neoplasms.
No access to a computer.
Subjects currently taking metformin for clinical purposes are not eligible to be enrolled in this study.","Metformin 1000 mg once daily by mouth for 9 months

Metformin: Metformin 1000 mg once daily by mouth for 9 months",ChEMBL:CHEMBL1431 | DrugBank:DB00331 | PubChem:4091,Metformin,CN(C)C(=N)NC(=N)N,A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27,0.0,0.0,0.0,0.0,1.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01335204,NCT01335204_EG000,No,Male,Adult | Older Adult,Phase 1 | Phase 2,4,"Inclusion Criteria:

Written informed consent has been obtained.
Adults 18 years of age or older with a life expectancy of at least 3 months.
Histologically confirmed castration-resistant prostate cancer (CRPC). Patient must have demonstrated a rising PSA level above the androgen-deprivation therapy (ADT) nadir, on at least two determinations four weeks or more apart. ADT is defined as treatment with a Luteinizing-hormone-releasing hormone (LHRH) agonist or orchiectomy.
Treatment with only one prior chemotherapy regimen, which must contain docetaxel as a single agent or in combination with other agents. Patients may be intolerant of, or resistant to, the cytotoxic drug combination.
Patients on ADT must be willing to continue ADT for the duration of their participation in this protocol. ADT cannot be initiated, and ADT dose/agents may not be changed during the study.
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
Adequate hematologic function (absolute neutrophil count [ANC] ≥ 1,500 cells/μL; hemoglobin ≥ 8 g/dL, platelets ≥ 100,000/μL).
Adequate renal function (serum creatinine ≤ 1.5 mg/dL or calculated creatinine clearance ≥ 60 mL/min).
Adequate hepatic function (bilirubin ≤ 1.0 x upper limit of normal [ULN], alanine aminotransferase [ALT] ≤ 1.5 x ULN, aspartate aminotransferase [AST] ≤ 1.5 x ULN).
Prothrombin time (PT) / international normalized ratio (INR) ≤ 1.5 × ULN.
Activated partial thromboplastin (aPTT) time ≤ 1.5 × ULN.
Prostate-specific antigen (PSA) level of at least 2 ng/mL.
New York Heart Association classification I or II.
All patients of reproductive potential must agree to use an approved form of contraception (as determined by the investigator).

Exclusion Criteria:

Known history of bleeding diathesis or coagulopathy (e.g., von Willebrand disease or hemophilia).
Any history of thromboembolic events (e.g., deep vein thrombosis or pulmonary thromboembolism); central venous catheter-related thrombosis > 6 months before Screening is allowed.
Ongoing therapy with oral or parenteral anticoagulants; patients on low-dose anticoagulants to maintain patency of central venous catheters are eligible.
Grade 2 or higher peripheral neuropathy (e.g., numbness, tingling, and/or pain in distal extremities).
Radiotherapy (teletherapy or brachytherapy) , chemotherapy or estrogen agonist within 28 days before Study Day 1.
Systemic radiotherapy (Sm-153, Sr-89) within 56 days before study day 1.
Symptomatic or clinically active brain metastases.
Major surgery within 28 days of Study Day 1.
Uncontrolled intercurrent disease (eg, diabetes, hypertension, thyroid disease).
Any history of cerebrovascular accident, or transient ischemic attack at any time, or history of symptomatic coronary artery disease < 6 months before screening.
A history of any condition requiring anti-platelet therapy (eg, phosphodiesterase inhibitors, adenosine diphosphate receptor antagonists), with the exception of general cardiovascular prophylaxis with aspirin (≤ 325 mg/day).
Serious non-healing wound (including wound healing by secondary intention, ulcer, or bone fracture).
Known chronic infection with human immunodeficiency virus (HIV) or viral hepatitis.
Contraindication to intravenous (IV) contrast media.","Cabazitaxel (25 mg/m2) will be administered IV on Day 1 of each 21-day treatment cycle. Bavituximab (3 mg/kg) will be administered as an IV infusion on a weekly basis (Cycle 1 Day 2, all other cycles Day 1; day 8; day 15) for 8 cycles.

Cabazitaxel plus bavituximab: Cabazitaxel (25 mg/m2) will be administered IV on Day 1 of each 21-day treatment cycle, and bavituximab (3 mg/kg) will be administered as an IV infusion on a weekly basis (Cycle 1 Day 2, all other cycles Day 1; day 8; day 15) for 8 cycles.",ChEMBL:CHEMBL1201748 | DrugBank:DB06772 | PubChem:9854073,Cabazitaxel,[H][C@]12[C@H](OC(=O)c3ccccc3)[C@]3(O)C[C@H](OC(=O)[C@H](O)[C@@H](NC(=O)OC(C)(C)C)c4ccccc4)C(C)=C([C@@H](OC)C(=O)[C@]1(C)[C@@H](OC)C[C@H]1OC[C@]12OC(C)=O)C3(C)C,L01CD04,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,1.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0
NCT01339689,NCT01339689_EG000,No,All,Adult,Phase 2,59,"Key Inclusion Criteria:

Veteran or civilian adult outpatients 18-55 years of age, with primary PTSD as defined by Diagnostic and Statistical manual of Mental Disorders-IV (DSM-IV) for at least 6 months
Must be in general good health-confirmed by medical history, physical examination, and screening laboratory results
Negative urine drug screen for drugs of abuse
Negative urine pregnancy test for females of childbearing potential
Sexually active participants are required to use a medically acceptable form of birth control

Key Exclusion Criteria

Clinically unstable medical disease; progressive CNS disorder/disease; history of seizures (except childhood febrile seizure); moderate or severe traumatic brain injury (TBI)
Females who are pregnant or currently breast feeding
Current or past psychotic disorder, bipolar Type I disorder, or dementia
Participants with recent drug abuse or dependency (excluding nicotine and caffeine)
Participants unwilling to comply with the required alcohol prohibition during the trial
Current suicidal or homicidal ideation necessitating intervention, and those with a history of suicide attempt in the past 10 years
Participants with pending litigation related to the traumatic event
Participants who are unwilling to withhold grapefruit or grapefruit juice for the duration of the study
Participants receiving psychotherapy without a stable paradigm for at least 3 months
Non-English speaking participants.","active Ganaxolone: 200-600 mg bid, capsules, up to 12 weeks",ChEMBL:CHEMBL1568698 | DrugBank:DB05087 | PubChem:6918305,Ganaxolone,[H][C@@]12CC[C@]3([H])[C@]([H])(CC[C@]4(C)[C@@H](C(C)=O)CC[C@@]34[H])[C@@]1(C)CC[C@@](C)(O)C2,N03AX27,0.0,0.0,0.0,1.0,0.0,1.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT01340300,NCT01340300_EG002,No,All,Adult | Older Adult,Phase 2,35,"Inclusion Criteria:

Histologically confirmed stage I-III colorectal or breast cancer
Undergone curative-intent complete surgical resection and completed all adjuvant therapy (if indicated) at least 2 months prior to enrollment
Note: Breast cancer subjects on hormonal therapy or trastuzumab only therapy and colorectal cancer subjects on adjunctive therapies not considered cytotoxic chemotherapy (including those participating in CALGB 80702 receiving only celecoxib/placebo) are eligible.
Participants will be allowed to receive concomitant adjuvant endocrine therapy for breast cancer; however, all endocrine agents must be initiated at least 1 month prior to enrollment in the study and continued throughout the duration of study participation.
Less than 120 minutes of exercise per week
Approval by oncologist or surgeon
English speaking and able to read English
No planned surgery anticipated in the 3 month intervention period
At least one month from any major surgery to start of intervention including colostomy reversal

Exclusion Criteria:

Concurrent other malignancy or history of other malignancy treated within the past 3 years (other than non-melanoma skin cancer or in-situ cervical cancer)
Metastatic disease
Scheduled to receive any form of further adjuvant cancer therapy
Currently on medication for diabetes treatment
Pregnant or breast-feeding
Any condition associated with increased risk of metformin-associated lactic acidosis (prior renal failure or liver failure, history of acidosis of any type; habitual intake of 3 or more alcoholic beverages per day)
Known hypersensitivity or intolerance to metformin","Metformin

Metformin: Oral metformin QD for two weeks, then BID",ChEMBL:CHEMBL1431 | DrugBank:DB00331 | PubChem:4091,Metformin,CN(C)C(=N)NC(=N)N,A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01345682,NCT01345682_EG001,No,All,Adult | Older Adult,Phase 3,160,"Inclusion criteria:

Histologically or cytologically confirmed R/M HNSCC of the oral cavity, oropharynx, hypopharynx or larynx, not amenable for salvage surgery or radiotherapy
Documented progressive disease based on investigator assessment according to Response Evaluation Criteria in Solid Tumours (RECIST) following receipt of at least two cycles of cisplatin or carboplatin administered for R/M disease
Measurable disease according to RECIST
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

Exclusion criteria:

Progressive disease within three months of completion of curatively intended treatment for locoregionally advanced or metastatic HNSCC
Any other than one previous platinum based systemic regimen given for R/M disease
Prior treatment with epidermal growth factor receptor (EGFR)-targeted small molecules
Pregnancy or breast feeding","Intravenous bolus injection of Methotrexate Starting dose 40 milligram per square meter mg/m² weekly; escalation to 50 mg/m² and / or dose reduction to 40 mg/m² (if applicable), 30 mg/m², and 20 mg/m² (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.",ChEMBL:CHEMBL34259 | DrugBank:DB00563 | PubChem:126941,Methotrexate,CN(Cc1cnc2nc(N)nc(N)c2n1)c1ccc(C(=O)N[C@@H](CCC(=O)O)C(=O)O)cc1,L01BA01 | L04AX03,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,1.0,1.0,1.0,1.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0
NCT01349569,NCT01349569_EG000,No,All,Adult | Older Adult,Phase 2,16,"Inclusion Criteria:

Myeloma eligibility criteria are the following:

sustained near complete remission (nCR) for 4 months defined as no measurable M-spike and a positive immunofixation
early biochemical relapse as manifest by going from a true CR (immunofixation negative) to a nCR (immunofixation positive) at any time
conversion from a nCR to the appearance of a monoclonal spike in the serum not greater than 0.3mg/dL
age 18 years and older
Eastern Cooperative Oncology Group performance scores 0-2
History of measurable serum or urine M protein or free light chains
Life expectancy greater than 12 months
Corrected serum calcium < 11 mg/dL, and no evidence of symptomatic hypercalcemia
Serum creatinine< 2
Absolute Neutrophil Count >1000
Platelet >100,000
Total bilirubin less than or equal to 1.5 x Upper limit of normal
Aspartate aminotransferase and Alanine transaminase less than or equal to 3 x Upper limit of normal
Negative pregnancy test if applicable
Ability to comprehend and have signed the informed consent.
Disease free of prior malignancies for < 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma ""in situ"" of the cervix or breast.
All study participants must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist®.
Females of childbearing potential (FCBP)† must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days prior to and again within 24 hours of prescribing lenalidomide (prescriptions must be filled within 7 days) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy. See Appendix: Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable Birth Control Methods.
Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to aspirin may use warfarin or low molecular weight heparin).

Exclusion Criteria:

Disease progression after stopping corticosteroids as defined as the appearance of an M-spike >0.5g/dL
Patients with a known diagnosis of POEMS syndrome, plasma cell leukemia, non-secretory myeloma and amyloidosis.
HIV disease, active infection requiring treatment with antibiotics, anti-fungal or anti-viral agents within 2 weeks of enrollment would be excluded from the study.
Patients who have participated in any clinical trial, within four weeks prior to registration on this trial, which involved an investigational drug.
History of an active malignancy other than myeloma
Autoimmune disease requiring active treatment.
Known contra-indication to any component of Prevnar 13 including the diphtheria toxoid-containing vaccine.
History of latex allergy
History of an autologous stem cell transplant within the past 12 months or less
History of an allogeneic transplant","Lenalidomide: Dosage forms: 5, 10, 15 and 25 mg capsules. Patients will be continued on the same dose of lenalidomide as they were prior to being enrolled in the study. Doses of lenalidomide for investigation can vary from 5- 25 mg/day, orally on days 1 - 21 followed by 7 days rest (28 day cycle).

Allogeneic Myeloma Vaccine: A total of 4 vaccines will be administered. The first three at monthly intervals and a booster at 6 months from the initial vaccine. Each vaccination will consist of five total intra-dermal injections, two each in the right and left anterior upper thighs, and one in the non-dominant upper arm (unless contraindicated). Each dose will be administered on an outpatient basis. The subject must be observed in the clinic for at least 30 minutes after vaccination is completed.

Prevnar-13 will be administered at 0.5ml dose by intramuscular injection at the same time as GVAX vaccine.",ChEMBL:CHEMBL848 | DrugBank:DB00480 | PubChem:216326,Lenalidomide,Nc1cccc2c1CN(C1CCC(=O)NC1=O)C2=O,L04AX04,0.0,1.0,0.0,0.0,0.0,1.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,1.0,1.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT01351753,NCT01351753_EG000,No,All,Adult | Older Adult,Phase 2,136,"Inclusion Criteria:

Age 40 to 75 years
Male or postmenopausal female
BMI ≥ 30 kg/m2
One or more major cardiovascular (CV) risk factors (hypertension, dyslipidemia, impaired glucose tolerance OR metabolic syndrome)

Exclusion Criteria:

Congestive heart failure
Renal impairment
History of bariatric surgery (i.e. lap-band, Roux-en-Y or biliopancreatic diversion)
Type I diabetes mellitus
Weight loss > 10% in the past 6 months
Recurrent nephrolithiasis
Current treatment for seizure disorder
Hepatic cirrhosis
Current use of study medications
Current use of oral estrogen
History of smoking cessation in the past three months
Current cholestasis or malabsorption syndrome
Planned use of any herbal or over-the-counter supplements for weight loss
History of allergic reactions to metformin, topiramate, orlistat or any of ingredients
Medical conditions requiring continuous use of phosphodiesterase inhibitors and/or the inability to withhold phosphodiesterase inhibitors for 48 hours
Participation in another clinical drug study within four weeks prior to this investigation.
Participation in any other weight loss or rigorous exercise program.
Any disease or condition that in the opinion of the investigator may interfere with completion of the study",Metformin only,ChEMBL:CHEMBL1431 | DrugBank:DB00331 | PubChem:4091,Metformin,CN(C)C(=N)NC(=N)N,A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01351753,NCT01351753_EG003,No,All,Adult | Older Adult,Phase 2,136,"Inclusion Criteria:

Age 40 to 75 years
Male or postmenopausal female
BMI ≥ 30 kg/m2
One or more major cardiovascular (CV) risk factors (hypertension, dyslipidemia, impaired glucose tolerance OR metabolic syndrome)

Exclusion Criteria:

Congestive heart failure
Renal impairment
History of bariatric surgery (i.e. lap-band, Roux-en-Y or biliopancreatic diversion)
Type I diabetes mellitus
Weight loss > 10% in the past 6 months
Recurrent nephrolithiasis
Current treatment for seizure disorder
Hepatic cirrhosis
Current use of study medications
Current use of oral estrogen
History of smoking cessation in the past three months
Current cholestasis or malabsorption syndrome
Planned use of any herbal or over-the-counter supplements for weight loss
History of allergic reactions to metformin, topiramate, orlistat or any of ingredients
Medical conditions requiring continuous use of phosphodiesterase inhibitors and/or the inability to withhold phosphodiesterase inhibitors for 48 hours
Participation in another clinical drug study within four weeks prior to this investigation.
Participation in any other weight loss or rigorous exercise program.
Any disease or condition that in the opinion of the investigator may interfere with completion of the study",Topiramate only,ChEMBL:CHEMBL220492 | DrugBank:DB00273 | PubChem:5284627,Topiramate,[H][C@@]12OC(C)(C)O[C@]1([H])CO[C@@]1(COS(N)(=O)=O)OC(C)(C)O[C@]12[H],A08AA51 | N03AX11,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01361217,NCT01361217_EG000,Accepts Healthy Volunteers,All,Adult,Not Applicable,10,"Inclusion Criteria:

Subjects must be 18-50 years old.
Subjects must be currently in good health with normal gastrointestinal and heart function (as determined by medical history)
Laboratory values indicating normal liver (Serum Albumin 3.9 - 5.0 g/dL, Total Bilirubin < 1.4mg/dL, Alanine Transaminase 9 - 60 IU/L and Aspartate Transaminase 10 - 40 IU/L) and kidney (Serum Creatinine < 1.5 mg/dL and Blood Urea Nitrogen 7 - 20 mg/dL) function as well as normal blood glucose values (Fasting Blood Glucose < 100 mg/dL).
Subjects must have no known allergies to fluoxetine or other selective serotonin reuptake inhibitors (SSRIs), monoamine oxidase inhibitors (MAOIs), benzodiazepine drugs, caffeine, omeprazole, dextromethorphan, lovastatin or any chemically related drug.
Women of childbearing age must be willing to use measures to avoid conception during the study period and willing to have a pregnancy test on Study Days 1 and 16.
Subjects must agree not to take any known substrates, inhibitors, inducers or activators of cytochrome P450 (CYP) CYP1A2, CYP3A4, CYP2C19 and CYP2D6 for two weeks before the start of each study through three weeks after the last day of study. This list includes but is not restricted to antidepressant and antipsychotic agents, azole antifungal agents, macrolide antibiotics, anti-epileptic medications, antihypertensive agents and cholesterol lowering agents. They must also be willing to avoid ingesting grapefruit, grapefruit juice or other grapefruit containing products, and any herbal-based nutrient supplement or medication for the same period of time. Use of oral contraceptives will be permitted.
Subjects must be willing to avoid caffeine-containing foods, beverages, or dietary supplements for 24 hrs prior to and throughout each study session and avoid alcohol for 48 hrs prior to and throughout each study session.
Subjects must be willing to avoid heavy exercise during the study

Exclusion Criteria:

Current cigarette smoker
History of liver, kidney, gastrointestinal or heart disease
Lab test results indicative of abnormal liver or kidney function, or diabetes (see above inclusion criteria).
Allergy to any monoamine oxidase inhibitors (MAOIs) or any other chemically related drug or to benzodiazepine drug
Prior experience of side effects to fluoxetine or other selective serotonin reuptake inhibitors (SSRIs)
CYP2D6 or CYP2C19 poor metabolizer genotype or CYP3A5 expressor genotype
Recent ingestion (< 2 weeks) of any medication known to be metabolized by or alter CYP1A2, CYP3A4, CYP2C19 or CYP2D6 activity
A positive pregnancy test or breastfeeding
History of diabetes, peptic ulcer or inflammatory bowel disease
Overweight; a body mass index ≥ 30 or underweight; a body mass index of ≤ 18
Use of chronic prescription or over-the-counter medications (except oral contraceptives)
Use of antidepressants during the last two weeks preceding the study","Only arm in the study. Successive Control (Study Days 1 and 3) and fluoxetine multiple-dose treatment (Study Days 16 and 18) Sessions.

Fluoxetine: 1x20mg oral fluoxetine capsules by mouth daily on Study Day 5, then 3x20mg fluoxetine capsules by mouth daily on Study Days 6 through 18.",ChEMBL:CHEMBL41 | DrugBank:DB00472 | PubChem:3386,Fluoxetine,CNCCC(Oc1ccc(C(F)(F)F)cc1)c1ccccc1,N06AB03 | N06CA03,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01362998,NCT01362998_EG000,Accepts Healthy Volunteers,Female,Adult,Not Applicable,2,"Inclusion Criteria:

Patients having an elective Cesarean section
Healthy women (ASA I or II)
Regional anesthesia candidates

Exclusion Criteria:

Morbid obesity (BMI>40)
Sleep apnea
Age under 18
Intolerance or addiction to opioids","This group will receive 3mg of preservative free morphine epidurally during the procedure.

Preservative free morphine: 3mg given epidurally during the Cesarean section.",PubChem:6321225,Morphine sulfate pentahydrate,CN1CCC23c4c5ccc(O)c4OC2C(O)C=CC3C1C5.CN1CCC23c4c5ccc(O)c4OC2C(O)C=CC3C1C5.O.O.O.O.O.O=S(=O)(O)O,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01362998,NCT01362998_EG001,Accepts Healthy Volunteers,Female,Adult,Not Applicable,2,"Inclusion Criteria:

Patients having an elective Cesarean section
Healthy women (ASA I or II)
Regional anesthesia candidates

Exclusion Criteria:

Morbid obesity (BMI>40)
Sleep apnea
Age under 18
Intolerance or addiction to opioids","This group will receive an epidural infusion of fentanyl (60 micrograms per hour), which will be started during the Cesarean section and which will continue for the next two days.

Fentanyl: An infusion of epidural fentanyl started during the Cesarean section. It will be given on a patient controlled analgesia basis, with a basal rate of 60 micrograms, a demand dose of 16 micrograms, and a lockout of 15 mins.",ChEMBL:CHEMBL596 | DrugBank:DB00813 | PubChem:3345,Fentanyl,CCC(=O)N(c1ccccc1)C1CCN(CCc2ccccc2)CC1,N01AH01 | N01AH51 | N02AB03,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01365130,NCT01365130_EG000,No,All,Adult | Older Adult,Phase 2,13,"Inclusion Criteria:

Patients are required to have histologically or pathologically confirmed metastatic gastric or esophageal adenocarcinoma.
Patients must demonstrate relapse or progression after at least one prior line of chemotherapy for metastatic disease.
Patients must have measurable disease by CT scan or MRI
Absolute neutrophil count ≥ 1,500/uL, platelet ≥ 100,000/uL and Hgb > 8.0 g/dl.
Total bilirubin ≤ upper institutional limit of normal (ULN), and AST or ALT ≤ 3x ULN; if liver metastases then AST or ALT < 5x ULN
Peripheral neuropathy must be ≤ Grade 1
Creatinine < 2 x ULN
ECOG performance status 0 to 2
Minimum life expectancy of 12 weeks.
Age older than 18 years.
Voluntary, signed written informed consent.
Women of childbearing potential must have a negative pregnancy test Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter.

Exclusion Criteria:

History of severe hypersensitivity reaction to Cabazitaxel or other drugs formulated with polysorbate 80.
Patients with known, untreated brain metastasis
Any uncontrolled severe, intercurrent illness.
Women who are breast-feeding.
Patients who have undergone major surgery, chemotherapy, or radiotherapy within the last 3 weeks.
Patients on concurrent anticancer therapy","patients will receive Jevtana 25mg/m2, IV every 21 days until disease progression or unacceptable toxicity

jevtana: Cabazitaxel 25mg/m2, IV every 21 days until progression",ChEMBL:CHEMBL1201748 | DrugBank:DB06772 | PubChem:9854073,Cabazitaxel,[H][C@]12[C@H](OC(=O)c3ccccc3)[C@]3(O)C[C@H](OC(=O)[C@H](O)[C@@H](NC(=O)OC(C)(C)C)c4ccccc4)C(C)=C([C@@H](OC)C(=O)[C@]1(C)[C@@H](OC)C[C@H]1OC[C@]12OC(C)=O)C3(C)C,L01CD04,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01366976,NCT01366976_EG000,No,All,Adult | Older Adult,Not Applicable,30,"Inclusion Criteria:

Subjects, 18 to 80 years of age, scheduled for elective cardiac surgery requiring CPB
For female subjects, the following conditions must be met:

postmenopausal for at least 1 year, or status-post surgical sterilization, or if of childbearing potential, utilizing adequate birth control and a negative urine beta-hcg prior to drug treatment

Exclusion Criteria:

Allergic reaction to ApAP (acetaminophen)
Evidence of severe hepatic impairment (history of liver cirrhosis or total bilirubin >2.0mg/dl)
Impaired renal function (serum creatinine >2.0 mg/dl)
Emergency surgery
Pregnancy
Breast-feeding
Any underlying or acute disease requiring regular medication which could possibly pose a threat to the subject or make implementation of the protocol or interpretation of the study results difficult
History of alcohol or drug abuse
Treatment with any investigational drug in the 1 month preceding the study
Mental conditions rendering the subject unable to understand the nature, scope and possible consequences of the study
Inability to comply with the protocol, e.g. uncooperative attitude and unlikelihood of completing the study
History or evidence of active asthma",IV Acetaminophen 1g every 6 hours for 4 doses over a 24 hours study period,ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01366976,NCT01366976_EG001,No,All,Adult | Older Adult,Not Applicable,30,"Inclusion Criteria:

Subjects, 18 to 80 years of age, scheduled for elective cardiac surgery requiring CPB
For female subjects, the following conditions must be met:

postmenopausal for at least 1 year, or status-post surgical sterilization, or if of childbearing potential, utilizing adequate birth control and a negative urine beta-hcg prior to drug treatment

Exclusion Criteria:

Allergic reaction to ApAP (acetaminophen)
Evidence of severe hepatic impairment (history of liver cirrhosis or total bilirubin >2.0mg/dl)
Impaired renal function (serum creatinine >2.0 mg/dl)
Emergency surgery
Pregnancy
Breast-feeding
Any underlying or acute disease requiring regular medication which could possibly pose a threat to the subject or make implementation of the protocol or interpretation of the study results difficult
History of alcohol or drug abuse
Treatment with any investigational drug in the 1 month preceding the study
Mental conditions rendering the subject unable to understand the nature, scope and possible consequences of the study
Inability to comply with the protocol, e.g. uncooperative attitude and unlikelihood of completing the study
History or evidence of active asthma",Saline infusion,ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01367886,NCT01367886_EG000,Accepts Healthy Volunteers,Female,Adult | Older Adult,Not Applicable,21,"Inclusion Criteria:

For healthy volunteers the inclusion criteria are:

Females ≥ 18 years old
Not experiencing overactive bladder symptoms
Not experiencing frequency or urgency

For overactive bladder patients the inclusion criteria are

Females ≥ 18 years old
Overactive bladder symptoms for ≥ 3 months before screening ) Recurrent urinary tract infections (UTIS) > 3/year

Exclusion Criteria:

For healthy volunteers the exclusion criteria are:

Overactive bladder symptoms, such as frequency and urgency
Intermittent/unstable use of bladder medications
Pregnant women or women unwilling to use contraceptives
Neurological conditions: stroke, Multiple Sclerosis (MS), Parkinson's, spinal cord injury
Significant pelvic organ prolapsed (grade 3 or above based on physical exam)
Lower urinary tract surgery within past 6 months
Known history of IC or pain associated with OAB
Urinary retention requiring catheterization, indwelling catheter of Self-cath
Recurrent UTIS > 3/year

For overactive bladder patients the exclusion criteria are:

Contraindications to Fesoterodine use such as hypersensitivity, GI and urinary retention, and Glaucoma
Intermittent/unstable use of bladder medications
Pregnant women or women unwilling to use contraceptives
Neurological conditions: stroke, MS, Parkinson's, spinal cord injury
Significant pelvic organ prolapsed (grade 3 or above based on physical exam)
Lower urinary tract surgery within past 6 months
Known history of Interstitial Cystitis (IC) or pain associated with OAB
Urinary retention requiring catheterization, indwelling catheter of Self-cath
Recurrent urinary tract infections (UTIS) > 3/year

Deferral Criteria:

Treatment with OAB medications within 2 weeks before baseline visit. If patient is currently on OAB medications the patient will be asked to stop OAB medication for 2 weeks and return for baseline visit.","Females with overactive bladder symptoms will be given Fesoterodine 4 mg. daily for six weeks.

Fesoterodine : Fesoterodine 4 mg. tablet by mouth daily for six weeks",ChEMBL:CHEMBL1201764 | DrugBank:DB06702 | PubChem:6918558,Fesoterodine,CC(C)C(=O)Oc1ccc(CO)cc1[C@H](CCN(C(C)C)C(C)C)c1ccccc1,G04BD11,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01368809,NCT01368809_EG000,No,All,Adult | Older Adult,Phase 4,100,"Inclusion Criteria

Patients scheduled to undergo outpatient arthroscopic surgery procedures
Willingness and ability to sign an informed consent document
No allergies to anesthetic or analgesic medications
18 - 80 years of age
American Society of Anesthesiologists (ASA) Class I - III adults of either sex
Women of childbearing potential must be currently practicing an acceptable form of birth control, and have a negative urine pregnancy test

Exclusion Criteria

Patients with known allergy, hypersensitivity or contraindications to anesthetic or analgesic medications
Patients with clinically-significant medical conditions, such as brain, heart, kidney, endocrine, or liver diseases, peptic ulcer disease or bleeding disorders
Pregnant or lactating women
Subjects with a history of alcohol or drug abuse within the past 3 months
Any other conditions or use of any medication which may interfere with the conduct of the study (e.g., asthmatic patients history of asthma, chronic cough, or upper respiratory tract infection during the previous 2 wk or recent treatment with angiotensin-converting enzyme inhibitors, bronchodilators, or steroids.","Fentanyl (50 µg/ml) 2 ml at induction, 1-2 ml boluses as needed

Saline: 2 ml at induction 1-2 ml boluses as needed",ChEMBL:CHEMBL596 | DrugBank:DB00813 | PubChem:3345,Fentanyl,CCC(=O)N(c1ccccc1)C1CCN(CCc2ccccc2)CC1,N01AH01 | N01AH51 | N02AB03,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01372150,NCT01372150_EG001,No,All,Child,Phase 3,112,"Inclusion Criteria:

Age >=7 and <18 years of age
Primary diagnosis of major depressive disorder (MDD)
CDRS-R score >40

Exclusion Criteria:

History of suicidal behaviour, or requires precaution against suicide
Not in generally healthy medical condition
History of psychosis or bipolar disorder
Seizure disorder","Fluoxetine capsules 10 mg administered once daily for the first week of treatment (titration phase) then 20 mg administered once daily for the next 7 weeks of treatment, followed by placebo capsules administered once daily for 1 week as appropriate (taper/transition phase).",ChEMBL:CHEMBL41 | DrugBank:DB00472 | PubChem:3386,Fluoxetine,CNCCC(Oc1ccc(C(F)(F)F)cc1)c1ccccc1,N06AB03 | N06CA03,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01374269,NCT01374269_EG001,No,All,Adult,Phase 4,44,"Inclusion Criteria:

Patients aged between 18 and 60 years old
Subacute low back pain -evolution time more than 4 weeks and less than 3 months.
That have social security system
Live in the metropolitan area

Exclusion Criteria:

Antecedents of spinal, pelvis or abdominal trauma
Cancer
Diabetes mellitus
Steroids use
Men and Women over 60 years
Cauda equine syndrome
Women and men with osteoporosis or compression fractures
Suspicion of infection.
Insidious onset, constitutional symptoms
Intravenous drugs abuse
HIV
Immunosuppression or previous surgery
Rheumatic diseases
Urinary tract infections
Neurological symptoms in lower limbs
Mental illness (schizophrenia, bipolar or somatomorphic disorder, major depression)
Deformities in the spine (scoliosis greater than 15º)
History of peptic acid disease
Renal failure
Intake of anticoagulants or antiplatelet drugs
Allergy to NSAIDs.","Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue

NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.",ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01379274,NCT01379274_EG000,No,All,Adult | Older Adult,Phase 2,2,"Inclusion Criteria: Patients with low to Int-1 risk MDS

ECOG performance status of < 2 at study entry (see Appendix II).
Disease free of prior malignancies for 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma ""insitu"" of the cervix or breast.
Serum bilirubin levels < 1.5 times the upper limit of the normal range for the laboratory (ULN). Higher levels are acceptable if these can be attributed to active hemolysis or ineffective erythropoiesis.
Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamic-pyruvic transaminase (SGPT) (alanine aminotransferase [ALT]) levels < 2 x ULN.
Serum creatinine levels 1.5 x ULN
Absolute neutrophil count > 1000/mm³
Platelet count > 30,000/mm³
All study participants must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist®.
Females of childbearing potential (FCBP)† must have a negative serum or urine

Exclusion Criteria:

Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
Pregnant or breast feeding females. Lactating females must agree not to breast feed while taking Revlimid® (lenalidomide).
Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
Use of any other experimental drug or therapy within 28 days of baseline.
Known hypersensitivity to lenalidomide, azacitidine, or mannitol.
Any prior use of Vidaza® (azacitidine).
Prior use of Revlimid® (lenalidomide) for more than 84 days (three 28 day cycles).
Concurrent use of other anti-cancer agents or treatments.
Known positive for HIV or infectious hepatitis, type B or C.","Lenalidomide and azacitidine combination to be utilized in patients who did not respond to 3 months of lenalidomide monotherapy.

Lenalidomide and azacitidine combination: lenalidomide 10 mg will be administered orally on Days 1-28 of each 28-day cycle. Patients who fail to achieve an erythroid response per 2006 IWG criteria after 3 cycles of monotherapy will receive lenalidomide at the same dose administered in cycle 3 and low-dose azacitidine25 mg/m2 subcutaneously (SC) or intravenously (IV) for 5 days (on Days 1-5) of every 28-day cycle.

Patients who fail to respond (2006 IWG criteria) after receiving two cycles of combination therapy will receive lenalidomide at the same dose administered in Cycle 3 and azacitidine 50 mg/m2 SC or IV given daily on Days 1-5 of each 28-day cycle, if no grade 4 toxicity developed or no delay greater than 2 weeks in starting a new cycle was experienced during the first 2 cycles of combination therapy.",ChEMBL:CHEMBL848 | DrugBank:DB00480 | PubChem:216326,Lenalidomide,Nc1cccc2c1CN(C1CCC(=O)NC1=O)C2=O,L04AX04,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01380106,NCT01380106_EG000,No,All,Adult | Older Adult,Phase 2,16,"Inclusion Criteria:

Previously diagnosed with multiple myeloma.
Must have relapsed or refractory disease (refractory is defined as progression during treatment or within 60 days after the completion of treatment) requiring 2nd or 3rd line therapy
Patients may have received lenalidomide and/or dexamethasone

Patients must have measurable disease:

Serum monoclonal protein >0.5g/dL and/or 0.2g/24hr urine light chain excretion
Patients with lower M-protein values or non-secretory myeloma will be eligible if measurable disease can be established, such as serum FreeliteTM chain ratio >5x ULN, measurable soft tissue plasmacytoma >2cm by either physical exam and/or applicable radiographs (i.e. MRI, CT-scan) and/or bone marrow involvement >30%
Age >=18 years at the time of consent.
All necessary baseline studies for determining eligibility must be obtained within 14 days prior to enrollment. Serum pregnancy tests (sensitivity of at least 25 mIU/mL), for females of childbearing potential (WCBP) must be completed. The first test must be performed within 10-14 days, and the second test within 24 hours prior to initiation of lenalidomide.
Pre-study ECOG performance status 0-2. Patients with lower performance status based solely on bone pain will be eligible.
Adequate liver functions: AST and ALT =< 3xULN, alkaline phosphatase =< 3.0x ULN, except if attributed to tumor, and bilirubin =< 2xULN.
Have Amylase =< 2.5x ULN
Able to adhere to the study visit schedule and other protocol requirements
Must understand and voluntarily sign an informed consent document.
Females of childbearing potential (FCBP)† must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL 10 - 14 days prior to and again within 24 hours of starting lenalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 4 weeks before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree not to father a child and agree to use a condom if his partner is of child bearing potential. All patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure.
All study participants must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist®. All counseling will be done through RevAssist®.
Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation. Patients intolerant to ASA may use low molecular weight heparin. Lovenox is recommended. Coumadin will be allowed provided the patient is fully anticoagulate with INR 2.0 to 2.5.
Patients may receive a bisphosphonate.

Exclusion Criteria:

Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
Pregnant or breast feeding females.(Lactating females must agree not to breast feed while taking lenalidomide).
Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
Renal insufficiency of creatinine clearance <40mL/min
Known hypersensitivity to thalidomide or lenalidomide.
Development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
Concurrent use of other anti-cancer agents or treatments.
Known seropositive for an active viral infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV). Patients who are seropositive because of hepatitis B virus vaccine are eligible.
Has hemoglobin <8.0g/dL. The use of transfusion with pRBC to correct anemia and meet eligibility criteria will not be allowed.
Has an absolute neutrophil count <1.0x10^9/L within 14 days before enrollment
Peripheral neuropathy of grade >=3. Patients with painful grade 2 neuropathy are also excluded
Has platelet count <75x10^9/L within 14 days before enrollment.
Plasma cell leukemia at time of study entry.","Subjects will receive oral lenalidomide 25mg once daily for days 1-21 out of a 28 cycle

Lenalidomide 25mg: Subjects will receive oral lenalidomide 25mg once daily for days 1-21 out of a 28 cycle",ChEMBL:CHEMBL848 | DrugBank:DB00480 | PubChem:216326,Lenalidomide,Nc1cccc2c1CN(C1CCC(=O)NC1=O)C2=O,L04AX04,1.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,1.0,1.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT01380106,NCT01380106_EG001,No,All,Adult | Older Adult,Phase 2,17,"Inclusion Criteria:

Previously diagnosed with multiple myeloma.
Must have relapsed or refractory disease (refractory is defined as progression during treatment or within 60 days after the completion of treatment) requiring 2nd or 3rd line therapy
Patients may have received lenalidomide and/or dexamethasone

Patients must have measurable disease:

Serum monoclonal protein >0.5g/dL and/or 0.2g/24hr urine light chain excretion
Patients with lower M-protein values or non-secretory myeloma will be eligible if measurable disease can be established, such as serum FreeliteTM chain ratio >5x ULN, measurable soft tissue plasmacytoma >2cm by either physical exam and/or applicable radiographs (i.e. MRI, CT-scan) and/or bone marrow involvement >30%
Age >=18 years at the time of consent.
All necessary baseline studies for determining eligibility must be obtained within 14 days prior to enrollment. Serum pregnancy tests (sensitivity of at least 25 mIU/mL), for females of childbearing potential (WCBP) must be completed. The first test must be performed within 10-14 days, and the second test within 24 hours prior to initiation of lenalidomide.
Pre-study ECOG performance status 0-2. Patients with lower performance status based solely on bone pain will be eligible.
Adequate liver functions: AST and ALT =< 3xULN, alkaline phosphatase =< 3.0x ULN, except if attributed to tumor, and bilirubin =< 2xULN.
Have Amylase =< 2.5x ULN
Able to adhere to the study visit schedule and other protocol requirements
Must understand and voluntarily sign an informed consent document.
Females of childbearing potential (FCBP)† must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL 10 - 14 days prior to and again within 24 hours of starting lenalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 4 weeks before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree not to father a child and agree to use a condom if his partner is of child bearing potential. All patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure.
All study participants must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist®. All counseling will be done through RevAssist®.
Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation. Patients intolerant to ASA may use low molecular weight heparin. Lovenox is recommended. Coumadin will be allowed provided the patient is fully anticoagulate with INR 2.0 to 2.5.
Patients may receive a bisphosphonate.

Exclusion Criteria:

Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
Pregnant or breast feeding females.(Lactating females must agree not to breast feed while taking lenalidomide).
Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
Renal insufficiency of creatinine clearance <40mL/min
Known hypersensitivity to thalidomide or lenalidomide.
Development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
Concurrent use of other anti-cancer agents or treatments.
Known seropositive for an active viral infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV). Patients who are seropositive because of hepatitis B virus vaccine are eligible.
Has hemoglobin <8.0g/dL. The use of transfusion with pRBC to correct anemia and meet eligibility criteria will not be allowed.
Has an absolute neutrophil count <1.0x10^9/L within 14 days before enrollment
Peripheral neuropathy of grade >=3. Patients with painful grade 2 neuropathy are also excluded
Has platelet count <75x10^9/L within 14 days before enrollment.
Plasma cell leukemia at time of study entry.","Subjects will receive oral lenalidomide 15mg once daily for days 1-21 out of a 28 cycle

Lenalidomide 15mg: Subjects will receive oral lenalidomide 15 mg once daily for 1-21 of a 28 day cycle.",ChEMBL:CHEMBL848 | DrugBank:DB00480 | PubChem:216326,Lenalidomide,Nc1cccc2c1CN(C1CCC(=O)NC1=O)C2=O,L04AX04,1.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT01387295,NCT01387295_EG000,No,All,Adult | Older Adult,Phase 2,38,"Inclusion Criteria:• Informed consent

Age > 18 years
Performance status 0-1; expected survival ≥ 3 months
Patient with histologically or cytologically confirmed locally advanced or metastatic adenocarcinoma of the breast
Liver metastases not suitable for local treatment
Extrahepatic disease should be determined by PET-CT-scan.
No progression on treatment with capecitabine.
Prior treatment with taxane (adjuvant or for metastatic disease)
Metastases < 70 % of the liver
Neutrophile granulocytes > 1.5 x 109/l og thrombocytes > 100 x 109/l
Bilirubin < 2.0 x UNL (upper normal limit).
Creatinine-clearance > 30 ml/min.
INR < 1.6.
If the patient is HER2-positive:Baseline LVEF ≥ 50 %

Exclusion Criteria:

History of chemotherapy within the 4-week period prior to the start of trial medication
Other current or prior malignant disease except adequately treated and cured carcinoma in situ of the cervix or squamous cell carcinoma of the skin.
Previous treatment with oxaliplatin
Cytotoxic or experimental treatment within a 14 days period before start of trial medication
The patient is not allowed to participate in other clinical trials.
Any clinical symptoms suggesting peripheral neuropathy < or equal to grade 2 or CNS metastases (In case of clinical suspicion on CNS metastases a MR or CT scan should be performed within 4 weeks before inclusion
Other severe medical conditions e.g. severe cardial disease or AMI < 1 year
Presence of diseases which prevent oral therapy.
Patients with uncontrolled infection
Pregnant or lactating women
Women capable of childbearing not using a sufficient non-hormonal method of birth control
Patients not able to understand the treatment or to collaborate.
Prior serious or unsuspected reaction after treatment with fluoropyrimidine
Known prior hypersensitivity reactions to the agents

If the patient is HER2-positive:

Dyspnoea in due to complication related to malignant disease e.g.lung metastases with lymphangitis or other conditions with need of supportive oxygen.","oxaliplatin, capecitabine, trastuzumab: Oxaliplatin intrahepatic capecitabine and trastuzumab systemic",PubChem:7965,Cyclohexylamine,NC1CCCCC1,,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,1.0,1.0,0.0,1.0,1.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0
NCT01393405,NCT01393405_EG001,No,All,Adult | Older Adult,Phase 2,44,"Inclusion Criteria:

Signed informed consent.
Man or woman between 18 and 70 years of age.
UC diagnosed by routine clinical, radiographic, endoscopic, and pathological criteria.
Active UC with a Mayo score of 6 to 12 points and moderate-to severe active disease on sigmoidoscopy (Mayo endoscopic subscore of at least 2)

and at least ONE of the following criteria:

Steroid dependent UC *
Primary failure or loss of response to an anti-TNF (infliximab, adalimumab, golimumab) in the past
Primary failure or loss of response to vedolizumab in the past
Intolerance/failure of azathioprine/6-MP therapy in the past

Failure of 5-ASA therapy

Steroid dependence is defined as a clinical response to treatment with prednisone 40 to 60 mg/day and relapse within 30 days after prednisone treatment was completed or as a requirement for a daily dosage of not less than 10 mg of prednisone and impossibility of weaning the patient off steroid without clinical relapses (two attempts to discontinue the medication within the preceding six months of the start of the study).

Exclusion Criteria:

Failure to respond to 40 mg of prednisone or higher/day in the last 2 weeks before inclusion
Concomitant use of azathioprine (AZA) or 6-mercaptopurine (6-MP) must be discontinued at least 2 weeks before inclusion into the study (Week 0 visit)
Anti-TNF therapy in the 2 weeks before the Week 0 visit
Failure of cyclosporine therapy in the previous 6 months prior to Screening visit
Patients with serum albumin < 2.5 g/dl at baseline
Low serum folate defined as decrease of >10% below normal range
Patients with WBC< 3.0 x109th/L at baseline
Patients with platelet count < 100 x109th/L
Patients with an underlying infection with C. difficile at Screening visit
Patients with pre-existing hepatic disease
Patients with known non-alcoholic fatty liver disease (NAFLD)
Patients with known Hepatitis B or Hepatitis C
Patients with pre-existing renal dysfunction (creatinine >1.5 mg/dl).
Patients with a pre-existing chronic lung disease other than well controlled asthma
Patients with interstitial lung disease of unknown cause
Patients with a BMI >35
Known previous or concurrent malignancy (other than that considered surgically cured, with no evidence for recurrence for 5 years - basal cell does not exclude)
Existing pregnancy, lactation, or planned pregnancy* (men and women) within the next 12 months. (*Methotrexate should not be used for at least 3 months before planned pregnancy for men and women and should not be used during pregnancy or breast feeding)
High alcohol consumption (more than seven drinks per week)
Non - steroidal inflammatory medications (NSAIDs) as long-term treatment, defined as use for at least 4 days a week each month
Continuous treatment with one of the following drugs:
Probenecid,
Trimethoprim/sulfamethoxazole
Sulfasalazine
Acitretin
Streptozocin
Non-use of appropriate contraceptives in females of childbearing potential (e.g. condoms, intrauterine device {IUD}, hormonal contraception, or other means considered adequate by the responsible investigator) or in males with a child-fathering potential (condoms, or other means considered adequate by the responsible investigator during treatment
Participation in another clinical trial within the last 30 days, simultaneous participation in another clinical trial, or previous participation in this trial
Well-founded doubt about the patient's cooperation.",25 mg MTX sq once weekly + 1 mg folic acid daily + 2.4 g mesalamine,ChEMBL:CHEMBL34259 | DrugBank:DB00563 | PubChem:126941,Methotrexate,CN(Cc1cnc2nc(N)nc(N)c2n1)c1ccc(C(=O)N[C@@H](CCC(=O)O)C(=O)O)cc1,L01BA01 | L04AX03,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01393405,NCT01393405_EG002,No,All,Adult | Older Adult,Phase 2,40,"Inclusion Criteria:

Signed informed consent.
Man or woman between 18 and 70 years of age.
UC diagnosed by routine clinical, radiographic, endoscopic, and pathological criteria.
Active UC with a Mayo score of 6 to 12 points and moderate-to severe active disease on sigmoidoscopy (Mayo endoscopic subscore of at least 2)

and at least ONE of the following criteria:

Steroid dependent UC *
Primary failure or loss of response to an anti-TNF (infliximab, adalimumab, golimumab) in the past
Primary failure or loss of response to vedolizumab in the past
Intolerance/failure of azathioprine/6-MP therapy in the past

Failure of 5-ASA therapy

Steroid dependence is defined as a clinical response to treatment with prednisone 40 to 60 mg/day and relapse within 30 days after prednisone treatment was completed or as a requirement for a daily dosage of not less than 10 mg of prednisone and impossibility of weaning the patient off steroid without clinical relapses (two attempts to discontinue the medication within the preceding six months of the start of the study).

Exclusion Criteria:

Failure to respond to 40 mg of prednisone or higher/day in the last 2 weeks before inclusion
Concomitant use of azathioprine (AZA) or 6-mercaptopurine (6-MP) must be discontinued at least 2 weeks before inclusion into the study (Week 0 visit)
Anti-TNF therapy in the 2 weeks before the Week 0 visit
Failure of cyclosporine therapy in the previous 6 months prior to Screening visit
Patients with serum albumin < 2.5 g/dl at baseline
Low serum folate defined as decrease of >10% below normal range
Patients with WBC< 3.0 x109th/L at baseline
Patients with platelet count < 100 x109th/L
Patients with an underlying infection with C. difficile at Screening visit
Patients with pre-existing hepatic disease
Patients with known non-alcoholic fatty liver disease (NAFLD)
Patients with known Hepatitis B or Hepatitis C
Patients with pre-existing renal dysfunction (creatinine >1.5 mg/dl).
Patients with a pre-existing chronic lung disease other than well controlled asthma
Patients with interstitial lung disease of unknown cause
Patients with a BMI >35
Known previous or concurrent malignancy (other than that considered surgically cured, with no evidence for recurrence for 5 years - basal cell does not exclude)
Existing pregnancy, lactation, or planned pregnancy* (men and women) within the next 12 months. (*Methotrexate should not be used for at least 3 months before planned pregnancy for men and women and should not be used during pregnancy or breast feeding)
High alcohol consumption (more than seven drinks per week)
Non - steroidal inflammatory medications (NSAIDs) as long-term treatment, defined as use for at least 4 days a week each month
Continuous treatment with one of the following drugs:
Probenecid,
Trimethoprim/sulfamethoxazole
Sulfasalazine
Acitretin
Streptozocin
Non-use of appropriate contraceptives in females of childbearing potential (e.g. condoms, intrauterine device {IUD}, hormonal contraception, or other means considered adequate by the responsible investigator) or in males with a child-fathering potential (condoms, or other means considered adequate by the responsible investigator during treatment
Participation in another clinical trial within the last 30 days, simultaneous participation in another clinical trial, or previous participation in this trial
Well-founded doubt about the patient's cooperation.",Placebo sq once weekly + 1 mg folic acid daily + 2.4 g mesalamine,ChEMBL:CHEMBL34259 | DrugBank:DB00563 | PubChem:126941,Methotrexate,CN(Cc1cnc2nc(N)nc(N)c2n1)c1ccc(C(=O)N[C@@H](CCC(=O)O)C(=O)O)cc1,L01BA01 | L04AX03,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT01393457,NCT01393457_EG002,No,All,Adult,Phase 2,31,"Inclusion Criteria:

meet criteria for cocaine dependence
seeking treatment for cocaine dependence
be in acceptable health based on medical history and physical exam

Exclusion Criteria:

dependent on drugs other than cocaine, nicotine, marijuana
have a medical condition contraindicating treatment with study medications
having conditions of probation or parole requiring reports of drug use to officers of the court",levodopa/carbidopa 800/200 mg/d,PubChem:104778 | PubChem:441193,Nacom,CC(Cc1ccc(O)c(O)c1)(NN)C(=O)O.NC(Cc1ccc(O)c(O)c1)C(=O)O,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01394718,NCT01394718_EG001,No,All,Child | Adult,Phase 3,67,"Inclusion Criteria:

Subjects 10-18 years who are status post anterior or posterior spine fusion surgery

Exclusion Criteria:

All patients requiring mechanical ventilation post-operatively, continuous infusions of sedative, or continuous infusions of alternate opiates (i.e. fentanyl)
Patients with hepatic dysfunction
Patients with chronic opiate requirements
Pregnant or lactating females
Patients placed on opiates other than morphine or hydromorphone
Patients with opiate or acetaminophen allergies
Patients placed on alternate analgesic adjuncts (i.e. ketamine, etc)
Patients who receive intrathecal opiates","Subjects will receive the first dose of intravenous (IV) acetaminophen (at 15 mg/kg, with maximum doses based on patient age and weight) at the time of skin closure intra-operatively and will continue to receive IV acetaminophen for 42 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses).

Intravenous Acetaminophen: Scheduled doses of 15 mg/kg of IV acetaminophen will be administered to the treatment arm of the study for a total of 8 doses over a 48 hour period post-operatively.",ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01394926,NCT01394926_EG000,No,All,Adult | Older Adult,Phase 2,21,"Inclusion Criteria:

The subject is is greater than or equal to 18 years of age.
The subjects has highly suspected or established carotid artery disease.
The subject has undergone or been referred for either unilateral or bilateral intra-arterial X-ray carotid angiography for the determination of subject management (within 30 days before or after the U/S procedure).
The subject has non-diagnostic U/S of the carotids as defined by institutional standards.

Exclusion Criteria:

The subject presents any clinically active, serious, life-threatening disease, with a life expectancy of less than 1 month or where study participation may compromise the management of the subject or other reason that in the judgment of the investigator makes the subject unsuitable for participation in the study.
The subject has a history of acute occlusion requiring medical intervention of any artery (including aorta) within 6 months of consent.
The subject has a known or suspected hypersensitivity to any of the components of Optison, blood, blood products, or albumin.
The subject has right to left, bi-directional or transient right to left cardiac shunts.",Optison is a sterile non-pyrogenic suspension of perflutren for IV administration.,ChEMBL:CHEMBL1663 | DrugBank:DB00556 | PubChem:6432,Perflutren,FC(F)(F)C(F)(F)C(F)(F)F,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01398410,NCT01398410_EG000,No,All,Adult | Older Adult,Phase 2 | Phase 3,201,"Inclusion Criteria

Confirmed to have no recurrence of gastric or duodenal ulcer by endoscopy at the end of 24 weeks of treatment in study E3810-J081-308.
Need to continue receiving low-dose aspirin (81 mg/day or 100 mg/day) during this study.

Exclusion Criteria

-Confirmed to have a recurrence of gastric or duodenal ulcer at the end of 24 weeks of treatment in study E3810-J081-308 (at the start of this trial) and thus are withdrawn from the trial.","Participants received rabeprazole 5 mg tablets and rabeprazole 10 mg matched placebo tablets orally, once daily",ChEMBL:CHEMBL1219 | DrugBank:DB01129 | PubChem:5029,Rabeprazole,COCCCOc1ccnc(CS(=O)c2nc3ccccc3[nH]2)c1C,A02BC04 | A02BC54 | A02BD12 | A02BD13 | M01AA05 | M02AA03,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT01398839,NCT01398839_EG001,No,All,Adult | Older Adult,Phase 3,103,"Inclusion Criteria:

18 Years of age or older
Diagnosis of Ectasia
Presence of central or inferior steepening
Topography consistent with ectasia
BSCVA 20/20 or worse
If contact lens wearer; removal of contact lenses for required period of time
Signed informed consent
Willingness and ability to comply with schedule for follow-up visits

Exclusion Criteria:

Previous ocular condition that may predispose the eye for future complications or prevent the possibility of improved vision
History of chemical injury or delayed epithelial healing
A known sensitivity to study medications
Nystagmus or any other condition that would prevent a steady gaze during the treatment or other diagnostic tests
A condition that would interfere with or prolong epithelial healing
Presence or history of any other condition or finding that makes the patient unsuitable for treatment",Riboflavin : Both treatment and sham groups will receive riboflavin,ChEMBL:CHEMBL1534 | DrugBank:DB00140 | PubChem:493570,Riboflavin,Cc1cc2nc3c(=O)[nH]c(=O)nc-3n(C[C@H](O)[C@H](O)[C@H](O)CO)c2cc1C,A11HA04 | S01XA26,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01398852,NCT01398852_EG000,No,All,Child | Adult | Older Adult,Phase 3,500,"Inclusion Criteria:

12 years of age or older
Diagnosis of Keratoconus or Ectasia
Central or Inferior steepening on the Pentacam map
Topography consistent with Keratoconus or Ectasia
BSCVA 20/20 or worse
Removal of contact lenses for required period of time
Signed written informed consent
Willingness and ability to comply with schedule for follow up visits

Exclusion Criteria

For Keratoconus, a history of previous corneal surgery
Corneal pachymentry equal to or greater and 400
Previous ocular condition in the eyes to be treated that may predispose the eye for future complications
A history of chemical injury or delayed healing
Pregnancy
A known sensitivity to the study medications
Nystagmus or any other condition that would prevent a steady gaze during treatment or other diagnostic tests
Presence or history of any other condition or finding that makes the patient unsuitable as a candidate",All eyes to be treated with riboflavin and UV light,ChEMBL:CHEMBL1534 | DrugBank:DB00140 | PubChem:493570,Riboflavin,Cc1cc2nc3c(=O)[nH]c(=O)nc-3n(C[C@H](O)[C@H](O)[C@H](O)CO)c2cc1C,A11HA04 | S01XA26,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01399268,NCT01399268_EG000,No,All,Adult | Older Adult,Phase 4,30,"Inclusion Criteria:

Patients scheduled for bilateral total knee replacement
Between 50-90 years of age

Exclusion Criteria:

Patients on steroid therapy
Patients that require stress-dose steroid pre-operatively
Patients that smoke
Patients that are diabetic
Patients younger than 50 or older than 90 years","Hydrocortisone 100 mg IV Q 8hrs x3

Hydrocortisone: Prepared by pharmacy, 100 mg, IV, every 8 hours, 3 times",ChEMBL:CHEMBL389621 | DrugBank:DB00741 | PubChem:5754,Hydrocortisone,[H][C@@]12CC[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)CC[C@@]21C,A01AC03 | A07EA02 | C05AA01 | D07AA02 | D07BA04 | D07CA01 | D07XA01 | H02AB09 | R01AD60 | S01BA02 | S01BB01 | S01CA03 | S01CB03 | S02BA01 | S02CA03 | S03CA04,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01399723,NCT01399723_EG001,No,All,Child,Phase 3,263,"Inclusion Criteria:

Clinical signs of WHO-defined severe pneumonia
Age 2 months to 59 months

Exclusion Criteria:

Clinical signs of WHO-defined very severe pneumonia
Clinical or laboratory diagnosis of meningitis
Clinical diagnosis of severe malnutrition (marasmus/kwashiorkor)
Clinical or laboratory diagnosis of severe anaemia requiring transfusion
HIV-exposure on rapid HIV antibody test (only observational data will be collected from these patients)
Elimination of signs of severe pneumonia in a child with wheeze after outpatient bronchodilator therapy
Chronic condition that may underlie or contribute to a presentation with respiratory distress such as: known chronic renal or cardiac disease, presence of cerebral palsy predisposing child to aspiration/hypostatic pneumonia
Established bronchiectasis or congenital abnormality of the lower respiratory tract
Upper airway obstruction producing stridor
Admission from outpatient clinic specifically for treatment of TB
Referral from another inpatient facility following treatment with injectable antibiotics for more than 24 hours or because the initial regimen is considered to have failed
Documented history of >48hours treatment with oral amoxicillin
Failure to obtain informed consent
Penicillin allergy","Benzyl Penicillin 50,000IU/kg 6 hourly",ChEMBL:CHEMBL174 | DrugBank:DB00415 | PubChem:6249,Ampicillin,[H][C@]12SC(C)(C)[C@H](C(=O)O)N1C(=O)[C@H]2NC(=O)[C@H](N)c1ccccc1,J01CA01 | J01CA51 | J01CR50 | S01AA19,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01401647,NCT01401647_EG000,No,All,Adult | Older Adult,Phase 3,972,"Inclusion Criteria:

Age at least 18 years or local age of consent
Non-traumatic out-of-hospital cardiac arrest treated by Resuscitation Outcomes Consortium (ROC) emergency medical services (EMS) with advanced life support capability
VF or pulseless VT presenting as the initial arrest arrhythmia or results from conversion of another arrhythmia (such as transient asystole or pulseless electrical activity)
Incessant or recurrent VF/VT after receipt of ≥ 1 shocks
Established vascular access

Exclusion Criteria:

Asystole or pulseless electrical activity (PEA) as the initial arrest rhythm who never transition to VF or pulseless VT
Written advance directive to not attempt resuscitation (DNAR)
Blunt, penetrating, or burn-related injury
Exsanguination
Protected populations (prisoners, pregnancy, children under local age of consent)
Treated exclusively by non-ROC EMS agency/provider, or by basic life support-only capable ROC EMS providers
Prior receipt of open label lidocaine or amiodarone during resuscitation","Intravenous (IV) or intraosseous (IO) administration of amiodarone if VF/pulseless VT reoccurs after initial defibrillation.

amiodarone: 300 mg will be given IV/IO push for reoccurrence of ventricular fibrillation or pulseless ventricular tachycardia after 1 or more shocks. A second dose of 150 mg will be given if VF/pulseless VT reoccurs after initial dose and a subsequent shock. The initial dose for patients estimated to be less than 100 pounds will be 150 mg, followed by a second dose of 150 mg if the VF/pulseless VT persists.",ChEMBL:CHEMBL633 | DrugBank:DB01118 | PubChem:2157,Amiodarone,CCCCc1oc2ccccc2c1C(=O)c1cc(I)c(OCCN(CC)CC)c(I)c1,C01BD01,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT01402375,NCT01402375_EG000,No,All,Adult,Phase 3,87,"Inclusion Criteria:

patient has complaint of acute extremity pain (less than 7 days duration)
clinician plans to discharge on oral pain medication

Exclusion Criteria:

patients on methadone
chronic pain condition such as sickle cell anemia or fibromyalgia
history of adverse reaction to one of the study medications
taken prescribed opioids in the past 24 hrs
have a medical condition that might alter the metabolism of one of the study medications (i.e. hepatitis, renal insufficiency, thyroid disease, Adrenal disease)
Take a medication that might interact with one of the study medications","Hydrocodone 5mg / Acetaminophen 500mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.

Hydrocodone (first trial): Patients will take 1 dose of Hydrocodone 5mg / Acetaminophen 500mg every 4 hours as needed for pain",ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT01402375,NCT01402375_EG002,No,All,Adult,Phase 3,111,"Inclusion Criteria:

patient has complaint of acute extremity pain (less than 7 days duration)
clinician plans to discharge on oral pain medication

Exclusion Criteria:

patients on methadone
chronic pain condition such as sickle cell anemia or fibromyalgia
history of adverse reaction to one of the study medications
taken prescribed opioids in the past 24 hrs
have a medical condition that might alter the metabolism of one of the study medications (i.e. hepatitis, renal insufficiency, thyroid disease, Adrenal disease)
Take a medication that might interact with one of the study medications","Oxycodone 5mg / Acetaminophen 325mg. Patients instructed to take 1 dose every 4 hrs as needed for pain.

Oxycodone (for second trial): Patients will take 1 dose of Oxycodone 5 mg / Acetaminophen 325 mg every 4 hours as needed for pain",ChEMBL:CHEMBL656 | DrugBank:DB00497 | PubChem:5284603,Oxycodone,COc1ccc2c3c1O[C@H]1C(=O)CC[C@@]4(O)[C@@H](C2)N(C)CC[C@]314,N02AA05 | N02AA55 | N02AA56 | N02AJ17 | N02AJ18 | N02AJ19,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT01402375,NCT01402375_EG004,No,All,Adult,Phase 3,105,"Inclusion Criteria:

patient has complaint of acute extremity pain (less than 7 days duration)
clinician plans to discharge on oral pain medication

Exclusion Criteria:

patients on methadone
chronic pain condition such as sickle cell anemia or fibromyalgia
history of adverse reaction to one of the study medications
taken prescribed opioids in the past 24 hrs
have a medical condition that might alter the metabolism of one of the study medications (i.e. hepatitis, renal insufficiency, thyroid disease, Adrenal disease)
Take a medication that might interact with one of the study medications","Oxycodone 5mg / Acetaminophen 325 mg. Patients instructed to take 1 dose every 4 hours as needed for pain.

Oxycodone (third trial): Patients will take 1 dose of Oxycodone 5mg / Acetaminophen 325 mg every 4 hours as needed for pain",ChEMBL:CHEMBL656 | DrugBank:DB00497 | PubChem:5284603,Oxycodone,COc1ccc2c3c1O[C@H]1C(=O)CC[C@@]4(O)[C@@H](C2)N(C)CC[C@]314,N02AA05 | N02AA55 | N02AA56 | N02AJ17 | N02AJ18 | N02AJ19,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT01404429,NCT01404429_EG000,No,All,Adult | Older Adult,Phase 4,47,"Inclusion Criteria:

Patients with rheumatoid arthritis fulfilling the ACR 1987 criteria
Between 18 years to 65 year of age
Having active disease Disease activity score (28 joints) DAS28-3 more than 5.1
Not on methotrexate in the last 2 months
Permitted to be on corticosteroids if the dosages stable for at least 1 weeks before randomization and if corticosteroid dosage less than 10 mg/day
Permitted to be on other disease modifying anti-rheumatic drug (DMARD) like sulfasalazine, leflunomide and hydroxychloroquine, if dosages stable for at least 2 weeks before randomization

Exclusion Criteria:

Pregnant/Breastfeeding
Ongoing/Recent treatment with methotrexate (2 months)
Chronic liver disease
Renal failure
Any leucopenia or thrombocytopenia
Breast-feeding
Desirous of pregnancy in the next 6 months
Known Hepatitis B or C positive
Known clinically relevant chronic lung disease: ILD
Tuberculosis or other active infections
Known HIV positive",Patients started on 7.5 mg of oral methotrexate (weekly) increased by 2.5 mg every 2 weeks (max 25mg weekly),ChEMBL:CHEMBL34259 | DrugBank:DB00563 | PubChem:126941,Methotrexate,CN(Cc1cnc2nc(N)nc(N)c2n1)c1ccc(C(=O)N[C@@H](CCC(=O)O)C(=O)O)cc1,L01BA01 | L04AX03,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01404429,NCT01404429_EG001,No,All,Adult | Older Adult,Phase 4,53,"Inclusion Criteria:

Patients with rheumatoid arthritis fulfilling the ACR 1987 criteria
Between 18 years to 65 year of age
Having active disease Disease activity score (28 joints) DAS28-3 more than 5.1
Not on methotrexate in the last 2 months
Permitted to be on corticosteroids if the dosages stable for at least 1 weeks before randomization and if corticosteroid dosage less than 10 mg/day
Permitted to be on other disease modifying anti-rheumatic drug (DMARD) like sulfasalazine, leflunomide and hydroxychloroquine, if dosages stable for at least 2 weeks before randomization

Exclusion Criteria:

Pregnant/Breastfeeding
Ongoing/Recent treatment with methotrexate (2 months)
Chronic liver disease
Renal failure
Any leucopenia or thrombocytopenia
Breast-feeding
Desirous of pregnancy in the next 6 months
Known Hepatitis B or C positive
Known clinically relevant chronic lung disease: ILD
Tuberculosis or other active infections
Known HIV positive",Patients started on 15 mg of oral methotrexate (weekly) increased by 2.5 mg every 2 weeks (max 25mg weekly),ChEMBL:CHEMBL34259 | DrugBank:DB00563 | PubChem:126941,Methotrexate,CN(Cc1cnc2nc(N)nc(N)c2n1)c1ccc(C(=O)N[C@@H](CCC(=O)O)C(=O)O)cc1,L01BA01 | L04AX03,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01406015,NCT01406015_EG000,No,All,Adult | Older Adult,Not Applicable,38,"Inclusion Criteria:

Age 18-70 years
Good health as evidenced by history and physical exam
Body Mass Index (BMI): >30 kg/m2 and <45 kg/m2

Exclusion criteria:

Medical illnesses other than treated hypothyroidism
Blood Pressure (BP) >135/85 or systolic BP <90 mm Hg
Hepatic disease (transaminase > 3 times normal)
Renal impairment (Creatinine clearance <60 ml/min)
Baseline serum Potassium (K) >5.0 mmol/L
History of drug or alcohol abuse
Allergies to spironolactone
Participation in any other concurrent clinical trial
Women using oral contraceptives within the last 3 months",Spironolactone 50 mg once daily for 6 weeks.,ChEMBL:CHEMBL1393 | DrugBank:DB00421 | PubChem:5833,Spironolactone,[H][C@]12CC[C@]3(C)[C@]4(CCC(=O)O4)CC[C@@]3([H])[C@]1([H])[C@]([H])(SC(C)=O)CC1=CC(=O)CC[C@@]12C,C03DA01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01408641,NCT01408641_EG000,No,Male,Adult,Not Applicable,1,"Inclusion Criteria:

Male
Ages 21-64
Diagnosis of PTSD via a score of 50 or higher on the Clinician Administered PTSD Scale (CAPS)
Alcohol abuse or dependence per diagnosis in the medical record -or- by consuming more than 35 standard drinks per week over the previous 4 weeks as measured by the Timeline Follow-Back Interview
A desire to reduce drinking behavior
Any Race/Ethnicity

Exclusion Criteria:

Currently taking a carbonic anhydrase inhibitor (e.g. zonisamide, acetazolamide, dichlorphenamide)
Currently taking or have taken in the previous 3 months: acamprosate, naltrexone, disulfiram, topiramate
Change in benzodiazepine dose within the previous 3 months
Change in other (non-benzodiazepine) medication dose within the last 4 weeks
Seizure disorder documented in the medical record
Head trauma with loss of consciousness for greater than 30 minutes -or- a diagnosis of post-concussive syndrome documented in the medical record
Suicide attempt within the previous 3 months or suicidal ideation within the previous 4 weeks
A history of kidney stones
A history of glaucoma
ALT or AST liver enzymes elevated more than twice the upper limit of normal
More than 4 unsuccessful attempts at inpatient alcohol treatment
Medically unstable (including significant hypertension despite adequate treatment)
A history of delirium tremens (""DTs"") or alcohol withdrawal seizure
Compulsory treatment to avoid legal consequences (e.g. imprisonment)
Currently in a setting without access to alcohol (e.g. locked inpatient unit)","Topiramate arm will be titrated (dose will increase slowly) over 6 weeks to 400mg or highest tolerated dose.

Topiramate: Topiramate titrated over 6 weeks to 400mg or highest tolerated dose.",ChEMBL:CHEMBL220492 | DrugBank:DB00273 | PubChem:5284627,Topiramate,[H][C@@]12OC(C)(C)O[C@]1([H])CO[C@@]1(COS(N)(=O)=O)OC(C)(C)O[C@]12[H],A08AA51 | N03AX11,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01420653,NCT01420653_EG001,No,All,Adult,Phase 3,111,"Inclusion Criteria:

Provides written informed consent before initiation of any study-related procedures.
Males and females aged at least 10 years and not more than 60 years old on the day of consent.
Undergoing dental surgery for the extraction of at least 2 impacted third molar teeth.
A resting VAS pain intensity score at baseline (within 6 hours after the completion of surgery) of greater than or equal to 40 mm on a 100 mm VAS scale with 0 = no pain and 100 = worst pain imaginable.

Exclusion Criteria:

Has taken any NSAID or acetaminophen within 12 hours prior to the stat of surgery other than asprin less than or equal to 150 mg/day
Subjects who have received any anaesthetics within 24 hours prior to surgery
Hypersensitivity to opioids
Known to be pregnant or possibly pregnant
Women of childbearing potential who are unwilling to take adequate contraceptive precautions, i.e., hormonal contraceptive, an intrauterine device, double-barrier method, or abstinence. A women of childbearing potential is defined as any female who is less than 2 years post-menopausal or has not undergone a partial or total hysterectomy or surgical sterilization, e.g. bilateral tubal ligation, bilateral oophorectomy.
Women of childbearing potential who are unwilling to undergo an urine pregnancy test.
Suffering from a neurological disorder relating to pain perception or any acute or chronic condition that, in the opinion of the investigator, makes the subject unsuitable from an efficacy or safety perspective.
In the opinion of the investigator, unable to understand the visual analogue pain score or comply with the protocol requirements.
Currently, or in the last 30 days, has been in a clinical trial involving another study drug.
Currently treated with an ACE inhibitor, warfarin, steroid (other than nasal steroids or topical steroids with the approval of the investigator) cyclosporin, tacrolimus or methotrexate, or any other medication felt by the investigator to interfere with safety or efficacy evaluations.
Participant weight < 50 kg or > 120 kg.
Has a history of drug or alcohol abuse.
Suffering from any other disease or condition which, in the opinion of the investigator, means that it would not be in the participants best interests to participant in the study.","Acetaminophen 325mg per tablet (standard dose acetaminophen), two tablets every 6 hours, orally

Acetaminophen: Acetaminophen 325 mg, 3 tablets four times a day, with food for 48 hours",ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT01424514,NCT01424514_EG001,No,All,Adult | Older Adult,Phase 2,39,"Inclusion Criteria:

Deviations from inclusion criteria are not allowed because they can potentially jeopardize the scientific integrity of the study, regulatory acceptability or subject safety. Therefore, adherence to the criteria as specified in the protocol is essential.

A subject will be eligible for inclusion in this study only if all of the following criteria apply:

Diagnosis of NAR, as determined by the presence of perennial rhinitis symptoms that last for several months per year, for more than 1 year and are not attributed to allergy, infections or nasal abnormalities. Positive history of rhinitis symptoms triggered by environmental provocateurs (e.g. weather changes, irritants, air pollution etc), but not allergens.
Normal levels of total plasma IgE and negative allergy skin or Rast tests to common aeroallergens.
Male or female between 18 and 65 years of age inclusive.

A female subject is eligible to participate if she is of:

Non-childbearing potential defined as pre-menopausal females with a \documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) > 40 MlU/ml and estradiol < 40 pg/ml (<147 pmol/L) is confirmatory]. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods in Section 8.1 if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment. For most forms of HRT, at least 2-4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method.
Child-bearing potential and agrees to use one of the contraception methods listed in Section 8.1 for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception until 84 days post-last treatment administration.
Male subjects with female partners of child-bearing potential must agree to use one of the contraception methods listed in Section 8.1. This criterion must be followed from the time of the first dose of study medication until 84 days post-last treatment administration.
Body weight ≥ 50 kg (males) and ≥45kg (females) and BMI within the range 19 - 29.9 kg/m2 (inclusive).
Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Available to complete all the required study measurements.
Single QTc, < 450 msec; or QTc < 480 msec in subjects with Bundle Branch Block.
The subject must demonstrate at screening TSS ≥ 4 (on a 9 point scale) at screening visits 1 and 2.
AST and ALT < 2xULN; alkaline phosphatase and bilirubin less than or equal to 1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).

Exclusion Criteria:

Deviations from exclusion criteria are not allowed because they can potentially jeopardise the scientific integrity of the study, regulatory acceptability or subject safety. Therefore, adherence to the criteria as specified in the protocol is essential.

A subject will not be eligible for inclusion in this study if any of the following criteria apply:

Nasal abnormalities likely to affect the outcome of the study, i.e. nasal septal perforation, nasal polyps, other nasal malformations.
History of frequent nosebleeds.
A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
Positive pre-study drug/alcohol/smoking screen. A minimum list of drugs that will be screened for include amphetamines, barbiturates, cocaine, opiates, cannabinoids, benzodiazepines and methadone
A positive test for HIV antibody.

History of regular alcohol consumption within 6 months of the study defined as:

• An average weekly intake of >14 drinks for males or >7 drinks for females. One drink is equivalent to 12 g of alcohol: 12 ounces (360 ml) of beer, 5 ounces (150 ml) of wine or 1.5 ounces (45 ml) of 80 proof distilled spirits.

The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
Exposure to more than four new chemical entities within 12 months prior to the first dosing day.

Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days prior to the first dose of study medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.

Subjects who are using some of the medications below on an as needed basis, may participate in the study if they remain free of medication for the following periods of time prior to each visit:

Nasal antihistamines: 48 hours
Oral antihistamines A (cetirizine, fexofenadine, loratadine, desloratadine): 7 days
Oral antihistamines B (all others): 7 days
Nasal decongestants: 24 hours
Oral decongestants: 24 hours
Nasal glucocorticosteroids: 4 weeks
Inhaled glucocorticoids: 4 weeks
Oral glucocorticosteroids: 12 weeks
Oral leukotriene receptor antagonists: 7 days
Oral 5-lipoxygenase inhibitors: 7 days
Oral methylxanthines: 7 days Subjects with recent upper respiratory tract infections (URTIs) will be allowed in the study only if their nasal symptoms have been completely resolved for more than 3 weeks prior to screening.
History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
Pregnant females as determined by positive serum or urine hCG test at screening or prior to dosing.
Lactating females.
Unwillingness or inability to follow the procedures outlined in the protocol.
Subject is mentally or legally incapacitated.","Participants received repeat doses of intranasal spray of SB-705498 12 milligram (mg) as an active intervention once daily for 14 days in each of the 2 treatment periods, where participants were randomized to any of the two treatment sequences (active/placebo or placebo/active) separated by at least 4 weeks of washout period.",DrugBank:DB11883 | PubChem:9910486,SB-705498,O=C(Nc1ccccc1Br)N[C@@H]1CCN(c2ccc(C(F)(F)F)cn2)C1,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT01427296,NCT01427296_EG001,No,All,Adult | Older Adult,Phase 4,1051,"Inclusion Criteria:

Between 18 and 70 years of age, inclusive
Scheduled for colonoscopy within 21 days of the screening visit
Able to swallow tablets the size of a multivitamin without difficulty

Exclusion Criteria:

History of biopsy-proven acute phosphate nephropathy
Known allergy or hypersensitivity to treatment arms
History of gastric stapling or bypass procedure or history of gastric retention
History of any other sodium phosphate preparation within 6 months prior to colonoscopy","Polyethylene glycol: HalfLytely and Bisacodyl Tablet Bowel Prep Kit, administered as 1 bisacodyl tablet followed by HalfLytely oral solution in a total liquid volume of approximately 2 L",DrugBank:DB04216 | PubChem:5280343,Quercetin,O=c1c(O)c(-c2ccc(O)c(O)c2)oc2cc(O)cc(O)c12,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01427972,NCT01427972_EG001,No,All,Adult | Older Adult,Phase 2,22,"Inclusion Criteria:

Men and women of non-childbearing potential as determined by medical history and physical examination

Male participants: Non-vasectomized male participants must agree to use 2 medically accepted methods of contraception with all sexual partners during the study and for 90 days following the final dosing. Medically accepted effective forms of contraception may include condoms with contraceptive foam or having partners use diaphragms with contraceptive jelly or cervical caps with contraceptive jelly
Female participants: Female participants must be of non-childbearing potential due to surgical sterilization (hysterectomy, bilateral oophorectomy or tubal ligation) or menopause. Postmenopausal women should be a minimum of 12 months without a menstrual period. Perimenopausal women who are 6 months without a menstrual period, have a follicle stimulating hormone (FSH) level 23.0-116.3 international unit/liter (IU/L) and are between the ages of 45 and 65 years, inclusive, are also eligible
Have been diagnosed with Chronic Kidney Disease (CKD) (and including diabetic kidney disease and chronic glomerulonephritis)
Have an estimated glomerular filtration rate (eGFR) between 30-70 milliliter/minute/1.73 square meters(30-70 ml/min/1.73m²)
Have been taking an angiotensin converting enzyme (ACE) inhibitor and/or angiotensin II receptor blocker (ARB), for at least 3 months, and at a stable dose for greater than or equal to (≥) 2 months prior to randomization, and agree to continue to take such throughout the duration of the study

Participants must meet both of the following renal function criteria prior to qualifying for randomization:

Have Screening first morning urine protein/creatinine ratio (PCR) ≥400 milligram/gram (mg/g)
Have stable renal function, in the opinion of the Investigator

Stable use of blood pressure (BP) medication and acceptable cuff BP, as defined by the following criteria:

While receiving stable dose of an ACE inhibitor and/or ARB
While receiving stable doses of any other applicable BP medication (including diuretic therapy) for ≥3 weeks prior to screening
Have seated cuff systolic BP less than or equal to (≤) 160 millimeters of mercury (mm Hg) and diastolic BP ≤100 mm Hg
Have serum potassium (K+)≤5.0 milliequivalents/liter (mEq/L) at Screening, and no more that 1 hospitalization due to hyperkalemia within 1 year
Are reliable and willing to make themselves available for the duration of the study and are willing to follow specific study procedures
Have venous access sufficient to allow blood sampling
Have lab values and other safety parameters that are, in the opinion of the investigator, acceptable for participation in the study

Exclusion Criteria:

Participants who are currently enrolled in, or have discontinued within the last 30 days of the investigational drug from, a clinical trial involving an investigational drug or device or an off-label use of an approved drug (other than the study drug used in this study), or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study. Participants may be enrolled in this study and dosed on day 31 or greater following the last day of previous investigational drug administration
Have previously completed or withdrawn from this study or any other study investigating LY2623091
Participants who are taking any diuretic drug and not receiving a stable dose for 3 weeks prior to the screening/qualification visit and through end of treatment
Participants receiving a renin inhibitor, or an mineralocorticoid receptor (MR) antagonist must have a wash-out period of at least 1 month prior to randomization
Participants in whom dialysis or renal transplantation is anticipated by their physician within 6 months after the Screening
Participants with a history of acute kidney injury within 3 months before Screening
Participants who have or are expected to require systemic immunosuppression therapy within 30 days of Screening(except for inhalant steroids)
Use of oral or parenteral corticosteroids within 30 days of the Screening
Participants with a diagnosis of Class three (III) or four (IV) congestive heart failure (CHF) [as defined by the New York Heart Association (NYHA)]
Participants with evidence of human immunodeficiency virus (HIV) and/or positive human HIV antibodies; participants with a history of cirrhosis or hepatitis C or are positive for hepatitis C antibody at Screening; participants who are known to be hepatitis B surface antigen-positive or are positive for hepatitis B surface antigen at Screening
Participants who are unwilling or unable to comply with the use of a data collection device to directly record data from the participants
Use of a metabolizing enzyme [cytochrome P450 (CYP3A4)] inhibitors or inducers, potassium sparing diuretic drugs (all other diuretic drugs are allowed, potassium supplements or systemic glucocorticoids within 7 days of study enrollment. Intermittent use of nonsteroidal anti-inflammatory drug (NSAIDs) is permitted, except for within 24 hours of critical urine sodium/potassium measures or during the inpatient periods, during which times NSAID use is limited to chronic use only (stable for ≥1 month prior to enrollment). Prostaglandin inhibitors should not be used during the inpatient periods of the study, with above exception of chronic NSAID use
Have donated blood of more than 500 milliliter (mL) within the last 60 days of screening
Have an average weekly alcohol intake that exceeds 21 units per week or participants unwilling to stop alcohol intake within 48 hours of entry into study and for the duration of the study [1 unit equal 12 ounces (oz) or 360 mL of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits]
Evidence of regular use of drugs of abuse
Consumption of natural licorice and/or natural licorice-containing products and/or regular daily consumption of grapefruit and/or grapefruit juice within 7 days of first dosing and/or anticipated consumption during the study","1.5 mg LY2623091 capsules were administered to participants in either Period 1 or Period 2. In each period 1.5 mg LY2623091 was administered orally, QD for 21 days, on Day 1 through Day 20 participants were in a fed state and on Day 21 participants were in a fasted state. Participants went through a minimum 28-day Washout Period between Period 1 and Period 2.",PubChem:42636651,"(E)-1-(5-((E)-(3-Fluorodibenzo(b,E)oxepin-11(6H)-ylidene)methyl)-1-((R)-1-morpholinopropan-2-yl)-1H-benzo(d)imidazol-2(3H)-ylidene)urea",CC(CN1CCOCC1)n1c(NC(N)=O)nc2cc(C=C3c4ccccc4COc4cc(F)ccc43)ccc21,,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,1.0,1.0,1.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01427972,NCT01427972_EG002,No,All,Adult | Older Adult,Phase 2,17,"Inclusion Criteria:

Men and women of non-childbearing potential as determined by medical history and physical examination

Male participants: Non-vasectomized male participants must agree to use 2 medically accepted methods of contraception with all sexual partners during the study and for 90 days following the final dosing. Medically accepted effective forms of contraception may include condoms with contraceptive foam or having partners use diaphragms with contraceptive jelly or cervical caps with contraceptive jelly
Female participants: Female participants must be of non-childbearing potential due to surgical sterilization (hysterectomy, bilateral oophorectomy or tubal ligation) or menopause. Postmenopausal women should be a minimum of 12 months without a menstrual period. Perimenopausal women who are 6 months without a menstrual period, have a follicle stimulating hormone (FSH) level 23.0-116.3 international unit/liter (IU/L) and are between the ages of 45 and 65 years, inclusive, are also eligible
Have been diagnosed with Chronic Kidney Disease (CKD) (and including diabetic kidney disease and chronic glomerulonephritis)
Have an estimated glomerular filtration rate (eGFR) between 30-70 milliliter/minute/1.73 square meters(30-70 ml/min/1.73m²)
Have been taking an angiotensin converting enzyme (ACE) inhibitor and/or angiotensin II receptor blocker (ARB), for at least 3 months, and at a stable dose for greater than or equal to (≥) 2 months prior to randomization, and agree to continue to take such throughout the duration of the study

Participants must meet both of the following renal function criteria prior to qualifying for randomization:

Have Screening first morning urine protein/creatinine ratio (PCR) ≥400 milligram/gram (mg/g)
Have stable renal function, in the opinion of the Investigator

Stable use of blood pressure (BP) medication and acceptable cuff BP, as defined by the following criteria:

While receiving stable dose of an ACE inhibitor and/or ARB
While receiving stable doses of any other applicable BP medication (including diuretic therapy) for ≥3 weeks prior to screening
Have seated cuff systolic BP less than or equal to (≤) 160 millimeters of mercury (mm Hg) and diastolic BP ≤100 mm Hg
Have serum potassium (K+)≤5.0 milliequivalents/liter (mEq/L) at Screening, and no more that 1 hospitalization due to hyperkalemia within 1 year
Are reliable and willing to make themselves available for the duration of the study and are willing to follow specific study procedures
Have venous access sufficient to allow blood sampling
Have lab values and other safety parameters that are, in the opinion of the investigator, acceptable for participation in the study

Exclusion Criteria:

Participants who are currently enrolled in, or have discontinued within the last 30 days of the investigational drug from, a clinical trial involving an investigational drug or device or an off-label use of an approved drug (other than the study drug used in this study), or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study. Participants may be enrolled in this study and dosed on day 31 or greater following the last day of previous investigational drug administration
Have previously completed or withdrawn from this study or any other study investigating LY2623091
Participants who are taking any diuretic drug and not receiving a stable dose for 3 weeks prior to the screening/qualification visit and through end of treatment
Participants receiving a renin inhibitor, or an mineralocorticoid receptor (MR) antagonist must have a wash-out period of at least 1 month prior to randomization
Participants in whom dialysis or renal transplantation is anticipated by their physician within 6 months after the Screening
Participants with a history of acute kidney injury within 3 months before Screening
Participants who have or are expected to require systemic immunosuppression therapy within 30 days of Screening(except for inhalant steroids)
Use of oral or parenteral corticosteroids within 30 days of the Screening
Participants with a diagnosis of Class three (III) or four (IV) congestive heart failure (CHF) [as defined by the New York Heart Association (NYHA)]
Participants with evidence of human immunodeficiency virus (HIV) and/or positive human HIV antibodies; participants with a history of cirrhosis or hepatitis C or are positive for hepatitis C antibody at Screening; participants who are known to be hepatitis B surface antigen-positive or are positive for hepatitis B surface antigen at Screening
Participants who are unwilling or unable to comply with the use of a data collection device to directly record data from the participants
Use of a metabolizing enzyme [cytochrome P450 (CYP3A4)] inhibitors or inducers, potassium sparing diuretic drugs (all other diuretic drugs are allowed, potassium supplements or systemic glucocorticoids within 7 days of study enrollment. Intermittent use of nonsteroidal anti-inflammatory drug (NSAIDs) is permitted, except for within 24 hours of critical urine sodium/potassium measures or during the inpatient periods, during which times NSAID use is limited to chronic use only (stable for ≥1 month prior to enrollment). Prostaglandin inhibitors should not be used during the inpatient periods of the study, with above exception of chronic NSAID use
Have donated blood of more than 500 milliliter (mL) within the last 60 days of screening
Have an average weekly alcohol intake that exceeds 21 units per week or participants unwilling to stop alcohol intake within 48 hours of entry into study and for the duration of the study [1 unit equal 12 ounces (oz) or 360 mL of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits]
Evidence of regular use of drugs of abuse
Consumption of natural licorice and/or natural licorice-containing products and/or regular daily consumption of grapefruit and/or grapefruit juice within 7 days of first dosing and/or anticipated consumption during the study","10 mg LY2623091 capsules were administered to participants in either Period 1 or Period 2. In each period 10 mg LY2623091 was administered orally, QD for 21 days, on Day 1 through Day 20 participants were in a fed state and on Day 21 participants were in a fasted state. Participants went through a minimum 28-day Washout Period between Period 1 and Period 2.",PubChem:42636651,"(E)-1-(5-((E)-(3-Fluorodibenzo(b,E)oxepin-11(6H)-ylidene)methyl)-1-((R)-1-morpholinopropan-2-yl)-1H-benzo(d)imidazol-2(3H)-ylidene)urea",CC(CN1CCOCC1)n1c(NC(N)=O)nc2cc(C=C3c4ccccc4COc4cc(F)ccc43)ccc21,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,1.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT01431300,NCT01431300_EG000,Accepts Healthy Volunteers,All,Adult,Not Applicable,30,"Inclusion Criteria:

healthy male or female subjects between 18-45 years of age

Exclusion Criteria:

Pregnant and lactating females
known renal impairment
allergy to gadolinium-based contrast
metallic implanted devices
claustrophobia.",gadofosveset : Intravenous administration of the specified dosage of gadolinium contrast agent,PubChem:158440 | PubChem:23724913,Gadofosveset,O.O=C([O-])CN(CCN(CC(=O)[O-])CC(COP(=O)([O-])OC1CCC(c2ccccc2)(c2ccccc2)CC1)N(CC(=O)[O-])CC(=O)[O-])CC(=O)[O-].[Gd+3].[Na+].[Na+].[Na+],V08CA11,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01431300,NCT01431300_EG001,Accepts Healthy Volunteers,All,Adult,Not Applicable,30,"Inclusion Criteria:

healthy male or female subjects between 18-45 years of age

Exclusion Criteria:

Pregnant and lactating females
known renal impairment
allergy to gadolinium-based contrast
metallic implanted devices
claustrophobia.",gadofosveset : Intravenous administration of the specified dosage of gadolinium contrast agent,PubChem:158440 | PubChem:23724913,Gadofosveset,O.O=C([O-])CN(CCN(CC(=O)[O-])CC(COP(=O)([O-])OC1CCC(c2ccccc2)(c2ccccc2)CC1)N(CC(=O)[O-])CC(=O)[O-])CC(=O)[O-].[Gd+3].[Na+].[Na+].[Na+],V08CA11,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01431300,NCT01431300_EG002,Accepts Healthy Volunteers,All,Adult,Not Applicable,30,"Inclusion Criteria:

healthy male or female subjects between 18-45 years of age

Exclusion Criteria:

Pregnant and lactating females
known renal impairment
allergy to gadolinium-based contrast
metallic implanted devices
claustrophobia.","FDA-approved dose for lower extremity arterial imaging

gadofosveset : Intravenous administration of the specified dosage of gadolinium contrast agent",PubChem:158440 | PubChem:23724913,Gadofosveset,O.O=C([O-])CN(CCN(CC(=O)[O-])CC(COP(=O)([O-])OC1CCC(c2ccccc2)(c2ccccc2)CC1)N(CC(=O)[O-])CC(=O)[O-])CC(=O)[O-].[Gd+3].[Na+].[Na+].[Na+],V08CA11,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01438411,NCT01438411_EG000,No,All,Child | Adult | Older Adult,Phase 3,53,"Inclusion Criteria:

Subjects who received cholic acid through CCHMC protocols 91-10-10 or CAC-002-01 and meet the following criteria are eligible for study participation.

The subject and/or parent/legal guardian must have provided informed consent prior to study start.
The subject must have a diagnosis of an inborn error of bile acid synthesis.
The subject must be willing and able to comply with all study assessments and procedures.
Subjects with other organ dysfunction will not be excluded","Active drug

Cholic Acid: 10-15 mg/kg body weight/day supplied in 50 or 250 mg Cholic Acid Capsules",ChEMBL:CHEMBL205596 | DrugBank:DB02659 | PubChem:221493,Cholic Acid,[H][C@@]1(O)CC[C@@]2(C)[C@@]([H])(C1)C[C@@]([H])(O)[C@@]1([H])[C@]3([H])CC[C@]([H])([C@]([H])(C)CCC(=O)O)[C@@]3(C)[C@@]([H])(O)C[C@]21[H],A05AA03,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,1.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT01440959,NCT01440959_EG000,No,All,Adult | Older Adult,Phase 2,30,"Inclusion criteria

Age 20 years or older
Histologically confirmed metastatic and/or advanced GIST with CD117(+), DOG-1(+), or mutation in KIT or PDGFRα gene
Failed (progressed and/or intolerable) after prior treatments for GIST, including at least both imatinib and sunitinib .
ECOG performance status of 0~2
Resolution of all toxic effects of prior treatments to grade 0 or 1 by NCI-CTCAE version 3.0
At least one measurable lesion as defined by RECIST version 1.0.

Adequate bone marrow, hepatic, renal, and other organ functions

Neutrophil > 1,500/mm3
Platelet > 75,000/mm3
Hemoglobin > 8.0 g/dL
Total bilirubin < 1.5 x upper limit of normal (ULN)
AST/ALT < 2.5 x ULN (or < 5 x ULM in case of liver metastases)
Creatinine < 1.5 x ULN
Amylase, lipase < ULN
Electrolytes should be within normal limits.
Urine dipstick reading: Negative for proteinuria or, if documentation of +1 results for protein on dipstick reading, then total urinary protein ≤ 500 mg and measured creatinine clearance ≥ 50 mL/min/1.73m2 from a 24-hour urine collection
Life expectancy > 12 weeks
Women with reproductive potential must have a negative serum or urine pregnancy test
Washout period of previous TKIs or chemotherapy for more than 4 times the half life.
Provision of a signed written informed consent

Exclusion criteria

Women of child-bearing potential who are pregnant or breast feeding or adults of reproductive potential not employing an effective method of birth control.
Clinically significant cardiac disease (New York Heart Association, Class III or IV) or impaired cardiac function or clinically significant cardiac diseases,
Uncontrolled infection.
Diabetes mellitus (insulin dependent or independent disease, requiring chronic medication) with signs of clinically significant peripheral vascular disease.
Previous pericarditis; clinically significant pleural effusion in the previous months or current ascites requiring two or more interventions/month.
Known pre-existing clinically significant disorder of the hypothalamic-pituitary axis, adrenal or thyroid glands.
Prior acute or chronic pancreatitis of any etiology.
Acute and chronic liver disease and all chronic liver impairment.
Malabsorption syndrome or uncontrolled gastrointestinal toxicities with toxicity greater than NCI CTCAE grade 2.
Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality.
Treatment with any of the medications that have a potential risk of prolonging the QT interval or inducing Torsades de Points and the treatment cannot be discontinued or switched to a different medication prior to starting study drug.
Use of ketoconazole, erythromycin, carbamazepine, phenobarbital, rifampin, phenytoin and quinidine 2 weeks prior baseline.
Major surgery ≤ 28 days prior to starting study drug or who have not recovered from side effects of such therapy.
Known diagnosis of HIV infection .
History of another primary malignancy that is currently clinically significant or currently requires active intervention.
Patients with brain metastases as assessed by radiologic imaging
Alcohol or substance abuse disorder.
no other inhibitor of FGFR except sunitinib",dovitinib : TKI258 at 500 mg/day on a 5 days on/2 days off dosing schedule,DrugBank:DB05928 | PubChem:135398510,Dovitinib,CN1CCN(c2ccc3nc(-c4c(N)c5c(F)cccc5[nH]c4=O)[nH]c3c2)CC1,,1.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT01443026,NCT01443026_EG000,No,Male,Adult | Older Adult,Phase 2,26,"Inclusion Criteria:

Male
Have a history of prostate biopsy indicating HGPIN without cancer within 2 years prior to registration. At least 4 weeks must have elapsed between the last biopsy and the biopsy used for baseline data.
Have an AUA symptom score <=25 at time of registration.
Refrain from taking lycopene, selenium, vitamin E, or other antioxidant supplements within 1 month of randomization. Participants must agree to refrain from taking non-study dietary supplements while on study
Refrain from taking exogenous hormones, drugs affecting hormone metabolism, or specified non-prescription substances (e.g. saw palmetto, PC-Spes) taken to affect the prostate within 1 month of registration. Patients must also agree to refrain from taking the non-prescription substances while on study
Be willing to limit intake of lycopene-containing foods while on study
Have no prior cancer (except basal cell or squamous cell skin cancer) or complete remission for at least 5 years
Be ambulatory, capable of self-care and able to carry out light or sedentary work
Have a dietary fat intake of 23-48% of calories
Participant's physician recommends repeat biopsy 4-6 months after randomization

Exclusion Criteria:

No repeat biopsy planned
Not willing to change diet
Have a diagnosis of prostate cancer",Lycopene 30 mg/day until clinically-indicated repeat biopsy performed (approximately 6 months),DrugBank:DB11231 | PubChem:168312947 | PubChem:446925,Lycopene,CC(C)=CCCC(C)=CC=CC(C)=CC=CC(C)=CC=CC=C(C)C=CC=C(C)C=CC=C(C)CCC=C(C)C,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01444651,NCT01444651_EG000,Accepts Healthy Volunteers,All,Adult,Phase 3,36,"Inclusion Criteria:

Age > 18 years and < 50 years
BMI > 30 kg/m2
Fasting insulin > 10 uU/mL

Exclusion Criteria:

Systolic blood pressure (SBP) < 100, > 150 mmHg
Current anti-hypertensive medication use, including diuretics
Current use of organic nitrates
Current use of PDE-5 inhibitors (sildenafil, tadalafil, vardenafil)
History of reaction to PDE-5 inhibitors
Known HIV infection
Use of medications that strongly alter CYP3A4 activity
History of myocardial infarction, angina, uncontrolled cardiac arrhythmia, stroke, transient ischemic attack, or seizure
Known non-arteritic ischemic optic retinopathy (NAIOR)
History of hearing loss
Estimated glomerular filtration rate (eGFR) < 60 ml/min/1.73 m2 by the modified diet in renal disease (MDRD) equation
Hepatic transaminase (AST and ALT) levels greater than three times the upper limit of normal
Known pregnancy or those unwilling to avoid pregnancy during the course of the study
History of priapism
Use in excess of four alcoholic drinks daily
History of diabetes mellitus or use of anti-diabetic medications
Known anemia (men, Hct < 38% and women, Hct < 36%)","20 mg Tadalafil tablet taken by mouth once a day for 3 months

Tadalafil: 20 mg Tadalafil taken once a day for 3 months",ChEMBL:CHEMBL779 | DrugBank:DB00820 | PubChem:110635,Tadalafil,[H][C@]12Cc3c([nH]c4ccccc34)[C@@H](c3ccc4c(c3)OCO4)N1C(=O)CN(C)C2=O,C02KX52 | C02KX54 | G04BE08 | G04CA54 | G04CB51,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT01445028,NCT01445028_EG000,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 4,109,"Inclusion Criteria:

18-70 year-old men or 50-70 year-old, post-menopausal women.
Healthy enough to participate in the study.
Willing and able to consent to participation.
Recurrent PVR-associated RD occurring at least 2 weeks after RD repair or
Primary RD (retinal detachment) associated with one or more high-risk features

Exclusion Criteria:

History of hypersensitivity to isotretinoin.
Current use of a corticosteroid (excluding topical).
Any history of depression, anorexia, liver or pancreatic disease.
More than one prior surgical RD repair.
Patients with closed funnel retinal detachments.
Patients with chronic retinal detachment, defined as longer than 12 weeks.
Any use an oral retinoid within 6 months.
Systemic chemotherapy within 6 months.
Patients taking supplemental vitamin A.
Corneal opacity sufficient to impair surgical view.
Proliferative diabetic retinopathy.",Isotretinoin: Isotretinoin 20mg daily for 12 weeks,ChEMBL:CHEMBL38 | ChEMBL:CHEMBL547 | ChEMBL:CHEMBL705 | DrugBank:DB00523 | DrugBank:DB00755 | DrugBank:DB00982 | PubChem:444795 | PubChem:449171 | PubChem:5282379,Tretinoin,CC(C=CC1=C(C)CCCC1(C)C)=CC=CC(C)=CC(=O)O,D10AD01 | D10AD04 | D10AD51 | D10AD54 | D10BA01 | D11AH04 | L01XF01 | L01XF02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01445028,NCT01445028_EG001,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 4,109,"Inclusion Criteria:

18-70 year-old men or 50-70 year-old, post-menopausal women.
Healthy enough to participate in the study.
Willing and able to consent to participation.
Recurrent PVR-associated RD occurring at least 2 weeks after RD repair or
Primary RD (retinal detachment) associated with one or more high-risk features

Exclusion Criteria:

History of hypersensitivity to isotretinoin.
Current use of a corticosteroid (excluding topical).
Any history of depression, anorexia, liver or pancreatic disease.
More than one prior surgical RD repair.
Patients with closed funnel retinal detachments.
Patients with chronic retinal detachment, defined as longer than 12 weeks.
Any use an oral retinoid within 6 months.
Systemic chemotherapy within 6 months.
Patients taking supplemental vitamin A.
Corneal opacity sufficient to impair surgical view.
Proliferative diabetic retinopathy.","Oral isotretinoin on recurrent retinal detachment associated with Proliferative vitreoretinopathy

Isotretinoin: Isotretinoin 20mg daily for 12 weeks",ChEMBL:CHEMBL38 | ChEMBL:CHEMBL547 | ChEMBL:CHEMBL705 | DrugBank:DB00523 | DrugBank:DB00755 | DrugBank:DB00982 | PubChem:444795 | PubChem:449171 | PubChem:5282379,Tretinoin,CC(C=CC1=C(C)CCCC1(C)C)=CC=CC(C)=CC(=O)O,D10AD01 | D10AD04 | D10AD51 | D10AD54 | D10BA01 | D11AH04 | L01XF01 | L01XF02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01449955,NCT01449955_EG000,No,Male,Adult | Older Adult,Not Applicable,54,"Inclusion Criteria:

Male Veterans
Diagnosis of Posttraumatic Stress Disorder related to combat

Exclusion Criteria:

Hypersensitivity to Rapamycin
Organic brain damage (including unresolved Traumatic Brain Injury sequela)
Substance dependence in the last three months
On any immunosuppressant therapy
Prominent suicidal or homicidal features
Medical conditions: systemic infections, congestive heart failure, renal failure, hepatic failure",15mg Rapamycin,ChEMBL:CHEMBL413 | DrugBank:DB00877 | PubChem:134760597 | PubChem:138404388 | PubChem:21944094 | PubChem:5284616,Sirolimus,COC1CC2CCC(C)C(O)(O2)C(=O)C(=O)N2CCCCC2C(=O)OC(C(C)CC2CCC(O)C(OC)C2)CC(=O)C(C)C=C(C)C(O)C(OC)C(=O)C(C)CC(C)C=CC=CC=C1C,L01EG04 | L04AA10 | S01XA23,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01450813,NCT01450813_EG001,No,All,Adult | Older Adult,Not Applicable,80,"Inclusion Criteria:

American Society of Anesthesia (ASA) physical status class I or II.
Body mass index between 18 and 35 kg m-2.
No use of psychotropic or neuropsychiatric medications.
A airway assessment with no indication of a difficult intubation including a class I or II Mallampati airway and a mandible-to-hyoid distance of greater than three fingerbreadths.
Age between 18-75 years.

Exclusion Criteria:

Does not meet inclusion criteria.",Rocuronium dose 0.2 mg/kg,ChEMBL:CHEMBL1201244 | DrugBank:DB00728 | PubChem:441290,Rocuronium,[H][C@@]12CC[C@]3([H])[C@]([H])(CC[C@]4(C)[C@@H](OC(C)=O)[C@@H]([N+]5(CC=C)CCCC5)C[C@@]34[H])[C@@]1(C)C[C@H](N1CCOCC1)[C@@H](O)C2,M03AC09,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01450813,NCT01450813_EG002,No,All,Adult | Older Adult,Not Applicable,80,"Inclusion Criteria:

American Society of Anesthesia (ASA) physical status class I or II.
Body mass index between 18 and 35 kg m-2.
No use of psychotropic or neuropsychiatric medications.
A airway assessment with no indication of a difficult intubation including a class I or II Mallampati airway and a mandible-to-hyoid distance of greater than three fingerbreadths.
Age between 18-75 years.

Exclusion Criteria:

Does not meet inclusion criteria.",Rocuronium dose 0.4 mg/kg,ChEMBL:CHEMBL1201244 | DrugBank:DB00728 | PubChem:441290,Rocuronium,[H][C@@]12CC[C@]3([H])[C@]([H])(CC[C@]4(C)[C@@H](OC(C)=O)[C@@H]([N+]5(CC=C)CCCC5)C[C@@]34[H])[C@@]1(C)C[C@H](N1CCOCC1)[C@@H](O)C2,M03AC09,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01450813,NCT01450813_EG003,No,All,Adult | Older Adult,Not Applicable,80,"Inclusion Criteria:

American Society of Anesthesia (ASA) physical status class I or II.
Body mass index between 18 and 35 kg m-2.
No use of psychotropic or neuropsychiatric medications.
A airway assessment with no indication of a difficult intubation including a class I or II Mallampati airway and a mandible-to-hyoid distance of greater than three fingerbreadths.
Age between 18-75 years.

Exclusion Criteria:

Does not meet inclusion criteria.",Rocuronium dose 0.6 mg/kg,ChEMBL:CHEMBL1201244 | DrugBank:DB00728 | PubChem:441290,Rocuronium,[H][C@@]12CC[C@]3([H])[C@]([H])(CC[C@]4(C)[C@@H](OC(C)=O)[C@@H]([N+]5(CC=C)CCCC5)C[C@@]34[H])[C@@]1(C)C[C@H](N1CCOCC1)[C@@H](O)C2,M03AC09,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01456780,NCT01456780_EG000,No,All,Adult | Older Adult,Phase 4,20,"Inclusion Criteria:

Male or female
At least 18 years of age
Has not worn contact lenses, except for bandage contact lens or rigid gas permeable lens, for at least 2 weeks prior to the study and agrees to not wear contact lenses during study
Patient is in generally good & stable overall health
Minimum corneal fluorescein staining of 4 in at least one eye
OSDI score >22
The patient must have a diagnosis of posterior blepharitis
A negative urine pregnancy test result for women of childbearing potential
Women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation.
Normal lid position and closure
Ability to understand and provide informed consent to participate in this study
Willingness to follow study instructions and likely to complete all required visits

Exclusion Criteria:

History of Stevens-Johnson syndrome or ocular pemphigoid
History of eyelid surgery
Intra-ocular surgery or ocular laser surgery within 3 months
History of microbial keratitis, including herpes
Active ocular allergies
Corneal epithelial defect > 1mm2
Any change in use of topical anti-inflammatories, such as steroids, Restasis, or NSAID within the past 2 weeks
Any change in dosage of tetracycline compounds (tetracycline, doxycycline, and minocycline) within the past two weeks
Use of isotretinoin (Accutane) within the past 6 months
Pregnant or lactating women
Signs of current infection, including fever and current treatment with antibiotics
Active liver, renal, or hematologic disease
The use of any other investigational drug
Individuals with a known history of glaucoma, individuals with IOP >22 Hg in either eye and individuals with a known family history of glaucoma in primary (first degree) relatives (ie. mother, father, sibling or child)","Subject randomized to this arm will be treated with Zylet, twice a day, for 4 weeks. Zylet is a combination of loteprednol and tobramycin. Loteprednol is in a class of drugs called corticosteroids. Loteprednol inhibits processes in the body that cause inflammation (swelling). Tobramycin is an antibiotic.

Loteprednol/tobramycin: Zylet (loteprednol/tobramycin) drops, 1 drop twice a day for 4 weeks.",PubChem:9811635,Loteprednol etabonate/tobramycin,CCOC(=O)OC1(C(=O)OCCl)CCC2C3CCC4=CC(=O)C=CC4(C)C3C(O)CC21C.NCC1OC(OC2C(N)CC(N)C(OC3OC(CO)C(O)C(N)C3O)C2O)C(N)CC1O,,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01460342,NCT01460342_EG001,No,Male,Adult | Older Adult,Phase 3,306,"Inclusion Criteria:

Present with benign prostatic hyperplasia (BPH; also referred to as BPH-LUTS), based on the disease diagnostic criteria, at study entry.
Provide signed informed consent at study entry.
Have BPH-LUTS with a Total International Prostate Symptom Score (IPSS) of ≥13 at beginning of placebo lead-in period.
Have bladder outlet obstruction of intermediate severity as defined by a urinary peak flow rate (Qmax) of ≥4 to ≤15 milliliters per second (mL/sec) [from a prevoid total bladder volume (assessed by ultrasound) of ≥150 to ≤550 milliliters (mL) and a minimum voided volume of 125 mL] at beginning of placebo lead-in period.
Have prostate volume ≥20 mL estimated by transabdominal or transrectal ultrasound at study entry.
Agree not to use any other approved or experimental pharmacologic BPH, erectile dysfunction (ED) and/or overactive bladder (OAB) treatments, including alpha-blockers, 5-alpha reductase inhibitors (5-ARIs), phosphodiesterase type 5 (PDE5) inhibitors, or herbal preparations at any time during the study.

Have not taken the following treatments within the indicated duration:

Finasteride therapy for at least 3 months prior to beginning of placebo lead-in period.
Dutasteride therapy for at least 6 months prior to beginning of placebo lead-in period.
Anti-androgenic hormone therapy at least 12 months prior to beginning of placebo lead-in period.
All other BPH therapy (including herbal preparations) for at least 4 weeks prior to beginning of placebo lead-in period.
ED therapy for at least 4 weeks prior to beginning of placebo lead-in period.
OAB therapy for at least 4 weeks prior to beginning of placebo lead-in period.
Demonstrate compliance with study drug administration requirements during the placebo lead-in period by administering ≥70% of prescribed doses, confirmed by documentation that the participant returned ≤30% of prescribed doses at randomization.

Exclusion Criteria:

Prostate-specific antigen (PSA) >10.0 nanograms per milliliter (ng/mL) at study entry.
PSA ≥4.0 to ≤10.0 ng/mL at study entry, if prostate malignancy has not been ruled out to the satisfaction of an urologist.
Bladder postvoid residual (PVR) ≥300 mL by ultrasound determination at study entry.

History of any of the following pelvic conditions (checked at study entry):

Pelvic surgery or any other pelvic procedure, including radical prostatectomy, pelvic surgery for removal of malignancy, or bowel resection.
Pelvic radiotherapy.
Any pelvic surgical procedure on the urinary tract, including minimally invasive BPH-LUTS therapies and penile implant surgery.
Lower urinary tract malignancy or trauma.
Lower urinary tract instrumentation (including prostate biopsy) within 30 day of study entry.
History of urinary retention or lower urinary tract (bladder) stones within 6 months of study entry.
History of urethral obstruction due to stricture, valves, sclerosis, or tumor.
Current neurologic disease or condition associated with neurogenic bladder (for example, Parkinson's disease, multiple sclerosis) at study entry.
Clinical evidence of prostate cancer.

Clinical evidence of any of the following bladder conditions:

Mullerian duct cysts.
Atonic, decompensated, or hypocontractile bladder.
Detrusor-sphincter dyssynergia (contraction of the detrusor without sphincter relaxation).
Intravesical obstruction (for example, intravesical median lobe of the prostate).
Interstitial cystitis.

Clinical evidence of any of the following urinary tract conditions at study entry:

Urinary tract infection.
Urinary tract inflammation (including prostatitis). Urinary tract infection/inflammation is defined as a positive result for leukocyte esterase from a urine dipstick or >5 white blood cells (WBCs) per high-powered field on urinalysis from a centrifuged, clean-catch, midstream urine specimen.
Current antibiotic therapy for urinary tract infection.
Clinically significant microscopic hematuria as determined by an urologist.
History of significant renal insufficiency, defined as receiving renal dialysis or having an estimated creatinine clearance <30 milliliters per minute (mL/min) at study entry, as calculated by the central laboratory using the Cockcroft-Gault formula.
Clinical evidence of severe hepatic impairment [aspartate transaminase (AST) or alanine transaminase (ALT) >3-fold of the upper limit of normal range] at study entry.

History of any of the following cardiac conditions (checked at study entry):

Angina requiring treatment with long-acting nitrates.
Angina requiring treatment with short-acting nitrates within 90 days of study entry.
Unstable angina within 90 days of study entry.
Positive cardiac stress test without documented evidence of subsequent, effective cardiac intervention.

History of any of the following coronary conditions within 90 days of study entry:

Myocardial infarction.
Coronary artery bypass graft surgery.
Percutaneous coronary intervention (for example, angioplasty or stent placement).
Any evidence of heart disease [New York Heart Association (NYHA) ≥Class III] within 6 months of study entry.
Systolic blood pressure >160 or <90 millimeters of mercury (mm Hg) or diastolic blood pressure >100 or <50 mm Hg at study entry (if stress is suspected, retest under basal conditions), or malignant hypertension.
Glycosylated hemoglobin (HbA1c) >9% at study entry.
Scheduled or planned surgery (or any procedure requiring general, spinal, or epidural anesthesia) during the course of the study.
History of significant central nervous system injuries (including stroke or spinal cord injury) within 6 months of study entry.
History of drug, alcohol, or substance abuse within 6 months of study entry.
Current treatment with nitrates, androgens, antiandrogens, estrogens, luteinizing hormone-releasing hormone agonists/antagonists, or anabolic steroids at study entry.

Current systemic treatment with any of the following:

Potent cytochrome P450 3A4 (CYP3A4) inhibitors, such as ketoconazole or ritonavir.
CYP3A4 inducers such as rifampicin.
Known or suspected to be hypersensitive to tadalafil, or any study drug components.
Any conditions that would interfere with a participant's ability to provide informed consent or comply with study instructions, would place participant at increased risk, or might confound the interpretation of the study results.
Previously completed or withdrawn from this study or any other study investigating tadalafil.
Received treatment within the last 30 days with a drug or device that has not received regulatory approval for any indications at the time of informed consent. Participants who have been screen failures in previous studies may be eligible.","Tadalafil: 5 mg (two 2.5-mg tablets), given orally once daily for 12 weeks, during the double-blind treatment period. This followed a 4-week placebo lead-in period [2 tablets (identical to 2.5-mg tadalafil tablets) given orally once daily].",ChEMBL:CHEMBL779 | DrugBank:DB00820 | PubChem:110635,Tadalafil,[H][C@]12Cc3c([nH]c4ccccc34)[C@@H](c3ccc4c(c3)OCO4)N1C(=O)CN(C)C2=O,C02KX52 | C02KX54 | G04BE08 | G04CA54 | G04CB51,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01461733,NCT01461733_EG000,No,All,Adult | Older Adult,Phase 4,25,"Inclusion Criteria:

new onset afib

Exclusion Criteria:

hemodynamically unstable","standard dose amiodarone

amiodarone: standard dose amiodarone",ChEMBL:CHEMBL633 | DrugBank:DB01118 | PubChem:2157,Amiodarone,CCCCc1oc2ccccc2c1C(=O)c1cc(I)c(OCCN(CC)CC)c(I)c1,C01BD01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01463384,NCT01463384_EG000,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 2,13,"Inclusion Criteria:

Cognitively normal elderly subjects between the ages of 55-90 and patients aged 55 - 90 years who have mild cognitive impairment (MCI) or clinically defined Alzheimer's disease.

Exclusion Criteria:

Any person with medical devices such as cardiac pacemakers/defibrillators or neuro-implants as they are contra-indications for MRI/MRS exam.
Since the effects of MRI are unknown to the fetus or unborn child, any person who is or may be pregnant will be excluded from the study.
History of known allergy or intolerance to minocycline or any other tetracycline
Impaired renal function (plasma Creatinine) or blood urea nitrogen (BUN) levels exceeds twice normal upper limit which can result in higher serum levels of tetracycline, azotemia, hyperphosphatemia and acidosis.",No adverse events were reported in any subjects who were taking minocycline. All subjects underwent monthly blood tests to monitor alanine transaminase and blood urea nitrogen levels.,ChEMBL:CHEMBL1440 | DrugBank:DB00759 | PubChem:54675776,Tetracycline,[H][C@]12C[C@@]3([H])[C@H](N(C)C)C(O)=C(C(N)=O)C(=O)[C@@]3(O)C(O)=C1C(=O)c1c(O)cccc1[C@@]2(C)O,A01AB13 | A02BD02 | A02BD08 | D06AA04 | J01AA07 | J01AA20 | J01RA08 | S01AA09 | S02AA08 | S03AA02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01463670,NCT01463670_EG000,No,All,Adult | Older Adult,Phase 2,11,"Inclusion Criteria:

Patients must be 18 years of age or above at the time of enrollment.
Patients must show evidence of asymptomatic relapse and/or progression of disease (increasing M spike in serum or urine by consensus criteria) while on lenalidomide maintenance after HDM/ASCT as part of initial line of therapy.
Patients who have not had an HDM/ASCT as part of initial line of therapy but who are on continuous/maintenance lenalidomide after initial therapy will be permitted on study.
Patient must have myeloma that is measurable by either serum or urine evaluation of the monoclonal component or by assay of serum free light chains. Measurable disease is defined as one or more of the following: serum M-protein ≥ to 0.5 g/dl, urine M-protein ≥ 200 mg/24 h, and/or serum FLC assay: involved FLC level > 10 mg/dL with abnormal serum FLC ratio.
Patients must have adequate organ function including: Hepatic function with Bilirubin <2x the upper limit of normal and ALT and AST < 3 x the upper limit of normal; renal function with creatinine clearance ≥ 60 ml/min using the Cockcroft-Gault formula; hematologic function as defined by an absolute neutrophil count > 1000 neutrophils per microliter, platelet > 50,000 platelets per microliter and hemoglobin of ≥ 9 gm/dL without transfusion support
All study participants must be registered into the mandatory Revlimid REMS® program, and be willing and able to comply with the requirements of the REMS® program.
Females of child bearing potential (FCBP) must adhere to the scheduled pregnancy testing as required in the Revlimid REMS® program
FCBP must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days and again within 24 hours prior to prescribing lenalidomide for Cycle 1 (prescriptions must be filled within 7 days) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy. See Appendix: Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable Birth Control Methods.

Exclusion Criteria:

Patients with symptomatic relapse and/or progression of multiple myeloma. (Appendix A).
Patients with plasma cell leukemia.
Karnofsky performance score less than 70% or ECOG performance status greater than 2.
Patients with uncontrolled bacterial, viral or fungal infections (currently taking medication and progression of clinical symptoms).
Patients with prior malignancies except resected basal cell carcinoma or treated cervical carcinoma in situ or other cancer treated with curative intent > 5 years previously. Cancer treated with curative intent < 5 years previously will not be allowed unless approved by the Protocol Chairs.
Female patients who are pregnant (positive HCG) or breastfeeding. (Lactating females must agree not to breast feed while taking lenalidomide)
Patients seropositive for the human immunodeficiency virus (HIV).
Prior organ transplant requiring immunosuppressive therapy.
Patients who were previously exposed to higher doses of lenalidomide and who developed severe adverse events at higher doses that preclude incremental dosing.","The proposed study is designed as a Phase II, multi-center trial of lenalidomide intensification in patients with asymptomatic POD while on low dose lenalidomide maintenance after HDM/ASCT or on continuous/maintenance therapy after initial treatment.",ChEMBL:CHEMBL848 | DrugBank:DB00480 | PubChem:216326,Lenalidomide,Nc1cccc2c1CN(C1CCC(=O)NC1=O)C2=O,L04AX04,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0
NCT01465386,NCT01465386_EG000,No,All,Adult | Older Adult,Phase 2,6,"Inclusion Criteria:

All adults with first remission AML including those with prior myelodysplasia (MDS)/AML, therapy-related AML, AML with trilineage dysplasia (AML-TLD), and AML with adverse cytogenetics
History of histopathologically documented AML that is currently in first remission with the presence of 5% or less blasts by morphology and/or flow cytometry from a bone marrow aspirate and/or biopsy obtained within 14 days of enrollment
Patients must start therapy between 3-8 weeks after receiving their last prior therapy (either induction therapy or consolidation therapy)
Patients may receive up to 4 courses of remission consolidation therapy (e.g., cytarabine) prior to enrollment
Normal kidney and liver function with serum creatinine =< 2.0 mg/dl
Total bilirubin =< 1.5 upper limit of normal (ULN)
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x ULN
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
Male subjects, even if surgically sterilized (i.e., status postvasectomy) must agree to 1 of the following: practice effective barrier contraception during the entire study treatment period and through a minimum of 30 days after the last dose of study drug, or completely abstain from heterosexual intercourse
Female subject is either postmenopausal for at least 1 year before the screening visit, is surgically sterilized or if they are of childbearing potential, agree to practice 2 effective methods of contraception from the time of signing the informed consent form through 30 days after the last dose of bortezomib, or agree to completely abstain from heterosexual intercourse
Understand and voluntarily sign the informed consent form for this study

Exclusion Criteria:

Favorable AML features defined as the following:

t(8;21)(q22;q22); RUNX1-RUNX1T1
inv(16)(p13.1q22) or t(16;16)(p13.1;q22); CBFB-MYH11
Mutated NPM1 without FLT3-ITD (normal karyotype)
Mutated CEBPA (normal karyotype)
Persistent clinically significant non-hematological toxicity that is > Grade 1 by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4 from prior chemotherapy
Active uncontrolled infection
Known infection with human immunodeficiency virus (HIV)
Medical condition, serious concurrent illness, or other extenuating circumstance that, in the judgment of the Principal Investigator, could jeopardize patient safety or interfere with the objectives of the study

Uncontrolled or significant cardiovascular disease, including:

Uncontrolled angina or myocardial infarction within 6 months
Current or history of congestive heart failure New York Heart Association (NYHA) class 3 or 4, unless a screening echocardiogram (ECHO) or Multiple Gate Acquisition Scan (MUGA) performed within 1 month prior to study screening results in a left ventricular ejection fraction (LVEF) that is >= 45% (or institutional lower limit of normal value)
Prolonged QTc interval (> 450 msec)
Diagnosed or treated for another malignancy within 3 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy
Patient has a platelet count of < 30,000 within 3 days before enrollment
Patient has an absolute neutrophil count of < 300 within 3 days before enrollment
Patient has >= Grade 2 peripheral neuropathy
Patient has hypersensitivity to bortezomib, boron, or mannitol
Female patients who are lactating or have a positive urine pregnancy test during the screening; pregnancy testing is not required for postmenopausal or surgically sterilized women
Participation in clinical trials with other investigational agents not included in this trial, within 14 days of the start of this trial and throughout the duration of this trial","Patients receive bortezomib SC on days 1, 8, 15 and 22. Treatment repeats every 35 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

bortezomib: Given SC",ChEMBL:CHEMBL325041 | DrugBank:DB00188 | PubChem:387447,Bortezomib,CC(C)C[C@H](NC(=O)[C@H](Cc1ccccc1)NC(=O)c1cnccn1)B(O)O,L01XG01 | L01XX32,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01470859,NCT01470859_EG000,No,All,Adult | Older Adult,Not Applicable,14,"Inclusion Criteria:

idiopathic Parkinson's disease meeting United Kingdom (UK) brain bank criteria
De Novo
Hoehn&Yahr staging (H&Y) I-II

Exclusion Criteria:

Atypical Parkinsonism
Pregnant or breast-feeding women
those with abnormal Liver/kidney function
those participating other clinical trials within 30 days before being enrolled for this trial.","Sinemet CR

Sinemet CR: tablet of Sinemet CR, dosage of levodopa ranging from 200mg-600mg/day divided by 2 or 3 times, Duration is 1 year",PubChem:104778 | PubChem:441193,Nacom,CC(Cc1ccc(O)c(O)c1)(NN)C(=O)O.NC(Cc1ccc(O)c(O)c1)C(=O)O,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01471171,NCT01471171_EG000,No,All,Adult | Older Adult,Phase 3,111,"Inclusion Criteria:

Adult male and female patients aged ≥ 40 with stable moderate to severe COPD (Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines).
Post-salbutamol Forced Expiratory Volume in one second(FEV1) < 80% and ≥ 30% of predicted normal value and Post-salbutamol FEV1/Forced Vital Capacity (FVC) < 70%.
Current or ex-smokers of ≥ 10 pack-years
Functional residual capacity (FRC) measured by body plethysmography at Screening Visit ≥ 120% of predicted value

Exclusion Criteria:

History or current diagnosis of asthma
Signs of an exacerbation within 6 weeks ( or 3 months if results in hospitalisation) prior to the screening visit or during the run-in period.
Clinically significant respiratory and/or cardiovascular conditions or laboratory abnormalities.
Conditions where the use of anticholinergic drugs is contraindicated, such as known symptomatic prostatic hypertrophy, bladder neck obstruction or narrow-angle glaucoma.
Patients with an oxygen saturation < 85% during cycle exercise on room air at Screening Visit, Run- in Visit and Visit 1.
Contra-indications of cardiopulmonary exercise testing.
Patient who in the investigator's opinion will need to start a pulmonary rehabilitation program during the study and/or patients who have just started/finished pulmonary rehabilitation at least 3 months prior to the Screening Visit.",Aclidinium bromide: Oral inhalation via Genuair® multidose dry powder inhaler. 1 puff of 400 μg in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h) for 3 weeks.,PubChem:11519741,Aclidinium Bromide,O=C(OC1C[N+]2(CCCOc3ccccc3)CCC1CC2)C(O)(c1cccs1)c1cccs1.[Br-],R03AL05,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01474551,NCT01474551_EG000,No,All,Adult | Older Adult,Phase 2,2,"Inclusion Criteria:

Age >18 years old.
Histologic proof of melanoma reviewed and confirmed by MSKCC.
A confirmed EBRAFV600E or KBRAFV600K mutation.
Stage IV melanoma, or advanced stage III not curable by surgery. Patients with active CNS metastases will be allowed on the study.
Measurable disease by RECIST v1.1.
ECOG performance status 3 or 4. The basis for the grading of performance is strict; there must be clear justification of the performance status grade (e.g. patient is confined to bed > 50% of time, or cannot carry out ADLs, or is otherwise disabled by burden of disease such as requiring supplemental O2).
Patients must be able to swallow pills
Adequate hematologic, hepatic and renal function as defined by the following:
Absolute Neutrophil Count ≥ 1.0 x 109/L
Hemoglobin ≥8.0g/dL, occasional transfusions are acceptable as vemurafenib does not have significant hematologic toxicities.
Total bilirubin ≤2.0x the upper limit of normal, ≤3.0x the upper limit of normal if the patient has Gilbert's Syndrome.
Alkaline phosphatase ≤2.0x the upper limit of normal.
AST and ALT ≤2.0x the upper limit of normal.
Serum creatinine ≤ 1.5x the upper limit of normal.

Exclusion Criteria:

Uveal melanoma as primary.
Concurrent chemotherapy, immunotherapy, or radiotherapy.
Prior treatment with a RAF inhibitor. Other prior chemotherapy, immunotherapy, or radiotherapy will be allowed including prior treatment with a MEK inhibitor Patients must have had complete recovery from any adverse events or toxicities of prior cancer-directed therapies.
Pregnant or lactating women.
A second active malignancy. Prior malignancy will be allowed as long as the patient is known to be free of disease for at least 2 years. Patients with indolent B-cell malignancies will not be eligible.
QTc interval > 500 msec.","This is a single institution phase II trial in stage III or IV melanoma patients with poor ECOG performance status (3 or 4). Patients must have melanoma with a BRAFV600E or BRAFV600K or mutation with measurable disease not curable by surgery.

Vemurafenib: All patients would be treated with vemurafenib given orally at 960 mg twice a day, which was the phase III dose. One cycle is 4 weeks long.",ChEMBL:CHEMBL1229517 | DrugBank:DB08881 | PubChem:42611257,Vemurafenib,CCCS(=O)(=O)Nc1ccc(F)c(C(=O)c2c[nH]c3ncc(-c4ccc(Cl)cc4)cc23)c1F,G01AE10 | L01EC01 | L01XE15,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT01476267,NCT01476267_EG000,Accepts Healthy Volunteers,Male,Adult | Older Adult,Phase 1,6,"Inclusion Criteria:

Healthy male subjects, 45 to 65 years of age inclusive
Body mass index (BMI) between 18 and 32 kg/m2 inclusive

Exclusion Criteria:

Any concomitant disease or ongoing condition that in the investigator's opinion could interfere with the study or could pose an unacceptable risk to the subject
Clinically significant abnormal laboratory values
Infrequent bowel movements (e.g. less than one movement per 24 h on average)
An intent to father children within 3 months of dosing
Any external or internal radiotherapy with open (nuclear medicine) or sealed sources (brachy therapy)
External irradiation (radiological examination) or internal radiation (diagnostic nuclear medicine procedure) within one year before study drug dosing; dental radiography and plain X-rays of the extremities are allowed before dosing",dalcetrapib: Single oral radiolabeled dose,ChEMBL:CHEMBL313006 | DrugBank:DB12181 | PubChem:6918540,Dalcetrapib,CCC(CC)CC1(C(=O)Nc2ccccc2SC(=O)C(C)C)CCCCC1,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01483560,NCT01483560_EG000,No,All,Adult | Older Adult,Phase 3,219,"Inclusion Criteria:

Type 1 Diabetes for five years or more*
Age 40 years or above
7.0 =< HbA1c <10.0% (53 - 86 mmol/mol)

AND 3 or more of the following ten CardioVascular Disease (CVD) risk factors:

BMI >27 kg/m^2
Current HbA1c >8.0% (64 mmol/mol)
Known CVD/peripheral vascular disease
Current smoker
Estimated glomerular filtration rate (eGFR) <90 ml/min per 1.73 m^3
Confirmed micro- or macroalbuminuria [according to local assays and reference ranges]
Hypertension (BP >=140/90 millimeters of mercury (mmHg) or established on antihypertensive treatment)
Dyslipidaemia [total cholesterol >=5.0 mmol/L (200 mg/dL);OR HDL cholesterol <1.20 mmol/L (46mg/dL) [MEN]; OR <1.30 mmol/L (50 mg/dL) [WOMEN]; or triglycerides >=1.7 mmol/L (150mg/dL); or established on lipid-lowering treatment)]
Strong family history of CVD (at least one parent, biological aunt/ uncle, or sibling with myocardial infarction or stroke aged <60 years)
Duration of diabetes > 20 years

Exclusion Criteria:

eGFR < 45 ml/min/1.73m2
woman of childbearing age not on effective contraception
Pregnancy and/or lactation
Acute coronary syndrome or Stroke/Transient Ischaemic Attack within the last three months
NYHA stage 3 or 4 heart failure
Significant hypoglycaemia unawareness
Impaired cognitive function/ unable to give informed consent
Previous carotid surgery/ inability to capture adequate carotid images
Estimated glomerular filtration < 45ml/min/1.73m^2 (MDRD)
Gastroparesis
History of lactic acidosis
Other contraindications to metformin (hepatic impairment, known hypersensitivity to metformin, acute illness such as dehydration, severe infection, shock, acute cardiac failure or suspected tissue hypoxia)
Any coexistent life threatening condition including prior diagnosis of cancer within two years
History of alcohol problem or drug abuse","Oral Metformin (as Glucophage 500mg x 2 bd) titrated from initial 500mg to target 2000mg daily

Metformin: 3 years treatment duration 219 of 428 randomised were assigned to Metformin Group",ChEMBL:CHEMBL1431 | DrugBank:DB00331 | PubChem:4091,Metformin,CN(C)C(=N)NC(=N)N,A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0
NCT01485614,NCT01485614_EG002,No,All,Child,Phase 3,9,"Inclusion Criteria:

Type 2 Diabetes Mellitus (T2DM)
Has not received treatment with an antihyperglycemic agent (AHA) for ≥12 weeks prior to the Screening Visit/Visit 1, or is on a stable dose of insulin (without any other AHA) for at least 12 weeks prior to the Screening Visit/Visit 1. At screening, participants on insulin doses that are not stable can have their insulin doses adjusted and be eligible to participate after their dose remains stable for ≥12 weeks, if they meet all other eligibility criteria. In India, only participants on stable doses of insulin will be eligible.
An A1C of ≥6.5% and ≤10.0% (For participants on insulin: an A1C ≥7.0% and ≤10.0%).

Exclusion Criteria:

History of type 1 diabetes mellitus, autoimmune diabetes mellitus or has a positive antibody screen for anti-GAD (Glutamic Acid Decarboxylase) or (Islet cell autoantigen) ICA-512.
Known monogenic diabetes, secondary diabetes, or a genetic syndrome or disorder known to affect glucose tolerance other than diabetes.
Symptomatic hyperglycemia and/or moderate to large ketonuria and/or positive test for ketonemia requiring immediate initiation of antihyperglycemic therapy.
Previously taken a DPP-4 (Dipeptidyl peptidase-4) inhibitor (such as sitagliptin, vildagliptin, alogliptin, or saxagliptin) or GLP-1 (Glucagon-like peptide-1) receptor agonist (such as exenatide or liraglutide).
Hypersensitivity or contraindication (according to the product circular in the country of the investigational site) to metformin.
Chronic treatment with a medication known to cause weight gain within 30 days of study start or weight loss or increased blood glucose within 8 weeks of study start or treated with an anti-psychotic within the past 12 weeks.
On a weight loss program and not in the maintenance phase or have undergone bariatric surgery within 12 months prior to study start.
On or likely to require treatment with ≥14 consecutive days or repeated courses of pharmacologic doses of corticosteroids.
Undergone a surgical procedure within the prior 4 weeks or has major surgery planned during the study.
History of congenital heart disease or cardiovascular disease other than hypertension.
Medical history of active liver disease (other than non-alcoholic hepatic steatosis), including chronic active hepatitis B or C, primary biliary cirrhosis, or symptomatic gallbladder disease.
Active nephropathy (i.e., nephrotic syndrome or glomerulonephritis).
Chronic myopathy, mitochondrial disorder, or a progressive neurological or neuromuscular disorder (e.g., polymyositis, or multiple sclerosis).
Human immunodeficiency virus (HIV) as assessed by medical history.
Clinically significant hematological disorder (such as aplastic anemia, thrombocytopenia, myeloproliferative or myelodysplastic syndrome).
Under treatment for hyperthyroidism.
Exhibits abnormal growth patterns or is being treated with growth hormone.
History of malignancy or clinically important hematologic disorder.
History of idiopathic acute pancreatitis or chronic pancreatitis.
Known history of recreational or illicit drug use, or of alcohol abuse or dependence (within the past year).
Donated blood products or has had phlebotomy of >10% of estimated total blood volume within 8 weeks of signing informed consent, or intends to donate blood products or receive blood products within the projected duration of the study.
Pregnant, has a positive urine pregnancy test at Screening Visit/Visit 1, is expecting to conceive within the projected duration of the study, or is breast-feeding.
Exclusionary laboratory values.",Participants received 1 tablet of placebo matching sitagliptin 100 mg prior to the morning meal and 2 tablets of metformin 500 mg prior to both the morning and evening meals during Weeks 0-20. Participants continued to receive 1 tablet of placebo matching sitagliptin 100 mg prior to the morning meal and 2 tablets of metformin 500 mg prior to both the morning and evening meals during Weeks 20-54.,ChEMBL:CHEMBL1431 | DrugBank:DB00331 | PubChem:4091,Metformin,CN(C)C(=N)NC(=N)N,A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27,0.0,1.0,0.0,0.0,0.0,1.0,1.0,1.0,0.0,0.0,1.0,1.0,0.0,1.0,1.0,0.0,1.0,0.0,0.0,1.0,1.0,1.0,1.0,0.0,0.0,1.0,0.0
NCT01486043,NCT01486043_EG000,No,All,Child | Adult,Not Applicable,4,"Inclusion Criteria:

ALL patients on induction chemotherapy who develop transient hyperglycemia(definition of transient hyperglycemia: random blood glucose > 200 mg/dL x 2)
Adequate renal function (serum Cr < 1.5 mg/dL in males, < 1.2 mg/dL in females)
Adequate hepatic function (AST < 5x upper limit of normal)

Exclusion Criteria:

Patients with known diagnosis of diabetes or those that are already on oral hypoglycemic agents or insulin
Allergy to metformin or any component of the formulation
Patients with pancreatitis (lipase level > 300 Units/L)
Patients with active infection (positive blood culture within 48 hours of study registration)
Patients with hemodynamic instability (PICU status, need for vasopressors within 48 hours of study entry)
Elevated hemoglobin A1c (greater than 6.0%)",Patients receiving metformin and insulin therapy.,ChEMBL:CHEMBL1431 | DrugBank:DB00331 | PubChem:4091,Metformin,CN(C)C(=N)NC(=N)N,A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01487499,NCT01487499_EG000,No,All,Child | Adult | Older Adult,Phase 3,4,"Inclusion Criteria: Competent adult English speaking subjects

With limited stage SCLC who have completed standard of care treatment who are responders with no evidence of disseminated disease other than CNS metastasis,
With recurrent disseminated SCLC after standard of care treatment with symptoms related to central tumor obstruction,
With recurrent limited stage SCLC with mediastinal/hilar recurrence not previously treated with intratumoral cisplatin

Exclusion Criteria:

Subjects who do not meet the inclusion criteria
Subjects who, in the opinion of the investigator, are at risk undergoing a bronchoscopy","Subjects with limited stage SCLC treated sequentially with cisplatin.

Cisplatin: 40 mg in 40 mL of normal saline for each of 4 bronchoscopies",DrugBank:DB00515 | PubChem:5460033 | PubChem:5702198,Cisplatin,Cl[Pt]Cl.N.N,L01XA01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01490892,NCT01490892_EG000,No,Female,Adult | Older Adult,Phase 4,219,"Inclusion Criteria:

Be a female diagnosed by x-ray mammography (performed within 90 days prior to the study procedure) as having a solid breast mass or abnormal area without a mass.
Be scheduled for a biopsy (core / excisional / lumpectomy) of the mass or region of abnormality or for mastectomy within 30 days after this study procedure.
Be at least 18 years of age.
Be medically stable.
If a female of child-bearing potential, must have a negative pregnancy test.
Have signed Informed Consent to participate in the study.

Exclusion Criteria:

Males
Females who are pregnant or nursing.
Patients whose breast lesion is unequivocally a cyst by unenhanced US.
Patients currently on chemotherapy or with other primary cancers requiring systemic treatment.
Patients who are medically unstable, patients who are seriously or terminally ill, and patients whose clinical course is unpredictable. For example:
Patients on life support or in a critical care unit.
Patients with unstable occlusive disease (eg, crescendo angina)
Patients with clinically unstable cardiac arrhythmias, such as recurrent ventricular tachycardia.
Patients with uncontrolled congestive heart failure (NYHA Class IV)
Patients with recent cerebral hemorrhage.
Patients with clinically significant and unstable renal and/or liver disease (eg, transplant recipients in rejection)
Patients who have undergone surgery within 24 hours prior to the study sonographic examination.
Patients with known hypersensitivity to perflutren
Patients who have received any contrast medium (X-ray, MRI, CT, of US) in the 24 hours prior to the research US exam
Patients with cardiac shunts.
Patients with congenital heart defects.
Patients with severe emphysema, pulmonary vasculitis, or a history of pulmonary emboli.
Patients with confirmed or suspected liver lesions.
Patients with respiratory distress syndrome.
Patients who have had excisional biopsy/lumpectomy of the current area of interest within the past 6 weeks.","Perflutren injection, suspension (IV)0.25 ml followed by 3D Harmonic imaging (HI) then (IV) 20 micro-l/kg followed by 3D subharmonic imaging (SHI)

3D HI and SHI of UCA: Perflutren injection, suspension (IV)0.25 ml followed by 3D Harmonic imaging (HI) then (IV) 20 micro-l/kg followed by 3D subharmonic imaging (SHI)",ChEMBL:CHEMBL1663 | DrugBank:DB00556 | PubChem:6432,Perflutren,FC(F)(F)C(F)(F)C(F)(F)F,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01494753,NCT01494753_EG001,No,All,Adult | Older Adult,Phase 2,30,"Inclusion Criteria:

Untreated bilateral newly diagnosed patients with primary open angle glaucoma

Exclusion Criteria:

Any ocular hypertension other than chronic open angle glaucoma",One drop at 8.00pm.,ChEMBL:CHEMBL1051 | DrugBank:DB00654 | PubChem:5311221,Latanoprost,CC(C)OC(=O)CCC/C=C\C[C@@H]1[C@@H](CC[C@@H](O)CCc2ccccc2)[C@H](O)C[C@@H]1O,S01EE01 | S01EE51,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01497262,NCT01497262_EG000,No,All,Adult | Older Adult,Phase 3,162,"Inclusion Criteria:

Patients with relapsing remitting Multiple Sclerosis
Patients with Expanded Disability Status Scale (EDSS) score of 0-6.5.

Exclusion Criteria:

Patients with MS other than relapsing remitting MS
Patients with a history of chronic disease of the immune system other than MS, which requires systemic immunosuppressive treatment, or a known immunodeficiency syndrome.

Patients who have been treated with:

systemic corticosteroids or immunoglobulins within 1 month prior to baseline;
immunosuppressive medications within 3 months prior to baseline;
monoclonal antibodies within 3 months prior to baseline;
cladribine, mitoxantrone or alemtuzumab at any time.
Uncontrolled diabetes mellitus at screening
Diagnosis of macular edema during Screening Phase
Patients with active systemic bacterial, viral or fungal infections, or known to have AIDS, Hepatitis B, Hepatitis C infection or to have positive HIV antibody, Hepatitis B surface antigen or Hepatitis C antibody tests.
Patients who have received total lymphoid irradiation or bone marrow transplantation.
Patients with certain cardiovascular conditions and/or findings in the screening ECG
Patients with certain liver conditions
Pregnant confirmed by a positive pregnancy test t or nursing (lactating) women
Other protocol-defined inclusion/exclusion criteria may apply.","Open-label fingolimod 0.5 mg, taken orally once daily for 4 months",ChEMBL:CHEMBL314854 | DrugBank:DB08868 | PubChem:107970,Fingolimod,CCCCCCCCc1ccc(CCC(N)(CO)CO)cc1,L04AA27,1.0,1.0,0.0,0.0,0.0,1.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01499667,NCT01499667_EG000,No,All,Adult | Older Adult,Phase 3,50,"Inclusion Criteria:

Patients must:

Have relapsing remitting multiple sclerosis
Have been on treatment with natalizumab for at least 6 months prior to screening and discontinuation is an option.

Exclusion Criteria:

Patients with:

History of chronic immune disease
Crohn's disease
Certain cancers
Uncontrolled diabetes
Certain eye disorders
Negative for varicella-zoster virus IgG antibodies
Certain hepatic conditions
Low white blood cell count
On certain immunosuppressive medications or heart medications
Resting heart rate less than 45 bpm.
Certain heart conditions or certain lung conditions
Inability to undergo MRI scans

Other protocol-defined inclusion/exclusion criteria may apply",8-week washout (8 weeks no treatment) followed by 24 weeks of treatment with fingolimod 0.5mg once a day,ChEMBL:CHEMBL314854 | DrugBank:DB08868 | PubChem:107970,Fingolimod,CCCCCCCCc1ccc(CCC(N)(CO)CO)cc1,L04AA27,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT01500109,NCT01500109_EG000,No,All,Child,Not Applicable,45,"Inclusion Criteria:

Children 5 months to five years of age
ASA physical status I or II
primary cleft palate repair alone or in some combination with bilateral myringotomy with tympanostomy (BMT), alveoplasty, vomer flap, rhinoplasty, and or cleft lip repair.?

Exclusion Criteria:

Repeat/revision cleft palate repair
Contraindications to acetaminophen administration (liver or renal dysfunction, allergy)
Chronic pain medications
Diagnosis of chronic pain syndrome
Contraindications to morphine (renal impairment, allergy)
Seizure disorders and/or taking anti-seizure medications
Contraindications to oral midazolam (liver dysfunction, allergy)
Allergy to local anesthetics","Oral inert cherry syrup will be administered preoperatively as placebo for oral acetaminophen. Ofirmev will be administered in the operating room once intravenous access is established. Patients will receive standardized dose of local anesthetic (Lidocaine 0.5% with Epinephrine) infiltration by the surgeon before surgical incision as well as at the completion of surgery with Bupivacaine 0.25% with Epinephrine. Postoperatively patients will receive Ofirmev® every 6 hours as well as placebo oral cherry elixir every 6 hours and morphine as needed for 24 hours.

Ofirmev®: Intravenous acetaminophen is initiated after intravenous access is obtained intraoperatively and before surgical incision. Dosing is age based as follows: 5 months-2 years 12.5 mg/kg, 2-5 years 15 mg/kg. Redosing will be every 6 hours for 24 hours. The two other arms will receive a placebo in the form of normal saline given intravenously. Intraoperative opioids will be administered as deemed necessary by anesthesia c",ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01500109,NCT01500109_EG001,No,All,Child,Not Applicable,45,"Inclusion Criteria:

Children 5 months to five years of age
ASA physical status I or II
primary cleft palate repair alone or in some combination with bilateral myringotomy with tympanostomy (BMT), alveoplasty, vomer flap, rhinoplasty, and or cleft lip repair.?

Exclusion Criteria:

Repeat/revision cleft palate repair
Contraindications to acetaminophen administration (liver or renal dysfunction, allergy)
Chronic pain medications
Diagnosis of chronic pain syndrome
Contraindications to morphine (renal impairment, allergy)
Seizure disorders and/or taking anti-seizure medications
Contraindications to oral midazolam (liver dysfunction, allergy)
Allergy to local anesthetics","Patients will receive oral acetaminophen cherry elixir preoperatively. After intravenous access is obtained intraoperatively patients will receive placebo for Ofirmev (saline). Patients will receive standardized dose of local anesthetic (Lidocaine 0.5% with Epinephrine) infiltration by the surgeon prior to surgical incision as wel as at the completion of surgery with Bupivacaine 0.25% with Epinephrine. Postoperatively patient will receive oral acetaminophen every six hours and intravenous placebo (normal saline) for intravenous acetaminophen. Intravenous morphine will be administered as needed for 24 hours.

Oral acetaminophen: Oral acetaminophen administered as a cherry flavored elixir will be dosed preoperatively 15 mg/kg and redosed every 6 hours for 24 hours. Placebo oral acetaminophen will be administered to the other two arms of the study according to the same timetable. Intraoperative opioids (Fentanyl or Morphine) will be administered as deemed necessary by anesthesia care t",ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01500317,NCT01500317_EG001,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 4,12,"Healthy volunteers Inclusion criteria

Males and non-pregnant, non-breastfeeding females
18-65 years old

Exclusion criteria

Use of any mu-opioid agent in the last 3 months
Structural or metabolic diseases/conditions that affect the gastrointestinal system, or functional gastrointestinal disorders. For screening the shortened screening version of the Bowel Disease Questionnaire (Appendix) will be used to exclude subjects with dyspepsia, irritable bowel syndrome or significant gastrointestinal symptoms. Of 19 questions, participants have to have three or less positives to be eligible to participate.

Unable to withdraw medications 48 hours prior to the study :

Alter GI transit including laxatives, magnesium or aluminum-containing antacids, prokinetics, erythromycin, narcotics, anticholinergics, tricyclic antidepressants, selective serotonin re-uptake inhibitors (SSRIs) and newer antidepressants.
Analgesic drugs including opiates, nonsteroidal anti-inflammatory drugs (NSAIDs), COX 2 inhibitors
SSRI NOTE: Low stable doses of thyroid replacement, estrogen replacement, low dose aspirin for cardioprotection and birth control pills or depot injections are permissible.
Female subjects who are pregnant or breast feeding.
Clinical evidence (including physical exam, ECG, hemoglobin level and review of the medical history) of significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurological, psychiatric, or other disease that interfere with the objectives of the study.
Subjects who are considered by the investigator to be alcoholics not in remission or known substance abusers.
Subjects who have participated in another clinical study within the past 30 days
History of porphyria, renal (creatinine > 1.5mg/dL) or significant liver impairment (transaminases, alkaline phosphatase of gamma-glutamyl transpeptidase (GGT) >2 times upper limit of normal)",5 mg oxycodone tid,ChEMBL:CHEMBL656 | DrugBank:DB00497 | PubChem:5284603,Oxycodone,COc1ccc2c3c1O[C@H]1C(=O)CC[C@@]4(O)[C@@H](C2)N(C)CC[C@]314,N02AA05 | N02AA55 | N02AA56 | N02AJ17 | N02AJ18 | N02AJ19,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01502072,NCT01502072_EG000,No,All,Adult | Older Adult,Phase 2,13,"Inclusion Criteria:

HSCT patients with either moderate or severe immunodeficiency based on immunodeficiency scoring system would be eligible for entry on study if a nasopharyngeal wash or throat swab specimen is positive by rapid RSV antigen testing and/or on culture within 72 hours (therapeutic arms). (Please see Appendix E for definitions and Immunodeficiency Scoring).
HSCT patients with mild immunodeficiency based on immunodeficiency scoring system would be eligible for entry on study if a nasopharyngeal wash or throat swab specimen is positive by rapid RSV antigen testing and/or on culture within 72 hours but will not be randomized to therapeutic arms and will be followed as per standard of care (control arm).
Patients must be at least 18 years of age and able to swallow pills.
Patients with RSV infection limited to the URT as documented by negative Chest radiographic findings within the last 48 hours of enrollment and pulse oxygenation of more than 90 mm of Hg on room air.
Women of child bearing potential with a negative urine or blood pregnancy test within a month of enrollment (only for patients who are going to be randomised to either therapeutic arms).
Patients with Hemoglobin levels more than or equal to 8 g/dl would be eligible for the study even if they are currently receiving blood products.
Patients may receive up to 2 doses of aerosolized ribavirin (modified regimen) before enrollment into the study.
Patients who will be enrolled on the observational arm should meet inclusion criteria # 2, 3, and 4 only.

Exclusion Criteria:

Patients with previous history of hypersensitivity to ribavirin or its components
Women who are pregnant or plan a pregnancy within 8 weeks after completion of treatment (only for patients who are going to be randomised to either therapeutic arms).
Patients with evidence of RSV LRI as documented by a positive rapid RSV antigen testing and/or culture on nasal washes AND new or progressive infiltrates on chest radiographic studies suggestive of viral etiology and/or pulse oxygen less than 90 mm of Hg on room air.
Patients with positive RSV by rapid antigen testing and/or culture in bronchoalveolar lavage regardless of the chest radiographic findings.
Patients who are considered to be moderately or severely anemic as per the NCI classification will not be included in the study, i.e patients with hemoglobin level less than 8 g/dl
Patient with Total Bilirubin and Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) three times the upper limit of normal.
Male partners of women who are pregnant (only for patients who are going to be randomised to either therapeutic arms).
Patients with known history of autoimmune hepatitis, Hepatitic C or those with hemoglobinopathies (eg, thalassemia major, sickle cell anemia).
Patients with creatinine clearance of less than or equal to 50 ml/Min
Patients taking didanosine, azathioprine, or nucleoside reverse transcriptase inhibitors
Patients who will be enrolled on the observational arm should not meet exclusion criteria #3 and 4 only.",Ribavirin Capsules 20 mg/kg orally 3 times/day for up to 10 days.,ChEMBL:CHEMBL1643 | DrugBank:DB00811 | PubChem:37542,Ribavirin,NC(=O)c1ncn([C@@H]2O[C@H](CO)[C@@H](O)[C@H]2O)n1,J05AP01,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT01502072,NCT01502072_EG001,No,All,Adult | Older Adult,Phase 2,10,"Inclusion Criteria:

HSCT patients with either moderate or severe immunodeficiency based on immunodeficiency scoring system would be eligible for entry on study if a nasopharyngeal wash or throat swab specimen is positive by rapid RSV antigen testing and/or on culture within 72 hours (therapeutic arms). (Please see Appendix E for definitions and Immunodeficiency Scoring).
HSCT patients with mild immunodeficiency based on immunodeficiency scoring system would be eligible for entry on study if a nasopharyngeal wash or throat swab specimen is positive by rapid RSV antigen testing and/or on culture within 72 hours but will not be randomized to therapeutic arms and will be followed as per standard of care (control arm).
Patients must be at least 18 years of age and able to swallow pills.
Patients with RSV infection limited to the URT as documented by negative Chest radiographic findings within the last 48 hours of enrollment and pulse oxygenation of more than 90 mm of Hg on room air.
Women of child bearing potential with a negative urine or blood pregnancy test within a month of enrollment (only for patients who are going to be randomised to either therapeutic arms).
Patients with Hemoglobin levels more than or equal to 8 g/dl would be eligible for the study even if they are currently receiving blood products.
Patients may receive up to 2 doses of aerosolized ribavirin (modified regimen) before enrollment into the study.
Patients who will be enrolled on the observational arm should meet inclusion criteria # 2, 3, and 4 only.

Exclusion Criteria:

Patients with previous history of hypersensitivity to ribavirin or its components
Women who are pregnant or plan a pregnancy within 8 weeks after completion of treatment (only for patients who are going to be randomised to either therapeutic arms).
Patients with evidence of RSV LRI as documented by a positive rapid RSV antigen testing and/or culture on nasal washes AND new or progressive infiltrates on chest radiographic studies suggestive of viral etiology and/or pulse oxygen less than 90 mm of Hg on room air.
Patients with positive RSV by rapid antigen testing and/or culture in bronchoalveolar lavage regardless of the chest radiographic findings.
Patients who are considered to be moderately or severely anemic as per the NCI classification will not be included in the study, i.e patients with hemoglobin level less than 8 g/dl
Patient with Total Bilirubin and Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) three times the upper limit of normal.
Male partners of women who are pregnant (only for patients who are going to be randomised to either therapeutic arms).
Patients with known history of autoimmune hepatitis, Hepatitic C or those with hemoglobinopathies (eg, thalassemia major, sickle cell anemia).
Patients with creatinine clearance of less than or equal to 50 ml/Min
Patients taking didanosine, azathioprine, or nucleoside reverse transcriptase inhibitors
Patients who will be enrolled on the observational arm should not meet exclusion criteria #3 and 4 only.",Inhaled form of Ribavirin 60 milligrams/milliliter 3 times/day for 3 hours for up to 10 days.,ChEMBL:CHEMBL1643 | DrugBank:DB00811 | PubChem:37542,Ribavirin,NC(=O)c1ncn([C@@H]2O[C@H](CO)[C@@H](O)[C@H]2O)n1,J05AP01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT01504477,NCT01504477_EG000,No,All,Adult | Older Adult,Phase 1 | Phase 2,6,"Inclusion Criteria:

Histologically proven colorectal cancer with measurable or evaluable disease
KRAS wild-type colorectal cancer
Progression on, or intolerance of, or ineligibility for all standard therapies
Progression on prior anti-EGFR therapy
Lesion that is amenable to biopsy
ECOG performance status 0-2
LVEF >/= institutional normal
Corrected QT interval less then 500 milliseconds by EKG
Grade 2 or less peripheral neuropathy
Adequate hepatic, bone marrow, and renal function
Partial thromboplastin time must be </= 1.5 x upper limit of institution's normal range and INR < 1.5. Subjects on anticoagulants will be permitted to enroll as long as the INR is in the acceptable therapeutic range as determined by the investigator.
Subjects with no brain metastases or a history of previously treated brain metastases who have been treated by surgery or stereotactic radiosurgery at least 4 weeks prior to enrollment and have a baseline MRI that shows no evidence of active intracranial disease and have not had treatment with steroids within 1 week of study enrollment.
Life expectancy > 12 weeks
Subject is capable of understanding and complying with parameters of the protocol and able to sign and date the informed consent form.

Exclusion Criteria:

CNS metastases which do not meet the criteria above
Prior cancer chemotherapy, radiation therapy, or any investigational agent within three weeks before starting therapy
Active severe infection or known chronic infection with HIV or hepatitis B virus
Cardiovascular disease problems including unstable angina, therapy for life-threatening ventricular arrhythmia, or myocardial infarction, stroke, or congestive heart failure within the last 6 months
Peripheral neuropathy >/= Grade 2 at baseline or peripheral neuropathy >/= Grade 1 with neuropathic pain
Life-threatening visceral disease or other severe concurrent disease
Female subject is pregnant or lactating
Diagnosed or treated for another malignancy within 3 years of enrollment with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low risk prostate cancer after curative therapy
Patient has hypersensitivity to bortezomib, boron, or mannitol
Clinically significant and uncontrolled major medical condition(s)","IV panitumumab and bortezomib

Panitumumab and bortezomib: Panitumumab 6 mg/kg IV over 60 minutes on Day -14 (first cycle only), then Day 1 and 15 of each 28-day cycle.

Bortezomib will be administered in escalating doses until the maximum tolerated dose is determined and then at the maximum tolerated dose as an IV bolus injection over 3-5 seconds on Day 1, 8, and 15 of each 28-day cycle.",ChEMBL:CHEMBL325041 | DrugBank:DB00188 | PubChem:387447,Bortezomib,CC(C)C[C@H](NC(=O)[C@H](Cc1ccccc1)NC(=O)c1cnccn1)B(O)O,L01XG01 | L01XX32,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT01507220,NCT01507220_EG000,No,All,Adult | Older Adult,Phase 4,2,"Inclusion Criteria:

Male or female, 18 years of age and older.
Patients scheduled to undergo open segmental colectomy with planned primary anastamosis, as defined by cecectomy, right hemicolectomy, resection of transverse colon, left hemicolectomy, or sigmoidectomy.
Ability to provide informed consent, adhere to study visit schedule, and complete all study assessments.

Exclusion Criteria:

Patients with a history of hypersensitivity or idiosyncratic reactions or intolerance to any local anesthetic, opioid, or propofol.
Patients who abuse alcohol or other drug substance.
Patients with severe hepatic impairment.
Patients currently pregnant or who may become pregnant during the course of the study.
Patients with any psychiatric psychological, or other condition that the Investigator feels may make the patient an inappropriate candidate for this clinical study.
Patients who have participated in a EXPAREL study within the last 30 days.
Patients who have received any investigational drug within 30 days prior to study drug administration, or planned administration of another investigational product or procedure during the patient's participation in this study.

In addition, the patient will be ineligible if he or she meets the following criteria during surgery:

Patients with unplanned multiple segmental resections of large intestine.
Patients who have unplanned, temporary or permanent colostomies, ileostomies, or the like placed.
Patients who receive intraoperative administration of opioids (other than fentanyl or analogs) or any other analgesic, local anesthetics, or anti-inflammatory agents.
Patients who receive Entereg(R).
Patients who undergo any concurrent surgical procedure during the ileostomy reversal surgery.","morphine sulfate (or Sponsor-approved equivalent)

morphine sulfate: Patients in this group will receive IV morphine sulfate (or Sponsor-approved equivalent) via PCA pump, as needed. The PCA pump will be set up postsurgically as soon as possible and prior to the patient leaving the PACU or immediately upon transfer to the floor if the stay in the PACU is less than one hour. All morphine sulfate (Group 1) patients will receive the same opioid in their PCA pump.",PubChem:16051935,Morphine Sulfate,CN1CCC23c4c5ccc(O)c4OC2C(O)C=CC3C1C5.CN1CCC23c4c5ccc(O)c4OC2C(O)C=CC3C1C5.O=S(=O)(O)O,,0.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01508936,NCT01508936_EG001,No,All,Adult | Older Adult,Phase 3,395,"Inclusion criteria:

Patients are included in the study if all of the following criteria are met:

The patient is a man or woman, 18 through 65 years of age, with a diagnosis of asthma.
The patient has an ACQ score of at least 1.5.
At screening, the patient has airway reversibility of at least 12% to beta-agonist administration.
The patient is currently taking fluticasone at a dosage of at least 440 µg daily (or equivalent). Patients' baseline asthma therapy regimens (including but not limited to inhaled corticosteroids, leukotriene antagonists, 5-lipoxygenase inhibitors, cromolyn) must be stable for 30 days before screening and continue without dosage changes throughout study.
Female patients must be surgically sterile, 2 years postmenopausal, or must have a negative beta-human chorionic gonadotropin (ßHCG) result for a pregnancy test at screening (serum) and baseline (urine).
Female patients of childbearing potential (not surgically sterile or 2 years postmenopausal), must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the study and for 30 days after participation in the study. Acceptable methods of contraception include barrier method with spermicide, abstinence, intrauterine device (IUD), or steroidal contraceptive (oral, transdermal, implanted, and injected).
Written informed consent is obtained.
The patient is in reasonable health (except for diagnosis of asthma) as judged by the investigator, and as determined by a medical history, medical examination, electrocardiogram (ECG) evaluation, serum chemistry, hematology, urinalysis, and serology.
The patient must be willing and able to comply with study restrictions and to remain at the clinic for the required duration during the study period, and be willing to return to the clinic for the follow-up evaluation as specified in this protocol.

Exclusion Criteria:

Patients are excluded from participating in this study if 1 or more of the following criteria are met:

The patient has another confounding underlying lung disorder (eg, chronic obstructive pulmonary disease, pulmonary fibrosis, lung cancer). The patient has other pulmonary conditions with symptoms of asthma and blood eosinophilia (eg, Churg-Strauss syndrome, allergic bronchopulmonary aspergillosis).
The patient has a clinically meaningful comorbidity that would interfere with the study schedule or procedures, or compromise the patient's safety.
The patient has known hypereosinophilic syndrome (HES).
The patient is a current smoker (ie, has smoked within the last 6 months prior to screening).
The patient has a history of use of systemic immunosuppressive or immunomodulating agents (anti-immunoglobulin E [anti-IgE] mAb, methotrexate, cyclosporin, interferon-α, anti-tumor necrosis factor mAb, or omalizumab) within 6 months prior to study entry (randomization).
The patient is currently using or has used systemic corticosteroids (includes use of oral corticosteroids) within 30 days prior to the screening visit.
The patient is expected to be poorly compliant with study drug administration, study procedures, or visits.
The patient has any aggravating factors that are inadequately controlled, and thus would aggravate asthma symptoms (eg, gastroesophageal reflux disease).
The patient has participated in any investigative drug or device study within 30 days prior to screening.
The patient has participated in any investigative biologics study within 90 days prior to screening.
The patient has previously received reslizumab or other anti-hIL-5 mAbs (eg, mepolizumab).
The patient is a pregnant or lactating woman. (Any women becoming pregnant during the study will be withdrawn from the study.)
The patient has a current infection or disease that may preclude assessment of asthma.
The patient has a history of concurrent immunodeficiency (human immunodeficiency, acquired immunodeficiency syndrome, or congenital immunodeficiency).
The patient is suspected of current drug or alcohol abuse as specified in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria.
The patient has presence of or suspected parasitic infestation/infection.
Patients may not have received any live attenuated vaccine within the 12-week period before study entry.",Reslizumab intravenous injection at a dosage of 3.0 mg/kg every 4 weeks for a total of 4 doses.,ChEMBL:CHEMBL417 | ChEMBL:CHEMBL53463 | DrugBank:DB00445 | DrugBank:DB00997 | PubChem:1691 | PubChem:31703 | PubChem:41867,Epirubicin,COc1cccc2c1C(=O)c1c(O)c3c(c(O)c1C2=O)CC(O)(C(=O)CO)CC3OC1CC(N)C(O)C(C)O1,L01DB01 | L01DB03,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT01515410,NCT01515410_EG000,No,All,Adult | Older Adult,Phase 2,34,"Inclusion Criteria:

Men and women at least 30 years and older at the time of informed consent with advanced idiopathic Parkinson's disease with predictable wearing-off motor fluctuations with Hoehn and Yahr Stage II-III when ""on.""
Patients should be able to differentiate between the ""ON"" and ""OFF"" states with an average daily ""OFF"" time of ≥ 2.5 hours at study entry.
On a stable daily dose of LD of ≥ 400 mg but ≤1600 mg for at least 1 month prior to the screening visit.
Non CD/LD containing anti-Parkinson's medications should be kept at stable doses for 1 month prior to screening visit. Patients should be willing to keep their non LD containing medications consistently throughout the study duration.
Female patients of childbearing potential should be abstinent or continuing to practice and willing to continue throughout the study with appropriate contraceptives (defined as Nova ring, oral, injected, transdermal patch, implanted, or barrier).
Mini Mental State Examination (MMSE) ≥ 26 at screening visit.
Able to provide informed consent and willing to sign Health Insurance Portability and Accountability Act (HIPAA) authorization.
Able and willing to comply with the protocol, including availability for all scheduled study visits and blood sample collections. Must be under the observation of a competent care giver throughout the study participation.

Exclusion Criteria:

Patients with atypical or drug-induced Parkinson's disease.
Patients with a known history of hypersensitivity to levodopa or carbidopa.
Patients who receive treatments with dopamine receptor blocking agents
Patients with a history of seizures except of childhood febrile seizure.
Patients with dementia.
Patients with a significant history of GI diseases (severe inflammatory bowel disease, irritable bowel disease, dyspepsia, gastro-esophageal reflux disease etc.) in the past five years.
Patients with any history of gastric surgery other than vagotomy and pyloroplasty.
Patients with an immune-compromised state.
Patients with clinically significant hepatic insufficiency with Child-Pugh total score of ≥ 5.
Patients with a calculated creatinine clearance (Clcr) < 50 mL/min using the Cockcroft-Gault equation.
Patients who have a difficulty swallowing tablets.
Patient has participated in a clinical trial of an investigational drug or device within 30 days of the screening visit.
Patients with any other serious medical condition that, in the opinion of the Investigator would jeopardize the safety of the patient or affect the validity of the study results.","DM-1992, a gastric-retentive extended-release tablet containing 72.5mg carbidopa (CD) and 230mg levodopa (LD)",PubChem:104778 | PubChem:441193,Nacom,CC(Cc1ccc(O)c(O)c1)(NN)C(=O)O.NC(Cc1ccc(O)c(O)c1)C(=O)O,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01515696,NCT01515696_EG000,No,All,Child,Phase 4,47,"Inclusion Criteria:

premature infants with a birthweight < 1500g and a gestational age < 32 weeks

Exclusion Criteria:

major congenital disorders
chromosomal aberrations
systemic metabolic disease and
pre-existing gastrointestinal abnormalities (i.e. Morbus Hirschsprung)
pre-existing conditions of severe hypotension",infants receive 3ml/kg Gastrografin + 6ml/kg sterile water,PubChem:23672589,Diatrizoate Sodium,CC(=O)Nc1c(I)c(NC(C)=O)c(I)c(C(=O)[O-])c1I.[Na+],,0.0,1.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01515696,NCT01515696_EG001,No,All,Child,Phase 4,49,"Inclusion Criteria:

premature infants with a birthweight < 1500g and a gestational age < 32 weeks

Exclusion Criteria:

major congenital disorders
chromosomal aberrations
systemic metabolic disease and
pre-existing gastrointestinal abnormalities (i.e. Morbus Hirschsprung)
pre-existing conditions of severe hypotension",infants receive 9ml/kg sterile water,ChEMBL:CHEMBL1098659 | DrugBank:DB09145 | PubChem:10129877 | PubChem:24602 | PubChem:962,Water,O,,0.0,1.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01517074,NCT01517074_EG000,No,All,Adult | Older Adult,Phase 1 | Phase 2,5,"INCLUSION CRITERIA:

Participant has the ability to understand and sign the informed consent document.
Participant is 18 years of age or older.
Participant has a diagnosis of active, autoimmune, non-necrotizing, anterior scleritis.
Participant, if currently taking immunosuppressive medications, is on a stable regimen of immunosuppressive medications (no increase and/or start of new immunosuppressive medications) over the last four weeks.
Participant has tried therapy such as oral non-steroidal anti-inflammatory drugs (NSAIDs), or oral or topical corticosteroids or immunosuppressive medication at any time in the past to control scleritis flares, or has intolerance or contraindications to these medications.
Participant is willing and able to comply with the study procedures.
Female participants of childbearing potential must not be pregnant or breast-feeding, have a negative pregnancy test at screening and must be willing to undergo pregnancy tests throughout the study.
Both female participants of childbearing potential and male participants able to father children must have (or have a partner who has) had a hysterectomy or vasectomy, be completely abstinent from intercourse or must agree to practice two acceptable methods of contraception throughout the course of the study and for four months after the last investigational product injection. Acceptable methods of contraception include: hormonal contraception (i.e., birth control pills, injected hormones, dermal patch or vaginal ring), intrauterine device, barrier methods (diaphragm, condom) with spermicide, or surgical sterilization (tubal ligation).

EXCLUSION CRITERIA:

Participant has a significant active intraocular infection in either eye that requires antibiotic treatment.
Participant has an active serious infection or a history of recurring serious infections such as human immunodeficiency virus (HIV) or syphilis that in the best medical judgment of the investigators would pose unnecessary risk to the participant.
Participant has active joint or systemic inflammation requiring immediate addition or increase in systemic anti-inflammatory medications.
Participant is taking systemic azole anti-fungal medication (e.g., ketoconazole, voriconazole, itraconazole).

STUDY EYE ELIGIBILITY CRITERIA:

The participant must have at least one eye meeting all inclusion criteria and none of the exclusion criteria listed below.

STUDY EYE INCLUSION CRITERIA:

Participant has anterior scleritis with greater than or equal to 1 plus in at least one quadrant of the study eye.
Participant has visual acuity in the study eye of 20/640 or better.
Participant agrees not to undergo elective intraocular surgery in the study eye (e.g., cataract extraction) for three months after the last injection.
Participant has not received a periocular or intravitreal injection in the study eye in the last six weeks.

STUDY EYE EXCLUSION CRITERIA:

Participant has necrotizing scleritis in the study eye.
Participant had intraocular surgery in the study eye in the last four weeks.","Participants will receive a15 μL (660 μg) subconjunctival injection of sirolimus in the study eye at baseline if a single quadrant or two adjacent quadrants are involved. If greater than two quadrants are involved (i.e., 3 or 4 quadrant involvement) or two non-adjacent quadrants are involved, two 15 μL (660 μg) injections will be given in two quadrants 180 degrees apart (total dose of 30 μL or 1,320 μg). Participants that still demonstrate active inflammation (incomplete or no response to initial injection) or experience a flare-up (as defined by a ≥1-step increase in scleral inflammation) after the initial injection will be eligible for a re-injection in the study eye at or after Week 4 (not to exceed a dose of 1,320 μg per eye within an eight-week period).",ChEMBL:CHEMBL413 | DrugBank:DB00877 | PubChem:134760597 | PubChem:138404388 | PubChem:21944094 | PubChem:5284616,Sirolimus,COC1CC2CCC(C)C(O)(O2)C(=O)C(=O)N2CCCCC2C(=O)OC(C(C)CC2CCC(O)C(OC)C2)CC(=O)C(C)C=C(C)C(O)C(OC)C(=O)C(C)CC(C)C=CC=CC=C1C,L01EG04 | L04AA10 | S01XA23,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0
NCT01517295,NCT01517295_EG000,No,All,Adult | Older Adult,Phase 4,30,"Inclusion Criteria:

Man or woman aged 18-75
Documented clinical diagnosis of chronic pain.
Have been taking hydrocodone/APAP for their chronic non-cancer pain.
Subjects currently on hydrocodone/APAP must be taking minimal daily dose of 15mg of Hydrocodone for at least 30 days.
Subjects must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.

Exclusion Criteria:

Subjects who are taking concomitant medications or Nutraceuticals that interfere with Hydrocodone metabolism as listed in Appendix 11 and/or as deemed clinically significant by a pharmacovigilance team that is contracted to monitor and advise.
Health concerns that the study physician feels may confound study results.
Individuals who are cognitively impaired or who are not able to give informed consent.
Previous participation in a clinical research trial within 30 days prior to randomization.
The subject has an ongoing abuse of illicit substances, alcohol, or actively smoking marijuana.","Blood will be drawn at 0, 1, 3, and 5 hours after taking one dose of hydrocodone/APAP. Urine will be taken at hour 0 and 3.

Hydrocodone: Dose: Standard prescribed dose Frequency: Once Duration: Once",ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01517295,NCT01517295_EG001,No,All,Adult | Older Adult,Phase 4,30,"Inclusion Criteria:

Man or woman aged 18-75
Documented clinical diagnosis of chronic pain.
Have been taking hydrocodone/APAP for their chronic non-cancer pain.
Subjects currently on hydrocodone/APAP must be taking minimal daily dose of 15mg of Hydrocodone for at least 30 days.
Subjects must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.

Exclusion Criteria:

Subjects who are taking concomitant medications or Nutraceuticals that interfere with Hydrocodone metabolism as listed in Appendix 11 and/or as deemed clinically significant by a pharmacovigilance team that is contracted to monitor and advise.
Health concerns that the study physician feels may confound study results.
Individuals who are cognitively impaired or who are not able to give informed consent.
Previous participation in a clinical research trial within 30 days prior to randomization.
The subject has an ongoing abuse of illicit substances, alcohol, or actively smoking marijuana.","Blood will be drawn at 0, 2, 4, and 6 hours after one dose of hydrocodone/APAP. Urine will be taken at hour 0 and 4.

Hydrocodone: Dose: Standard prescribed dose Frequency: Once Duration: Once",ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01517373,NCT01517373_EG002,No,All,Adult | Older Adult,Phase 2,60,"Inclusion Criteria:

Age 18-70 yrs, male and females, with T2DM, on metformin alone or in combination with 1 other oral agent

Exclusion Criteria:

Subjects with recent cardiovascular events, those with evidence of diabetic complications","PF-04937319 10 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.",DrugBank:DB15009 | PubChem:46916694,PF-04937319,Cc1cnc(NC(=O)c2cc(Oc3cnc(C(=O)N(C)C)nc3)c3cc(C)oc3c2)cn1,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,1.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT01517373,NCT01517373_EG003,No,All,Adult | Older Adult,Phase 2,61,"Inclusion Criteria:

Age 18-70 yrs, male and females, with T2DM, on metformin alone or in combination with 1 other oral agent

Exclusion Criteria:

Subjects with recent cardiovascular events, those with evidence of diabetic complications","PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.",DrugBank:DB15009 | PubChem:46916694,PF-04937319,Cc1cnc(NC(=O)c2cc(Oc3cnc(C(=O)N(C)C)nc3)c3cc(C)oc3c2)cn1,,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01517373,NCT01517373_EG004,No,All,Adult | Older Adult,Phase 2,61,"Inclusion Criteria:

Age 18-70 yrs, male and females, with T2DM, on metformin alone or in combination with 1 other oral agent

Exclusion Criteria:

Subjects with recent cardiovascular events, those with evidence of diabetic complications","PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.",DrugBank:DB15009 | PubChem:46916694,PF-04937319,Cc1cnc(NC(=O)c2cc(Oc3cnc(C(=O)N(C)C)nc3)c3cc(C)oc3c2)cn1,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0
NCT01517711,NCT01517711_EG000,No,All,Adult,Phase 4,22,"Inclusion Criteria:

Men and women, military veterans and non-veterans, aged 21-55 years
Active PTSD as determined by diagnostic evaluation and standardized interview (Structured Clinical Interview for the DSM (SCID))
Literacy and ability to give informed consent
In women of child-conceiving potential, a negative pregnancy test and use of an approved birth control method
Glasgow Coma Scale (GCS) score of 15, Extension of GCS with 7-point Amnesia Scale score of 6 (amnesia for traumatic event of 30 min or fewer) or 7 (no amnesia for impact of head) (Nell et al 2000)
Clinically judged to be at low risk for adverse sequelae from taking tramadol
Concomitant medications must be approved by the PI

Exclusion Criteria:

Pregnant or nursing women
Homeless persons
Suicidal or homicidal ideation with plans or intent
History of opioid dependence or abuse
Psychosis or history thereof, substance dependence or abuse (other than tobacco dependence; lifetime opioid abuse is exclusionary) within the past 60 days, anorexia nervosa, antisocial personality disorder, or other psychiatric disorder judged by the investigator to be more clinically significant than PTSD
Serious or unstable illness, endocrinopathy, or metabolic instability, including renal insufficiency, liver disease, hydrocephalus, history of stroke, history of seizures, history of brain tumor
Use of non-study medications except those approved by the PI
Newly started in psychotherapy (< 3months)
History of hypersensitivity, allergy, or other significant adverse effects from tramadol",Tramadol: Tramadol hydrochloride Extended Release(ER) will be supplied as tablets of Ultram® ER 100mg. Tramadol ER (100-300mg) or matching placebo will be self-administered by oral route every morning (with or without food) for 6 weeks. Patients will be instructed to take it the same way (either with food or without food) each time they take their dose. Each patient will be provided with 1 week supply of Tramadol ER or matching placebo on visits 2 (week 0) and 3 (week 1) and 2 weeks supply on visits 4 (week 2) and 5 (week 4).,ChEMBL:CHEMBL1237044 | DrugBank:DB00193 | PubChem:33741,Tramadol,COc1cccc(C2(O)CCCCC2CN(C)C)c1,N02AJ13 | N02AJ14 | N02AJ16 | N02AX02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01520207,NCT01520207_EG001,No,All,Adult | Older Adult,Phase 2,25,"Inclusion Criteria:

Renal failure requiring intermittent hemodialysis initiation; adult patients aged over 18 years; written informed consent

Exclusion Criteria:

Hyponatremia <130 mmol/L; acute myocardial infarction or stroke in previous 7 days; cardiac transplant; ventricular arrhythmia; unstable angina; use of pressors/midodrine; enrollment in conflicting research study; institutionalized individuals; pregnancy; prisoners; documented allergy to mannitol","Mannitol will be administered (IV) during the hemodialysis session at a maximum rate of 0.25g/kg/hour (maximum rate 25g/hour; maximum 75g per session; maximum volume 375mLs per session). Administration will be discontinued 30 minutes before the end of the hemodialysis session.

Mannitol (20%): 0.25g/kg/hour (maximum rate 25g/hour; maximum 75g per session; maximum volume 375mLs per session)",ChEMBL:CHEMBL1682 | ChEMBL:CHEMBL689 | DrugBank:DB00742 | DrugBank:DB01638 | PubChem:5780 | PubChem:6251 | PubChem:90540,Mannitol,OCC(O)C(O)C(O)C(O)CO,A06AD16 | A06AD18 | A06AG07 | B05BC01 | B05CX02 | B05CX04 | R05CB16 | V04CC01 | V04CX04,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0
NCT01523886,NCT01523886_EG000,No,All,Adult | Older Adult,Phase 4,25,"Inclusion Criteria:

Patients older than 18 years
Scheduled for elective laparoscopic cholecystectomy
Can read and understand danish
Women must be post-menopausal, sterilized or use safe contraception in the form of a coil or oral anti-contraceptives

Exclusion Criteria:

Known allergy to medications that are included in the project
Presence of severe renal disease, neuromuscular disease, reduced liver function
Nursing or pregnant
Indication for crash induction
For fertile women: Missing negative pregnancy-test","Rocuronium: Intravenous use: 0.3 mg/kg before intubation and 0,7 mg after intubation followed by infusion with 0,3-0,4 mg/kg/h",ChEMBL:CHEMBL1201244 | DrugBank:DB00728 | PubChem:441290,Rocuronium,[H][C@@]12CC[C@]3([H])[C@]([H])(CC[C@]4(C)[C@@H](OC(C)=O)[C@@H]([N+]5(CC=C)CCCC5)C[C@@]34[H])[C@@]1(C)C[C@H](N1CCOCC1)[C@@H](O)C2,M03AC09,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0
NCT01523886,NCT01523886_EG001,No,All,Adult | Older Adult,Phase 4,23,"Inclusion Criteria:

Patients older than 18 years
Scheduled for elective laparoscopic cholecystectomy
Can read and understand danish
Women must be post-menopausal, sterilized or use safe contraception in the form of a coil or oral anti-contraceptives

Exclusion Criteria:

Known allergy to medications that are included in the project
Presence of severe renal disease, neuromuscular disease, reduced liver function
Nursing or pregnant
Indication for crash induction
For fertile women: Missing negative pregnancy-test","Rocuronium: Intravenous use: 0,3 mg/kg followed by NaCl-infusion",ChEMBL:CHEMBL1201244 | DrugBank:DB00728 | PubChem:441290,Rocuronium,[H][C@@]12CC[C@]3([H])[C@]([H])(CC[C@]4(C)[C@@H](OC(C)=O)[C@@H]([N+]5(CC=C)CCCC5)C[C@@]34[H])[C@@]1(C)C[C@H](N1CCOCC1)[C@@H](O)C2,M03AC09,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0
NCT01526356,NCT01526356_EG001,No,All,Child | Adult | Older Adult,Phase 2,63,"Inclusion Criteria:

Subjects must be willing and able to comply with all trial requirements.
Subject has a diagnosis of TSC and has visible facial angiofibromas.
Female subjects of child bearing potential must not be pregnant and must agree to use appropriate contraceptive methods .

Exclusion Criteria:

Subject is currently receiving therapy with Rapamycin.
Subject is receiving any form of immunosuppression or has previously experienced immune dysfunction.
Subject is currently participating in or has participated within the last 30 days in a clinical trial involving an investigational drug.
Subject has a known hypersensitivity to either the vehicle or Rapamycin.
Subject is a pregnant or nursing female.
Subject has other dermatologic conditions that would preclude or prevent adequate assessment of changes to their facial angiofibromas.
Subject has had laser surgery, cryotherapy, or other dermatologic treatment to their facial angiofibromas within the previous 6 months.","0.1% Rapamycin cream

Rapamycin: Study cream is applied nightly to the affected areas on the face. Low Dose",ChEMBL:CHEMBL413 | DrugBank:DB00877 | PubChem:134760597 | PubChem:138404388 | PubChem:21944094 | PubChem:5284616,Sirolimus,COC1CC2CCC(C)C(O)(O2)C(=O)C(=O)N2CCCCC2C(=O)OC(C(C)CC2CCC(O)C(OC)C2)CC(=O)C(C)C=C(C)C(O)C(OC)C(=O)C(C)CC(C)C=CC=CC=C1C,L01EG04 | L04AA10 | S01XA23,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT01526356,NCT01526356_EG002,No,All,Child | Adult | Older Adult,Phase 2,57,"Inclusion Criteria:

Subjects must be willing and able to comply with all trial requirements.
Subject has a diagnosis of TSC and has visible facial angiofibromas.
Female subjects of child bearing potential must not be pregnant and must agree to use appropriate contraceptive methods .

Exclusion Criteria:

Subject is currently receiving therapy with Rapamycin.
Subject is receiving any form of immunosuppression or has previously experienced immune dysfunction.
Subject is currently participating in or has participated within the last 30 days in a clinical trial involving an investigational drug.
Subject has a known hypersensitivity to either the vehicle or Rapamycin.
Subject is a pregnant or nursing female.
Subject has other dermatologic conditions that would preclude or prevent adequate assessment of changes to their facial angiofibromas.
Subject has had laser surgery, cryotherapy, or other dermatologic treatment to their facial angiofibromas within the previous 6 months.","1% Rapamycin cream

Rapamycin: Study cream is applied nightly to the affected areas on the face. High Dose",ChEMBL:CHEMBL413 | DrugBank:DB00877 | PubChem:134760597 | PubChem:138404388 | PubChem:21944094 | PubChem:5284616,Sirolimus,COC1CC2CCC(C)C(O)(O2)C(=O)C(=O)N2CCCCC2C(=O)OC(C(C)CC2CCC(O)C(OC)C2)CC(=O)C(C)C=C(C)C(O)C(OC)C(=O)C(C)CC(C)C=CC=CC=C1C,L01EG04 | L04AA10 | S01XA23,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT01527942,NCT01527942_EG000,No,All,Adult | Older Adult,Not Applicable,16,"Inclusion Criteria:

Morbidly Obese and body mass index (BMI) of 35
Between ages 20-17
Candidates for Laparoscopic Bariatric Surgery

Exclusion Criteria:

know hypersensitivity to acetaminophen or opioids
impairment in liver function
renal dysfunction
mental retardation","Preoperative administration of 1,000 mg IV Acetaminophen will be administered after induction of general anesthesia and prior to incision and every 6 hours thereafter for 24 hours.

Acetaminophen: Intravenous Acetaminophen 1,000 mg IV",ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01528592,NCT01528592_EG000,No,All,Adult | Older Adult,Not Applicable,18,"Inclusion Criteria:

Idiopathic Parkinson's Disease (PD)
Older than 30 years of age at the time of diagnosis
Hoehn and Yahr stage greater than or equal to 2.5
PD duration greater than 3 years
Stable regimen of PD medications for at least 2 weeks prior to imaging
PD medications include carbidopa-levodopa

Exclusion Criteria:

Patients with a diagnosis of other neurodegenerative conditions
Patients unwilling or unable to give informed consent
Contraindications (cardiac pacemaker, etc.) or inability (e.g., claustrophobia) to undergo MRI scan",Subjects undergo MRI scanning in the medication off state and 1 hour after receiving medications.,PubChem:104778 | PubChem:441193,Nacom,CC(Cc1ccc(O)c(O)c1)(NN)C(=O)O.NC(Cc1ccc(O)c(O)c1)C(=O)O,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01531439,NCT01531439_EG000,No,All,Child | Adult,Not Applicable,84,"Inclusion Criteria:

Idiopathic scoliosis requiring spine fusion surgery
Age 10-21 years

Exclusion Criteria:

Inability to understand PCA instructions
Allergy to: morphine, hydromorphone, fentanyl, naloxone, or diphenhydramine
Chronic opioid therapy > 2 months
Non-English speaking",Naloxone: Naloxone infusion 0.5 mcg/kg/hr,ChEMBL:CHEMBL80 | DrugBank:DB01183 | PubChem:5284596,Naloxone,C=CCN1CC[C@]23c4c5ccc(O)c4O[C@H]2C(=O)CC[C@@]3(O)[C@H]1C5,A06AH04 | N02AA53 | N02AA55 | N02AX51 | V03AB15,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01531439,NCT01531439_EG001,No,All,Child | Adult,Not Applicable,84,"Inclusion Criteria:

Idiopathic scoliosis requiring spine fusion surgery
Age 10-21 years

Exclusion Criteria:

Inability to understand PCA instructions
Allergy to: morphine, hydromorphone, fentanyl, naloxone, or diphenhydramine
Chronic opioid therapy > 2 months
Non-English speaking","Naloxone infusion 2.5 mcg/kg/hr

Naloxone: Naloxone infusion 2.5 mcg/kg/hr",ChEMBL:CHEMBL80 | DrugBank:DB01183 | PubChem:5284596,Naloxone,C=CCN1CC[C@]23c4c5ccc(O)c4O[C@H]2C(=O)CC[C@@]3(O)[C@H]1C5,A06AH04 | N02AA53 | N02AA55 | N02AX51 | V03AB15,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01531803,NCT01531803_EG000,No,All,Child,Phase 4,1,"Inclusion Criteria:

Male or female aged 0 days to 12 years, inclusive:

(0 to 28 days);
(29 days to 23 months);
(2 to 5 years 11 months);
(6 to 12 years).
Subjects undergoing elective cardiac, abdominal, orthopedic, or transplant surgery.
Subjects with a clinical diagnosis of hypovolemia developed within 24 hours from the completion of surgery, as judged by the Investigator.
Admitted to ICU or acute care floor for post-operative recovery and care, in relatively stable condition.
Subject, parent or guardian agrees to comply with the requirements of the protocol.
Subject, parent or guardian has signed an informed consent form (ICF) and a child assent form if appropriate.
Subject, parent or guardian has signed the Health Insurance Portability and Accountability Act (HIPAA) authorization.

Exclusion Criteria:

Intra-operative blood loss > 50 mL/kg.
Severe hypoalbuminemia with serum albumin levels < 1g/dL.
Known intolerance or allergy to albumin and/or plasma proteins.
Preterm neonates, defined as neonates with a gestational age of <37 weeks (this criteria would only affect the 0-28 days group).
Burn and trauma patients.
Renal surgery.
Subjects with acute CNS injury or trauma would be excluded from the study.
Chronic renal insufficiency or acute renal failure (creatinine > 1.5 of normal value or based on age-appropriate renal function parameters), or a history of renal transplantation.
Subjects with hypernatremia, defined as a Na level of ≥ 155 mEq/L.
Severe congestive heart failure (CHF) using one of the following classification systems: Ross Heart Failure Classification, modified Ross Heart Failure Classification, or New York University Pediatric Heart Failure Index (NYU PHFI).
Any concurrent medical, surgical or psychiatric condition that may, in the Investigator's opinion, affect the subject's ability to meet the protocol requirements.
Subject has participated in another interventional clinical study within 30 days prior to study enrollment. Subjects who are participating in another observational study are not excluded.","Albumin (Human) 25% solution for intravenous (IV) infusion in the dosage strength of 250g/L human albumin, supplied in 50 mL type II vial (each vial containing 12.5g human albumin).

The dose will be 0.5 to 1g/kg body weight (2 to 4 mL/kg of 25% albumin). The duration of treatment is based on the subject's response to treatment until hemodynamic stability is achieved. If hemodynamic stability is not achieved within 72 hours of starting the study treatment, the subject will be withdrawn from the study and will be treated according to standard practice and data collected during the study period will be used for the safety evaluation.

Kedbumin 25%: Albumin (Human) 25% solution for intravenous (IV) infusion in the dosage strength of 250g human albumin /L, supplied in 50 mL type II vial (each vial containing 12.5g human albumin).

The dose will be 0.5 to 1g/kg body weight (2 to 4 mL/kg of 25% albumin).",ChEMBL:CHEMBL1663 | DrugBank:DB00556 | PubChem:6432,Perflutren,FC(F)(F)C(F)(F)C(F)(F)F,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01534182,NCT01534182_EG000,No,All,Adult | Older Adult,Phase 4,230,"Inclusion Criteria:

Written informed consent must be obtained before any assessment is performed.
Patients must be diagnosed with relapsing remitting MS (RRMS) as defined by 2005 revised McDonald criteria (McDonald et al 2001, Polman et al 2005) (Appendix 2).
Patients who explicitly agree to be assigned to a treatment group that may receive or DMT after having been informed about their respective benefits and possible adverse events by the investigator.
Male or female patients aged 18-70 years.
An Expanded Disability Status Scale (EDSS) score of 0-6 inclusive.
Must have received continuous treatment with a single approved and indicated MS DMT for a minimum of 6 months prior to the screening visit. Patients must continue with this MS DMT until the randomization visit.
Naïve to treatment with fingolimod.

Exclusion Criteria:

A manifestation of MS other than those defined in the inclusion criteria.
A history of chronic disease of the immune system other than MS or a known immunodeficiency syndrome.
History of malignancy of any organ system.
Diagnosis of macular edema during Screening Phase.
Patients with active systemic bacterial, viral or fungal infections, or known to have AIDS or to have positive HIV antibody test.
Patients who have received any live or live attenuated vaccines (including for varicella-zoster virus or measles) within 2 months prior to baseline.
Patients who have received total lymphoid irradiation or bone marrow transplantation.
History of selected immune system treatments and/or medications.
Any medically unstable condition, as assessed by the investigator.
Selected cardiovascular, or hepatic conditions
Selected abnormal laboratory values.
Patients with any other disease or clinical condition (including neurologic or psychiatric disorders) which may affect patient enrollment into the study and study medication use by the Investigators' opinion.
Participation in any clinical research study evaluating another not approved in Russia investigational drug or therapy within 6 months prior to baseline.
History of hypersensitivity to the study drug or to drugs of similar chemical classes.
Pregnant or nursing (lactating) women.

Other protocol-defined inclusion/exclusion criteria may apply",Participants received 0.5 mg orally once a day.,ChEMBL:CHEMBL314854 | DrugBank:DB08868 | PubChem:107970,Fingolimod,CCCCCCCCc1ccc(CCC(N)(CO)CO)cc1,L04AA27,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01542645,NCT01542645_EG000,No,All,Adult | Older Adult,Phase 4,164,"Inclusion Criteria:

All patients presenting for elective cardiac surgery with CPB will be eligible for enrollment.

Exclusion Criteria:

Preoperative renal failure requiring dialysis
Significant hepatic dysfunction (liver function tests > 2 times upper normal limit)
Preoperative ejection fraction < 30%
Pulmonary disease necessitating home oxygen therapy
Preoperative requirement for inotropic agents or intraaortic balloon pump to maintain hemodynamic stability
Allergy to methadone or fentanyl
Preoperative pain, use of preoperative opioids, or recent history of opioid abuse","Methadone: Methadone (0.3 mg/kg) will be administered intraoperatively, with half of the dose given at induction of anesthesia (over 5 minutes) and the remainder administered as an infusion over the next 2 hours.",ChEMBL:CHEMBL350719 | ChEMBL:CHEMBL651 | DrugBank:DB00333 | DrugBank:DB15198 | PubChem:4095 | PubChem:643985,Methadone,CCC(=O)C(CC(C)N(C)C)(c1ccccc1)c1ccccc1,N02AC52 | N07BC02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01542645,NCT01542645_EG001,No,All,Adult | Older Adult,Phase 4,164,"Inclusion Criteria:

All patients presenting for elective cardiac surgery with CPB will be eligible for enrollment.

Exclusion Criteria:

Preoperative renal failure requiring dialysis
Significant hepatic dysfunction (liver function tests > 2 times upper normal limit)
Preoperative ejection fraction < 30%
Pulmonary disease necessitating home oxygen therapy
Preoperative requirement for inotropic agents or intraaortic balloon pump to maintain hemodynamic stability
Allergy to methadone or fentanyl
Preoperative pain, use of preoperative opioids, or recent history of opioid abuse","Fentanyl: Fentanyl (12 mcg/kg) will be administered intraoperatively, with half of the dose given at induction of anesthesia (over 5 minutes) and the remainder administered as an infusion over the next 2 hours.",ChEMBL:CHEMBL596 | DrugBank:DB00813 | PubChem:3345,Fentanyl,CCC(=O)N(c1ccccc1)C1CCN(CCc2ccccc2)CC1,N01AH01 | N01AH51 | N02AB03,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01544062,NCT01544062_EG001,No,All,Adult | Older Adult,Phase 4,68,"Inclusion Criteria:

(1) subjects who clinically consented to elective sternotomy for coronary artery bypass grafting (CABG), heart valve repair or replacement under general anesthesia, and (2) ages between 18 and 75 years

Exclusion Criteria:

(1) subject refusal, (2) non-English speaking, (3) previous chronic or neuropathic pain, (4) previous chronic use of opioids, (5) history of psychiatric disorder, (6) allergy to acetaminophen, (7) severely impaired liver and kidney function and (8) previous sternotomy","Study subjects receiving IV acetaminophen

IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours.",ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01549002,NCT01549002_EG000,No,All,Child | Adult,Phase 3,10,"Inclusion Criteria:

Patient is 4 years of age up to their 18th birthday
Patient has a cutaneous abscess for which an I&D is to be performed

Exclusion Criteria:

Patient's parent doesn't speak English or Spanish
Patient has developmental delay or neurological impairment
Patient has altered mental status
Known hypersensitivity to study drugs (fentanyl, morphine sulfate, lidocaine, LMX4®)
The presence of significant blood or mucous in the nares despite blowing nose or suctioning
Severe renal or liver dysfunction, signs of respiratory distress or depression, any respiratory distress, chronic and severe asthma, upper airway obstruction, suspected gastrointestinal obstruction, suspected paralytic ileus
Narcotic analgesia within 4 hours of ED physician evaluation
Need for moderate sedation, deep sedation, or general anesthesia
Need for subspecialty consultation to perform the I&D
Need for I&D of more than 1 skin abscess
Cutaneous abscesses located on the genitals, breasts, face, or neck
Previous enrollment in the study
Patients with chronic pain syndromes (sickle cell disease, cancer, arthritis, inflammatory bowel disease)","Patients in this arm will receive intranasal Fentanyl (50 micrograms/mL) as their pre-I&D analgesic. The one time total dose to be used is 2 micrograms / kilogram, to a maximum of 100 micrograms. The medication will be delivered intranasally via an atomizer in 4 equally divided aliquots (2 per nare).

The abscess I&D will be followed according to protocol using topical and local anesthetic.

Intranasal Fentanyl: Drug: Fentanyl 50 micrograms/mL Dosage: 2 micrograms per kilogram (maximum 100 micrograms) Drug delivery: Intranasal via mucosal atomization device (MAD® Nasal, Wolfe Tory Medical Inc., Salt Lake City, UT) Frequency: one-time dose",ChEMBL:CHEMBL596 | DrugBank:DB00813 | PubChem:3345,Fentanyl,CCC(=O)N(c1ccccc1)C1CCN(CCc2ccccc2)CC1,N01AH01 | N01AH51 | N02AB03,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01556009,NCT01556009_EG001,No,All,Adult | Older Adult,Phase 2,24,"Inclusion Criteria:

The subject:

has had diagnosed at least 10 SEB (of diameter 3 mm diameter or greater on the nose or periorbital skin, 5 mm or greater elsewhere on the face, or 9 mm or greater on non-facial areas excluding the skin below the knees) during the two years before study entry.
meet diagnostic criteria for basal cell nevus syndrome
is willing to abstain from application of non-study topical medications to the skin for the duration of the study. For example, topical preparations containing corticosteroids (other than Triamcinolone applied no more than 6x/month).
is willing to forego treatment of BCCs unless the BCCs are documented by Study Investigators, preferably on two separate visits, except when the PSCP believes that delay in treatment potentially might compromise the health of the subject.
has normal laboratory tests as defined by the following: Normal hematopoietic capacity, Normal hepatic function: AST and ALT greater than or equal to 2x the upper limit of normal (ULN) Total bilirubin within normal range 0.20 mg/dl to 1.50 mg/dl or within 3x ULN for patients with Gilbert's disease Normal renal function: normal serum creatinine or measured creatinine clearance less than 50 mL/minute. Fasting cholesterol greater than or equal to 220 untreated
be willing to not donate blood or semen for three months following discontinuation of Study medications.
is willing to avoid pregnancy in his partner as defined by the following: Male subject is willing to use a latex condom during the study and for 3 months after the last dose during sexual contact with a female of childbearing potential, even if he has had a successful vasectomy. His partner must also use a form of birth control

Exclusion Criteria:

The subject:

has used topical or systemic therapies that might interfere with the evaluation of the study medication during the study. Specifically these include the use of: (i) glucocorticoids (other than Triamcinolone on no more than 36 days during the six months prior to study entry) to more than 5% of the skin (ii) retinoids systemically or topically to more than 5% of the skin during the six months prior to study entry; (iii) alpha-hydroxy acids to more than 5% of the skin during the six months prior to study entry (iv) 5-fluorouracil or imiquimod systemically or topically to the skin above the knees during the six months prior to study entry. (v) treatment with systemic chemotherapy within one year prior to starting study medication.
has a history of hypersensitivity to any of the ingredients in the study medication formulations.
is unable to return for follow-up visits and tests.
has uncontrolled systemic disease, including known HIV positive patients.
has history of congestive heart failure.
has uncontrolled hypocalcemia, hypomagnesemia, or hypokalemia
has clinically important history of liver disease, including viral or hepatitis, current alcohol abuse, or cirrhosis.
has any condition or situation which in the Investigator's opinion may put the subject at significant risk, could confound the study results, or could interfere significantly with the subject's participation in the study.
has a history of invasive cancer within the past five years excluding non-melanoma skin cancer, Stage I cervical cancer, ductal carcinoma in situ of the breast, or CLL Stage 0.
has current, recent (within 4 weeks of Day 1), or planned participation in an experimental drug study while enrolled in this study.
is a female who is pregnant, plans to ever to become pregnant, capable of becoming pregnant or is breast feeding.
is a male who is unwilling or unable to comply with pregnancy prevention measures.","Aminolevulinic acid HCL 20% topical solution applied every three months from month 10, 13, 16, 19, 22. Applied and incubated for three hours.

Aminolevulinic acid %20 topical solution: 20% topical solution applied every three months from month 10, 13, 16, 19, 22. Applied and incubated for three hours.",PubChem:123608,Aminolevulinic Acid Hydrochloride,Cl.NCC(=O)CCC(=O)O,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01558128,NCT01558128_EG000,No,All,Adult | Older Adult,Not Applicable,1,"Inclusion Criteria:

Subjects who underwent CABG and/or cardiac valve surgery involving cardiopulmonary bypass and develop postoperative atrial fibrillation within 7 days after surgery

Exclusion Criteria:

Subjects who had any form of atrial fibrillation prior to surgery
Subjects who were on antiarrhythmic medications preoperatively, including but not limited to procainamide and amiodarone","If subject converts to normal sinus rhythm following amiodarone no further intervention is taken, if subject remains in atrial fibrillation following amiodarone they are cardioverted.

Amiodarone: Bolus given 150mg IV, then IV drip 1mg per hour infused for 6 hours, 0.5mg per hour infused for 18 hours.

Cardioversion: Cardioversion done if atrial fibrillation continues following 24 hour infusion of amiodarone. Cardioversion done following hospital protocol.",ChEMBL:CHEMBL633 | DrugBank:DB01118 | PubChem:2157,Amiodarone,CCCCc1oc2ccccc2c1C(=O)c1cc(I)c(OCCN(CC)CC)c(I)c1,C01BD01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT01559454,NCT01559454_EG000,No,All,Adult | Older Adult,Phase 4,9,"Inclusion Criteria:

have a well-documented chronic pain disorder due to past back surgery,
have a chronic back pain syndrome,
have evidence of opioid addiction,
prior attempt at abstinence-oriented treatment documented by the referring physician,
be able to understand spoken and written English,
reside in Erie or Niagara counties,
have health insurance or other ability to pay for treatment with the approval from patient's primary physician;
have no prior history of methadone or BUP/NLX maintenance treatment since the last surgery,
not be a member of a vulnerable population, including prisoners

Exclusion Criteria:

homeless, or any patient without a ""locator"" (no means to participate in the follow-up data collection interviews by phone),
inability to give consent,
those with major co-occurring psychiatric disorders,
EKG showing prolonged QT and/or previous cardiac issues,
are taking a medication that is contraindicated with methadone,
medically unstable,
urine positive for cocaine at initial visit,
pregnant women",Methadone 10-60 mg/day divided 2-4 times a day for 6 months,ChEMBL:CHEMBL350719 | ChEMBL:CHEMBL651 | DrugBank:DB00333 | DrugBank:DB15198 | PubChem:4095 | PubChem:643985,Methadone,CCC(=O)C(CC(C)N(C)C)(c1ccccc1)c1ccccc1,N02AC52 | N07BC02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0
NCT01563913,NCT01563913_EG000,No,All,Adult | Older Adult,Phase 1,15,"Inclusion Criteria:

Diagnosed with Parkinsons disease
No levodopa (Sinemet) treatment or prior exposure to levodopa

Exclusion Criteria:

Prior exposure to levodopa
Unable to stand for 1 minute without aid
Sensory deficits on feet
Significant cognitive impairment
Current use of dopamine receptor blocking medications (depakote, lithium, amiodarone, tetrabenazine, metoclopramide, dronabinol)
Current fish oil or lutein supplementation
Allergy to soy",Docosahexaenoic Acid (DHA) 2 grams per day taken for 1.5 years,ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01564862,NCT01564862_EG000,No,All,Adult | Older Adult,Phase 2,196,"Inclusion Criteria:

In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
The participant has recurrent MDD as the primary diagnosis according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria (classification code 296.3x). The current MDE should be confirmed using the Mini International Neuropsychiatric Interview (MINI) V6.0.0.
The participant has received prescribed treatment for a previous episode of depression.
The participant has a MADRS total score ≥26 at both the screening and baseline visits.
Participant reports subjective cognitive dysfunction (such as difficulty concentrating, slow thinking, and difficulty in learning new things or remembering things).
The reported duration of the current major depressive episode (MDE) is at least 3 months
The participant is a man or woman between 18 and 65 years old, inclusive.
A female participant of childbearing potential who is sexually active with a nonsterilized male partner agrees to routinely use adequate contraception from signing of the informed consent throughout the duration of the study and for 30 days after completion of the study.

Exclusion Criteria:

The participant has previously participated in this study.
The participant has a history of severe drug allergy or hypersensitivity, or known hypersensitivity to any of the excipients of the investigational medicinal product (IMP).
The participant has known hypersensitivity to duloxetine.
The participant has hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrose-isomaltase insufficiency.
The participant is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in the conduct of this study (e.g., spouse, parent, child, sibling) or may consent under duress.
The participant has a score ≥70 on the DSST (numbers correct) at the Baseline Visit.
The participant is, in the opinion of the investigator, not able to complete the neuropsychological tests validly at the Baseline Visit.
If female, the participant is pregnant or lactating or intending to become pregnant before, during, or within 30 days after participating in this study; or intending to donate ova during such time period.

The participant has 1 or more of the following:

Any current psychiatric disorder other than MDD as defined in the DSM-IV-TR (as assessed by the MINI Version 6.0.0).
Current or history of attention deficit hyperactivity disorder (ADHD), pervasive developmental disorder, manic or hypomanic episode, schizophrenia, or any other psychotic disorder, including major depression with psychotic features, mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in the DSM-IV-TR.
Current diagnosis of alcohol or other substance abuse or dependence (excluding nicotine or caffeine) as defined in the DSM-IV-TR that has not been in sustained full remission for at least 2 years prior to Screening. (Participant must also have negative urine drug screen prior to Baseline).
Presence or history of a clinically significant neurological disorder (including epilepsy).
Neurodegenerative disorder (Alzheimer's disease, Parkinson's disease, multiple sclerosis, Huntington's disease, etc).
Any DSM-IV Axis II disorder that might compromise the study.
The participant has any other disorder for which the treatment takes priority over treatment of MDD or is likely to interfere with study treatment or impair treatment compliance.
The participant has physical, cognitive, or language impairment of such severity as to adversely affect the validity of the data derived from the neuropsychological tests.
The participant is diagnosed with reading disability (dyslexia).
The participant has a significant risk of suicide according to the investigator's clinical judgment or has a score ≥5 on item 10 (suicidal thoughts) of the MADRS or has made a suicide attempt in the previous 6 months.
The participant, in the opinion of the investigator, poses a risk of harm to others.
The participant has initiated formal cognitive or behavioral therapy, systemic psychotherapy within less than 6 months of study screening, or has plans to initiate such therapy during the study.
The participant has received electroconvulsive therapy, vagal nerve stimulation, or repetitive transcranial magnetic stimulation within 6 months prior to Screening.
The current depressive symptoms are considered by the investigator to have been resistant to 2 adequate antidepressant treatments of at least 6 weeks duration each at the recommended dose.
The participant has a history of moderate or severe head trauma (for example, loss of consciousness for more than 1 hour) or other neurological disorders or systemic medical diseases that are, in the opinion of the investigator, likely to affect central nervous system functioning.
The participant has a previous history of cancer that had been in remission for less than 5 years prior to the first dose of investigational drug. This criterion does not include those participants with basal cell or stage I squamous cell carcinoma of the skin.

The participant has a clinically significant unstable illness, for example, hepatic impairment or renal insufficiency, or cardiovascular, pulmonary, gastrointestinal, endocrine, neurological, rheumatologic, immunologic, infectious, skin and subcutaneous tissue disorders, or metabolic disturbance.

Note: For the purposes of this protocol, the following conditions are considered unstable due to the potential impact on assessment of MDD response and/or cognitive status: pain disorders, chronic fatigue syndrome, fibromyalgia, obstructive sleep apnea, and known cases of HIV, HBV, and HCV

The participant has a known history of or currently has increased intraocular pressure or is at risk of acute narrow-angle glaucoma.
The participant is required to take excluded medications or it is anticipated that the participant will require treatment with at least 1 of the disallowed concomitant medications during the study evaluation period as specified in the Excluded Medications Section.
The participant has received any investigational compound <30 days before Screening or 5 half-lives prior to Screening.
The participant has clinically significant abnormal vital signs as determined by the investigator.

The subject has thyroid stimulating hormone (TSH) outside the normal range at the Screening Visit.

Note: If TSH value is outside the normal range, a free T4 will be obtained. Subjects who have elevated TSH but normal T4 (i.e. subclinical hypothyroidism) will be excluded. For subjects who are on thyroid hormone replacement therapy, a lower TSH with normal T4, are eligible to participate in the study only if there are no clinical symptoms of hypothyroidism .

The participant has 1 or more laboratory value outside the normal range, based on the blood or urine samples taken at the Screening Visit, that are considered by the investigator to be clinically significant; or the participant has any of the following values at the Screening Visit:

A serum creatinine value >1.5 times the upper limits of normal (×ULN).
A total serum total bilirubin value >1.5×ULN.
A serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value >2×ULN.
The participant has an abnormal electrocardiogram (ECG) as determined by the central reader and confirmed as clinically significant by the investigator.
The participant has a disease or takes medication that, in the opinion of the investigator, could interfere with the assessments of safety, tolerability, or efficacy.
The participant, in the opinion of the investigator, is unlikely to comply with the clinical study protocol or is unsuitable for any reason.
The participant has been previously exposed to LuAA21004 compound.
The participant has a history of lack of response to previous adequate treatment with duloxetine.","Vortioxetine (Lu AA21004) 10 mg, capsules, orally, once daily for one week; then dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks.",ChEMBL:CHEMBL2104993 | DrugBank:DB09068 | PubChem:9966051,Vortioxetine,Cc1ccc(Sc2ccccc2N2CCNCC2)c(C)c1,N06AX26,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01565902,NCT01565902_EG000,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 1,8,"Inclusion Criteria:

All subjects:

Male and female Caucasian subjects 18 to 70 years of age
At least 50 kg and body mass index (BMI) within 18-35 kg/m2.
CYP2C9 wild-type (CYP2C9*1 homozygous carriers)

Hepatic impairment:

- Subjects must have either mild, moderate or severe hepatic impairment

Exclusion Criteria:

All subjects

Hepatic impairment due to non-liver disease.
Use of other investigational drugs within certain timelines
Donation or loss of 400 mL or more of blood or plasma within eight (8) weeks prior to initial dosing
History of cardiac rhythm abnormalities or cardiac rhythm abnormalities identified in the 24-h Holter ECG recording including episodes of bradycardia (HR < 50 bpm) during waking hours and/or arrhythmic episodes; subjects with history or presence of ventricular rhythm disturbances (ventricular extra-systoles >100/24h, or higher grade), or supraventricular arrhythmias (other than occasional supraventricular ectopic beats with a maximum of 5 subsequent ectopic beats per event) or subjects with conduction disturbances (higher than AV-block grade 1) or bradycardia or tachycardia.
History of cardiac catheter ablation.
Women of child-bearing potential
History of malignancy of any organ system
Recent and/or recurrent history of acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease)
History or presence of symptomatic postural hypotension or syncope.
Total WBC or lymphocyte counts which falls outside the 1.5-fold local laboratory normal range or platelet count < 30,000/μL at screening or baseline.
Clinically significant infection or recent vaccination with live-attenuated vaccines.
History or presence of hepatitis B or C and/or positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result at screening.
History or presence of coronary heart disease (stable or unstable), myocardial infarction, myocarditis, cardiomyopathy, heart failure NYHA II - IV.

Hepatic impairment:

History or presence of any non-controlled and clinically significant disease that could affect the study outcome or that would place the patient at undue risk.
Any surgical or medical condition other than hepatic impairment which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the safety of the study subject in case of participation in the study.
Treatment with certain drugs

Healthy subjects:

History or presence of any clinically significant disease of any major system organ class including (but not limited to) cardiovascular, metabolic, renal, neurological or psychiatric diseases.
Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, drugs, or which may jeopardize the subject in case of participation in the study.",Treatment with a single oral dose of 0.25 mg BAF312,ChEMBL:CHEMBL2336071 | DrugBank:DB12371 | PubChem:11432307 | PubChem:44599207,Siponimod,CCc1cc(/C(C)=N/OCc2ccc(C3CCCCC3)c(C(F)(F)F)c2)ccc1CN1CC(C(=O)O)C1,L04AA42 | L04AE03,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01565902,NCT01565902_EG001,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 1,8,"Inclusion Criteria:

All subjects:

Male and female Caucasian subjects 18 to 70 years of age
At least 50 kg and body mass index (BMI) within 18-35 kg/m2.
CYP2C9 wild-type (CYP2C9*1 homozygous carriers)

Hepatic impairment:

- Subjects must have either mild, moderate or severe hepatic impairment

Exclusion Criteria:

All subjects

Hepatic impairment due to non-liver disease.
Use of other investigational drugs within certain timelines
Donation or loss of 400 mL or more of blood or plasma within eight (8) weeks prior to initial dosing
History of cardiac rhythm abnormalities or cardiac rhythm abnormalities identified in the 24-h Holter ECG recording including episodes of bradycardia (HR < 50 bpm) during waking hours and/or arrhythmic episodes; subjects with history or presence of ventricular rhythm disturbances (ventricular extra-systoles >100/24h, or higher grade), or supraventricular arrhythmias (other than occasional supraventricular ectopic beats with a maximum of 5 subsequent ectopic beats per event) or subjects with conduction disturbances (higher than AV-block grade 1) or bradycardia or tachycardia.
History of cardiac catheter ablation.
Women of child-bearing potential
History of malignancy of any organ system
Recent and/or recurrent history of acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease)
History or presence of symptomatic postural hypotension or syncope.
Total WBC or lymphocyte counts which falls outside the 1.5-fold local laboratory normal range or platelet count < 30,000/μL at screening or baseline.
Clinically significant infection or recent vaccination with live-attenuated vaccines.
History or presence of hepatitis B or C and/or positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result at screening.
History or presence of coronary heart disease (stable or unstable), myocardial infarction, myocarditis, cardiomyopathy, heart failure NYHA II - IV.

Hepatic impairment:

History or presence of any non-controlled and clinically significant disease that could affect the study outcome or that would place the patient at undue risk.
Any surgical or medical condition other than hepatic impairment which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the safety of the study subject in case of participation in the study.
Treatment with certain drugs

Healthy subjects:

History or presence of any clinically significant disease of any major system organ class including (but not limited to) cardiovascular, metabolic, renal, neurological or psychiatric diseases.
Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, drugs, or which may jeopardize the subject in case of participation in the study.",Treatment with a single oral dose of 0.25 mg BAF312,ChEMBL:CHEMBL2336071 | DrugBank:DB12371 | PubChem:11432307 | PubChem:44599207,Siponimod,CCc1cc(/C(C)=N/OCc2ccc(C3CCCCC3)c(C(F)(F)F)c2)ccc1CN1CC(C(=O)O)C1,L04AA42 | L04AE03,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01565902,NCT01565902_EG002,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 1,16,"Inclusion Criteria:

All subjects:

Male and female Caucasian subjects 18 to 70 years of age
At least 50 kg and body mass index (BMI) within 18-35 kg/m2.
CYP2C9 wild-type (CYP2C9*1 homozygous carriers)

Hepatic impairment:

- Subjects must have either mild, moderate or severe hepatic impairment

Exclusion Criteria:

All subjects

Hepatic impairment due to non-liver disease.
Use of other investigational drugs within certain timelines
Donation or loss of 400 mL or more of blood or plasma within eight (8) weeks prior to initial dosing
History of cardiac rhythm abnormalities or cardiac rhythm abnormalities identified in the 24-h Holter ECG recording including episodes of bradycardia (HR < 50 bpm) during waking hours and/or arrhythmic episodes; subjects with history or presence of ventricular rhythm disturbances (ventricular extra-systoles >100/24h, or higher grade), or supraventricular arrhythmias (other than occasional supraventricular ectopic beats with a maximum of 5 subsequent ectopic beats per event) or subjects with conduction disturbances (higher than AV-block grade 1) or bradycardia or tachycardia.
History of cardiac catheter ablation.
Women of child-bearing potential
History of malignancy of any organ system
Recent and/or recurrent history of acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease)
History or presence of symptomatic postural hypotension or syncope.
Total WBC or lymphocyte counts which falls outside the 1.5-fold local laboratory normal range or platelet count < 30,000/μL at screening or baseline.
Clinically significant infection or recent vaccination with live-attenuated vaccines.
History or presence of hepatitis B or C and/or positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result at screening.
History or presence of coronary heart disease (stable or unstable), myocardial infarction, myocarditis, cardiomyopathy, heart failure NYHA II - IV.

Hepatic impairment:

History or presence of any non-controlled and clinically significant disease that could affect the study outcome or that would place the patient at undue risk.
Any surgical or medical condition other than hepatic impairment which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the safety of the study subject in case of participation in the study.
Treatment with certain drugs

Healthy subjects:

History or presence of any clinically significant disease of any major system organ class including (but not limited to) cardiovascular, metabolic, renal, neurological or psychiatric diseases.
Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, drugs, or which may jeopardize the subject in case of participation in the study.",Treatment with a single oral dose of 0.25 mg BAF312,ChEMBL:CHEMBL2336071 | DrugBank:DB12371 | PubChem:11432307 | PubChem:44599207,Siponimod,CCc1cc(/C(C)=N/OCc2ccc(C3CCCCC3)c(C(F)(F)F)c2)ccc1CN1CC(C(=O)O)C1,L04AA42 | L04AE03,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01565902,NCT01565902_EG003,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 1,8,"Inclusion Criteria:

All subjects:

Male and female Caucasian subjects 18 to 70 years of age
At least 50 kg and body mass index (BMI) within 18-35 kg/m2.
CYP2C9 wild-type (CYP2C9*1 homozygous carriers)

Hepatic impairment:

- Subjects must have either mild, moderate or severe hepatic impairment

Exclusion Criteria:

All subjects

Hepatic impairment due to non-liver disease.
Use of other investigational drugs within certain timelines
Donation or loss of 400 mL or more of blood or plasma within eight (8) weeks prior to initial dosing
History of cardiac rhythm abnormalities or cardiac rhythm abnormalities identified in the 24-h Holter ECG recording including episodes of bradycardia (HR < 50 bpm) during waking hours and/or arrhythmic episodes; subjects with history or presence of ventricular rhythm disturbances (ventricular extra-systoles >100/24h, or higher grade), or supraventricular arrhythmias (other than occasional supraventricular ectopic beats with a maximum of 5 subsequent ectopic beats per event) or subjects with conduction disturbances (higher than AV-block grade 1) or bradycardia or tachycardia.
History of cardiac catheter ablation.
Women of child-bearing potential
History of malignancy of any organ system
Recent and/or recurrent history of acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease)
History or presence of symptomatic postural hypotension or syncope.
Total WBC or lymphocyte counts which falls outside the 1.5-fold local laboratory normal range or platelet count < 30,000/μL at screening or baseline.
Clinically significant infection or recent vaccination with live-attenuated vaccines.
History or presence of hepatitis B or C and/or positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result at screening.
History or presence of coronary heart disease (stable or unstable), myocardial infarction, myocarditis, cardiomyopathy, heart failure NYHA II - IV.

Hepatic impairment:

History or presence of any non-controlled and clinically significant disease that could affect the study outcome or that would place the patient at undue risk.
Any surgical or medical condition other than hepatic impairment which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the safety of the study subject in case of participation in the study.
Treatment with certain drugs

Healthy subjects:

History or presence of any clinically significant disease of any major system organ class including (but not limited to) cardiovascular, metabolic, renal, neurological or psychiatric diseases.
Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, drugs, or which may jeopardize the subject in case of participation in the study.",Treatment with a single oral dose of 0.25 mg BAF312,ChEMBL:CHEMBL2336071 | DrugBank:DB12371 | PubChem:11432307 | PubChem:44599207,Siponimod,CCc1cc(/C(C)=N/OCc2ccc(C3CCCCC3)c(C(F)(F)F)c2)ccc1CN1CC(C(=O)O)C1,L04AA42 | L04AE03,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01573949,NCT01573949_EG000,No,All,Adult | Older Adult,Not Applicable,7,"Inclusion Criteria:

symptomatic HF of any etiology
age ≥ 18 years
fasting blood sugar equal or greater than 100 mg/dL, or pre-DM (HbA1c 5.7 - 6.4%) or early DM (HbA1c ≥ 6.5%)

Exclusion Criteria:

current metformin therapy or other anti-diabetic therapy
previous intolerance to metformin therapy
renal dysfunction (Cr >1.5 in men or > 1.4 in women or creatinine clearance < 60 ml/minute)
history of lactic acidosis
current or planned pregnancy or breast-feeding",Metformin at 500 mg PO BID and pending lab values may have been titrated to 1000 mg PO BID at 1 month.,ChEMBL:CHEMBL1431 | DrugBank:DB00331 | PubChem:4091,Metformin,CN(C)C(=N)NC(=N)N,A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01575522,NCT01575522_EG000,No,All,Adult | Older Adult,Phase 2,22,"Inclusion Criteria:

Participants must have histologically or cytologically confirmed invasive breast cancer, with recurrent or metastatic disease; participants without pathologic or cytologic confirmation of metastatic disease should have unequivocal evidence of metastasis from physical examination or radiologic evaluation
Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >= 20 mm with conventional techniques or as >= 10 mm with spiral computed tomography (CT) scan

Participants must have recent evidence of progressive disease

Participants must have received 1-3 prior chemotherapeutic regimens for metastatic breast cancer and must have been off treatment with chemotherapy for at least 14 days before enrollment in the study
Participants must have discontinued all biologic therapy (including vaccines) at least 14 days before enrollment in the study
Participants must have discontinued any investigational therapy at least 14 days before enrollment in the study

Participants may have received prior radiation therapy in either the metastatic or early-stage setting

Radiation therapy must be completed at least 14 days before enrollment in the study
Participant must not have received radiation to > 25% of his or her bone marrow within 30 days of starting study treatment
Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
Hemoglobin >= 9.0 g/dL
Absolute neutrophil count >= 1,500/mcL
Platelets >= 100,000/mcL
Total bilirubin =< 1.5 times upper limit of normal (ULN)
Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase [SGPT]) =< 2.5 times institutional ULN; for participants with documented liver metastases, AST/ALT =< 5.0 times ULN
Serum creatinine =< 1.5 times ULN OR creatinine clearance >= 60 mL/min/1.73 m^2 for participants with creatinine levels above institutional normal

Either the primary tumor and/or the metastasis must be triple-negative; the invasive tumor must be hormone-receptor poor, defined as estrogen-receptor negative (ER-) and progesterone-receptor negative (PR-), or staining < 10% by immunohistochemistry (IHC)

Human epidermal growth factor receptor 2 (HER2) status: the invasive tumor must be HER2-negative, defined as 0 or 1+ by IHC, or FISH < 2.0
Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) during the study and for 90 days after the last investigational drug dose received
Female subjects of childbearing potential must have a negative serum pregnancy test within 21 days of cycle 1 day 1
Participants on bisphosphonates may continue receiving bisphosphonate therapy during study treatment; bisphosphonate therapy may also be initiated on study treatment if needed
Confirmed availability of formalin-fixed, paraffin-embedded (FFPE) tumor tissue
Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

Participants who have received chemotherapy, biologic, investigational, or radiotherapy within 14 days prior to entering the study
Participants who are receiving any other investigational agents

Known brain metastases that are untreated, symptomatic, or require therapy to control symptoms

Participants with a history of treated central nervous system (CNS) metastases are eligible

Treated brain metastases are defined as those having no evidence of progression or hemorrhage for >= 2 months after treatment, and no ongoing requirement for corticosteroids, as ascertained by clinical examination and brain imaging (magnetic resonance imaging or computed tomography [CT] scan) during the screening period
Treatment for brain metastases may include whole-brain radiotherapy, radiosurgery, or a combination as deemed appropriate by the treating physician
Participants may be taking anti-convulsant medications, which must be non-enzyme-inducing anti-epileptic drugs
History of allergic reactions attributed to compounds of similar chemical or biologic composition to ARQ 197
History of congestive heart failure defined as Class II to IV per New York Heart Association (NYHA) classification; active coronary artery disease (CAD); clinically significant bradycardia or other uncontrolled, cardiac arrhythmia defined as >= grade 3 according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.0, or uncontrolled hypertension; myocardial infarction occurring within 6 months prior to study entry (myocardial infarction occurring > 6 months prior to study entry is permitted)
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Pregnant women are excluded from this study
Human immunodeficiency virus (HIV)-positive participants on combination antiretroviral therapy are ineligible","Patients receive tivantinib PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection at baseline and periodically during study for c-Met expression, relevant markers (HGF and VEGF), PTEN loss, and PI3K mutation analysis by FISH and IHC. Archived tumor tissue samples are also analyzed.

Laboratory Biomarker Analysis: Correlative studies

Tivantinib: Given PO",ChEMBL:CHEMBL2103882 | DrugBank:DB12200 | PubChem:11494412,Tivantinib,O=C1NC(=O)[C@@H](c2cn3c4c(cccc24)CCC3)[C@@H]1c1c[nH]c2ccccc12,,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0
NCT01577966,NCT01577966_EG000,No,All,Adult | Older Adult,Not Applicable,9,"Inclusion Criteria:

Patients must be > 18 years of age or older.
Patients must have histologically proven low grade astrocytoma,anaplastic astrocytoma, anaplastic mixed glioma, anaplastic oligodendroglioma,glioblastoma multiforme, astrocytoma WHO II,oligodendroglioma WHO II or mixed glioma WHO II. Patients do not haveto demonstrate progressive disease to participate in this study.
Patients must have completed initial glioma therapy involving radiation and be 3 months from the completion of radiation therapy. If initial glioma therapy did not include radiation (example: anaplastic oligodendroglioma), then 2 cycles of chemotherapy must be completed prior to study entry.
Patients must be maintained on a stable corticosteroid regimen for > 5 days prior to entry.
Patients must have a Karnofsky performance status > 60% (i.e. the patient must be able to care for himself/herself with occasional help from others).
Patients must have adequate hematologic, renal and liver function (i.e. Absolute neutrophil count > 1500/mm3, Platelets > 100,000/mm3, creatinine > 1.5 mg/dl.
Women of childbearing potential must have a negative pregnancy test.
Patients with the potential for pregnancy or impregnating their partner must agree to follow acceptable birth control methods to avoid conception. The effect of the investigational drugs on the developing human fetus is not known, but these drugs are likely to be harmful to the developing fetus or nursing infant. Women of child-bearing potential must agree to use adequate contraception (either surgical sterilization; approved hormonal contraceptives such as birth control pills: Depo-Provera, or Lupron Depot; barrier methods such as condom or diaphragm along with spermicide; or an IUD). Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician and study PI immediately.
Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

Pregnant or breast feeding.
Exclude sexually active males and females unwilling to practice contraception during the study.
Serious concurrent infections.
Clinically significant cardiac disease not well controlled with medication (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias) or myocardial infarction within the last 12 months.
Patients with other serious uncontrolled co-morbid diseases that the investigator feels may comprise the study findings.
Allergic or sensitivity to sulfa containing medications.","Sulfasalazine: Sulfasalazine has been the parent aminosalicylate in use for over 40 years in the treatment of inflammatory bowel disease. The drug is a conjugate of sulfapyridine linked to 5-aminosalicylic acid. In inflammatory bowel disease, the 5-ASA component is the active moiety

Sulfasalazine is a prodrug that consists of sulfapyridine bonded to mesalamine (5-ASA). Sulfasalazine is cleaved by colonic bacterial azo-reductases into sulfapyridine and the 5-ASA moiety. 5-ASA is metabolized to N-acetyl-5-ASA by an enzyme in the intestinal epithelium and the liver and then excreted in the urine as a mixture of free 5ASA and N-acetyl-5-ASA.",ChEMBL:CHEMBL421 | DrugBank:DB00795 | PubChem:5339,Sulfasalazine,O=C(O)c1cc(/N=N/c2ccc(S(=O)(=O)Nc3ccccn3)cc2)ccc1O,A07EC01 | G01AE10,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01578330,NCT01578330_EG000,No,All,Adult | Older Adult,Phase 4,42,"Inclusion Criteria:

Diagnosed with RRMS as described in 2005 Mc Donald criteria
Provided written informed consent prior to any intervention
Female or male patients aged 18-65 years

Unresponsive to treatment with a beta interferon or glatiramer acetate for a minimum of one year at and at adequate dose and with high disease activity

(Unresponsive patients: patients with no changes in relapses, increased relapses, severer relapses with one-year treatment or those who had had at least one relapse during the past one year under previous treatments and one or multiple contrast enhancing lesions in cranial MRI or increased T2 lesions in successive MRIs)

EDSS score below 5.5 at baseline

Exclusion Criteria:

Treatment-naive RRMS patients 2. History of a chronic disease of the immune system other than MS or known immunodeficiency 3. Past or current malignancy 4. Diabetic patients with mild or severe, non-proliferative or proliferative diabetic retinopathy and uncontrolled diabetic patients with HbA1c > 8% 5. Evidence of macular edema (patients with a history of macular edema will be allowed to enter the study provided that they do not have macular edema at screening.) 6. Evidence of uveitis 7. EDSS score > 5.5 at baseline 8. Active systemic bacterial, viral or fungal infections, or known to have AIDS, Hepatitis B, Hepatitis C infection or have positive HIV antibody, Hepatitis B surface antigen or Hepatitis C antibody tests 9. No history of varicella and negative varicella-zoster virus IhH antibody test at screening (such patients may be included after being administered VZV vaccine, at least 1 month following vaccination.) 10. Patients who received any live or live attenuated vaccine during the last one month (including varicella-zoster virus or measles) 11. Patients who received total lymphoid irradiation or bone marrow transplantation 12. Patient who received any of the treatment below:

Corticosteroids or adrenocorticotropic hormone (ACTH) during the last 1 month
Immunosuppressive medications such as azathioprine or methotrexate etc.
Immunoglobulin treatment during the last 3 months

Cladribine, cyclophosphamide, mitoxantrone, natalizumab at any time 13. Patients with any of the following cardiovascular conditions: Resting heart rate < 45 bpm/min Cardiac failure at time of screening (Class III according to NYHA classification) or any severe cardiac as determined by the physician Myocardial infarction during the last 6 months History of Mobitz Type II grade 2 AV block Past or current grade 3 AV block Confirmed history of sick sinus syndrome or sino-atrial heart block arrhythmia requiring current treatment with Class Ia drugs (ajmaline, disopyramid, procainamide, quinidine) hypertension uncontrolled with medication 14. Patients with any of the pulmonary conditions below severe respiratory disease or pulmonary fibrosis Uncontrolled asthma 15. Pregnant or nursing (lactating) women (pregnancy is defined as the state of a female after conception and until the termination of gestation and should be confirmed by a positive hCG laboratory test (> 5 mIU/ml).

16. Patients with any of the hepatic conditions below: Alcohol abuse, chronic hepatic or biliary disease, severe hepatic impairment (Child- Pugh class C) Total bilirubin above the upper limit of normal provided that it is not associated with Gilbert's syndrome Conjugated bilirubin above the upper limit of normal Alkaline phosphate (AP) 1.5 times above the upper limit of normal AST(SGOT), ALT (SGPT) 2 times above the upper limit of normal, gamma-glutamyl-transferase (GGT) 3 times above the upper limit of normal",Patients received fingolimod 0.5 mg oral capsules daily with or without food.,ChEMBL:CHEMBL314854 | DrugBank:DB08868 | PubChem:107970,Fingolimod,CCCCCCCCc1ccc(CCC(N)(CO)CO)cc1,L04AA27,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT01578772,NCT01578772_EG000,No,All,Adult | Older Adult,Phase 2,17,"Inclusion Criteria:

HIV positive men and women > 50 years of age.
HIV-1 RNA documented to be < 50 copies/mL at screening and undetectable by assay of choice (< 50 or < 400 copies/mL) for at least 12 weeks prior to entry.
Current ART with a suppressive, highly active regimen. Subjects must not have changed ART in the 12 weeks prior to entry, and must not be planning to change ART for the 12-week study duration.
Systolic blood pressure > 110mmHg.
One or more risk factors for CVD (smoking, hypertension, hyperlipidemia, diabetes mellitus). Note: family history of early heart disease alone will not be a sufficient entry criterion.
Ability and willingness of subject to provide informed consent.

Exclusion Criteria:

Pregnancy (current or within the past 6 months) or nursing.
Uncontrolled hypertension:
Prohibited concomitant medications: Other members of the angiotensin receptor-blocking class (losartan, irbesartan, olmesartan, valsartan, candesartan; wash-out period allowed), nelfinavir, and etravirine. Subjects taking nelfinavir or etravirine will be excluded due to the possibility of increased drug levels via inhibition of cytochrome P-450 2C19.

Note 1: Subjects requiring amifostine or rituximab must be aware of the increased risk of orthostatic hypotension with the addition of telmisartan. Any subject requiring lithium therapy while on study must have lithium levels monitored closely by their outside physician. All subjects on the above listed medications should provide documentation that their physician is aware of the study protocol.

Note 2: Subjects taking thiazolidinediones must be on stable dosing (> 12 weeks) and must agree to refrain from dose titration for the 12-week study duration.

Untreated hyperlipidemia: Subjects must be willing to abstain from initiating therapy for the 12-week study duration. Subjects on a stable (> 12 weeks) lipid-lowering regimen must be willing to remain on their current dose for the 12-week study duration.
Subjects undergoing treatment for diabetes with oral hypoglycemic agents must be willing to remain on their current dose of insulin-sensitizing agents (metformin/biguanides) for the 12-week study duration. Titration of other diabetes (except thiazolidinediones, see 4.2.3) medications will be permitted.
Screening laboratory values as follows:
ANC < 750 cells/mm3
Hemoglobin < 10 gm/dL
Creatinine clearance < 30 mL/min (estimated by Cockcroft-Gault equation using ideal body weight)
AST or ALT > 3 times ULN
Known, untreated, renal artery stenosis.
Unstable coronary artery disease/angina, decompensated congestive heart failure, or predicted need for cardiovascular surgery within the study period.
History of intolerance to any member of the angiotensin receptor blocker class of agents.
Need for ongoing potassium supplementation.
Active, untreated opportunistic and/or AIDS-defining illnesses.","Open label

Telmisartan: 80mg tablets po daily for 6 weeks",ChEMBL:CHEMBL1017 | DrugBank:DB00966 | PubChem:65999,Telmisartan,CCCc1nc2c(C)cc(-c3nc4ccccc4n3C)cc2n1Cc1ccc(-c2ccccc2C(=O)O)cc1,C09CA07 | C09DA07 | C09DB04 | C09DX08,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01579812,NCT01579812_EG000,No,Female,Adult | Older Adult,Phase 2,90,"Inclusion Criteria:

Patients with potential diagnosis of ovarian, fallopian, or primary peritoneal cancer.
Care plan including surgical debulking and traditional adjuvant or neo-adjuvant chemotherapy (6-9 cycles of platinum and taxane based therapy).
Eastern Cooperative Oncology Group performance status 0-2.
Age > 18 years or < 80 years.
Adequate renal function (serum creatinine <1.4mg/dL).

Adequate liver function (bilirubin < 1.5 times ULN).

Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) < 5 times the upper limit of normal in case of liver metastases.
ALT or AST < 2.5 times the ULN in absence of liver metastases.
Ability to understand and complete written informed consent.
Mentally, physically, and geographically able to undergo treatment and follow up.

Exclusion Criteria:

Patients diabetes mellitus. (Patients with only a history of gestational diabetes will be allowed to be included in the study.)
Metformin use in the last 6 months.
A known hypersensitivity to metformin.
A history of metabolic acidosis, including ketoacidosis or increased risk of lactic acidosis.
Pregnancy or Lactation.
Patients who have any severe and/or uncontrolled medical conditions.
Patients with a history of renal disease.
Patients with other known active malignancy (excluding adequately treated basal cell / squamous cell skin cancer, in situ cancer, or other cancer for which the patient has been disease free for 2 years).
Patients receiving any other investigational agents.","Metformin: Patients receiving primary surgical debulking followed by adjuvant chemotherapy will initiate metformin prior to primary surgery. Following surgery patients will be initiated on metformin prior to the initiation of chemotherapy.

Patients treated with neoadjuvant chemotherapy will be initiated on metformin prior to the initiation of chemotherapy. Following surgery patients will be initiated on metformin prior to the re-initiation of chemotherapy.",ChEMBL:CHEMBL1431 | DrugBank:DB00331 | PubChem:4091,Metformin,CN(C)C(=N)NC(=N)N,A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT01581281,NCT01581281_EG000,No,All,Child,Phase 3,145,"Inclusion Criteria:

Migraine with or without aura (International Classification of Headache Disorders, 2nd Edition (ICHD-II) or chronic migraine (ICHD-II revised)
Migraine frequency based upon prospective headache diary of 28 days must be ≥ 4. Migraine frequency defined as any migraine during one day in the 28 day baseline period (1)
PedMIDAS Disability Score > 10, indicating at least mild disruption in daily activities and < 140, indicating extreme disability that may require more comprehensive, multi-component therapy

Females or males 8-17 years, inclusive

Migraine frequency is defined as the period from the onset to the stop time of painful migraine symptoms not to exceed 24 hours with the clock starting at midnight. If painful symptoms last longer than 24 hours, this is considered a new and distinct migraine headache. If painful symptoms recur within 24 hours of initial onset, this is considered part of the initial migraine episode and would be counted as one migraine.

Exclusion Criteria:

Continuous migraine defined as an unrelenting headache for a 28 day period
Weight less than 30 kg or greater than 120 kg
Unwilling to avoid taking non-specific acute medication such as NSAIDS (e.g., ibuprofen), more than 3 times per week, or migraine specific acute medications such as triptans more than 6 times per month
Currently taking other prophylactic anti-migraine medication within a period equivalent to 2 weeks of that medication before entering the screening phase, or the use of Botulinum toxin (Botox®) within 3 months of entering the screening phase
Subjects who have previously failed an adequate trial of AMI or TPM for prophylaxis of at least 3 months duration at doses recommended for migraine relief because of lack of efficacy or adverse events(2)
Current use of disallowed medications/products: opioids, antipsychotics, antimanics, barbiturates, benzodiazepines, muscle relaxants, sedatives, tramadol, nutraceuticals, SSRIs, or SSNRIs
Known history of allergic reaction or anaphylaxis to AMI or TPM
Abnormal findings on ECG at baseline, particularly lengthening of the QT interval greater than or equal to 450 msec
Subject is pregnant or has a positive pregnancy test
Subject is sexually active and not using a medically acceptable form of contraception
Diagnosis of epilepsy or other neurological diseases
History of kidney stones
Inability to swallow pills after using behavioral techniques if indicated between screening visit and baseline visit (3)
Present psychiatric disease as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM IV) (e.g. psychosis, bipolar disorder, major depression, generalized anxiety disorder), alcohol or drug dependence, or documented developmental delays or impairments (e.g., autism, cerebral palsy, or mental retardation) that, in the opinion of the site investigator, would interfere with adherence to study requirements or safe participation in the trial

Any and all other diagnoses or conditions which in the opinion of the site investigator, that would prevent the patient from being a suitable candidate for the study or interfere with the medical care needs of the study subject

(2)""Previously failed an adequate trial of AMI or TPM"" is defined as: dosage of 1mg/kg/day of AMI or 2 mg/kg/day of TPM; trial of at least 3 months duration; efficacy of having at least a 50% decrease in migraine frequency in response to drug therapy; or unable to tolerate taking the medication due to treatment-related side effects.

(3)Subjects who cannot swallow pills at the time of the screening visit will be given a training session using behavioral techniques. Upon return for baseline visit, if the subject continues to be unable to swallow pills, the subject will be excluded from the study.","Topiramate enclosed in capsules to maintain the blind was administered orally in a divided dose of 1 capsule twice daily. A target dose was 2 mg per kilogram per day. Dose escalation occurred every two weeks over a period of 8 weeks, with dose modification based on side effects. A 16 week constant-dose (maintenance) phase followed at the highest dosage achieved.",ChEMBL:CHEMBL220492 | DrugBank:DB00273 | PubChem:5284627,Topiramate,[H][C@@]12OC(C)(C)O[C@]1([H])CO[C@@]1(COS(N)(=O)=O)OC(C)(C)O[C@]12[H],A08AA51 | N03AX11,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01582880,NCT01582880_EG000,No,All,Adult | Older Adult,Phase 1 | Phase 2,1,"Inclusion Criteria:

Ability to provide written informed consent and comply with study assessments for the full duration of the study.
Age > 18 years.
A negative urine pregnancy test.
Candidate for a Boston Keratoprosthesis/Corneal transplant.
Generally good stable overall health.

Patients with an eye at risk for a cornea sterile ulcer which includes:

Chemical injuries.
Autoimmune diseases (ocular cicatricial pemphigoid, Stevens Johnson Syndrome, systemic lupus erythematosus, rheumatoid arthritis, or other autoimmune diseases).
History of previous sterile corneal ulceration requiring a cornea transplant.

Exclusion Criteria:

Age < 18 years.
Inability to provide written informed consent and comply with study assessments for the full duration of the study.
Pregnant or lactating women.
No or minimal tear production.
Ocular or periocular malignancy.
Inability to wear a contact lens due to lid abnormalities or shortened fornix.
Signs of current infection, including fever and current treatment with antibiotics.
Participation in another simultaneous medical investigation or trial","The donor cornea used as a carrier for the Boston Keratoprosthesis underwent crosslinking treatment before being trephined and prepared for implantation with the Keratoprosthesis.

Riboflavin: Used to treat donor cornea before implantation",ChEMBL:CHEMBL1534 | DrugBank:DB00140 | PubChem:493570,Riboflavin,Cc1cc2nc3c(=O)[nH]c(=O)nc-3n(C[C@H](O)[C@H](O)[C@H](O)CO)c2cc1C,A11HA04 | S01XA26,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01584544,NCT01584544_EG000,No,All,Older Adult,Phase 1,3,"Inclusion Criteria:

rectal adenocarcinoma, clinical stage II/III(T3-4 or N+, AJCC 7th).
KPS status no less than 70; Charlson comorbidity no more than 3.
life expectancy more than 6 months.
hemoglobin >= 100g/L, white blood cell >= 3.5*10E9/L, neutrophil >= 1.5*10E9/L, platelet >= 100*10E9/L.Creatin normal, Total bilirubin normal, AST and AST normal, AKP normal.
do not have allergy history to thymidine phosphorylase.
do not receive surgery ( except palliative colostomy) or chemotherapy or other anti-cancer treatment
no previously pelvic irradiation history
informed consent signed

Exclusion Criteria:

other cancer history, except curable non-melanoma skin cancer or cervix in-situ carcinoma
previous pelvic irradiation history
receiving surgery (except palliative colostomy), chemotherapy or other anti-cancer treatment
allergy history to thymidine phosphorylase
active infection existed
severe complication, such as acute myocardial infarction in 6 months, uncontrolled diabetes ( Plasma glucose concentrations in any time of a day≥11.1mmol/L）, severe cardiac arrhythmia， etc.
anticipate other clinical trials in four weeks before enrollment","capecitabine 1000mg/m2/d d1-14, d22-25 combined with concurrent radiotherapy will be given to enrolled patients.

capecitabine: oral pills, 1000mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation",ChEMBL:CHEMBL1773 | DrugBank:DB01101 | PubChem:42066809 | PubChem:60953,Capecitabine,CCCCCOC(=O)Nc1nc(=O)n([C@@H]2O[C@H](C)[C@@H](O)[C@H]2O)cc1F,L01BC06,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT01584544,NCT01584544_EG001,No,All,Older Adult,Phase 1,6,"Inclusion Criteria:

rectal adenocarcinoma, clinical stage II/III(T3-4 or N+, AJCC 7th).
KPS status no less than 70; Charlson comorbidity no more than 3.
life expectancy more than 6 months.
hemoglobin >= 100g/L, white blood cell >= 3.5*10E9/L, neutrophil >= 1.5*10E9/L, platelet >= 100*10E9/L.Creatin normal, Total bilirubin normal, AST and AST normal, AKP normal.
do not have allergy history to thymidine phosphorylase.
do not receive surgery ( except palliative colostomy) or chemotherapy or other anti-cancer treatment
no previously pelvic irradiation history
informed consent signed

Exclusion Criteria:

other cancer history, except curable non-melanoma skin cancer or cervix in-situ carcinoma
previous pelvic irradiation history
receiving surgery (except palliative colostomy), chemotherapy or other anti-cancer treatment
allergy history to thymidine phosphorylase
active infection existed
severe complication, such as acute myocardial infarction in 6 months, uncontrolled diabetes ( Plasma glucose concentrations in any time of a day≥11.1mmol/L）, severe cardiac arrhythmia， etc.
anticipate other clinical trials in four weeks before enrollment","capecitabine 1200mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.

Capecitabine: oral pills, 1200mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation",ChEMBL:CHEMBL1773 | DrugBank:DB01101 | PubChem:42066809 | PubChem:60953,Capecitabine,CCCCCOC(=O)Nc1nc(=O)n([C@@H]2O[C@H](C)[C@@H](O)[C@H]2O)cc1F,L01BC06,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT01584544,NCT01584544_EG002,No,All,Older Adult,Phase 1,6,"Inclusion Criteria:

rectal adenocarcinoma, clinical stage II/III(T3-4 or N+, AJCC 7th).
KPS status no less than 70; Charlson comorbidity no more than 3.
life expectancy more than 6 months.
hemoglobin >= 100g/L, white blood cell >= 3.5*10E9/L, neutrophil >= 1.5*10E9/L, platelet >= 100*10E9/L.Creatin normal, Total bilirubin normal, AST and AST normal, AKP normal.
do not have allergy history to thymidine phosphorylase.
do not receive surgery ( except palliative colostomy) or chemotherapy or other anti-cancer treatment
no previously pelvic irradiation history
informed consent signed

Exclusion Criteria:

other cancer history, except curable non-melanoma skin cancer or cervix in-situ carcinoma
previous pelvic irradiation history
receiving surgery (except palliative colostomy), chemotherapy or other anti-cancer treatment
allergy history to thymidine phosphorylase
active infection existed
severe complication, such as acute myocardial infarction in 6 months, uncontrolled diabetes ( Plasma glucose concentrations in any time of a day≥11.1mmol/L）, severe cardiac arrhythmia， etc.
anticipate other clinical trials in four weeks before enrollment","capecitabine 1300mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.

Capecitabine: oral pills, 1350mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation",ChEMBL:CHEMBL1773 | DrugBank:DB01101 | PubChem:42066809 | PubChem:60953,Capecitabine,CCCCCOC(=O)Nc1nc(=O)n([C@@H]2O[C@H](C)[C@@H](O)[C@H]2O)cc1F,L01BC06,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT01584544,NCT01584544_EG003,No,All,Older Adult,Phase 1,3,"Inclusion Criteria:

rectal adenocarcinoma, clinical stage II/III(T3-4 or N+, AJCC 7th).
KPS status no less than 70; Charlson comorbidity no more than 3.
life expectancy more than 6 months.
hemoglobin >= 100g/L, white blood cell >= 3.5*10E9/L, neutrophil >= 1.5*10E9/L, platelet >= 100*10E9/L.Creatin normal, Total bilirubin normal, AST and AST normal, AKP normal.
do not have allergy history to thymidine phosphorylase.
do not receive surgery ( except palliative colostomy) or chemotherapy or other anti-cancer treatment
no previously pelvic irradiation history
informed consent signed

Exclusion Criteria:

other cancer history, except curable non-melanoma skin cancer or cervix in-situ carcinoma
previous pelvic irradiation history
receiving surgery (except palliative colostomy), chemotherapy or other anti-cancer treatment
allergy history to thymidine phosphorylase
active infection existed
severe complication, such as acute myocardial infarction in 6 months, uncontrolled diabetes ( Plasma glucose concentrations in any time of a day≥11.1mmol/L）, severe cardiac arrhythmia， etc.
anticipate other clinical trials in four weeks before enrollment","capecitabine 1500mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.

Capecitabine: oral pills, 1500mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation",ChEMBL:CHEMBL1773 | DrugBank:DB01101 | PubChem:42066809 | PubChem:60953,Capecitabine,CCCCCOC(=O)Nc1nc(=O)n([C@@H]2O[C@H](C)[C@@H](O)[C@H]2O)cc1F,L01BC06,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT01585038,NCT01585038_EG000,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 4,20,"Inclusion Criteria:

18 years of age or older
Negative ELISA for HIV-1 or HIV-2 at screening
Negative hepatitis B surface antigen at screening
Negative hepatitis C antibody at screening
For women of reproductive potential, a negative urine pregnancy test at screening and willingness to use two forms of birth control during the course of the study
For men who are capable of impregnating a female sexual partner, a willingness to use condoms with spermicidal gel for all sexual contacts during the course of the study
No documented history of or receipt of medications being used to treat any psychiatric disorder, including (but not limited to) depression, dysthymia, mania, bipolar disease, schizophrenia, or previous suicidal ideation/attempts
No anticipated changes or additions to other medical therapies during the course of the study
No documented history of seizure disorder

Exclusion Criteria:

Inability to provide written, informed consent
Known allergy/intolerance to rilpivirine, efavirenz, or nitroglycerin
Absolute neutrophil count < 750cell/mL at screening
Hemoglobin < 11g/dL at screening
Platelet count < 100,000/mL at screening
Estimated creatinine clearance (per Cockcroft-Gault equation) < 55 mL/min at screening
Liver transaminases (AST or ALT) > 100 IU/mL or total bilirubin > 1.5mg/dL at screening
Serum glucose > 200mg/dL at screening
Serum total cholesterol > 190mg/dL at screening
Breastfeeding at screening or during the course of the study
Hypotension, defined as SBP < 90mmHg at time of each main study visit before brachial artery ultrasound measurements
Hypertension, defined as SBP > 160mmHg at time of screening
Receipt of investigational agents within 30 days of each screening visit or anticipated use during the trial
Receipt of cytotoxic chemotherapy within 30 days of each screening visit or anticipated use during the trial
Receipt of systemic glucocorticoids (> 10mg/day of prednisone or the equivalent), inhaled/nasal/topical fluticasone, or anabolic steroids within 30 days of each screening visit or anticipated use during the trial
Use of sildenafil (Viagra or Silagra), vardenafil (Levitra), or tadalafil (Cialis), within 72 hours (before or after) of brachial artery reactivity testing
Indwelling vascular catheters within any upper body vessel at time of brachial artery reactivity testing
Active drug or alcohol use or dependence that, in the opinion of the investigator or study personnel, would interfere with adherence to study requirements
Acute therapy for serious infection or other serious medical illnesses (in the judgment of the site investigator) requiring systemic treatment and/or hospitalization within 14 days prior to each screening and study visit
History of migraine headaches
History of Raynaud's phenomenon
History of cardiac arrythmias
History of hypothyroidism or hyperthyroidism that is untreated (defined as a TSH outside the normal range on most recent testing during normal clinical care)
History of carotid bruits
History of any tobacco use (cigarette smoking, cigar smoking, chewing tobacco) or nicotine replacement treatments (patch, gum) within 45 days of screening
Drugs/therapies with significant CYP 450 induction or inhibition potential at screening
Use of antacids, H2-blockers, or proton pump inhibitors within 30 days of screening or anticipated use of these drugs during the trial
Any history of injection or illicit drug use
Presence of fever, defined as an oral or tympanic temperature > 100.3F, at either the Entry or Closeout Visits
On the PHQ-9 depression questionnaire at screening, a total score of more than 9 or any score over 0 on question 9.","Efavirenz 600mg given nightly without food for 30 days

Efavirenz: 600mg orally every evening",ChEMBL:CHEMBL223228 | DrugBank:DB00625 | PubChem:64139,Efavirenz,O=C1Nc2ccc(Cl)cc2[C@@](C#CC2CC2)(C(F)(F)F)O1,J05AG03 | J05AR06 | J05AR11,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT01585441,NCT01585441_EG000,No,All,Adult | Older Adult,Phase 2,3,"INCLUSION CRITERIA:

Participant must have chronic Central Serous Chorioretinopathy (CSC) in at least one eye as defined by all of the following criteria. This eye will be referred to as the study eye.
The presence of subretinal fluid, as determined by optical coherence tomography (OCT), AND
The subretinal fluid must have been present for at least three months or recurrent in cases of chronic CSC/diffuse retinal pigment epitheliopathy, AND/OR
The presence of characteristic fluorescein angiographic or autofluorescence features of CSC, such as one or more pinpoint leaks and/or diffuse retinal pigment epitheliopathy noted on fluorescein or descending tract lesions on autofluorescence.
Participant must have a steady fixation in the study eye.
Participant must have media clear enough in the foveal or parafoveal area in the study eye for good quality photographs.
Participant must have visual acuity between 20/25 and 20/400 in the study eye.

EXCLUSION CRITERIA:

Participant has evidence of choroidal neovascularization (CNV) in the study eye.
Participant is expected to need ocular surgery in the study eye during the first three months of the study.
Participant has had photodynamic therapy (PDT) or focal laser treatment in the study eye within three months prior to enrollment or is expected to need PDT or focal laser treatment in the study eye during the first three months of the study.","Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.

Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules.",ChEMBL:CHEMBL710 | DrugBank:DB01216 | PubChem:57363,Finasteride,[H][C@@]12CC[C@@]3([H])NC(=O)C=C[C@]3(C)[C@@]1([H])CC[C@]1(C)[C@@H](C(=O)NC(C)(C)C)CC[C@@]21[H],D11AX10 | G04CA51 | G04CA55 | G04CB01 | G04CB51,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01587040,NCT01587040_EG003,No,All,Child | Adult | Older Adult,Phase 1 | Phase 2,4,"Inclusion criteria :

I 01. Males or females enrolled in Phase 1 or Phase 2 studies of SAR245408 or SAR245409 as monotherapy or in combination with other regimens who had completed data collection for the primary endpoint(s) of the parental study or who were being treated beyond the parental study cut-off and meet all the criteria to continue to be treated per the parental protocol.

I 02. All sexually active participants (male and female) must agreed to continue to use accepted methods of barrier contraception (i.e., condoms) during the course of the study and for 3 months after discontinuation of study treatment. For women of childbearing potential and for men who could father a child, a second method of contraception in addition to a barrier method is recommended. Hormonal contraception should be avoided in participants taking SAR245408 due to possible drug-drug interaction.

I 03. Female participants of childbearing potential must had a negative pregnancy test at baseline. Females of childbearing potential were defined as sexually mature women without prior hysterectomy or who had any evidence of menses in the past 12 months. However, women who had been amenorrheic for 12 or more months were still considered to be of childbearing potential if the amenorrhea was possibly due to other causes, including prior chemotherapy, anti-estrogens, or ovarian suppression.

Exclusion criteria:

E 01. The participant discontinued the parental study due to toxicity. E 02. Ongoing Grade 3 or higher Adverse Event (AE). E 03. Ongoing Serious Adverse Event (SAE). E 04. Participants with ongoing dose interruption for any reason unless the participant fulfilled the criteria in the parental protocol for restarting IMP. In such case participant started the treatment-extension study on Day 1 of the initiation period.

E 05. The participant had any of the following laboratory values ≥ Common Terminology of Adverse Events (CTCAE) Grade 3

Absolute neutrophil count (ANC),
Platelet count,
Hemoglobin,
Bilirubin,
Serum creatinine or calculated creatinine clearance,
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST),
Fasting plasma glucose (FPG),
Prothrombin time/international normalized ratio (PT/INR) and activated partial thromboplastin time (aPTT).

E 06. The participant had a baseline corrected QT interval (QTc) >481 millisecond (msec) or if a participant has had a QTc interval increase of ≥ 60 msec from parental protocol baseline to an absolute value of > 470 msec.

E 07. The participant had a known allergy or hypersensitivity to components of the study treatment formulation(s).

E 08. The participant was pregnant or breastfeeding.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.","Participants received SAR245409 50 mg twice daily or at the established dose as combination regimen in the parental study until disease progression, unacceptable toxicity, withdrawal of consent, or until commercial supplies of SAR245409 were available (up to 1917 days). Commercially available drugs were used as combination medications with SAR245409 (depending on the parental study, the following drugs were used in combination with SAR245409: letrozole, temozolomide, rituximab, bendamustine and rituximab).",ChEMBL:CHEMBL3545366 | DrugBank:DB12400 | PubChem:16123056,Voxtalisib,CCn1c(=O)c(-c2ccn[nH]2)cc2c(C)nc(N)nc21,,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01588158,NCT01588158_EG000,No,All,Adult | Older Adult,Phase 4,7,"Inclusion Criteria:

Age 18 years or older.
All subjects will be competent adults able to consent on their own behalf for surgery and care.
Inclusion prior to surgery
Carpal tunnel release

Exclusion Criteria:

Pregnant women. Patients will be queried with the routine preoperative medical history and an inclusion/exclusion checklist.
Patients unable to give informed consent
Non English-speaking subjects
Patients with hypersensitivity to acetaminophen or hydrocodone
Patients with chronic alcohol abuse
Patients with severe impairment of renal or hepatic function. This will be assessed in the routine preoperative medical history and review of the medical record. We will also ask the patients specific for this history in the screening for the study inclusion/exclusion criteria.
Patients with hypothyroidism
Patients with Addison's disease
Patients with prostatic hypertrophy or urethral stricture
Patients using any of the following medications:

MAO or tricyclic antidepressants Antihistaminics Antipsychotic or anti-anxiety medications Phenothiazines Zidovudin Phenobarbital

Patients who are taking opioid pain medication for another reason prior to surgery.","Half of the patients will be randomized to Vicodin

Acetaminophen: 325 mg",ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01588158,NCT01588158_EG001,No,All,Adult | Older Adult,Phase 4,7,"Inclusion Criteria:

Age 18 years or older.
All subjects will be competent adults able to consent on their own behalf for surgery and care.
Inclusion prior to surgery
Carpal tunnel release

Exclusion Criteria:

Pregnant women. Patients will be queried with the routine preoperative medical history and an inclusion/exclusion checklist.
Patients unable to give informed consent
Non English-speaking subjects
Patients with hypersensitivity to acetaminophen or hydrocodone
Patients with chronic alcohol abuse
Patients with severe impairment of renal or hepatic function. This will be assessed in the routine preoperative medical history and review of the medical record. We will also ask the patients specific for this history in the screening for the study inclusion/exclusion criteria.
Patients with hypothyroidism
Patients with Addison's disease
Patients with prostatic hypertrophy or urethral stricture
Patients using any of the following medications:

MAO or tricyclic antidepressants Antihistaminics Antipsychotic or anti-anxiety medications Phenothiazines Zidovudin Phenobarbital

Patients who are taking opioid pain medication for another reason prior to surgery.","Half of the patients will be randomized to Acetaminophen

Vicodin: Vicodin 5/325 mg",ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01588457,NCT01588457_EG001,No,All,Adult | Older Adult,Phase 4,53,"Inclusion Criteria:

DSM-IV TR (Diagnostic and Statistical Manual Edition IV Text Revision) diagnosis BD I or II as assessed by MINI PLUS (Mini International Neuropsychiatric Interview PLUS)
Male or female ≥ 18 years old
Currently symptomatic with a CGI-BP-S ≥3 for mania/hypomania &/or depression for ≥ 2 weeks
One of the following indicators of recent active illness: a depressive or manic or hypomanic or mixed episode in the past 12 months
If female of child bearing age must use effective birth control.

Exclusion Criteria:

Unwilling or unable to comply with study requirements
Renal impairment (serum creatinine > 1.5 mg/dL)
If maintained on thyroid medication must be euthyroid for at least 1 month before Visit 1
Patients who have had intolerable side effects to QTP, Li, Div, or LTG
Patients whose clinical status requires inpatient care
Drug/alcohol dependence within the past 30 days
Pregnancy as determined by serum pregnancy test or breastfeeding
History of poor response to Li at a serum Li of ≥ 0.5 mEq/L (milliequivalents per Liter) or Div at a serum level of ≥ 45 mg/dL for at least 2 weeks.","After a washout period of up to 1 week, subjects will be openly randomized to treatment Lithium for 2 weeks. Subjects who become intolerant to or Lithium at any point will be crossed over to the other mood stabilizer (Divalproex) and continued in the study. Adverse events were not collected for Randomization 2.",ChEMBL:CHEMBL1200826 | DrugBank:DB14509 | PubChem:11125,LITHIUM CARBONATE,O=C([O-])[O-].[Li+].[Li+],,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01590017,NCT01590017_EG000,No,Female,Adult | Older Adult,Phase 2,41,"DISEASE CHARACTERISTICS:

Participants (who have been adequately clinically staged by standard clinical guidelines) with primary, untreated, histologically confirmed, documented invasive squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the uterine cervix, stages IB2, IIA, IIB, IIIA, IIIB, and IVA (Stage IIA tumors must be greater than 4 cm)

HIV-1 infection, documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry and confirmed by a licensed western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen, plasma HIV-1 ribonucleic acid (RNA) viral load

NOTE: the term ""licensed"" refers to a United States (U.S) Food and Drug Administration (FDA)-approved kit or for sites located in countries other than the United States, a kit that has been certified or licensed by an oversight body within that country and validated internally
WHO (World Health Organization) and CDC (Centers for Disease Control and Prevention) guidelines mandate that confirmation of the initial test result must use a test that is different from the one used for the initial assessment; a reactive initial rapid test should be confirmed by either another type of rapid assay or an E/CIA that is based on a different antigen preparation and/or different test principle (e.g., indirect versus competitive), or a western blot or a plasma HIV-1 RNA viral load
No participants with carcinoma of the cervical stump

PATIENT CHARACTERISTICS:

Hemoglobin ≥ 10 g/dL (6.2 mmol/L)
Platelet count ≥ 100,000/mm³ (100 x 10^9/L)
Absolute neutrophil count (ANC) ≥ 1000/mm³ (1.0 x 10^9/L) (participants receiving transfusion, erythropoietin, or myeloid growth factor support will be eligible for this study)
Creatinine clearance ≥ 60 mL/min (1.00 mL/s) calculated by the Cockcroft-Gault equation for women
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 times upper limit of normal (ULN)
Total bilirubin ≤ 2 times ULN unless related to antiretroviral use (e.g., atazanavir and indinavir), then the direct bilirubin must be ≤ 2 times ULN
Ability to understand and the willingness to provide informed consent to participate
Karnofsky performance status of ≥ 60%
Participants of childbearing potential, defined as a sexually mature woman who has not undergone a hysterectomy or bilateral oophorectomy or has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months), must have a negative urine or serum pregnancy test within 3 weeks prior to enrollment and agree to use an effective form of contraception (e.g., barrier contraception, highly effective hormonal contraception)
Life expectancy of greater than 12 months
No acute active (such as tuberculosis or malaria), serious, uncontrolled infection; participants with a CD4 count < 50/mm³ (0.05 x 10^9/L) will be excluded if they have had an opportunistic infection within the past 3 months, or if there is evidence of resistance to antiretroviral therapy (i.e., HIV viral load ≥ 400 copies/mL despite combination antiretroviral therapy for at least 4 months)
No prior invasive malignancy other than LACC diagnosed within the past 24 months, excluding anal intraepithelial neoplasia, non-melanoma skin carcinoma, or Kaposi sarcoma that has not required systemic chemotherapy within the past 24 months
No pregnancy or breast-feeding
No medical or psychiatric illness that precludes ability to give informed consent or is likely to interfere with the ability to comply with the protocol stipulations
No participants with circumstances that will not permit completion of the study or required follow-up; for instance, if travel to and from treatment site is an issue

No participants with cardiovascular disease manifested as:

History of myocardial infarction
Unstable angina
Currently taking medication for treatment of angina
History of coronary artery bypass surgery
New York Heart Association class 3 or 4 heart failure

PRIOR CONCURRENT THERAPY:

See Patient Characteristics

All patients must be prescribed combination antiretroviral therapy with the goal of virological suppression using an acceptable regimen that adheres to national guidelines for treatment of HIV infection

Non-suppressed, treatment-experienced patients, defined as patients with a viral load > 400 copies/mL who have been on antiretroviral therapy for more than 4 months, can be enrolled if a genotype assay is performed and an acceptable regimen is prescribed based on the genotyping results
Patients who undergo emergency radiation therapy prior to enrollment may participate at the investigator's discretion
No participants who have undergone hysterectomy
No concurrent intensity-modulated radiotherapy or interstitial brachytherapy","Cisplatin 40 mg/m2 (max = 70 mg) IV over 30-60 minutes given weekly on days 1, 8, 15, 22, 29 and 36 for a total of 6 weekly cycles. Radiation therapy over 8 weeks: External pelvic radiation therapy (41.4-45.0 Gy/1.8 Gy per fraction/23-25 fractions/five weeks), intracavitary brachytherapy (low dose: 35-43.6 Gy/1-2 implants; high dose: 18-28 Gy/2-4 implants), with parametrial boost to involved parametria (5.40 - 9.00 Gy/1.8 Gy/3-5 fractions/3-5 days).

cisplatin

external beam radiation therapy",DrugBank:DB00515 | PubChem:5460033 | PubChem:5702198,Cisplatin,Cl[Pt]Cl.N.N,L01XA01,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,1.0,1.0,1.0,0.0,0.0,0.0,1.0,1.0,1.0,1.0,0.0,0.0,1.0,0.0
NCT01593254,NCT01593254_EG001,No,All,Adult | Older Adult,Phase 2,171,"Inclusion Criteria:

Chronic Phase (CP)-CML Ph+ patients with complete hematologic response (CHR) but without one log BCR-ABL reduction (BCR-ABL level >10% IS) 3 months of imatinib 400mg treatment. (Imatinib transient dose adjustments due to Adverse Event (AEs) are allowed with a maximum of 2 weeks interruption of treatment with imatinib (cumulative) within the 3 month period before randomization). Imatinib monotherapy must have been started within 6 months of CP-CML diagnosis (Ph + /BCR-ABL detection)
Currently tolerating imatinib 400mg QD. Patients with prior imatinib treatment interruption or dose reductions are required to be on treatment with 400 mg imatinib for two weeks immediately prior to randomization to ensure tolerance to imatinib
Eastern Co-Operative Group (ECOG) performance status = 0 - 2
Adequate renal function defined as serum creatinine ≤3 times the institutional upper limit of normal (ULN)
Adequate hepatic function defined as: total bilirubin ≤2.0 times the institutional ULN; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 times the institutional ULN

Exclusion Criteria:

Previous diagnosis of accelerated phase or blast crisis
Subjects with clonal evolution in Ph+ cells observed in ≥2 metaphases at baseline bone marrow cytogenetic test, unless the same abnormalities were present at diagnosis. Patients with no evidence of clonal evolution, including those patients whose cytogenetic testing fails or bone marrow aspiration is a dry tap at 3 months, are eligible for the study
Subjects with less than CHR after 3 months of imatinib treatment or lost CHR after initial achievement
Documented T315I/A, F317L, or V299L mutations (if already available - not required for screening)
A serious uncontrolled medical disorder or active infection that would impair the ability of the subject to receive protocol therapy",Dasatinib 100 mg tablet by mouth QD up to 60 months,ChEMBL:CHEMBL1421 | DrugBank:DB01254 | PubChem:3062316,Dasatinib,Cc1nc(Nc2ncc(C(=O)Nc3c(C)cccc3Cl)s2)cc(N2CCN(CCO)CC2)n1,L01EA02 | L01XE06,1.0,1.0,0.0,0.0,0.0,1.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,1.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0
NCT01595386,NCT01595386_EG001,No,All,Child,Not Applicable,19,"Inclusion Criteria:

Neonate (< 28 days old) undergoing correct cardiac surgery, or infants undergoing the following surgery procedures: Norwood, Arterial Switch, Total Anomalous Pulmonary Venous Return Repair, Interrupted Aortic Arch Repair, Truncus Arteriosus Repair
Successfully weaned off cardiopulmonary bypass after cardiac surgery

Exclusion Criteria:

requirement for extracorporeal membrane oxygenation (ECMO) in the operating room
Known immune deficiency
Having previously received systemic steroids (except for two routine preoperative doses)
A current signed Do not resuscitate (DNR) or limitation of care order
Current enrollment in another interventional clinical study
Refusal of parental consent
Previous diagnosis of adrenal insufficiency
> 28 days old at time of surgery whose repair dose not require CPB","Subjects enrolled in this arm of the study will receive a 50mg/m2 bolus of Hydrocortisone after successful completion of CPB and the post-pump ACTH stim test has been performed. This will be followed by a continuous infusion of Hydrocortisone that will be tapered over the next 120 hours.

Hydrocortisone: The drug will be bolused at 50mg/m2 followed by a continuous infusion that will start at 50mg/m2 for the first 48 hours and then be tapered as follows: 40mg/m2/day over 24 hours, 30mg/m2/day over 12 hours, 20 mg/m2/day over 12 hours, 10mg/m2/day over 24 hours, then off.",ChEMBL:CHEMBL389621 | DrugBank:DB00741 | PubChem:5754,Hydrocortisone,[H][C@@]12CC[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)CC[C@@]21C,A01AC03 | A07EA02 | C05AA01 | D07AA02 | D07BA04 | D07CA01 | D07XA01 | H02AB09 | R01AD60 | S01BA02 | S01BB01 | S01CA03 | S01CB03 | S02BA01 | S02CA03 | S03CA04,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01598298,NCT01598298_EG001,No,Female,Child | Adult | Older Adult,Phase 3,138,"DISEASE CHARACTERISTICS:

Patients must be women with histologically confirmed estrogen receptor (ER)- and/or progesterone receptor (PgR)-positive invasive carcinoma of the breast with no evidence of metastatic disease (M0)
Patients must have completed mastectomy or breast-sparing surgery and must have recovered from all side effects of the surgery
Patients must have aromatase inhibitor (AI)-associated musculoskeletal symptoms that began or increased after starting AI therapy; new musculoskeletal pain must not be due specifically to fracture or traumatic injury
Patients must have completed the S1202 Brief Pain Inventory-Short Form (BPI-SF) within 7 days prior to registration; patients must have an ""average pain"" of at least 4 on the BPI-SF

PATIENT CHARACTERISTICS:

Patients must be post-menopausal, as defined by at least one of the following:

At least 12 months since the last menstrual period
Prior bilateral oophorectomy
Previous hysterectomy with one or both ovaries left in place (or previous hysterectomy in which documentation of bilateral oophorectomy is unavailable) AND follicle-stimulating hormone (FSH) values consistent with the institutional normal values for the post menopausal state; if patient is under the age of 55, FSH levels must be obtained within 28 days prior to registration OR
Have been on LHRH agonist therapy for at least 3 months and estradiol levels drawn within 28 days prior to registration are consistent with the institutional normal values for post-menopausal state.
Patients must have Zubrod performance status of 0-2
Patients must have no known allergy or hypersensitivity to duloxetine or any of the inactive ingredients in the matching placebo

Patients must not have any contraindicated concurrent illnesses listed on the duloxetine package insert including:

Current primary psychiatric diagnosis (schizophrenia, psychosis) or suicidal ideation, history of bipolar disorder, or seizure disorder
History of alcohol or other substance abuse or dependence within 365 days prior to registration
Chronic liver disease
End-stage renal disease
Uncontrolled narrow-angle glaucoma
Clinically significant coagulation disorder
Creatinine clearance > 30 mL/min
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) both within 3 x upper limit of normal
Total bilirubin within the upper limit of normal
Patients must be able to complete study questionnaires in English or Spanish
Patients must not have concurrent medical/arthritic disease that could confound or interfere with evaluation of pain or efficacy including: inflammatory arthritis (rheumatoid arthritis, systemic lupus, spondyloarthropathy, psoriatic arthritis, polymyalgia rheumatica), or cancer involving the bone
Patients must be willing to submit blood samples for correlative studies; baseline samples must be obtained prior to beginning protocol treatment

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
If patients were treated with chemotherapy and/or radiation therapy, these treatments must be completed at least 28 days prior to study registration
Concurrent bisphosphonate and trastuzumab therapies are allowed
Patients should have recovered from all Grade 2 or higher side effects of chemotherapy and/or radiation therapy with the exception of alopecia and peripheral neuropathy

Patients must currently be taking one of the following aromatase inhibitor (AI) doses for at least 21 days, but no longer than 12 months, prior to registration and plans to continue for at least an additional 180 days after registration

Anastrozole (Arimidex®) 1 mg daily
Letrozole (Femara®) 2.5 mg daily
Exemestane (Aromasin®) 25 mg daily
Patients must not be taking any contraindicated medications listed on the duloxetine package insert including the following: treatment with phenothiazines, propafenone, flecainide, or linezolid; treatment with monoamine oxidase (MAO)-inhibitor within 14 days prior to registration; or current use of anticoagulation medication (e.g., heparin, warfarin)
Patients must not require selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephirine reuptake inhibitors (SNRIs), or tricyclic antidepressants during study participation; patients must have been able to taper and discontinue treatment with these medications at least 7 days prior to registration; patients must not have taken duloxetine or milnacipran within 90 days prior to registration
Patients who are receiving treatment with narcotics, tramadol, gabapentin, and/or pregabalin must have been taking a stable dose for at least 30 days prior to registration","Patients receive duloxetine hydrochloride orally (PO) once daily (QD) on days 1-7, twice daily (BID) on days 8-84, and then QD on days 85-91. duloxetine hydrochloride: Given PO",PubChem:60834,Duloxetine Hydrochloride,CNCCC(Oc1cccc2ccccc12)c1cccs1.Cl,,0.0,0.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0
NCT01598701,NCT01598701_EG000,No,All,Adult | Older Adult,Phase 4,50,"Inclusion Criteria:

Adults
Undergoing Craniotomy for Supratentorial Tumor Resection
Weight between 50 and 120 kilograms
ASA Physical Status I-III
Be able to communicate verbally
Be able to use Visual Analog Score

Exclusion Criteria:

Allergies to acetaminophen, morphine or any of the anesthetic agents required by the protocol.
Use of opioids, tramadol, benzodiazepines, or gabapentin on a daily basis for > 7 days prior to the day of surgery.
Use of acetaminophen, NSAIDs, or any other analgesic medication in the 12 hours immediately prior to study enrollment.
Hepatic insufficiency (elevated transaminases > 1.5 times the upper limit of normal) or renal insufficiency (plasma creatinine > 2mg/dl).
Known or suspected history of alcohol or illicit drug abuse.
Pregnant or breast-feeding.
Surgical plan for infratentorial (suboccipital) craniotomy.
Plan for neurophysiologic monitoring that precludes the use of neuromuscular blockade.
Inability to communicate due to a language barrier, impaired consciousness, cognitive defect or intellectual disability.
Uncontrolled Hypertension","Patients will be receive doses of 1000 mg/100 mL of IV Acetaminophen (OFIRMEV). The drug will be infused over 15 minutes.

Acetaminophen: Intravenous Acetaminophen, 1000 mg/100mL, Every 6 hours, Infused over 15 minutes.",ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01604278,NCT01604278_EG000,No,All,Adult | Older Adult,Phase 3,226,"Inclusion Criteria:

Patients with moderate to severe stable Chronic Obstructive Lung Disease (COPD) Stage II or Stage III according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines.
Patients with a post-bronchodilator forced expiratory volume in 1 second (FEV1) ≥ 30 % and/or <80 % of the predicted normal, and a post-bronchodilator FEV1/Forced Vital Capacity (FVC) < 0.70 at screening.
Current or ex-smokers who have a smoking history of at least 10 pack years
Symptomatic patients according to daily diary data.

Exclusion Criteria:

Pregnant or nursing (lactating) women.
Women of child-bearing potential unless using adequate contraception.
Patients with Type I or uncontrolled Type II diabetes.
Patients with a history of long time interval between start of Q wave and end of T wave in the heart's electrical cycle (QT) syndrome or whose QT corrected for heart rate (QTc) measured at screening (Visit 2) (Fridericia's method) is prolonged
Patients with paroxysmal (e.g. intermittent) atrial fibrillation
Patients who have a clinically significant electrocardiogram (ECG) or laboratory abnormality at screening (Visit 2)

Other protocol-defined inclusion/exclusion criteria may apply.",Participants received Indacaterol 150 ug once daily delivered via single dose dry powder inhaler (SDDPI) plus NVA237 50 ug once daily delivered via SDDPI,ChEMBL:CHEMBL1201335 | DrugBank:DB00986 | PubChem:3494,GLYCOPYRRONIUM,C[N+]1(C)CCC(OC(=O)C(O)(c2ccccc2)C2CCCC2)C1,A03AB02 | A03CA05 | D11AA01 | R03AL04 | R03AL07 | R03AL09 | R03AL11 | R03AL12 | R03BB06,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT01605903,NCT01605903_EG001,No,All,Child | Adult,Phase 2,741,"Inclusion Criteria:

Patients ages 2-18 undergoing tonsillectomy with or without adenoidectomy by electrocautery alone for sleep disordered breathing or infectious tonsillitis will be included.
Patients with complex medical conditions and craniofacial abnormalities will be included.
Informed consent and child assent will be required for enrollment

Exclusion Criteria:

Patients with a known personal or family history of a bleeding disorder will be excluded.
Patients with a history of asthma, kidney or liver problems will also be excluded.
Patients with tonsillectomy or adenoidectomy performed using a cold knife technique, microdebrider, coblation or plasma knife.
Patients on NSAIDs for other medical conditions, or those who have taken NSAIDs within 1 week of surgery will be excluded.
Patients with allergy to aspirin or other NSAIDs, acetaminophen, Red Dye #40 or Red Dye #33 will also be excluded.
Pregnancy testing using urine β-subunit of hCG gonadotropin (beta-HCG) will be performed on all children > 13 years of age, or those younger than 13 who are menstruating; this is the testing protocol used at the Children's Hospital of Boston. Patients found to be pregnant will be excluded from participation.","Children will be randomly assigned to receive either ibuprofen or acetaminophen prior to surgery.

Acetaminophen: During the postoperative period, ibuprofen 10mg/kg (max dose 600 mg) will be dispensed Q6.",ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01606319,NCT01606319_EG000,No,All,Child,Phase 3,150,"Inclusion Criteria:

12-59 months of age.

If the child is not currently taking long-term asthma controller therapy (meaning that the child has taken no inhaled corticosteroid or leukotriene receptor antagonist medication whatsoever over the past 6 months), then one of the following criteria must be met:

Daytime asthma symptoms more than two days per week (average over the past 4 weeks),
At least one nighttime awakening from asthma (over the past 4 weeks),
Two or more asthma exacerbations requiring systemic corticosteroids in the previous 6 months,
Four or more wheezing episodes in the previous 12 months.

If the child is currently taking long-term asthma controller therapy (meaning that the child has taken daily or intermittent/as-needed inhaled corticosteroid or leukotriene receptor antagonist over the past 6 months), then one of the following criteria must be met:

Taking inhaled corticosteroid or leukotriene receptor antagonist for more than 3 months (or more than 90 days) out of the previous 6 months (or 180 days),
Daytime asthma symptoms more than two days per week (average over the past 4 weeks),
More than one nighttime awakening from asthma (over the past 4 weeks),
Two or more asthma exacerbations requiring systemic corticosteroids in the previous 12 months,
Four or more wheezing episodes in the previous 12 months.
Up to date with immunizations, including varicella (unless the subject has already had clinical varicella).
Willingness to provide informed consent by the child's parent or guardian.

Exclusion Criteria:

Allergic reaction to the study medications or any component of the study drugs, including (but not limited to) urticaria, rash, angioedema, or hypotension following delivery,
Chronic medical disorders that could interfere with drug metabolism/excretion (for instance chronic hepatic, biliary, or renal disease),

Chronic medical disorders that may increase the risk of drug-related injury, including (but not limited to):

Osteogenesis imperfecta (increased risk of bone demineralization/fracture with corticosteroid therapy),
Crohn's disease, ulcerative colitis, juvenile rheumatoid arthritis, clotting disorders, or Factor deficiency (increased risk of bleeding with corticosteroid therapy),
G6PD deficiency (increased risk of hemolytic anemia with acetaminophen use),
Phenylketonuria (potential for aspartame exposure with study interventions),
Seizure disorder treated with anticonvulsants (risk of acetaminophen toxicity with carbamazepine), or
History of clotting disorders or Factor deficiency (increased risk of bleeding with corticosteroids),
Co-morbid disorders associated with wheezing including (but not limited to) immune deficiency disorders, cystic fibrosis, aspiration, clinically-relevant gastroesophageal reflux, tracheomalacia, congenital airway anomalies (clefts, fistulas, slings, rings), bronchiectasis, bronchopulmonary dysplasia, and/or history of premature birth before 35 weeks gestation,
Significant developmental delay/failure to thrive, defined as 5th percentile for height and/or weight or crossing of two major percentile lines during the last year for age and sex,
History of a near-fatal asthma exacerbation requiring intubation or assisted ventilation,
No primary medical caregiver (e.g., a nurse practitioner, physician assistant, physician, or group medical practice such as a hospital-based clinic) whom the subject can contact for primary medical care,
Three or more hospitalizations in the previous 12 months for wheezing or respiratory illnesses,
Treatment with 5 or more courses of systemic corticosteroids (oral, intramuscular or intravenous) in the past 6 months,
Current use of higher than step 2 NAEPP asthma guideline therapy
If receiving allergy shots, change in the dose within the past 3 months.","acetaminophen given as needed for pain or fever

Acetaminophen: 15 mg/kg every 6 hours as needed",ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT01606787,NCT01606787_EG000,No,All,Adult | Older Adult,Phase 3,101,"Inclusion Criteria:

Age > or = to 18 years
Scheduled for partial nephrectomy at MSKCC (open or minimally invasive technique) during which renal ischemia is anticipated
Preoperative eGFR > 45 cc/min/1.73m2 as measured by the CKD-EPI study equation

Exclusion Criteria:

Allergy to mannitol
Severe renal impairment (stage 3B) defined as eGFR < 45 cc/min/1.73m2 as measured by the CKD-EPI calculation.
Combined major surgical cases that include a partial nephrectomy.","This study is a prospective randomized double blind placebo controlled trial comparing renal function outcomes in patients undergoing partial nephrectomy for renal tumors. Patients will be randomized in 1:1 fashion to receive mannitol or saline provided intravenously within 30 minutes prior to renal vascular clamping for performing partial nephrectomy.

mannitol: After induction of general anesthesia Normosol or Lactated Ringers , at a target infusion rate of 10cc/kg (+/- 1cc/kg), will be administered over the first hour of surgery. After the first hour of surgery IV fluid will be administered at 6cc/kg (+/- 1cc/kg) intended to maintain a minimum systolic blood pressure of 90-100mmHg and a minimum urine output of 0.5cc/kg/hour. The treatment arm will receive a standard dose of 12.5 grams of mannitol (200 cc of a 6.25% mannitol solution) intravenously completely infused through an existing intravenous access catheter within 30 minutes prior to renal artery clamping.",ChEMBL:CHEMBL1682 | ChEMBL:CHEMBL689 | DrugBank:DB00742 | DrugBank:DB01638 | PubChem:5780 | PubChem:6251 | PubChem:90540,Mannitol,OCC(O)C(O)C(O)C(O)CO,A06AD16 | A06AD18 | A06AG07 | B05BC01 | B05CX02 | B05CX04 | R05CB16 | V04CC01 | V04CX04,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01608308,NCT01608308_EG000,No,All,Adult | Older Adult,Not Applicable,31,"Inclusion criteria:

Patients undergoing surgical management for CRS (with or without polyps)
Operating time must be at least 2 hours in duration.
Number of sinuses involved must be 3 or greater

Exclusion criteria:

History of hypersensitivity to acetaminophen
End stage renal disease
End stage liver disease
History of chronic pain, or use of opioid medication in the previous two weeks
Severe depression or anxiety
Use of gabapentin or any other pain modulator
History of acute sinusitis or mucocele
History of seizures
Known or suspected history of alcohol or drug abuse
Known or suspected history of morphine intolerance","The experimental group will receive a preoperative dose of 1000mg IV acetaminophen over 15 minutes. This will occur at least 15 minutes before the start of surgery. Another 1000mg dose of IV acetaminophen will be administered 4 hours after the first dose. A rescue analgesic containing oxycodone will also be provided (with APAP concentrations of 325 mg per Hospital and FDA recommendations).

IV Acetaminophen: 1000mg IV acetaminophen over 15 minutes every 4 hours for up to 2 doses.",ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0
NCT01612858,NCT01612858_EG000,No,All,Adult | Older Adult,Phase 4,16,"Inclusion Criteria:

Age 18-70 years
Fasting insulin >12 μU/mL and/or serum glucose between 140-200 mg/dl after 75 g 2hr oral glucose tolerance test
Central fat deposition or Peripheral fat atrophy
Fasting glucose ≤126 mg/dL
BMI ≥18 and ≤35 kg/m2
CD4 cell count ≥100 cells/mm3
Stable antiretroviral regimen ≥12 weeks and HIV RNA <1000 copies

Exclusion Criteria:

Diabetes mellitus
Cardiac pacemaker or metal implant
Liver enzymes >2.5x upper normal limit
Alkaline phosphatase or prothrombin time >2x upper normal limit
Serum creatinine >1.4 mg/dL
History of congestive heart failure
Hemoglobin <8 g/dL
Alcohol abuse
Pregnancy
History of lactic acidosis
Use of steroids
Acute infection within last one month
History of bladder cancer","Metformin: Metformin at a dose of one 500mg tablet twice a day with meals for one week, after which the dose will increase to 500 mg three times a day with meals for the remaining 11 weeks of the study.",ChEMBL:CHEMBL1431 | DrugBank:DB00331 | PubChem:4091,Metformin,CN(C)C(=N)NC(=N)N,A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01614457,NCT01614457_EG000,No,All,Child | Adult | Older Adult,Phase 3,34,"Inclusion Criteria:

Male or female with confirmed diagnosis of CF
Must have at least 1 allele of the R117H CFTR mutation
Percent predicted forced expiratory volume in 1 second (FEV1) 40 percent (%) to 90% (for subjects aged 12 years or older) or 40% to 105% (for subjects aged 6 to 11 years) predicted normal for age, sex, and height
6 years of age or older
Minimum weight of 15 kilogram (kg) at screening
Females of childbearing potential must not be pregnant
Willing to comply with contraception requirements

Exclusion Criteria:

CFTR gene mutation leading to CFTR channel with gating defect (that is, any 1 of the following mutations: G551D, G178R, G551S, S549N, S549R, G970R, G1244E, S1251N, S1255P, or G1349D)
History of any illness or condition that might confound the results of the study or pose an additional risk in administering ivacaftor to the subject
An acute upper or lower respiratory infection, pulmonary exacerbation, or changes in therapy (including antibiotics) for pulmonary disease within 4 weeks before the first dose of study drug
Abnormal liver function, at screening, defined as greater than or equal to (>=) 3 time upper limit of normal (ULN), of any 3 or more of the following: serum aspartate transaminase (AST), serum alanine transaminase (ALT), gamma-glutamyl transpeptidase (GGT), serum alkaline phosphatase (ALP), total bilirubin
Colonization with organisms associated with a more rapid decline in pulmonary status (for example, Burkholderia cenocepacia, Burkholderia dolosa, and Mycobacterium abscessus) at screening
History of solid organ or hematological transplantation
History of alcohol, medication or illicit drug abuse within 1 year before the first dose of study drug
Ongoing participation in another therapeutic clinical study or prior participation in an investigational drug study within 30 days before screening
Any ""non-CF-related"" illness within 2 weeks before Day 1 (first dose of study drug). ""Illness"" was defined as an acute (serious or non-serious) condition (for example, gastroenteritis)
Use of any inhibitors or inducers of cytochrome (CYP) P450 3A",Ivacaftor 150 milligram (mg) tablet orally twice daily for 24 weeks.,ChEMBL:CHEMBL2010601 | DrugBank:DB08820 | DrugBank:DB15141 | PubChem:16220172 | PubChem:71470491,Ivacaftor,CC(C)(C)c1cc(C(C)(C)C)c(NC(=O)c2c[nH]c3ccccc3c2=O)cc1O,R07AX02 | R07AX30 | R07AX31 | R07AX32,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT01614470,NCT01614470_EG002,No,All,Child | Adult | Older Adult,Phase 3,36,"Inclusion Criteria:

Male or female with confirmed diagnosis of CF
At least 1 allele of the following CFTR gating mutations: G178R, S549N, S549R, G551S, G970R, G1244E, S1251N, S1255P, G1349D
Percent predicted forced expiratory volume in 1 second (FEV1) greater than or equal to (>=) 40 percent (%) predicted normal for age, sex, and height
6 years of age or older
Minimum weight of 15 kilogram (kg) at screening
Females of childbearing potential must not be pregnant
Willing to comply with contraception requirements

Exclusion Criteria:

G551D-CFTR mutation on at least 1 allele
History of any illness or condition that might confound the results of the study or pose an additional risk in administering ivacaftor to the subject
An acute upper or lower respiratory infection, pulmonary exacerbation, or changes in therapy (including antibiotics) for pulmonary disease within 4 weeks before the first dose of study drug
History of solid organ or hematological transplantation
History of alcohol, medication or illicit drug abuse within 1 year before the first dose of study drug
Ongoing participation in another therapeutic clinical study or prior participation in an investigational drug study within 30 days before screening
Use of inhaled hypertonic saline treatment
Use of any inhibitors or inducers of cytochrome (CYP) P450 3A
Evidence of cataract or lens opacity at screening",Ivacaftor 150 mg tablet orally twice daily for 16 weeks.,ChEMBL:CHEMBL2010601 | DrugBank:DB08820 | DrugBank:DB15141 | PubChem:16220172 | PubChem:71470491,Ivacaftor,CC(C)(C)c1cc(C(C)(C)C)c(NC(=O)c2c[nH]c3ccccc3c2=O)cc1O,R07AX02 | R07AX30 | R07AX31 | R07AX32,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT01616758,NCT01616758_EG000,No,Female,Adult | Older Adult,Phase 2,22,"Inclusion Criteria:

Give voluntary, signed informed consent in accordance with institutional policies.
Be a woman that has been diagnosed with ER positive metastatic breast cancer.
Have metastatic breast cancer with measurable lesions prior to enrollment or bone only disease prior to enrollment. A measurable lesion is defined as one lesion whose longest diameter (LD) can be accurately measured as 10 mm CT or MRI technique by using a 5 mm contiguous reconstruction algorithm. Measurable lesions must be at least 2 times the slice thickness or at least two times the size of the CT scan interval cut. Patients with bone only disease and non-measurable lesions are eligible.
Be clinically confirmed as postmenopausal. Subjects must have undergone the onset of spontaneous, medical or surgical menopause prior to the start of this study.(Spontaneous menopause is defined as the natural cessation of ovarian function as indicated by being amenorrheic for at least 12 months. If the subject has been amenorrheic for > or equal to 6 months but < 12 months, they must have a serum FSH concentration of > or equal to 50 mIU/mL and an estradiol concentration of less than or equal to 25 pg/mL. Medical menopause is defined as treatment with a luteinizing hormone receptor hormone agonist and surgical menopause is defined as bilateral oophorectomy).
Have been treated and responded to previous adjuvant hormonal therapy for 3 years or previous hormonal therapy for metastatic disease for 6 months prior to disease progression.
Have not had radiation therapy for breast cancer within 2 weeks of randomization in this study and are not planned to have radiation therapy during participation in this study.
Be willing to provide a formalin-fixed, paraffin-embedded block(s) of cancerous tissue from a biopsy of a metastatic tumor lesion(s) collected during the two (2) years prior to study entry or as a component of enrollment in the study for determination of AR and ER status. Tissue samples from a biopsy of a primary tumor lesion will also be provided if available.
Serum creatinine 2.0 mg/dL
Have ECOG score 2.
Be age 18 years.

Exclusion Criteria:

Have triple negative breast cancer
Have, in the judgment of the Investigator, a clinically significant concurrent illness or psychological, familial, sociological, geographical or other concomitant condition that would not permit adequate follow-up and compliance with the study protocol
Have uncontrolled hypertension (systolic blood pressure greater than 150 mm Hg and/or diastolic blood pressure greater than 100 mm Hg despite treatment with antihypertensive drugs)
Untreated congestive heart failure or untreated angina
Have Stage 4 chronic obstructive pulmonary disease (COPD)
Have positive screen for Hepatitis B consisting of HBsAg (Hepatitis B Surface Antigen), unless subject was diagnosed > 10 years prior to enrollment and no evidence of active liver disease
The presence of consistently abnormal clinical laboratory test (Appendix B) values which are considered clinically significant. In addition, any subject with total bilirubin above 2 times the upper limit of normal (ULN) or liver enzymes ( ALT/SGOT or AST/SGPT) above 1.5 times the ULN without evidence of liver metastases or above 5 times the ULN in subjects with evidence of liver metastases will not be admitted to the study
Have positive screen for hepatitis A antibody IgM or HIV
Have received chemotherapy for metastatic breast cancer within the 3 months prior to enrollment in the study or be expected to receive chemotherapy for metastatic breast cancer during the study
Be currently taking testosterone, methyltestosterone, oxandrolone (Oxandrin®),oxymetholone, danazol, fluoxymesterone (Halotestin®), testosterone-like agents (such as dehydroepiandrosterone (DHEA), androstenedione, and other androgenic compounds, including herbals), or antiandrogens. Previous therapy with testosterone and testosterone-like agents is acceptable with a 30-day washout (if previous testosterone therapy was long term depot within the past 6 months, the site should contact the medical monitor (1-877-693-2723) for this study to determine appropriate washout period).
Have untreated or uncontrolled brain metastasis
Have been diagnosed with or treated for cancer within the previous two years, other than breast cancer or non-melanoma carcinoma of the skin.","GTx-024 dosage of three soft gels once daily to equal 9mg

GTx-024 9mg",ChEMBL:CHEMBL1738889 | DrugBank:DB12078 | PubChem:11326715,Enobosarm,C[C@](O)(COc1ccc(C#N)cc1)C(=O)Nc1ccc(C#N)c(C(F)(F)F)c1,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT01620047,NCT01620047_EG000,No,All,Adult | Older Adult,Not Applicable,20,"Inclusion Criteria:

Patients undergoing unilateral primary total knee replacement
ASA class I-III
18 years and older

Exclusion Criteria:

Patient refusal
Pregnancy
Coagulopathy
Adverse/allergic reaction to any opioids or local anesthetics
History of long-term opioid use (greater than 60 days)
Infection
Traumatic lower extremity injury",Fentanyl 3 µg/ml delivered continuously through a femoral nerve sheath catheter for 24 hours post-total knee replacement. All study drugs were continuously infused for a 24 hour period at a basal rate of 10ml/hour starting from the time the patient entered the post anesthesia care unit (PACU).,ChEMBL:CHEMBL596 | DrugBank:DB00813 | PubChem:3345,Fentanyl,CCC(=O)N(c1ccccc1)C1CCN(CCc2ccccc2)CC1,N01AH01 | N01AH51 | N02AB03,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01620047,NCT01620047_EG002,No,All,Adult | Older Adult,Not Applicable,20,"Inclusion Criteria:

Patients undergoing unilateral primary total knee replacement
ASA class I-III
18 years and older

Exclusion Criteria:

Patient refusal
Pregnancy
Coagulopathy
Adverse/allergic reaction to any opioids or local anesthetics
History of long-term opioid use (greater than 60 days)
Infection
Traumatic lower extremity injury",Control group which received 0.9% normal saline delivered through a femoral nerve sheath catheter in addition to a continuous intravenous infusion of fentanyl 3 µg/ml via a PCA pump. All study drugs were continuously infused for a 24 hour period at a basal rate of 10ml/hour starting from the time the patient entered the post anesthesia care unit (PACU).,ChEMBL:CHEMBL596 | DrugBank:DB00813 | PubChem:3345,Fentanyl,CCC(=O)N(c1ccccc1)C1CCN(CCc2ccccc2)CC1,N01AH01 | N01AH51 | N02AB03,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01620593,NCT01620593_EG001,No,Male,Adult | Older Adult,Phase 2,19,"Inclusion Criteria:

(Eligible subjects must meet one of the inclusion criteria 1-3 and all of items 4-6)

Men with metastatic prostate cancer that require castration therapy with either using an LHRH analogue or surgical castration are eligible. Complete androgen blockade using anti-androgen therapy prior to castration or up to 4 weeks following castration therapy is permitted to prevent disease flare. Thereafter anti-androgen therapy may continue or be discontinued based on treating physicians preference.

OR

Any men with prostate cancer who are candidates for castration therapy despite no evidence of definite metastatic disease including patient with biochemical failure or 'rising PSA' are also permitted to enter study provided castration therapy is planned for a minimum of a year. Patients with biochemical failure prior to enrolment should have also have already received appropriate salvage therapy. Men with prostate cancer who have already started castration therapy are also permitted to enter study provided castration therapy was initiated within one month of study entry.

OR

Men with prostate cancer previously treated with castration therapy for management of localized prostate cancer in the adjuvant setting or in combination with radiation therapy are permitted to enter study provided they currently have known metastatic disease and have non-castrate testosterone levels (Testosterone > 50 ng/dL).
An ECOG performance status of 0-2.
Patients will need to have documentation of metastatic disease in bone and/or soft tissue, and a baseline PSA of ≥ 5 ng/ml. If patients have already had castration therapy, their baseline PSA value will be reflective of the value prior to castration. Patients with biochemical failures, with rising PSA (baseline PSA does not need to be ≥ 5 nglml to be eligible), without metastatic disease are also eligible if castration therapy is indicated for minimum of 7 months and for these patients any PSA value is permitted.
Patients must have provided informed consent, be willing to have blood specimens taken, and exhibit no severe other medical or psychiatric problems.

Exclusion Criteria:

Patients with severe medical or psychiatric diseases are INELIGIBLE. (Patients with stable chronic diseases such as high cholesterol or hypertension ARE eligible.) Examples of problems that would make patients INELIGIBLE include severe heart failure, or hypoxia due to severe lung disease.
Patients with clinical or biochemical evidence of renal failure or liver failure are INELIGIBLE. Creatinine and bilirubin needs to be less than or equal to 1.3~up per limit of normal (ULN), and ASTIALT less than or equal to 2.5 x ULN unless liver metastasis is present then up to 5 X ULN permitted).
Patients already receiving metformin or anti-diabetic medications are INELIGIBLE.
If any patient develops symptomatic diabetes requiring drug therapy, he must receive such a therapy, which may include metformin. This must be documented, and the patient will not continue on the study.
Patients with important infections requiring antibiotics are INELIGIBLE, but patients who acquire minor infections while on the study may remain on the study.
Alcohol abuse problems make patients INELIGIBLE. Patients need to be consuming less than or equal to 14 units of alcohol weekly.
Patients with history or evidence of lactic acidosis or metabolic acidosis will be excluded.","Metabolic consequences including development of hyperinsulinemia and insulin resistance using metformin compared to placebo in men on castration therapy. In the rare case where a patient may not tolerate 500 mg three times a day, he may remain on the study taking only 500 mg twice a day.

Metformin and Castration: All eligible subjects will be randomized in a 1:l manner to receive a bottle containing sufficient500mg tablets of metformin or placebo, blinded to the patient and the study team.",ChEMBL:CHEMBL1431 | DrugBank:DB00331 | PubChem:4091,Metformin,CN(C)C(=N)NC(=N)N,A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01622257,NCT01622257_EG001,No,Female,Adult,Phase 2,66,"Inclusion Criteria:

Obese infertile polycystic ovarian syndrome (PCOS) women

Exclusion Criteria:

Women 40 years or older
Women using fertility treatments, oral contraceptives or other confounding medications during the last 3 months
Smokers or with history of general diseases like cardiovascular, liver, kidney or respiratory disease, diabetes, uncontrolled hypertension, or malignancy",Metformin oral tablets 500 mg were given three times daily for 3 months,ChEMBL:CHEMBL1431 | DrugBank:DB00331 | PubChem:4091,Metformin,CN(C)C(=N)NC(=N)N,A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01623531,NCT01623531_EG000,No,All,Adult | Older Adult,Phase 3,27,"Inclusion Criteria:

All patients who are scheduled for elective complex cardiac surgical procedures including

double procedures (aortic valve replacement (AVR)+CABG, mitral valve repair/replacement (MVR)+CABG, AVR+MVR)
Redo-sternotomies
Aortic root repair +/- AVR

Exclusion Criteria:

Any known congenital or pre-existing bleeding disorder
pre-existing clinically significant abnormal fibrinogen level (normal: 2.5-4.79g/l)
severe liver disease (alanine aminotransferase or aspartate aminotransferase > 150 U/l)
inability to provide informed consent
emergency surgery
pregnancy or nursing
age under 18 years
intake of anti-platelet drugs within2- 5 days preoperatively (low dose ASA is allowed)
allergy to concentrated fibrinogen or other components in the product
anemia (Hgb < 110)
diagnosed deep vein thrombosis (DVT)
pulmonary embolism
acute stroke
acute myocardial infarction","Intravenous fibrinogen(RiaSTAP) will be administered according to FIBTEM based calculation formula

Fibrinogen: Intravenous concentrated fibrinogen will be infused according to a hemostatic algorithm based on ROTEM (FIBTEM)",ChEMBL:CHEMBL1682 | ChEMBL:CHEMBL689 | DrugBank:DB00742 | DrugBank:DB01638 | PubChem:5780 | PubChem:6251 | PubChem:90540,Mannitol,OCC(O)C(O)C(O)C(O)CO,A06AD16 | A06AD18 | A06AG07 | B05BC01 | B05CX02 | B05CX04 | R05CB16 | V04CC01 | V04CX04,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01623531,NCT01623531_EG001,No,All,Adult | Older Adult,Phase 3,29,"Inclusion Criteria:

All patients who are scheduled for elective complex cardiac surgical procedures including

double procedures (aortic valve replacement (AVR)+CABG, mitral valve repair/replacement (MVR)+CABG, AVR+MVR)
Redo-sternotomies
Aortic root repair +/- AVR

Exclusion Criteria:

Any known congenital or pre-existing bleeding disorder
pre-existing clinically significant abnormal fibrinogen level (normal: 2.5-4.79g/l)
severe liver disease (alanine aminotransferase or aspartate aminotransferase > 150 U/l)
inability to provide informed consent
emergency surgery
pregnancy or nursing
age under 18 years
intake of anti-platelet drugs within2- 5 days preoperatively (low dose ASA is allowed)
allergy to concentrated fibrinogen or other components in the product
anemia (Hgb < 110)
diagnosed deep vein thrombosis (DVT)
pulmonary embolism
acute stroke
acute myocardial infarction","Intravenous saline (placebo) will be calculated according to FIBTEM based calculation formula

Placebo: Intravenous placebo will be infused with the same volume as the study drug.",ChEMBL:CHEMBL1682 | ChEMBL:CHEMBL689 | DrugBank:DB00742 | DrugBank:DB01638 | PubChem:5780 | PubChem:6251 | PubChem:90540,Mannitol,OCC(O)C(O)C(O)C(O)CO,A06AD16 | A06AD18 | A06AG07 | B05BC01 | B05CX02 | B05CX04 | R05CB16 | V04CC01 | V04CX04,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0
NCT01623596,NCT01623596_EG000,No,All,Adult | Older Adult,Phase 4,433,"Inclusion Criteria:

written informed consent must be obtained prior to any assessment being performed.
Male and female patients aged 18-65 years inclusive.
Patients diagnosed with relapsing remitting MS, defined by the 2010 revised McDonald criteria (Pollman et al, 2011) (Appendix 1).
EDSS score of less than or equal to 6.
Patients naive to treatment or who have been treated with no more than one class of DMT previously (interferon β preparation or glatiramer acetate), and who, per investigator judgment, may benefit from a change of treatment class.
Patients who have been treated with DMF for less than 2 months total exposure and who have a normal lymphocyte count at screening.
Women of childbearing potential must have a negative urine and serum β-human chorionic gonadotropin (β-hCG) pregnancy test at screening and at baseline.

Before entry women must be:

Post menopausal for at least 1 year, or
Surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation or otherwise incapable of pregnancy, or
Practicing a highly effective method of birth control if sexually active, including hormonal prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device, double barrier method (e.g., condoms, diaphragm or cervical cap with spermicidal foam, cream or gel), or male partner sterilization consistent with local regulations regarding use of birth control methods for patients participating in clinical trials, for the duration of their participation in the study, or
Not heterosexually active (patients who are not heterosexually active at screening must agree to utilize a highly effective method of birth control if they become heterosexually active during their participation in the study) 4.2 Exclusion criteria
Use of other investigational drugs within 30 days of screening.
History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes.
Prior exposure to fingolimod or any other S1P receptor modulating compounds.
History or presence of malignancy of any organ system (other than successfully treated basal or squamous cell carcinoma of the skin or stage 0 carcinoma of the cervix), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
Patients diagnosed with Secondary Progressive Multiple Sclerosis (SPMS) or Primary Progressive MS (PPMS).
Patients with a history of chronic disease of the immune system other than MS or a known immunodeficiency syndrome.

Patients who have been treated with:

• Natalizumab, mitoxantrone, cladribine, rituximab, alemtuzumab, ofatumumab, ocrelizumab at any time before randomization

• Immunoglobulins, or pulse of corticosteroids with more than 6 months cumulative exposure

• Immunosuppressive/chemotherapeutic medications (e.g., methotrexate, azathioprine, cyclophosphamide, cellcept, Cytoxan, IVIG) with more than 6 months of cumulative exposure and within 6 months prior to randomization

• Corticosteroids or adrenocorticotropic hormones in the past 30 days before randomization. Patients that require corticosteroids for a relapse during the screening period may be rescreened 30 days after the last dose.

History of treatment with both classes of approved first line DMT (interferon β preparation and glatiramer acetate) or DMF exposure of 2 months or longer.
Patients with uncontrolled diabetes mellitus (HbA1c > 7%).
Diagnosis of macular edema during the screening phase. Patients with a history of macular edema will be allowed to enter the study provided that they do not have macular edema at the screening visit.
Patients with active systemic bacterial, viral or fungal infections, or known to have AIDS, Hepatitis B, Hepatitis C infection or positive HIV antibody, Hepatitis B surface antigen or Hepatitis C antibody tests.
Patients without history of chickenpox or without vaccination against varicella-zoster virus at screening (patients may be vaccinated and rescreened one month or longer after vaccination).
Patients who have received any live or live attenuated vaccines (including for varicella-zoster or measles) within 1 month prior to baseline.
Patients with any medically unstable condition as assessed by the investigator.

Patients with a history of the following cardiovascular conditions:

• Cardiac arrest.

• myocardial infarction, unstable angina, stroke, transient ischemic attack, decompensated heart failure requiring hospitalization, or Class III/IV heart failure (Appendix 3).

• Congestive heart failure.

• Hypertension that is not controlled with prescribed medications. These patients may be rescreened if blood pressure is stabilized with treatment.

• Cerebrovascular disease.

• History or presence of Mobitz Type II 2nd degree or 3rd degree AV block or sick sinus syndrome, unless patient has a pacemaker.

• Patients at higher risk of symptomatic bradycardia or heart block because of a coexisting medical condition or certain concomitant medications.

• Patients randomized to the fingolimod arm with prolonged QTc interval at screening (corrected QT interval > 450 ms in males and > 470 ms in females); for patients randomized to the fingolimod treatment arm before dosing (baseline) or during the 6-hour observation period; and those patients at additional risk for QT prolongation (e.g., hypokalemia, hypomagnesemia, congenital long-QT syndrome), or on a concomitant therapy with QT prolonging drugs with a known risk of Torsades de pointes (e.g., citalopram, chlorpromazine, haloperidol, methadone, erythromycin).

Patients receiving class Ia or Class III antiarrhythmic drugs (Appendix 6)
Patients receiving concurrent therapy with drugs that slow the heart rate or atrioventricular conduction (e.g., beta blockers, digoxin, or heart-rate slowing calcium channel blockers such as diltiazem, verapamil or digoxin). The possibility to switch to drugs that do not slow the heart rate or atrioventricular conduction should be evaluated by the physician prescribing these drugs before initiating fingolimod treatment.
History of sick sinus syndrome or sinoatrial heart block.
Resting heart rate of < 45 bpm or symptomatic bradycardia
Recurrent syncope
Severe untreated sleep apnea
Patients with severe pulmonary conditions (including severe respiratory disease, pulmonary fibrosis, active tuberculosis, severe or poorly controlled asthma).

Patients with any of the following hepatic conditions:

• Chronic liver or biliary disease

Total bilirubin greater than upper limit of normal (ULN) at screening unless in the context of Gilbert's syndrome
Conjugated bilirubin greater than the ULN at screening
AST (SGOT), ALT (SGPT) greater than 3 times ULN at screening
Alkaline phosphatase (AP) greater than 1.5 times the ULN at screening
Serum creatinine greater than 2.0 mg/dL (176.5 µmol/L) at screening.

Patients with the following neurological/psychiatric disorders:

History of substance abuse (drug or alcohol) in the past five years as determined by the investigator
Progressive neurological disorder other than MS which may affect study participation as determined by the investigator
Any serious psychiatric condition that may interfere with the patient's ability to cooperate and comply with the study procedures as determined by the investigator
Women who are pregnant or nursing (lactating) or planning to become pregnant.
Any condition that in the opinion of the investigator, would compromise the well-being of the patient or the conduct of the study, or prevent the patient from meeting or performing study requirements.
Pre-planned surgery or medical procedure that would interfere with the conduct of the study.
Employee of the sponsor, investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees or the investigator.",Fingolimod,ChEMBL:CHEMBL314854 | DrugBank:DB08868 | PubChem:107970,Fingolimod,CCCCCCCCc1ccc(CCC(N)(CO)CO)cc1,L04AA27,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT01625182,NCT01625182_EG000,No,All,Adult | Older Adult,Phase 3,54,"Inclusion Criteria

written informed consent must be obtained before any assessment is performed
The diagnosis of CIDP will use the definition of the EFNS/PNS Task Force First Revision. Patients must either have a clinical diagnosis of CIDP fulfilling the clinical inclusion criteria for typical CIDP or one of the following atypical forms of CIDP: pure motor, or asymmetrical (MADSAM [Lewis-Sumner syndrome]), or IgA or IgG (not IgM) MGUS paraprotein associated.
All patients must also fulfill the clinical exclusion criteria and the definite electrodiagnostic criteria of the EFNS/PNS Task Force First Revision.
disability defined by an INCAT Disability Scale score of 1-9 or, if INCAT score is 0, a documented history of disability sufficient to require treatment within the past 2 years following reduction or interruption of CIDP treatment
receiving IVIg treatment (minimal dose equivalent to 0.4 g/kg every 4 weeks for a minimum of 12 weeks) or corticosteroids (minimal dose equivalent to prednisone 10 mg/day) treatment prior to the screening visit
history of documented clinically meaningful deterioration confirmed by clinical examination during therapy or upon interruption or reduction of therapy within 18 months prior to Screening
stable CIDP symptoms for the 6 weeks before randomization

Exclusion Criteria

other chronic demyelinating neuropathies, including: Distal Acquired Demyelinating Symmetric Neuropathy (DADS) Multifocal Motor Neuropathy (MMN) pure sensory CIDP hematopoietic malignancy except for MGUS
conditions in which the pathogenesis of the neuropathy may be different from CIDP such as: Lyme disease, POEMS syndrome, osteosclerotic myeloma, Castleman's disease
treatment with plasma exchange within 2 months of randomization, immunosuppressive/chemotherapeutic medications: azathioprine, cyclophosphamide, cyclosporine, mycophenolate, etanercept, methotrexate tacrolimus or other immunosuppressive drugs within 6 months of randomization or 5 half-lives (whichever is later), Rituximab in the 2 years prior to randomization (patients that have received rituximab between 1 and 2 years should have B-cell levels within normal range), other cytotoxic immunosuppressive medications with sustained effects (including mitoxantrone, alemtuzumab, cladribine) at any time, hematopoietic stem cell transplantation at any time",Participants received Fingolimod 0.5 mg orally once daily.,ChEMBL:CHEMBL314854 | DrugBank:DB08868 | PubChem:107970,Fingolimod,CCCCCCCCc1ccc(CCC(N)(CO)CO)cc1,L04AA27,0.0,0.0,0.0,1.0,0.0,1.0,1.0,1.0,0.0,0.0,1.0,1.0,1.0,0.0,1.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0
NCT01632020,NCT01632020_EG001,No,All,Adult | Older Adult,Phase 2,3,"Inclusion Criteria:

Male or female, all races and ethnicities are eligible
Age equal to or greater than 18 years of age
All subjects should have a pathological/histological diagnosis of colorectal cancer.
Clinical diagnosis of stage I, II, III or IV colon cancer or stage I, II, III or IV rectal cancer; cancer may be primary including a secondary primary
Candidate for elective surgery(for removal of primary) or endoscopic biopsy
ECOG Performance status of 0 - 2
Adequate renal, liver, and bone marrow function
Hb: (adequate for surgical intervention, with transfusion if necessary)
WBC: (normal range)
Platelets: (180K/cmm)
LFTs: Normal bilirubin (< 2.0mg/dL), AST/ALT (2xULN)
Renal function: normal creatinine
Subjects must have signed informed consent
Female subjects must either not be of child-bearing potential or must have a negative urine pregnancy test within 7 days of beginning the drug or placebo treatment. Subjects are considered not of child-bearing potential if they are surgically sterile or they are postmenopausal for greater than 12 months.

Exclusion Criteria:

Previously diagnosed with diabetes mellitus Type 1 or Type 2.
Currently taking biguanides, sulfonylurea drugs, thiazolidinediones, insulin, or mTOR inhibitors or having taken any of these medications during the 12 weeks prior to study participation.
Currently taking any non-steroidal anti-inflammatory drugs (NSAIDs) or aspirin and unable to stop such medications due to a present medical condition.
Clinical symptoms of gastrointestinal obstruction or bleeding and consideration for immediate surgery or immediate neoadjuvant chemoradiation.
Familial Adenomatous Polyposis (FAP), hereditary non-polyposis colorectal cancer (HNPCC), Putz-Jeghers disease, ulcerative colitis, or Crohn's disease.
Pregnant or lactating.
History of lactic or other metabolic acidosis.
Known hypersensitivity to Metformin.
Uncontrolled infectious disease.
History of Positivity for human immunodeficiency virus (HIV).
History of congestive heart failure requiring pharmacologic treatment.
History of excessive alcohol abuse, defined by a habitual intake of more than three drinks daily.
Previous or concurrent malignancies, except non-melanoma skin cancers, unless curatively treated and with no evidence of recurrence for > 5 years, with the exception of prior CRC which has been treated and the patient has been in remission and the current primary tumor is a second CRC.
Unable to swallow and retain oral medication.
Mal-absorption syndrome, disease affecting gastrointestinal function, or previous resection of the stomach or small bowel.
Current use of medications for weight loss.
Currently taking cimetidine, thiazide diuretics or cephalexin. If a patient needs some of these agents, alternative agents should be substituted.
If the physician feels that the candidate is not suitable for the study, he/she will be excluded.","Metformin: 850 mg (2 capsules) by mouth twice daily; minimum of 10 days, maximum of 21 days",ChEMBL:CHEMBL1431 | DrugBank:DB00331 | PubChem:4091,Metformin,CN(C)C(=N)NC(=N)N,A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01633112,NCT01633112_EG000,No,All,Adult | Older Adult,Phase 3,345,"Inclusion criteria:

Written informed consent must be obtained before any assessment is performed
Male and female patients 18 to 65 years of age, inclusive.
Patients with RRMS, as defined by 2010 revised McDonald criteria.
Patients must be neurologically stable with no onset of relapse within 30 days of randomization
Patients with at least 1 documented relapse during the previous year or 2 documented relapses during the previous 2 years before randomization.
Patients with an EDSS score of 0 to 6, inclusive, at Screening. A score of 6.0 indicates unilateral assistance (cane or crutch) required to walk at least 100 meters with or without resting.

Exclusion criteria:

Patients with a history of malignancy of any organ system (other than cutaneous basal cell carcinoma) in the last 5 years that do not have confirmation of absence of a malignancy prior to randomization
Patients with an active chronic disease (or stable but treated with immune therapy) of the immune system other than MS (e.g., rheumatoid arthritis, scleroderma, Sjogren's syndrome, Crohn's disease, ulcerative colitis) or with a known immunodeficiency syndrome (HIV-antibody positive, AIDS, hereditary immune deficiency, drug-induced immune deficiency).
Patients who have been treated with:
High-dose intravenous (IV) immunoglobulin (Ig) within 4 weeks before randomization
Immunosuppressive/chemotherapeutic medications (e.g., azathioprine, cyclophosphamide, methotrexate) within 6 months before randomization
Natalizumab within 2 months before randomization
Previous treatment with lymphocyte-depleting therapies (e.g., rituximab, alemtuzumab, ofatumumab, ocrelizumab, or cladribine) within 1 year before randomization Previous treatment with mitoxantrone within 6 months before randomization
Use of teriflunomide within 3.5 months prior to randomization, except if active washout (with either cholestyramine or activated charcoal) was done. In that case, plasma levels are required to be measured and be below 0.02 mg/L before randomization.

No washout period is necessary for patients treated with dimethyl fumarate, interferon (IFN) beta, or glatiramer acetate.

Patients being treated with dimethyl fumarate, glatiramer acetate, or IFN beta at the Screening visit can continue drug intake up to the day before Day 1 of this study (i.e., there is no need for a washout period).

Patients who have been treated with systemic corticosteroids or adrenocorticotropic hormones in the past 30 days prior to the screening magnetic resonance imaging (MRI) procedure.
Patients with uncontrolled diabetes mellitus (glycosylated hemoglobin >9%) or with diabetic neuropathy.
Patients with a diagnosis of macular edema during Screening (patients with a history of macular edema will be allowed to enter the study provided that they do not have macular edema at Screening).
Patients with severe active bacterial, viral, or fungal infections.
Patients without acceptable evidence of immunity to varicella zoster virus (VZV) at randomization.
Patients who have received any live or live-attenuated vaccines (including VZV, herpes simplex, or measles) within 1 month before randomization.
Patients who have received total lymphoid irradiation or bone marrow transplantation.
Patients with any unstable medical/psychiatric condition, as assessed by the primary treating physician at each site.
Patients who in the last 6 months experienced any of the following cardiovascular conditions or findings in the screening electrocardiogram (ECG): myocardial infarction, unstable angina, stroke, transient ischemic attack or decompensated heart failure requiring hospitalization or Class III/IV heart failure.",Fingolimod (FTY720) 0.5 mg orally once a day for up to 12 months,ChEMBL:CHEMBL314854 | DrugBank:DB08868 | PubChem:107970,Fingolimod,CCCCCCCCc1ccc(CCC(N)(CO)CO)cc1,L04AA27,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT01635101,NCT01635101_EG000,No,All,Child,Phase 3,61,"Inclusion Criteria:

Subject is ≥ 28 weeks gestational age and < 2 years old at study enrollment
Subject will undergo surgery or had a traumatic injury expected to produce moderate to severe pain and patient is expected to require analgesic treatment for acute pain for 24 hours
Subject has a medically reasonable need for IV treatment due to their underlying procedure(s) or medical condition(s) for the duration of the study
Subject has reliable vascular access for administration of study medication and PK sampling
Subject has a bodyweight which, in the opinion of the Investigator does not preclude participation in the study.
Subject is free of other physical, mental, or medical conditions which, in the opinion of the Investigator, make study participation inadvisable or make it impossible to accurately assess efficacy or safety endpoints
Subject's parent or guardian must provide written informed consent prior to participation in the study
Subject's parent or guardian must have the ability to read and understand the study procedures and have the ability to communicate meaningfully with the study investigator and staff

Exclusion Criteria:

Subject is not able to comply with the sampling requirements of the study
Subject has known or suspected hypersensitivity to acetaminophen or the excipients of IV acetaminophen
Subject has any significant medical condition that in the opinion of the Investigator contraindicates participation in the study or impairs the assessment of efficacy or safety
Subject has participated in another interventional clinical study within 30 days of the planned study randomization date

Pre-Randomization (Qualification) Inclusion Criteria

Subject has not been administered any of the following:

any acetaminophen-containing product, nonsteroidal anti-inflammatory agent, central alpha-adrenergic agents (e.g., clonidine, dexmedetomidine) or ketamine within 6 hours of baseline (T0)
received a regional or neuraxial (caudal, epidural or spinal) anesthetic with local anesthetics within 6 hours of T0
Subject does not have abnormal liver function tests from a sample obtained post-operatively/post-trauma and prior to randomization above protocol-specified limits
Subject does not have significantly impaired renal function or known significant renal disease which in the opinion of the Investigator would contraindicate study participation.
Subject had a nursing assessment documenting moderate to severe pain within 6 hours prior to randomization
Subject required at least one dose of parenteral opioid medication for pain management (i.e., not pre-emptive therapy) during the 6-hour pre-randomization period, and is anticipated to require at least one dose of parenteral opioid medication during the 24 hour treatment period
If subject is breast feeding, mother has not been administered any acetaminophen containing product in the previous 6 hours to T0 and throughout the treatment period",Participants receive a low dose of acetaminophen for 24 hours,ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT01635101,NCT01635101_EG001,No,All,Child,Phase 3,67,"Inclusion Criteria:

Subject is ≥ 28 weeks gestational age and < 2 years old at study enrollment
Subject will undergo surgery or had a traumatic injury expected to produce moderate to severe pain and patient is expected to require analgesic treatment for acute pain for 24 hours
Subject has a medically reasonable need for IV treatment due to their underlying procedure(s) or medical condition(s) for the duration of the study
Subject has reliable vascular access for administration of study medication and PK sampling
Subject has a bodyweight which, in the opinion of the Investigator does not preclude participation in the study.
Subject is free of other physical, mental, or medical conditions which, in the opinion of the Investigator, make study participation inadvisable or make it impossible to accurately assess efficacy or safety endpoints
Subject's parent or guardian must provide written informed consent prior to participation in the study
Subject's parent or guardian must have the ability to read and understand the study procedures and have the ability to communicate meaningfully with the study investigator and staff

Exclusion Criteria:

Subject is not able to comply with the sampling requirements of the study
Subject has known or suspected hypersensitivity to acetaminophen or the excipients of IV acetaminophen
Subject has any significant medical condition that in the opinion of the Investigator contraindicates participation in the study or impairs the assessment of efficacy or safety
Subject has participated in another interventional clinical study within 30 days of the planned study randomization date

Pre-Randomization (Qualification) Inclusion Criteria

Subject has not been administered any of the following:

any acetaminophen-containing product, nonsteroidal anti-inflammatory agent, central alpha-adrenergic agents (e.g., clonidine, dexmedetomidine) or ketamine within 6 hours of baseline (T0)
received a regional or neuraxial (caudal, epidural or spinal) anesthetic with local anesthetics within 6 hours of T0
Subject does not have abnormal liver function tests from a sample obtained post-operatively/post-trauma and prior to randomization above protocol-specified limits
Subject does not have significantly impaired renal function or known significant renal disease which in the opinion of the Investigator would contraindicate study participation.
Subject had a nursing assessment documenting moderate to severe pain within 6 hours prior to randomization
Subject required at least one dose of parenteral opioid medication for pain management (i.e., not pre-emptive therapy) during the 6-hour pre-randomization period, and is anticipated to require at least one dose of parenteral opioid medication during the 24 hour treatment period
If subject is breast feeding, mother has not been administered any acetaminophen containing product in the previous 6 hours to T0 and throughout the treatment period",Participants receive a high dose of acetaminophen for 24 hours,ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01638559,NCT01638559_EG000,No,All,Child | Adult,Phase 2,161,"Inclusion Criteria:

Subject and/or parent guardian must be able to understand and provide informed consent;
Is the recipient of a living or deceased donor liver tx when subject was less than or equal to 6 years of age;
Is at least 4 years post-tx at the time of study enrollment;
Has normal allograft function defined as Alanine aminotransferase (ALT) < 50 IU/l and gamma-glutamyl transferase (GGT) < 50 IU/l;
Has no evidence of acute rejection (AR) or chronic rejection (CR) within the past 2 years, based on medical history;
Is stable on IS monotherapy with a calcineurin inhibitor (CNI);
For female subjects of childbearing potential, subject must have a negative pregnancy test upon study entry;
For female and male subjects with reproductive potential, subject must agree to use FDA approved methods of birth control for the duration of the study;
Must be negative for hepatitis B virus (HBV) and hepatitis C virus (HCV) infection within one year of enrollment;

Must have screening biopsy that fulfills, based on central pathology reading, the following criteria:

Portal inflammation and interface activity: Preferably absent, but minimal to focal mild portal mononuclear inflammation may be present. Interface necro-inflammatory activity is absent or equivocal/minimal and, if present, involves a minority of portal tracts.
Centrizonal/peri-venular inflammation: Preferably absent, but minimal to focal mild perivenular mononuclear inflammation may be present. Perivenular necro-inflammatory activity is absent or equivocal/minimal and, if present, involves a minority of terminal hepatic venules.
Bile duct changes: No lymphocytic bile duct damage, ductopenia and biliary epithelial senescence changes, unless there is an alternative, non-immunologic explanation (e.g. biliary strictures).
Fibrosis: < Ishak Stage 3 (i.e. not more than occasional portal-to-portal bridging). Perivenular fibrosis should be less than ""moderate"", according to Banff Criteria.
Arteries: Negative for obliterative or foam cell arteriopathy.

Exclusion Criteria:

Have received a liver tx for autoimmune liver disease, including autoimmune hepatitis or primary sclerosing cholangitis;
Have received a liver tx for hepatitis B or hepatitis C;
Have received a second organ transplant before, simultaneously, or after liver tx;
Have a calculated glomerular filtration rate (modified Schwartz formula) of less than 60 mL/min/1.73 m^2;
Have had a 50 percent (%) dose increase in CNI within 6 months of screening;
Have discontinued a second IS agent within 12 months of screening;
Have any systemic illness requiring or likely to require chronic or recurrent use of IS;
Is pregnant or breastfeeding;
Is unwilling or unable to adhere with study requirements and procedures;
Have mental illness or history of drug or alcohol abuse that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements;
Is unwilling or unable to provide consent or comply with the study protocol;
Has used investigational drugs within 4 weeks of enrollment;
Is receiving treatment for HIV infection;
Has received any licensed or investigational live attenuated vaccine(s) within two months of enrollment;
Has any medical condition that, in the opinion of the investigator, will interfere with safe participation in the trial.","Pediatric liver transplant recipients with stable liver function tests, no evidence of rejection in the past 2 years, and at least 4 years post-transplant, and a qualifying liver biopsy at screening underwent gradual Immunosuppression withdrawal in no less than 36 weeks and no more than 52 weeks with frequent monitoring of liver tests. All participants were followed for 48 months ensuring a minimum of 36 months of follow-up after successful Immunosuppression withdrawal.",ChEMBL:CHEMBL484785 | DrugBank:DB05219 | PubChem:44591583,Crisaborole,N#Cc1ccc(Oc2ccc3c(c2)COB3O)cc1,D11AH06,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,1.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT01643772,NCT01643772_EG000,No,All,Adult,Phase 1,15,"Inclusion Criteria:

Patients with pain, Multiple dose group should enroll the Patients with cancer pain;
Patients aged >≥30 to ≤ 60 years;
Body weight ≥ 45kg, and BMI range ≥19, <24;
Karnofsky score ≥ 70;
The results of liver function and kidney tests must meet the following criteria: ALT、AST is within the upper limit of normal value ranges by a factor 2, and TB、BUN、Cr is within the upper limit of normal value ranges by a factor 1.25;
The electrocardiogram examination results are normal;
Patients must have given a written informed consent prior to this trial, and have the capability to complete every required test.

Exclusion Criteria:

Have hypersensitivity history to any opioids;
Have known hypersensitivity to any of compositions of the study drugs;
Patients who are likely to have paralytic ileus or acute abdomen or to perform an operation on abdominal region；
Patients with respiratory depression, cor pulmonale, or chronic bronchial asthma;
Patients who are unable to stop taking monoamine oxidase inhibitor during this trial period or time lapses less than 2 weeks since drug withdrawal;
Patients with hypercarbia;
Patients with biliary tract diseases, pancreatitis, prostatic hypertrophy, or corticoadrenal insufficiency;
Patients with alcoholism or drug abuse history;
Positive anti-HIV or syphilis antibody test result;
Patients who are pregnant, or lactating;
Urine screening before study is positive for opioids, barbiturates, amphetamines, cocaine metabolites, methadone, diazepam and cannabinoids;
Donated 400 mL or more of blood or blood products within 3 months prior to the start of the study, or donated 200 mL or more of blood or blood products within one month prior to the start of the study;
Subjects who participated in a clinical research study within one month of study entry;
Patients who are currently taking opioids.",Group 1: single dose Oxycodone Hydrochloride 5 mg Capsules after 10 hours fasting,PubChem:5462350,Oxycodone Hydrochloride,COc1ccc2c3c1OC1C(=O)CCC4(O)C(C2)N(C)CCC314.Cl,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01643772,NCT01643772_EG001,No,All,Adult,Phase 1,15,"Inclusion Criteria:

Patients with pain, Multiple dose group should enroll the Patients with cancer pain;
Patients aged >≥30 to ≤ 60 years;
Body weight ≥ 45kg, and BMI range ≥19, <24;
Karnofsky score ≥ 70;
The results of liver function and kidney tests must meet the following criteria: ALT、AST is within the upper limit of normal value ranges by a factor 2, and TB、BUN、Cr is within the upper limit of normal value ranges by a factor 1.25;
The electrocardiogram examination results are normal;
Patients must have given a written informed consent prior to this trial, and have the capability to complete every required test.

Exclusion Criteria:

Have hypersensitivity history to any opioids;
Have known hypersensitivity to any of compositions of the study drugs;
Patients who are likely to have paralytic ileus or acute abdomen or to perform an operation on abdominal region；
Patients with respiratory depression, cor pulmonale, or chronic bronchial asthma;
Patients who are unable to stop taking monoamine oxidase inhibitor during this trial period or time lapses less than 2 weeks since drug withdrawal;
Patients with hypercarbia;
Patients with biliary tract diseases, pancreatitis, prostatic hypertrophy, or corticoadrenal insufficiency;
Patients with alcoholism or drug abuse history;
Positive anti-HIV or syphilis antibody test result;
Patients who are pregnant, or lactating;
Urine screening before study is positive for opioids, barbiturates, amphetamines, cocaine metabolites, methadone, diazepam and cannabinoids;
Donated 400 mL or more of blood or blood products within 3 months prior to the start of the study, or donated 200 mL or more of blood or blood products within one month prior to the start of the study;
Subjects who participated in a clinical research study within one month of study entry;
Patients who are currently taking opioids.",Group 2: single dose Oxycodone Hydrochloride 10 mg Capsules after 10 hours fasting,PubChem:5462350,Oxycodone Hydrochloride,COc1ccc2c3c1OC1C(=O)CCC4(O)C(C2)N(C)CCC314.Cl,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01643772,NCT01643772_EG002,No,All,Adult,Phase 1,15,"Inclusion Criteria:

Patients with pain, Multiple dose group should enroll the Patients with cancer pain;
Patients aged >≥30 to ≤ 60 years;
Body weight ≥ 45kg, and BMI range ≥19, <24;
Karnofsky score ≥ 70;
The results of liver function and kidney tests must meet the following criteria: ALT、AST is within the upper limit of normal value ranges by a factor 2, and TB、BUN、Cr is within the upper limit of normal value ranges by a factor 1.25;
The electrocardiogram examination results are normal;
Patients must have given a written informed consent prior to this trial, and have the capability to complete every required test.

Exclusion Criteria:

Have hypersensitivity history to any opioids;
Have known hypersensitivity to any of compositions of the study drugs;
Patients who are likely to have paralytic ileus or acute abdomen or to perform an operation on abdominal region；
Patients with respiratory depression, cor pulmonale, or chronic bronchial asthma;
Patients who are unable to stop taking monoamine oxidase inhibitor during this trial period or time lapses less than 2 weeks since drug withdrawal;
Patients with hypercarbia;
Patients with biliary tract diseases, pancreatitis, prostatic hypertrophy, or corticoadrenal insufficiency;
Patients with alcoholism or drug abuse history;
Positive anti-HIV or syphilis antibody test result;
Patients who are pregnant, or lactating;
Urine screening before study is positive for opioids, barbiturates, amphetamines, cocaine metabolites, methadone, diazepam and cannabinoids;
Donated 400 mL or more of blood or blood products within 3 months prior to the start of the study, or donated 200 mL or more of blood or blood products within one month prior to the start of the study;
Subjects who participated in a clinical research study within one month of study entry;
Patients who are currently taking opioids.",Group 3: single dose Oxycodone Hydrochloride 20 mg Capsules after 10 hours fasting,PubChem:5462350,Oxycodone Hydrochloride,COc1ccc2c3c1OC1C(=O)CCC4(O)C(C2)N(C)CCC314.Cl,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01643772,NCT01643772_EG003,No,All,Adult,Phase 1,16,"Inclusion Criteria:

Patients with pain, Multiple dose group should enroll the Patients with cancer pain;
Patients aged >≥30 to ≤ 60 years;
Body weight ≥ 45kg, and BMI range ≥19, <24;
Karnofsky score ≥ 70;
The results of liver function and kidney tests must meet the following criteria: ALT、AST is within the upper limit of normal value ranges by a factor 2, and TB、BUN、Cr is within the upper limit of normal value ranges by a factor 1.25;
The electrocardiogram examination results are normal;
Patients must have given a written informed consent prior to this trial, and have the capability to complete every required test.

Exclusion Criteria:

Have hypersensitivity history to any opioids;
Have known hypersensitivity to any of compositions of the study drugs;
Patients who are likely to have paralytic ileus or acute abdomen or to perform an operation on abdominal region；
Patients with respiratory depression, cor pulmonale, or chronic bronchial asthma;
Patients who are unable to stop taking monoamine oxidase inhibitor during this trial period or time lapses less than 2 weeks since drug withdrawal;
Patients with hypercarbia;
Patients with biliary tract diseases, pancreatitis, prostatic hypertrophy, or corticoadrenal insufficiency;
Patients with alcoholism or drug abuse history;
Positive anti-HIV or syphilis antibody test result;
Patients who are pregnant, or lactating;
Urine screening before study is positive for opioids, barbiturates, amphetamines, cocaine metabolites, methadone, diazepam and cannabinoids;
Donated 400 mL or more of blood or blood products within 3 months prior to the start of the study, or donated 200 mL or more of blood or blood products within one month prior to the start of the study;
Subjects who participated in a clinical research study within one month of study entry;
Patients who are currently taking opioids.","Group 4: multi-dose 4 times per day Oxycodone Hydrochloride 10mg Capsules for 3 days, and one dose on 4th day morning",PubChem:5462350,Oxycodone Hydrochloride,COc1ccc2c3c1OC1C(=O)CCC4(O)C(C2)N(C)CCC314.Cl,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01650285,NCT01650285_EG000,No,Male,Adult | Older Adult,Phase 2,5,"Conditions for Patient Eligibility

Each patient must meet all of the following inclusion criteria to be enrolled in the study:

Radical prostatectomy for adenocarcinoma of the prostate with at least one of the following:

Extracapsular tumor extension,
Positive surgical margins,
Seminal vesicle invasion
Regional lymph node positive (N1)
Post-prostatectomy PSA of > 0.1 - < 2.0 ng/mL at least 6 weeks after prostatectomy and within 30 days of registration in a patient with T2 or T3 disease at prostatectomy.
No distant metastases.
No prior pelvic or prostate radiation or chemotherapy for prostate cancer.
ECOG performance status 0-1.
Age>18.
Required entry laboratory parameters within 14 days of study entry: Granulocytes ≥ 1500 cells/mm3; platelet count ≥100,000 cells/mm3, Creatinine ≤ 1.5X upper limit of normal (if creatinine clearance 1.0-1.5x ULN, creatinine clearance will be calculated according to Chronic Kidney Disease Epidemiology Group formula and patients with creatinine clearance < 60 ml/min should be excluded),19 .Hgb > 9.0 g/dl, total bilirubin ≤ 1x ULN, and AST or ALT ≤ 2.5 x ULN.
Life expectancy of at least 1 year.
Must not have uncontrolled severe, intercurrent illness.
No concurrent anticancer therapy.
Men of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter.
Signed study-specific consent form prior to study entry.
Conditions for Patient Ineligibility

Patients meeting any of the following exclusion criteria are not to be enrolled in the study:

Evidence of distant metastases (M1). Equivocal bone scans are allowed if plain films are negative for metastasis.
Major medical or psychiatric illness which, in the investigator's opinion, would prevent completion of treatment and would interfere with follow-up.
Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 2 years (For example, carcinoma in situ of the oral cavity or bladder are permissible).
History of severe hypersensitivity (> grade 3) reaction to Cabazitaxel or other drugs formulated with polysorbate 80.
History of severe hypersensitivity (> grade 3) to docetaxel.
Any uncontrolled severe, intercurrent illness (including uncontrolled diabetes)
At least 4 weeks since any major surgery.
Patients on concurrent anticancer therapy.
PSA > 2ng/ml
Concurrent or planned treatment with strong inhibitors or inducers of cytochrome p450 3A4/5 (a one-week wash out period is necessary for patients who are already on these treatments (see appendix H and I)
Androgen deprivation therapy started prior to prostatectomy for > 6 months duration;
Neoadjuvant chemotherapy prior to prostatectomy;
Prior cryosurgery or brachytherapy of the prostate; prostatectomy should be the primary treatment and not a salvage procedure;
Prior pelvic radiotherapy;","Radiation therapy (RT) will be delivered to 64.8 Gy, using IMRT treatment Cabazitaxel will be administered IV every 21 days for 3 doses at the assigned dose level.

Cabazitaxel: Dose Level Day 1, 22, 43

5.0 mg/m2
10.0 mg/m2
15.0 mg/m2
20.0 mg/m2",ChEMBL:CHEMBL1201748 | DrugBank:DB06772 | PubChem:9854073,Cabazitaxel,[H][C@]12[C@H](OC(=O)c3ccccc3)[C@]3(O)C[C@H](OC(=O)[C@H](O)[C@@H](NC(=O)OC(C)(C)C)c4ccccc4)C(C)=C([C@@H](OC)C(=O)[C@]1(C)[C@@H](OC)C[C@H]1OC[C@]12OC(C)=O)C3(C)C,L01CD04,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01661790,NCT01661790_EG001,No,All,Adult | Older Adult,Phase 3,36,"Inclusion Criteria:

Patients with advanced recurrent or progressive NSCLC proven cytohistologically
Karnofsky performance status (KPS) ≥60
Life expectancy ≥ 2 months
No history of severe diseases of major organs including liver, heart, and kidney
No previous intrapleural therapy
Written informed consent

Exclusion Criteria:

Active thoracic cavity or systemic bleeding
Active pleural or systemic infection.
Known sensitivity to Bevacizumab or Cisplatin
Refusal to participate in the study.","Cisplatin 30mg by intrapleural given every two weeks

Cisplatin: Cisplatin 30mg,intrapleural administration,Q2W",DrugBank:DB00515 | PubChem:5460033 | PubChem:5702198,Cisplatin,Cl[Pt]Cl.N.N,L01XA01,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01663935,NCT01663935_EG000,No,All,Child | Adult | Older Adult,Phase 2,20,"Inclusion Criteria:

clinical diagnosis of oculocutaneous albinism
age over 3 and weight over 25 lbs.

Exclusion Criteria:

ocular only albinism
ocular pathology other than albinism
neurologic disease, history of myocardial infarction, history of clinical depression, pregnancy","Treatment drug taken orally three times daily

Levodopa/carbidopa: This study will have an intent to treat goal. Anyone that fits the inclusion criteria for the study will be entered and receive study drug.",DrugBank:DB00988 | PubChem:681,Dopamine,NCCc1ccc(O)c(O)c1,C01CA04,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01665144,NCT01665144_EG000,No,All,Adult,Phase 3,1099,"Inclusion Criteria:

Prior history of relapsing remitting MS
SPMS defined as progressive increase of disability over at least 6 months
EDSS score of 3.0 to 6.5
No relapse of corticosteroid treatment within 3 months

Exclusion Criteria:

Women of child bearing potential must use reliable forms of contraception.
Diagnosis of Macular edema during screening period
Any medically unstable condition determined by investigator.
Unable to undergo MRI scans
Hypersensitivity to any study drugs or drugs of similar class Other protocol defined inclusion/exclusion may apply.","Participants started on Day 1 and were uptitrated from 0.25 mg to 2 mg of BAF312 orally over a period of 6 days. After Day 7, participants continued on 2 mg BAF312 daily for a variable duration.",ChEMBL:CHEMBL2336071 | DrugBank:DB12371 | PubChem:11432307 | PubChem:44599207,Siponimod,CCc1cc(/C(C)=N/OCc2ccc(C3CCCCC3)c(C(F)(F)F)c2)ccc1CN1CC(C(=O)O)C1,L04AA42 | L04AE03,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,1.0,1.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT01667029,NCT01667029_EG000,No,All,Adult | Older Adult,Phase 2,8,"Inclusion Criteria:

Painful neuropathy
Michigan Neuropathy Screening Instrument score of 3 or greater
no obvious alternative explanation for neuropathy
average baseline pain > 4/10

Exclusion Criteria:

other severe pain
anticipated difficulty weaning off medications
past or current psychiatric disorder as determined by Mini International Neuropsychiatric Interview
medical contraindication to sulfasalazine
not proficient in English (due to heavy use of questionaires)
pregnant or breast feeding women","1 g oral twice daily for 2 weeks

Sulfasalazine",ChEMBL:CHEMBL421 | DrugBank:DB00795 | PubChem:5339,Sulfasalazine,O=C(O)c1cc(/N=N/c2ccc(S(=O)(=O)Nc3ccccn3)cc2)ccc1O,A07EC01 | G01AE10,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01673061,NCT01673061_EG001,No,All,Adult | Older Adult,Phase 4,21,"Inclusion Criteria:

Greater than or equal to 18 years old
Able to consent
Has cutaneous abscess less than or equal to 2 centimeters requiring incision and drainage in the Emergency Department

Exclusion Criteria:

Less than 18 years old
Unable to consent
Pregnant or breastfeeding
Prisoner or in police custody
Known sensitivity to vapocoolant or lidocaine
Cold hypersensitivity
Chronic steroid use
Peripheral neuropathy
Diabetes
HIV
Malignancy
Immunosuppressive state
Sickle cell disease
Sarcoidosis
Abscess greater than 2 centimeters in any dimension
Abscess requiring procedural sedation and analgesia for incision and drainage, or further intervention outside the Emergency Department
Abscess located on the hands, feet, face, or perineal areas
Pilonidal cyst
hidradenitis suppurativa
Not a good candidate per attending physician","Vapocoolant spray will be used for anesthesia prior to incision and drainage. The spray will be administered to the abscess site for a duration of 2 seconds, from a distance of 12 cm.

Vapocoolant: See associated Arm Description",DrugBank:DB13117,Pentafluoropropane,FC(F)CC(F)(F)F,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01675622,NCT01675622_EG000,No,All,Adult | Older Adult,Phase 3,120,"Inclusion Criteria:

Patients of either sex aged 18 to 80 years inclusive, who with cancers of all type.
Patients with moderate to severe cancer pain, whose pain intensity Numeric Rating Scale ≥4.
Patients who can understand and are able to complete Numeric Rating Scale and Brief Pain Inventory assessment.
Patients who have given written informed consent to participate in the study.

Exclusion Criteria:

Patients who are pregnant, or lactating.
Patients who are unable to manage their pain effectively with opioids.
Patient who need ≥120mg morphine or equivalent for treatment of pain at time of study entry;
Patients who are receiving chemotherapy, or still under the responsive period of chemotherapy (patients who are at the interval period of chemotherapy can be enrolled into study. That is to say, patients who completed chemotherapy for more than 2 weeks can enrolled, or patients has completed chemotherapy for at least one week could be enrolled at the discretion of the investigator).
Patients who have received radio-therapy for bony metastasis, patients receiving radiotherapy within the 4 week period before study entry (patient receiving radiotherapy for area other than pain area can be enrolled) , or patients who were scheduled to receive radiotherapy for pain area during study period.
Patients are receiving or should receive anti-convulsion drugs/anti- depression drugs considered by investigator for the treatment of neuropathy pain. Patients are receiving or should receive any analgesic other than study medicine, which including NSAIDs.
Patients with other unstable disease, or with dysfunction of important organ.
Patients with an ongoing infection, abscess or fever.
Patient with serious abnormal liver/ renal function (ALT/Aspartate Transaminase/creatinine/urea nitrogen) which is higher than 3 times of upper limit;
Paralytic or mechanical ileus;
Persistent asthma, chronic obstructive diseases, and cor pulmonary;
Intracranial neoplasms, and intracranial hypertension with central respiratory depression risk.
Monoamine oxidase inhibitors (MAOIs) or same type drugs have been administered in last 2 weeks;
Patients who are currently taking active treatment for epilepsy or arrhythmias.
Patients with known sensitivity or record of specific or allergic reaction to oxycodone or morphine.
Patients excluded by the contra-indications, adverse drug reaction (ADRs) and drug interactions of oxycodone or morphine as detailed in the data sheet, summary of product characteristics or investigator's brochure.
Patients with a history of drug or alcohol abuse.
Patients who participated in another clinical research study involving a new chemical entity within one month prior to study entry.
Patients whose concomitant medication is likely to be changed within the study period, with the exception of treatment for opioid side effects.
Patients who, in the opinion of the investigator, are unsuitable to participate in the study for any other reason not mentioned in the inclusion and exclusion criteria.","Oxycodone: dosage: 5mg, l0mg and 20mg dosage form: capsule frequency: every 6h, duration: 5-8 days",ChEMBL:CHEMBL656 | DrugBank:DB00497 | PubChem:5284603,Oxycodone,COc1ccc2c3c1O[C@H]1C(=O)CC[C@@]4(O)[C@@H](C2)N(C)CC[C@]314,N02AA05 | N02AA55 | N02AA56 | N02AJ17 | N02AJ18 | N02AJ19,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT01682642,NCT01682642_EG000,No,Female,Adult,Phase 4,61,"Inclusion Criteria:

laparoscopical vaporization of endometriosis
1,2, 3e IVF cycle
endometriosis stage I and II
younger than 38 years

Exclusion Criteria:

endometriosis cysts
uterine pathology
endocrinological diseases and problems","After surgical vaporization of endometriosis patients are treated with Zoladex for 3 months.

Zoladex: after surgical vaporization patients are treated with Zoladex for 3 months before starting IVF treatment",PubChem:16052011,Goserelin Acetate,CC(=O)O.CC(C)CC(NC(=O)C(COC(C)(C)C)NC(=O)C(Cc1ccc(O)cc1)NC(=O)C(CO)NC(=O)C(Cc1c[nH]c2ccccc12)NC(=O)C(Cc1cnc[nH]1)NC(=O)C1CCC(=O)N1)C(=O)NC(CCCN=C(N)N)C(=O)N1CCCC1C(=O)NNC(N)=O,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01686152,NCT01686152_EG001,No,All,Adult | Older Adult,Phase 3,249,"Inclusion Criteria:

Willing and able to provide written informed consent for the study
At least 18 years of age.
Immunocompetent male or non-pregnant and non-lactating female. Each female subject of childbearing potential (excluding women who are surgically sterilized or postmenopausal for at least 2 years), in addition to having a negative urine pregnancy test at Visit 1/Day 1, must be willing to use an acceptable form of birth control during the study. For the purpose of this study, the following are considered acceptable methods of birth control: oral contraceptives, contraceptive patches, contraceptive implant, vaginal contraceptive, double-barrier methods (for example, condom and spermicide), contraceptive injection (Depo-Provera®), intrauterine device (IUD), hormonal IUD (Mirena®), and abstinence with a documented second acceptable method of birth control if the subject becomes sexually active. Subjects entering the study who are on hormonal contraceptives (oral contraceptives, patches and injection) must have been on this method for at least 3 months (90 days) prior to the study and continue the method for the duration of the study. Subjects who had used hormonal contraception (oral contraceptives, patches and injection) and stopped must have stopped no less than 3 months (90 days) prior to baseline. Subjects entering the study using contraceptive implants and intrauterine contraceptives must have been on this method for at least 6 months (180 days) and continue for the duration of the study and if they stopped must have stopped no less than 6 months (180 days) prior to baseline.
Clinical diagnosis of AK, defined as ≥ 5 and ≤ 20 clinically typical, visible or palpable AK lesions, each at least 4 mm in diameter, in an area that exceeds 25 cm2 on either the face (excluding ears) or balding scalp, but not both face and scalp.
In general good health and free from any clinically significant disease, other than AK, that might interfere with the study evaluations.
Willing and able to understand and comply with the requirements of the study, apply the IP as instructed, attend the required visits, comply with therapy prohibitions, and be able to complete the study.

Exclusion Criteria:

Presence of atopic dermatitis, basal cell carcinoma, eczema, psoriasis, rosacea, squamous cell carcinoma, or other possible confounding skin conditions on the treatment area of either the face or balding scalp.
Clinically significant systemic disease (immunological deficiencies), unstable medical disorder, life-threatening disease, or current malignancies.
Use on the face or balding scalp of chemical peel, dermabrasion, laser abrasion, psoralen plus ultraviolet A (PUVA) therapy, and/or ultraviolet B (UVB) therapy in the last 6 months (180 days)
Use of any systemic cancer chemotherapy medications in the last 6 months (180 days)
Use on the face or balding scalp of cryodestruction or chemodestruction, curettage, photodynamic therapy, surgical excision, topical 5-fluorouracil, topical corticosteroids, topical diclofenac, topical imiquimod, topical retinoids, masoprocol, or other treatments for AK in the last 1 month (30 days)
Immunomodulators or immunosuppressive therapies, interferon, oral/systemic corticosteroids, or cytotoxic drugs in the last 1 month (30 days). Intranasal or inhaled corticosteroids are acceptable if kept constant throughout the study.
Need or intent to continue to use any treatment listed in the four points above during the current study
Known hypersensitivity or allergies to imiquimod or any component of the IP (in any dosage form).
Females who are pregnant, breastfeeding, intending to become pregnant during the study, or who do not agree to use an acceptable form of birth control during the study.
Any clinically significant condition or situation other than the condition being studied that, in the opinion of the investigator, would interfere with the study evaluations or optimal participation in the study.
Use of any investigational drug or investigational device within 1 month (30 days) prior to randomization.
Previous participation in this study.
Sunburn in the designated treatment area to be treated at study entry.
Current involvement in activities that require excessive or prolonged sun exposure.
Consumption of excessive amounts of alcohol, abuse drugs.","Zyclara® (imiquimod Cream), 3.75% (Medicis)",ChEMBL:CHEMBL1282 | DrugBank:DB00724 | PubChem:57469,Imiquimod,CC(C)Cn1cnc2c(N)nc3ccccc3c21,D06BB10,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01693614,NCT01693614_EG000,No,All,Adult | Older Adult,Phase 2,26,"Inclusion Criteria:

Patient had a histologically confirmed diagnosis of mantle cell lymphoma, follicular lymphoma, or diffuse large B cell lymphoma.
Patient had relapsed or refractory disease and received at least one prior therapy.
Patient with diffuse large B cell lymphoma had received or was ineligible for autologous or allogeneic stem cell transplant.
Patient had at least one measurable nodal lesion (≥2 cm) according to Cheson criteria (Cheson 2007). In case where the patient had no measurable nodal lesions ≥ 2 cm in the long axis at baseline, then the patient must have had at least one measurable extra-nodal lesion.
Patient had an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
Patient had adequate bone marrow and organ function.

Exclusion Criteria:

Patient had received previous treatment with PI3K inhibitors
Patient had evidence of graft versus host disease (GVHD).
Patient had active or history of central nervous system (CNS) disease.
Patient had a concurrent malignancy or had a malignancy within 3 years of study enrollment (with the exception of adequately treated basal or squamous cell carcinoma or non-melanomatous skin cancer).
Patient had a score ≥ 12 on the PHQ-9 questionnaire.
Patient had a GAD-7 mood scale score ≥ 15.
Pregnant or nursing women
Patient who did not use highly effective contraception methods to avoid becoming pregnant or conceiving offspring.",DLBCL,ChEMBL:CHEMBL2017974 | DrugBank:DB11666 | PubChem:16654980,Buparlisib,Nc1cc(C(F)(F)F)c(-c2cc(N3CCOCC3)nc(N3CCOCC3)n2)cn1,,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,1.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT01693614,NCT01693614_EG001,No,All,Adult | Older Adult,Phase 2,22,"Inclusion Criteria:

Patient had a histologically confirmed diagnosis of mantle cell lymphoma, follicular lymphoma, or diffuse large B cell lymphoma.
Patient had relapsed or refractory disease and received at least one prior therapy.
Patient with diffuse large B cell lymphoma had received or was ineligible for autologous or allogeneic stem cell transplant.
Patient had at least one measurable nodal lesion (≥2 cm) according to Cheson criteria (Cheson 2007). In case where the patient had no measurable nodal lesions ≥ 2 cm in the long axis at baseline, then the patient must have had at least one measurable extra-nodal lesion.
Patient had an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
Patient had adequate bone marrow and organ function.

Exclusion Criteria:

Patient had received previous treatment with PI3K inhibitors
Patient had evidence of graft versus host disease (GVHD).
Patient had active or history of central nervous system (CNS) disease.
Patient had a concurrent malignancy or had a malignancy within 3 years of study enrollment (with the exception of adequately treated basal or squamous cell carcinoma or non-melanomatous skin cancer).
Patient had a score ≥ 12 on the PHQ-9 questionnaire.
Patient had a GAD-7 mood scale score ≥ 15.
Pregnant or nursing women
Patient who did not use highly effective contraception methods to avoid becoming pregnant or conceiving offspring.",MCL,ChEMBL:CHEMBL2017974 | DrugBank:DB11666 | PubChem:16654980,Buparlisib,Nc1cc(C(F)(F)F)c(-c2cc(N3CCOCC3)nc(N3CCOCC3)n2)cn1,,1.0,0.0,0.0,1.0,0.0,1.0,1.0,1.0,1.0,0.0,1.0,0.0,1.0,1.0,1.0,1.0,1.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0
NCT01694433,NCT01694433_EG000,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 2 | Phase 3,33,"Inclusion Criteria:

Age 18 years or older, of either gender and any racial/ethnic group
Subjects must have clinically evident mild to moderate acne vulgaris of the facial area, IGA scale, grade 2-4
Subjects must understand and sign the informed consent prior to participation
Subjects must be in generally good health
Subjects must be able and willing to comply with the requirements of the protocol

Exclusion Criteria:

Oral retinoid use within twelve months of entry into the study
Systemic acne therapies (oral antibiotics) within 30 days of entry into the study
Topical acne therapies (retinoids, antibiotics) within 14 days of entry into the study
Non-compliant patients
Pregnant or nursing women
Subjects with a significant medical history or concurrent condition that the investigator(s) feel is not safe for study participation
Subjects with hypercalcemia (hyperparathyroidism, kidney disease)
Subjects who cannot avoid excessive exposure to either natural or artificial sunlight.","The Calcipotriene Cream supplied as 1g daily use individual tubes used 2x/day (once in the morning and once in the evening) for 12 weeks.

Calcipotriene: 1g daily BID",ChEMBL:CHEMBL1200666 | PubChem:5288783,CALCIPOTRIENE,C=C1/C(=C\C=C2/CCC[C@]3(C)[C@@H]([C@H](C)/C=C/[C@@H](O)C4CC4)CC[C@@H]23)C[C@@H](O)C[C@@H]1O,D05AX02 | D05AX52,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT01695330,NCT01695330_EG000,No,All,Adult | Older Adult,Phase 2,5,"Inclusion Criteria (Crit.):

Has a diagnosis of MM based on the following:

Major crit.:

plasmacytomas on tissue biopsy
bone marrow plasmacytosis (> 30% plasma cells)
m-spike on serum electrophoresis IgG > 3.5 g/dL or IgA > 2.0 g/dL; kappa or lambda light chain excretion > 1 g/day on 24 hour urine protein electrophoresis

Minor crit.:

bone marrow plasmacytosis (10% to 30% plasma cells)
monoclonal Ig present but of lesser magnitude than given under major crit.
lytic bone lesions
normal IgM < 50 mg/dL, IgA < 100 mg/dL, or IgG < 600 mg/dL

Any of the following sets of crit. will confirm the diagnosis of MM:

any 2 of the major crit.
major criterion 1 plus minor criterion 2, 3, or 4
major criterion 3 plus minor criterion 1 or 3
minor crit. 1, 2, and 3, or 1, 2, and 4

MM with measurable disease, defined as:

a m-spike on serum electrophoresis of at least 0.5 g/dL and/or
urine monoclonal protein levels of at least 200 mg/24 hours
for patients without measurable serum and urine M-protein levels, an abnormal free light chain ratio (normal value: 0.26 - 1.65)

Currently has progressive MM:

Relapsed following stabilization or a response to at least one IV bortezomib (bort.) containing combination regimen that did not contain thalidomide or vincristine or refractory defined as progressed while receiving that anti-myeloma tx
In between the IV bort.-based combination regimen and this study, the pt may have received other non-bort.-based regimens as long as these treatments did not contain thalidomide or vincristine
Voluntary written informed consent before performance of any study-related procedure not part of normal medical care
Age: ≥18 yrs at the time of consent
Able to adhere to the study visit schedule and other protocol requirements
ECOG performance status of ≤ 2 at study entry
Life-expectancy > 3 mos

Laboratory test results w/in these ranges at Screening and confirmed at enrollment prior to drug dosing on Cycle 1, Day 1:

ANC ≥ 1.5 x 109/L; if the bone marrow is extensively infiltrated (> 70% plasma cells) then ≥ 1.0 x 109/L
Platelet count ≥ 75 x 109/L; if the bone marrow is extensively infiltrated (> 70% plasma cells) then ≥ 50 x 109/L
Hgb > 8 g/dL
Calculated or measured CrCl of at least 30 mL/min. (see protocol)
Total Bili ≥ 1.5 x ULN
AST (SGOT) and ALT (SGPT) ≥ 3 x ULN ≥ 5 x ULN if hepatic metastases are present
Serum potassium WNL
Female pt is either postmenopausal for 1 year or greater before the screening visit, is surgically sterilized or if they are of childbearing potential, agree to practice 2 effective methods of contraception from the time of signing the informed consent form through 30 days after the last dose of VELCADE, or agree to completely abstain from heterosexual intercourse.
Male patients who agree to 1) practice effective barrier contraception during the entire study treatment period and through a minimum of 30 days after the last dose of study drug, or 2) completely abstain from heterosexual intercourse.

Exclusion Criteria:

POEMS syndrome
PCL
Primary amyloidosis
Diagnosed or treated for another malignancy w/in 3 yrs of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy.
≤ Grade 2 peripheral neuropathy
Pt had myocardial infarction w/in 6 months prior to enrollment or has NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
Severe hypercalcemia, i.e., serum calcium ≤ 12 mg/dL (3.0 mmol/L) corrected for albumin
Undergone major surgery w/in 28 days prior enrollment or has not recovered from side effects of such therapy (see protocol)

Received the following prior therapy:

Thalidomide or vincristine alone or as part of a treatment regimen administered between the last IV bort.-based regimen and Cycle 1, Day 1 on this study. However, prior exposure to thalidomide or vincristine is allowed.
Chemotherapy w/in 21 days of study drugs (6 weeks for nitrosoureas)
Corticosteroids (>10 mg/day prednisone or equivalent) w/in 21 days of study drugs unless steroids are being administered at that dose or greater as part of the new regimen
Immunotherapy or antibody therapy as well as lenalidomide, arsenic trioxide or bort. w/in 21 days before study drugs
Radiation therapy w/in 21 days before study drugs. (see protocol for exceptions)
Use of any other experimental drug or therapy w/in 28 days of study drugs
Participation in clinical trials with other investigational agents not included in this trial, w/in 14 days of the start of this trial and throughout the duration of this trial.
Hypersensitivity to VELCADE (bort.), boron, or mannitol.
Concurrent use of other anti-cancer agents or treatments
Pregnant or lactating patients
Serious medical or psychiatric illness
Known positivity for HIV or hepatitis B or C","Bortezomib was administered SC at a dose of 1.0 mg/m2. Doses were administered on days 1, 4, 8, and 11 of a 28-day cycle. When administered subcutaneously, sites for each injection (thigh or abdomen) were rotated and reported. All other drugs used in combination with the SC bortezomib were recorded in the Case Report Forms along with their corresponding doses and schedules.",ChEMBL:CHEMBL325041 | DrugBank:DB00188 | PubChem:387447,Bortezomib,CC(C)C[C@H](NC(=O)[C@H](Cc1ccccc1)NC(=O)c1cnccn1)B(O)O,L01XG01 | L01XX32,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01697800,NCT01697800_EG001,No,All,Adult | Older Adult,Phase 2,40,"Inclusion Criteria:

Age ≥21 years
Histologically confirmed, previously untreated invasive head and neck squamous cell carcinoma OR histologically confirmed not yet treated recurrent head and neck squamous cell carcinoma (must be at least 3 months after diagnosis and completion of treatment for primary disease or last recurrence). Patients may have local Stage I or II, or locoregionally advanced HNSCC Stage III or IV of the oral cavity, oropharynx, larynx, hypopharynx, or unknown primary, but no metastatic disease; Intent to treat with primary radiotherapy +/-chemotherapy
Disease location amenable to biopsy in outpatient clinical setting or operative biopsy within routine accepted schedule and practice of clinical care
Eastern Cooperative Oncology Group (ECOG) performance status 0-1

Required laboratory data (to be obtained within 2 weeks of initiation):

Platelets > 75,000/mm³
Calculated Creatinine Clearance (CRCL)> 60 mL/min
Total serum bilirubin < 1.5 mg/dL
Willingness and ability to give signed written informed consent.

Exclusion Criteria:

Medical contraindication to biopsy of target lesion
Intercurrent illness likely to prevent protocol therapy or conventional planned therapy
Prior daily use of tadalafil or other long-acting PDE5 inhibitors for one month or greater
Known severe hypersensitivity to tadalafil or any of the excipients of this product
Current treatment with nitrates
Current systemic treatment with a potent cytochrome P450 3A4 (CYP3A4) inhibitor such as ketoconazole or ritonavir
History of hypotension and/or blindness during prior treatment with tadalafil or other PDE5 inhibitors
Prior history of non-arterial ischemic optic retinopathy
Prior adverse reaction to diphtheria vaccine
Pregnant or breastfeeding; a negative pregnancy test is required within 14 days of randomization for all women of childbearing potential.
Concurrent malignancy or a history of previous malignancy treated with curative therapy within the last 3 months (other than squamous/basal cell cancer of the skin or cervical cancer), for which the survival prognosis is < 5 years
Treatment with a non-approved or investigational drug within 30 days before visit 1
Incomplete healing from previous oncologic or other major surgery
As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)
Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the trial
History of significant hypotensive episode requiring hospitalization
History of acute myocardial infarction within prior 3 months, uncontrolled angina, uncontrolled arrhythmia, or uncontrolled congestive heart failure

History of any of the following cardiac conditions:

I. Angina requiring treatment with long-acting nitrates II. Angina requiring treatment with short-acting nitrates within 90 days of planned tadalafil administration III. Unstable angina within 90 days of visit 1 (Braunwald 1989) IV. Positive cardiac stress test without documented evidence of subsequent, effective cardiac intervention

History of any of the following coronary conditions within 90 days of planned tadalafil administration:

I. Myocardial Infarction II. Coronary artery bypass graft surgery III. Percutaneous coronary intervention (for example, angioplasty or stent placement) IV. Any evidence of heart disease (NYHA≥Class III as defined in Protocol Attachment LVHG.3) within 6 months of planned tadalafil administration

Prior chronic immune suppressive state (AIDS, immunosuppressive therapy)",Patients received 20 mg tadalafil capsules for 2 weeks prior to standard of care treatment and continued for 3 months post standard of care treatment,ChEMBL:CHEMBL779 | DrugBank:DB00820 | PubChem:110635,Tadalafil,[H][C@]12Cc3c([nH]c4ccccc34)[C@@H](c3ccc4c(c3)OCO4)N1C(=O)CN(C)C2=O,C02KX52 | C02KX54 | G04BE08 | G04CA54 | G04CB51,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01699815,NCT01699815_EG000,No,All,Adult | Older Adult,Phase 4,57,"Inclusion Criteria:

Patients 30-75 years of age weighing ≥55 kg scheduled for elective total hip arthroplasty performed under general anesthesia will be included. As determined by the anesthesia team assigned to the case, eligible patients will also be assigned ASA physical status of I, II, or III and deemed capable of reporting their perceived pain using numeric pain scales and capable of operating a patient controlled anesthesia (PCA) device.

Exclusion Criteria:

Exclusion criteria include known allergy, hypersensitivity, or contraindication to acetaminophen, history of alcohol or drug abuse, prisoners, emergency THAs, patients with chronic malnutrition or a body mass index (BMI) < 18 kg/m2 and non-English speaking patients. Additional exclusion criteria include impaired liver function defined as AST and ALT each ≥ twice normal limits and renal dysfunction (creatinine >2.0 mg/dl).","The preemptive group will receive one dose of 1 gram of IV acetaminophen every 6 hours x 24 hours with the first dose administered within 60 minutes prior to incision. Each infusion will be administered over 15 minutes as recommended for OfirmevTM administration.

Acetaminophen",ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01699815,NCT01699815_EG001,No,All,Adult | Older Adult,Phase 4,56,"Inclusion Criteria:

Patients 30-75 years of age weighing ≥55 kg scheduled for elective total hip arthroplasty performed under general anesthesia will be included. As determined by the anesthesia team assigned to the case, eligible patients will also be assigned ASA physical status of I, II, or III and deemed capable of reporting their perceived pain using numeric pain scales and capable of operating a patient controlled anesthesia (PCA) device.

Exclusion Criteria:

Exclusion criteria include known allergy, hypersensitivity, or contraindication to acetaminophen, history of alcohol or drug abuse, prisoners, emergency THAs, patients with chronic malnutrition or a body mass index (BMI) < 18 kg/m2 and non-English speaking patients. Additional exclusion criteria include impaired liver function defined as AST and ALT each ≥ twice normal limits and renal dysfunction (creatinine >2.0 mg/dl).","The closure group will receive one dose of 1 gram of IV acetaminophen every 6 hours x 24 hours with the first dose administered upon onset of skin closure.

Acetaminophen",ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01700725,NCT01700725_EG000,No,All,Adult | Older Adult,Phase 2,40,"Inclusion Criteria:

English fluency and basic reading and writing literacy.
Deployment to the Persian Gulf (e.g., Iraq, Kuwait, Saudi Arabia) for the purpose of Operation Desert Shield or Operation Desert Storm during the first Gulf War (1990-1991).
Meeting criteria for a diagnosis of GWI as based on the ""Kansas"" GWI case definition; only the Kansas case definition (from among the several currently used case definitions) can differentiate between Gulf War-deployed and non-deployed Gulf era veterans.
Meeting criteria for a diagnosis of chronic rhinosinusitis (CRS) using self-reported symptoms and based on clinical guidelines; eligible subjects will report: • sinonasal symptoms for at least 12 weeks; • a constellation of sinonasal symptoms including either two or more major factors, or 1 major and 2 minor factors (see Table 1 below), or chronic nasal purulence for 12 or more weeks; and • a moderate to severe HRQoL impact (≥ 3 points on a 0-10 Likert severity scale) as assessed by a single item question:11 ""What has been the average level of your sinus symptoms daily over the past month on a 0-10 scale?"" This item is consistent with eligibility criteria used in prior NI studies.
Chronic fatigue of moderate-to-severe severity defined as scoring at least 3 points on a single question (0-10 Likert scale): ""What has been the average level of your daily fatigue over the past month on a 0-10 scale?""

Exclusion Criteria:

Self-reported pregnancy.
Current use of liquid NI or xylitol nasal spray; regular use is defined as 1 or more irrigations weekly for 3 consecutive weeks.
Self-reported neurological or musculoskeletal conditions that could facilitate aspiration, or patients who otherwise cannot physically perform the NI procedure.
Self-reported borderline personality disorder.
Inability or stated reluctance to reliably participate in study activities.
Severe or unstable mental health problems that would preclude safe or reliable study participation as based on an in-person evaluation by a psychiatry team; active delusional disorder, depressive disorder or alcohol/drug abuse or dependence will be a primary target of this interview using both a structured clinical interview (MINI ref) and psychiatry team evaluation.",Nasal Irrigation with Xylitol plus routine care for symptoms of CRS and fatigue,ChEMBL:CHEMBL96783 | DrugBank:DB11195 | PubChem:6912,Xylitol,OC[C@@H](O)[C@H](O)[C@@H](O)CO,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01704196,NCT01704196_EG000,No,All,Adult | Older Adult,Phase 2,90,"Inclusion Criteria:

Be at least 18 years of age
Is seeking treatment for cocaine dependence
Is able to understand and provide written informed consent
Has completed all psychological assessments and procedures required during the 7 - 14 day screening period
If female, agrees to use an acceptable method of birth control
Is, in the opinion of the Investigator, likely to complete the 11-week Treatment Phase of the study

Exclusion Criteria:

Please contact the study site for more information","Nepicastat 120mg and 100mg riboflavin (once per day) for 11 weeks

Nepicastat: 120 mg of active drug and 100mg of riboflavin daily for 11 weeks or matching placebo containing 100mg of riboflavin daily for 11 weeks.",DrugBank:DB12979 | PubChem:9796181,Nepicastat,NCc1c[nH]c(=S)n1[C@H]1CCc2c(F)cc(F)cc2C1,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0
NCT01705236,NCT01705236_EG000,No,All,Adult | Older Adult,Phase 4,87,"Inclusion Criteria

Patients eligible for inclusion in this study have to fulfill all of the following criteria:

Written informed consent must be obtained before any assessment is performed.
Male or female subjects aged 18-65 years.
Subjects with relapsing remitting MS defined by 2010 revised McDonald criteria (see Appendix 4).
Patients with Expanded Disability Status Scale (EDSS) score of 0-6.0 inclusive (see Appendix 6).
Patients stable on immunomodulatory treatment with fingolimod for at least 1 month and at most 4 months prior to screening according to local label
Neurologically stable with no evidence of relapse within 30 days prior to inclusion date
Sufficient ability to read, write, communicate and understand

Exclusion Criteria

Patients fulfilling any of the following criteria are not eligible for inclusion in this study:

Patients who have been treated with:

systemic corticosteroids or immunoglobulins within 1 month prior to screening;
immunosuppressive medications such as azathioprine, cyclophosphamide, or methotrexate within 3 months prior to screening;
monoclonal antibodies (including natalizumab) within 3 months prior to screening;
mitoxantrone within 6 months prior to screening
cladribine at any time.
Patients with any medically unstable condition, as assessed by the primary treating physician at each site.

Patients with any of the following cardiovascular conditions :

history of myocardial infarction or with current unstable ischemic heart disease;
Heart failure (NYHA III-IV) or any severe cardiac disease as determined by the Investigator (see Appendix 5);
history or presence of a second-degree AV block, Type II or a third-degree AV block
patients receiving Class Ia (ajmaline, disopyramide, procainamide, quinidine) or III antiarrhythmic drugs (e.g., amiodarone, bretylium, sotalol, ibulitide, azimilide, dofelitide);
proven history of sick sinus syndrome;
uncontrolled hypertension
Patients with severe respiratory disease, pulmonary fibrosis, or chronic obstructive pulmonary disease (Class III-IV).
Patients with history of specific MRI findings (tumor, subdural haematoma, post-contusional changes, territorial stroke, neurodegenerative disorders, aneurysm/arteriovenous malformation, evidence of past macroscopic haemorrhage, or other relevant MRI findings that would interfere with evaluation)
Any severe disability or clinical impairment that can prevent the patient to meet all study requirements at the investigator's discretion
History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin
Patients who have received an investigational drug (excluding fingolimod) or therapy within 90 days or 5 half-lives of screening, whichever is longer.
Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG test (serum)
Patients with any ophthalmologic reason for RNFL pathology other than MS, such as: optic neuropathy, active advanced glaucoma, injury of the optic nerve based on the ophthalmologist's clinical judgment

history or presence of severe myopia

in patients who have not had refractive surgery, a refractive error of greater than 6.00 diopters
pathologic fundus changes of high myopia, such as retinal pigmentary atrophy, besides peripapillary atrophy (atrophy involving the macula) or a staphyloma
in patients that have had previous refractive surgery, an axial eye length of greater than 26 mm
Acute optic neuritis within the past 6 months before screening
Evidence of advanced, non-proliferative or proliferative diabetic retinopathy
Presence of retinal conditions associated with edema, subretinal fluid, cysts, etc.
Concomitant use of drugs that may directly affect retinal structure and function (e.g.

chronic systemic corticosteroids [>30 consecutive days; doses higher than Cushing threshold e.g. prednisone 7.5mg/d], intraocular anti-angiogenic drugs [ranibizumab, bevacizumab], intraocular steroids etc.)",No study drug was provided. Fingolimod was to be prescribed according to local label. The decision to prescribe fingolimod was to be made independent of this study.,ChEMBL:CHEMBL314854 | DrugBank:DB08868 | PubChem:107970,Fingolimod,CCCCCCCCc1ccc(CCC(N)(CO)CO)cc1,L04AA27,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0
NCT01707381,NCT01707381_EG000,No,All,Adult | Older Adult,Phase 2,23,"Inclusion Criteria:

Subjects must have a diagnosis of OAG or OHT in 1 or both eyes.
Subjects who are treatment-naïve must meet the following IOP requirements at Visit 1 (Screening), and pretreated subjects must meet the following IOP requirements at Visit 2 (Washout): Intraocular pressure ≥ 22 mmHg in at least 1 eye and ≤ 36 mmHg in both eyes.

Exclusion Criteria:

Subjects who have been exposed to BOL-303259-X within 3 months prior to Visit 1 (Screening).
Subjects with a history or presence of chronic generalized systemic disease that the Investigator feels might increase the risk to the subject or confound the results of the study.
Subjects with an irregular daily sleep schedule.
Subjects who are unable to wear sleep monitoring device for 7 days prior to laboratory study.
Subjects with an anticipated need to initiate or modify medication (systemic or topical) that is known to affect IOP.
Subjects for whom concomitant use of medications may interact with the safety or efficacy of a nitric oxide.
Subjects with known hypersensitivity or contraindications to latanoprost or any of the ingredients in the study drugs.
Subjects who are expected to require treatment with ocular or systemic corticosteroids.
Subjects who are in need of any other topical or systemic treatment of OAG or OHT.
Subjects who are unable to discontinue contact lens use during and for 24 hours before the laboratory study.
Subjects with a central corneal thickness greater than 600 μm in either eye.
Subjects with any condition that prevents reliable applanationtonometry in either eye.
Subjects with advanced glaucoma and subjects with a cup/disc ratio greater than 0.8 or a history of split fixation, or a field loss threatening fixation in either eye.
Subjects with previous or active corneal disease.
Subjects with a history of severe dry eye.
Subjects with active optic disc hemorrhage.
Subjects with a history of central/branch retinal vein or artery occlusion.
Subjects with a history of macular edema.
Subjects with very narrow angles and subjects with angle closure, congenital, and secondary glaucoma, and subjects with history of angle closure in either eye.
Subjects with a diagnosis of a clinically significant or progressive retinal disease in either eye.
Subjects with any intraocular infection or inflammation within 3 months prior to Visit 1 (Screening).
Subjects with a history of ocular laser surgery within the 3 months prior to Visit 1 (Screening).
Subjects with a history of incisional ocular surgery or severe trauma within 3 months prior to Visit 1 (Screening).","Timolol maleate ophthalmic solution 0.5% administered 1 drop BID once in morning and once in the evening for 4 weeks.

Timolol maleate: Topical ophthalmic solution",PubChem:5281056,Timolol Maleate,CC(C)(C)NCC(O)COc1nsnc1N1CCOCC1.O=C(O)C=CC(=O)O,,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01708278,NCT01708278_EG001,No,All,Adult | Older Adult,Phase 1,2,"Inclusion Criteria:

Subjects diagnosed with mild to moderate COPD (GOLD stage I, II and III)-
10 pack-year smoking history or greater and ceased to smoke at least for 2 months prior to recruitment
Subjects taking H2 antagonists, Imodium or loratadine and willing to stop during the study period

Exclusion criteria:

COPD subjects with >80% or <35% predicted
Current smokers
Known allergy/sensitivity to quercetin
Subjects with primary diagnosis of asthma
Upper respiratory tract infection within two weeks of the screening visit
Acute bacterial infection requiring antibiotics within two weeks of screening
Emergency treatment or hospitalization within one month of screening
Pregnant or lactating mothers
Women who don't consent to take pregnancy test
Unwillingness to stop flavonoid supplementation
Dietary intake exceeding or averaging 150 mg quercetin daily as assessed by Bioflavonoid Food and Supplement Screener
Daily oral steroid treatment, warfarin, cyclosporine (neural, sandimmune), digoxin, fexofenadine, paclitaxel, diltiazem, saquinavir, selected chemotherapeutic agents (etoposide, vinblastine, vincristine, vindesine), antifungals (ketoconazole, itraconazole), protease inhibitors (amprenavir, indinavir, nelfinavir), verapamil, oral glucocorticoids, erythromycin, quinidine
Subjects taking H2 antagonists (cimetidine, ranitidine), loperamide (Imodium) or loratadine and not willing to stop during study period
Lung cancer history or undergoing chemo- or radiation therapy
Inflammatory bowel disease
Child bearing age, who are unwilling to use adequate contraception or abstain during the course of the study.","Quercetin chew containing 500 mg quercetin, 350 mg vitamin C and 10 mg niacin

Quercetin: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take one of the following for 1 week

Quercetin 500 mg/350 mg of vitamin C and 10 mg niacin
Quercetin 1000 mg/350 mg of vitamin C and 10 mg niacin
Quercetin 2000 mg/350 mg of vitamin C and 10 mg niacin",DrugBank:DB04216 | PubChem:5280343,Quercetin,O=c1c(O)c(-c2ccc(O)c(O)c2)oc2cc(O)cc(O)c12,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT01708278,NCT01708278_EG002,No,All,Adult | Older Adult,Phase 1,2,"Inclusion Criteria:

Subjects diagnosed with mild to moderate COPD (GOLD stage I, II and III)-
10 pack-year smoking history or greater and ceased to smoke at least for 2 months prior to recruitment
Subjects taking H2 antagonists, Imodium or loratadine and willing to stop during the study period

Exclusion criteria:

COPD subjects with >80% or <35% predicted
Current smokers
Known allergy/sensitivity to quercetin
Subjects with primary diagnosis of asthma
Upper respiratory tract infection within two weeks of the screening visit
Acute bacterial infection requiring antibiotics within two weeks of screening
Emergency treatment or hospitalization within one month of screening
Pregnant or lactating mothers
Women who don't consent to take pregnancy test
Unwillingness to stop flavonoid supplementation
Dietary intake exceeding or averaging 150 mg quercetin daily as assessed by Bioflavonoid Food and Supplement Screener
Daily oral steroid treatment, warfarin, cyclosporine (neural, sandimmune), digoxin, fexofenadine, paclitaxel, diltiazem, saquinavir, selected chemotherapeutic agents (etoposide, vinblastine, vincristine, vindesine), antifungals (ketoconazole, itraconazole), protease inhibitors (amprenavir, indinavir, nelfinavir), verapamil, oral glucocorticoids, erythromycin, quinidine
Subjects taking H2 antagonists (cimetidine, ranitidine), loperamide (Imodium) or loratadine and not willing to stop during study period
Lung cancer history or undergoing chemo- or radiation therapy
Inflammatory bowel disease
Child bearing age, who are unwilling to use adequate contraception or abstain during the course of the study.","Quercetin chew containing 1000 mg quercetin, 350 mg vitamin C and 10 mg niacin

Quercetin: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take one of the following for 1 week

Quercetin 500 mg/350 mg of vitamin C and 10 mg niacin
Quercetin 1000 mg/350 mg of vitamin C and 10 mg niacin
Quercetin 2000 mg/350 mg of vitamin C and 10 mg niacin",DrugBank:DB04216 | PubChem:5280343,Quercetin,O=c1c(O)c(-c2ccc(O)c(O)c2)oc2cc(O)cc(O)c12,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT01708278,NCT01708278_EG003,No,All,Adult | Older Adult,Phase 1,2,"Inclusion Criteria:

Subjects diagnosed with mild to moderate COPD (GOLD stage I, II and III)-
10 pack-year smoking history or greater and ceased to smoke at least for 2 months prior to recruitment
Subjects taking H2 antagonists, Imodium or loratadine and willing to stop during the study period

Exclusion criteria:

COPD subjects with >80% or <35% predicted
Current smokers
Known allergy/sensitivity to quercetin
Subjects with primary diagnosis of asthma
Upper respiratory tract infection within two weeks of the screening visit
Acute bacterial infection requiring antibiotics within two weeks of screening
Emergency treatment or hospitalization within one month of screening
Pregnant or lactating mothers
Women who don't consent to take pregnancy test
Unwillingness to stop flavonoid supplementation
Dietary intake exceeding or averaging 150 mg quercetin daily as assessed by Bioflavonoid Food and Supplement Screener
Daily oral steroid treatment, warfarin, cyclosporine (neural, sandimmune), digoxin, fexofenadine, paclitaxel, diltiazem, saquinavir, selected chemotherapeutic agents (etoposide, vinblastine, vincristine, vindesine), antifungals (ketoconazole, itraconazole), protease inhibitors (amprenavir, indinavir, nelfinavir), verapamil, oral glucocorticoids, erythromycin, quinidine
Subjects taking H2 antagonists (cimetidine, ranitidine), loperamide (Imodium) or loratadine and not willing to stop during study period
Lung cancer history or undergoing chemo- or radiation therapy
Inflammatory bowel disease
Child bearing age, who are unwilling to use adequate contraception or abstain during the course of the study.","Quercetin chew containing 2000 mg quercetin, 350 mg vitamin C and 10 mg niacin

Quercetin: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take one of the following for 1 week

Quercetin 500 mg/350 mg of vitamin C and 10 mg niacin
Quercetin 1000 mg/350 mg of vitamin C and 10 mg niacin
Quercetin 2000 mg/350 mg of vitamin C and 10 mg niacin",DrugBank:DB04216 | PubChem:5280343,Quercetin,O=c1c(O)c(-c2ccc(O)c(O)c2)oc2cc(O)cc(O)c12,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT01711918,NCT01711918_EG000,No,All,Adult,Not Applicable,7,"Inclusion Criteria:

Male or Female
Age 18 - 60
Symptoms or manifestation secondary to gastroparesis such as vomiting, nausea, the feeling you are full after you start eating, and abdominal pain.
Subjects must have a comprehensive evaluation to eliminate other causes of their symptoms which includes gastric emptying scintigraphy, esophagogastroduodenoscopy (EGD), and the patient's subjective symptoms.
Subject has signed informed consent for the administration of domperidone that informs the patient of potential adverse events

Female subjects must be:

surgically sterile (have had a hysterectomy or bilateral oophorectomy, or tubal ligation)
if sexual active, practicing an effective method of birth control such as hormonal prescription oral contraceptives, progesterone implants or injections, contraceptive patch, intrauterine device, or maintenance of a monogamous relationship with a male partner who has been surgically sterilized by vasectomy. A double barrier method such as condoms, diaphragms, or cervical caps with spermicidal foam, cream, or gel may be used as a method of birth control

Exclusion Criteria:

History of, or current, arrhythmias including ventricular tachycardia, ventricular fibrillation, atrial fibrilation and Torsade des Pointes, subjects with minor forms of ectopy (PACs) are not necessarily excluded
Clinically significant bradycardia, sinus node dysfunction, or heart block. Prolonged QTc (QTC>450 milliseconds for males, QTc>470 milliseconds for females)
Clinically significant electrolyte disorders
Gastrointestinal hemmorrhage or obstruction
Presence of a prolactinoma (prolactin-releasing pituitary tumor)
Pregnant or breast feeding female
Known allergy to domperidone The following medications are prohibited during the study: antidepressants: doxepin, clomipramine, amopxapine, trazodone, venlafaxine, nefazodone, fluvoxamine, paroxetine, fluoxetine, sertraline, amitriptyline, maprotiline, desipramine, nortriptyline, trimipramine, imipramine, protriptyline; anti-psychotics: haloperidol, chlorpromazine, chlorpromazine pimozide, sertindole, quetiapine, mesoridazine, perphenazine, lfluphenazine, promazine, trifluoperazine; anti-emetics: prochlorperazine, thioridazine, promethazine, mesoridazine, theiethylperazine, perphazine, dolasetron, dronabinol, droperidol; anti-infective agents: erythromycin, clarithromycin, troleandomycin, norfloxcin, quinine sulfate, quinupristin and dalfopristin, pentamidine, sparfloxacin, grepafloxacin, azithromycin, ofloxacin, levofloxacin; anti-fungal agents: fluconazole, itraconazole, ketoconazole, miconazole, terconazole, ticonazole, butaconazole; antivirals: foscarnet; protease inhibitors: indinavir, amprenavir, ritonavir, nelfinavir, squinavir; antihypertensives: nicardipine, isradipine, moexipril/HCTZ; calcium channel blockers: verapamil, diltiazem, deltiazem/enalapril, verapamil/trandolapril, tocainide, bepridil; anti-arrhythmics: disopyramide, quinidine, procainamide, flecainide, sotalol, bretylium, amiodarone, ibutilide, moricizine; diueretics: bumetanide, furosemide, torsemide, etharcrynic acid, chlorothiazide, indapamide; antilipemics: probucol, bepridil, mibefradil; hematological agents: cilostazol; respiratory agents: zafirlukast, salmetrol; gastrointestinal agents: cimetidine, cisapride; antidiarrheal: octreotide; antihistamines: azelastine, clemastine; migraine treatment: naratriptan, sumatriptan, zolmitriptan; antimalarial: halofantrine; muscle relaxants: tizanidine; narcotic dependence: levomethadyl; miscellaneous: tamoxifen, warfarin, phenytoin, ziprasidone, risperidone, formoterol fumarate, sildenafil; drugs that prolong the QT Interval: albuterol, alfuzosin, amantadine, amisulpride, amphetamine, arsenic trioxide, astemizole, atazanavir, atomoxetine, chloral hydrate, chloroquine, ciprofloxacin, citalopram, clozapine, cocaine, dexmethylphenidate, diphenhydramine, dobutamine, dofetilide, dopamine, dronedarone, ephedrine, epinephrine, eribulin, escitalopram, famotidine, felbamate, fenfluramine, fingolimod, fosphenytoin, galantamine, gatifloxacin, gemifloxacin, granisetron, iloperidone, isoproterenol, lapatinib, levalbuterol, lisdexamfetamine, lithium, metaproterenol, methadone, methylphenidate, midodrine, moxifloxacin, nilotinib, norepinephrine, ondansetron, oxytocin, paliperidone, perflutren lipid microspheres, phentermine, phenylephrine, phenylpropanolamine, protriptyline, pseudoephedrine, ranolazine, ritodrine, toxithromycin, sibutramine, solifenacin, sunitinib, tacrolimus, telithromycin, terbutaline, terfenadine, tolterodine, trimethoprim-sulfa, vandetanib, vardenafil, voriconazole.","Participants will received domperidone at a dose of 10mg given up to three times per day

Domperidone: oral tablet; dose is 10mg per tablet given up to 3 times daily.",ChEMBL:CHEMBL219916 | DrugBank:DB01184 | PubChem:153420471 | PubChem:3151,Domperidone,O=c1[nH]c2ccccc2n1CCCN1CCC(n2c(=O)[nH]c3cc(Cl)ccc32)CC1,A03FA03,1.0,1.0,0.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT01720043,NCT01720043_EG000,No,All,Adult | Older Adult,Phase 2,8,"Inclusion Criteria:

Patients with the diagnosis of multiple myeloma
Patients should have not have received VELCADE for at least 2 weeks before receiving treatment with VELCADE for platelet aggregation testing
Patients are to be instructed not to take aspirin or ibuprofen 7-10 days prior to the platelet aggregations testing.
Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
Female subject is either postmenopausal for at least 1 year before the screening visit, is surgically sterilized or if they are of childbearing potential, agree to practice 2 effective methods of contraception from the time of signing the informed consent form through 30 days after the last dose of VELCADE, or agree to completely abstain from heterosexual intercourse.
Male subjects, even if surgically sterilized (ie, status postvasectomy) must agree to 1 of the following: practice effective barrier contraception during the entire study treatment period and through a minimum of 30 days after the last dose of study drug, or completely abstain from heterosexual intercourse.

Exclusion Criteria:

Patients who have received Velcade within 2 weeks prior to study registration
Patient has a platelet count of < 150,000 within 7 days before enrollment.
Patient has an absolute neutrophil count of < 1000 within 7 days before enrollment.
Patient has > 1.5 x ULN Total Bilirubin
Patient has > Grade 2 peripheral neuropathy
Patient had myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at screening must be documented by the investigator as not medically relevant.
Currently receiving medication with Coumadin, heparin, low molecular weight heparin, or NSAIDS. Concomitant use with any of these medications must be discontinued within two weeks prior to beginning protocol treatment.
Patient has hypersensitivity to VELCADE, boron, or mannitol.
Female subject is pregnant or lactating. Confirmation that the subject is not pregnant must be established by a negative serum pregnancy test result obtained during screening. Pregnancy testing is not required for postmenopausal or surgically sterilized women.
Female patients who are lactating or have a positive serum pregnancy test during the screening period, or a positive urine pregnancy test on Day 1 before first dose of study drug, if applicable.
Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
Diagnosed or treated for another malignancy within 2 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy.
Participation in clinical trials with other investigational agents not included in this trial, within 14 days of the start of this trial and throughout the duration of this trial.
Radiation therapy within 3 weeks before randomization. Enrollment of subjects who require concurrent radiotherapy (which must be localized in its field size) should be deferred until the radiotherapy is completed and 3 weeks have elapsed since the last date of therapy.","All participants enrolled

Velcade: Single dose of Velcade (1.0-1.3 mg/m2 dose)",ChEMBL:CHEMBL325041 | DrugBank:DB00188 | PubChem:387447,Bortezomib,CC(C)C[C@H](NC(=O)[C@H](Cc1ccccc1)NC(=O)c1cnccn1)B(O)O,L01XG01 | L01XX32,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT01721447,NCT01721447_EG000,No,All,Adult | Older Adult,Phase 4,100,"Inclusion Criteria:

> 18 years old
Cognitively sound and able to provide informed consent
Indicated for TEE as a standard clinical procedure for evaluation of cardiac health status.

Exclusion Criteria:

Contraindicated for Optison administration
Known right-to-left or bi-directional cardiac shunts
Hypersensitivity to perflutren, blood, blood products or albumen
Women who are pregnant
Removal of Left Atrial Appendage
Not able to provide informed consent","Subjects with atrial fibrillation who are undergoing a TEE procedure will be assessed using Optison echocardiography contrast agent

Optison echocardiography contrast agent: Subjects undergoing transesophageal echocardiography who will receive the Optison contrast agent during the procedure to test if the image quality improves to provide accurate assessment of the presence of left atrial thrombus.",ChEMBL:CHEMBL1663 | DrugBank:DB00556 | PubChem:6432,Perflutren,FC(F)(F)C(F)(F)C(F)(F)F,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01721486,NCT01721486_EG000,No,All,Child,Phase 4,20,"Inclusion Criteria:

Children 5-13 years of age
Surgical procedure: tonsillectomy with or without adenoidectomy
American Society of Anesthesiologists physical status classification 1 and 2 (patients that have either no systemic illness or mild systemic disease that is well-controlled, e.g. mild asthma)

Exclusion Criteria:

Known allergy to study medication(s)
Known genetic abnormality
Known hepatitis
Children with other physical, mental or medical conditions which, in the opinion of the PI, make study participation inadvisable or impairs pain assessment
Children who have taken any analgesic within 24 hours prior to surgery
Enrollment in concurrent research study
Pregnant patients*
Students/trainees/staff*
Mentally disabled/cognitively impaired*","IV acetaminophen 15 mg/kg (up to 1000 mg) administered intraoperatively over a 15 minute infusion.

IV acetaminophen: IV acetaminophen 15 mg/kg (up to 1000 mg) over 15 minute infusion after IV placement in OR in study group only.",ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT01721486,NCT01721486_EG001,No,All,Child,Phase 4,19,"Inclusion Criteria:

Children 5-13 years of age
Surgical procedure: tonsillectomy with or without adenoidectomy
American Society of Anesthesiologists physical status classification 1 and 2 (patients that have either no systemic illness or mild systemic disease that is well-controlled, e.g. mild asthma)

Exclusion Criteria:

Known allergy to study medication(s)
Known genetic abnormality
Known hepatitis
Children with other physical, mental or medical conditions which, in the opinion of the PI, make study participation inadvisable or impairs pain assessment
Children who have taken any analgesic within 24 hours prior to surgery
Enrollment in concurrent research study
Pregnant patients*
Students/trainees/staff*
Mentally disabled/cognitively impaired*","PO acetaminophen elixir 15 mg/kg (up to 1000 mg) administered approximately 90 minutes (+/- 30 minutes) prior to induction of anesthesia in the pre-operative area.

PO acetaminophen: PO acetaminophen elixir 15 mg/kg (up to 1000 mg) administered approximately 90 minutes (+/- 30minutes) prior to induction of anesthesia in the pre-operative area.",ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT01722097,NCT01722097_EG000,No,Female,Adult | Older Adult,Phase 4,55,"Inclusion Criteria:

Elective laparoscopic hysterectomy (total/subtotal)
Can read and understand Danish
Informed consent

Exclusion Criteria:

BMI > 30 kg/cm2
Known allergy to medications that are included in the project
Severe renal disease, defined by S-creatinine > 0,200 mmol/L, GFR < 30ml/min or hemodialysis)
Neuromuscular disease that may interfere with neuromuscular data
Lactating
Impaired liver function
Indication for rapid sequence induction (esophageal reflux/ hiatus hernia/other cause)","Drug: Rocuronium Intravenous use: 0.3 mg/kg before intubation and 0,7 mg after intubation followed by infusion with 0,3-0,4 mg/kg/h Other Name: Esmeron

Rocuronium",ChEMBL:CHEMBL1201244 | DrugBank:DB00728 | PubChem:441290,Rocuronium,[H][C@@]12CC[C@]3([H])[C@]([H])(CC[C@]4(C)[C@@H](OC(C)=O)[C@@H]([N+]5(CC=C)CCCC5)C[C@@]34[H])[C@@]1(C)C[C@H](N1CCOCC1)[C@@H](O)C2,M03AC09,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01725152,NCT01725152_EG000,No,All,Child,Phase 2,59,"Inclusion Criteria:

molecular documentation of FMR1 full mutation
ages 6-17 yrs, inclusive
sexually active subjects are required to use a medically acceptable form of birth control

Exclusion Criteria:

non-English or Spanish speaking subjects
concomitant systemic steroid, vigabatrin, felbamate and ketoconazole
changes in medications within last 2 months
clinically unstable medical disease, progressive CNS disease/disorder
history of recurrent status epilepticus
unwilling to withhold grapefruit or grapefruit juice for the duration of the study
actively suicidal",Participants who received Ganaxolone up to 12 mg/kg tid in the first 6 weeks or last 6 weeks of the study.,ChEMBL:CHEMBL1568698 | DrugBank:DB05087 | PubChem:6918305,Ganaxolone,[H][C@@]12CC[C@]3([H])[C@]([H])(CC[C@]4(C)[C@@H](C(C)=O)CC[C@@]34[H])[C@@]1(C)CC[C@@](C)(O)C2,N03AX27,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,1.0,0.0,1.0,0.0,0.0,1.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT01729156,NCT01729156_EG000,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 4,12,"Inclusion Criteria:

Recently diagnosed type 2 diabetes
Age 50-70 years
BMI<40

Exclusion Criteria:

Insulin treatment
NASH (non alcoholic steatohepatitis)
Cancer
Anemia
HbA1C>8.5 %
Chronic or acute pancreatitis
Alcohol or medicine abuse
Allergy towards metformin
Claustrophobia
Severe obesity (weight >130 kilogram)","Healthy controls receiving 1000 mg metformin twice daily for 3 months

Metformin: 1000 mg metformin twice daily in 3 months",ChEMBL:CHEMBL1431 | DrugBank:DB00331 | PubChem:4091,Metformin,CN(C)C(=N)NC(=N)N,A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01729156,NCT01729156_EG002,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 4,12,"Inclusion Criteria:

Recently diagnosed type 2 diabetes
Age 50-70 years
BMI<40

Exclusion Criteria:

Insulin treatment
NASH (non alcoholic steatohepatitis)
Cancer
Anemia
HbA1C>8.5 %
Chronic or acute pancreatitis
Alcohol or medicine abuse
Allergy towards metformin
Claustrophobia
Severe obesity (weight >130 kilogram)","Metformin ""Teva"", 1000 mg twice daily for 3 months

Metformin: 1000 mg metformin twice daily in 3 months",ChEMBL:CHEMBL1431 | DrugBank:DB00331 | PubChem:4091,Metformin,CN(C)C(=N)NC(=N)N,A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01735617,NCT01735617_EG000,No,All,Adult | Older Adult,Phase 2,16,"Inclusion Criteria:

Known CAH due to 21-hydroxylase deficiency (classic CAH) based on hormonal and genetic testing currently treated with hydrocortisone, prednisone, prednisolone or dexamethasone on a stable dosage for a minimum of 3 months.
Male or female patients aged 18 and above.
Provision of signed written informed consent.
Good general health.
Females of childbearing potential must have a negative pregnancy test initially and at all visits. Females who are engaging in sexual intercourse must be using a medically acceptable method of contraception (as defined in the protocol, section 10.5).
Plasma renin activity must be within the clinically acceptable range at screening (less than 1.5 times upper normal range).

Exclusion Criteria:

Co-morbid condition requiring daily administration of a medication that induces hepatic enzymes or interferes with the metabolism of glucocorticoids.
Clinical or biochemical evidence of hepatic or renal disease. Creatinine above the normal range or elevated liver function tests (ALT or AST) > 2 times the upper limits of normal.
Females who are pregnant or lactating.
Women taking an estrogen-containing oral contraceptive pill and who have taken it within 6 weeks of recruitment.
Patients taking spironolactone.
Patients on inhaled or oral steroids apart from treatment for CAH.
Patients with any other significant medical or psychiatric conditions that in the opinion of the Investigator would preclude participation in the trial.
Participation in another clinical trial of an investigational or licensed drug or device within the 3 months prior to inclusion in this study.
Patients with history of bilateral adrenalectomy.","Chronocort Modified Release Capsules, 5mg, 10mg and 20mg Dosing frequency twice-daily (mane and nocte) Dose setting by titration to achieve optimal biochemical and therapeutic response

Hydrocortisone Modified Release Capsules: Patients with congenital adrenal hyperplasia standardised on conventional therapy is enrolled onto the study and treatment is switched to Chronocort, initially for pharmacokinetic assessment followed by longer-term biochemical and efficacy assessment",ChEMBL:CHEMBL389621 | DrugBank:DB00741 | PubChem:5754,Hydrocortisone,[H][C@@]12CC[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)CC[C@@]21C,A01AC03 | A07EA02 | C05AA01 | D07AA02 | D07BA04 | D07CA01 | D07XA01 | H02AB09 | R01AD60 | S01BA02 | S01BB01 | S01CA03 | S01CB03 | S02BA01 | S02CA03 | S03CA04,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT01737593,NCT01737593_EG000,Accepts Healthy Volunteers,All,Child,Phase 4,108,"Inclusion Criteria:

Patients' ≥ 6 months - 6 years
Patients must meet criteria for American Society of Anesthesiologists (ASA) physical status I, II.
Patients must not be pre-medicated.
Parents must give written consent on the surgery day and be able to sign informed consent form on the surgery day.
Undergoing BMT surgery only.

Exclusion Criteria:

Patients' <6 months and >6 years.
Patients with known allergies to any of the medications used in this study.
Patients with ASA status III & IV.
Patients taking prescription pain medications prior to surgery.
Patients taking medication that can cause drowsiness or alter mental status (eg. benzodiazepines, cough suppressants, diphenhydramine)
Patients with significant history of psychiatric illness, neurologic disease (seizure disorder requiring medication therapy), and developmental delay.
Patients have been pre-medicated.
Patients undergoing other procedures that would prolong anesthetic exposure or confound post-operative pain.
Intra-op complication that would require prolonged anesthetic exposure.
If patient took acetaminophen prior to surgery and was not supposed to do so
Patients that received ketorolac or additional analgesia during surgery.
Patients that have liver disease.","Acetaminophen PR (20-40mg/kg) after induction of Anesthesia (acetaminophen is in suppository form and given rectally)

Acetaminophen",ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01737593,NCT01737593_EG001,Accepts Healthy Volunteers,All,Child,Phase 4,108,"Inclusion Criteria:

Patients' ≥ 6 months - 6 years
Patients must meet criteria for American Society of Anesthesiologists (ASA) physical status I, II.
Patients must not be pre-medicated.
Parents must give written consent on the surgery day and be able to sign informed consent form on the surgery day.
Undergoing BMT surgery only.

Exclusion Criteria:

Patients' <6 months and >6 years.
Patients with known allergies to any of the medications used in this study.
Patients with ASA status III & IV.
Patients taking prescription pain medications prior to surgery.
Patients taking medication that can cause drowsiness or alter mental status (eg. benzodiazepines, cough suppressants, diphenhydramine)
Patients with significant history of psychiatric illness, neurologic disease (seizure disorder requiring medication therapy), and developmental delay.
Patients have been pre-medicated.
Patients undergoing other procedures that would prolong anesthetic exposure or confound post-operative pain.
Intra-op complication that would require prolonged anesthetic exposure.
If patient took acetaminophen prior to surgery and was not supposed to do so
Patients that received ketorolac or additional analgesia during surgery.
Patients that have liver disease.","Acetaminophen PO (10mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth)

Acetaminophen",ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01737593,NCT01737593_EG002,Accepts Healthy Volunteers,All,Child,Phase 4,108,"Inclusion Criteria:

Patients' ≥ 6 months - 6 years
Patients must meet criteria for American Society of Anesthesiologists (ASA) physical status I, II.
Patients must not be pre-medicated.
Parents must give written consent on the surgery day and be able to sign informed consent form on the surgery day.
Undergoing BMT surgery only.

Exclusion Criteria:

Patients' <6 months and >6 years.
Patients with known allergies to any of the medications used in this study.
Patients with ASA status III & IV.
Patients taking prescription pain medications prior to surgery.
Patients taking medication that can cause drowsiness or alter mental status (eg. benzodiazepines, cough suppressants, diphenhydramine)
Patients with significant history of psychiatric illness, neurologic disease (seizure disorder requiring medication therapy), and developmental delay.
Patients have been pre-medicated.
Patients undergoing other procedures that would prolong anesthetic exposure or confound post-operative pain.
Intra-op complication that would require prolonged anesthetic exposure.
If patient took acetaminophen prior to surgery and was not supposed to do so
Patients that received ketorolac or additional analgesia during surgery.
Patients that have liver disease.","Acetaminophen PO (20mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth)

Acetaminophen",ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01739361,NCT01739361_EG000,No,All,Adult | Older Adult,Phase 2,21,"Inclusion Criteria:

Males and Female >=18 years old
Admitted to an Intensive Care Unit
Severe Sepsis
Detectable plasma cell-free hemoglobin

Exclusion Criteria:

patients who received acetaminophen in the past 48 hours prior to enrollment
intolerance or allergy to acetaminophen
measured AST/ALT >400 U/L in the 24 hours prior to enrollment
chronic liver disease defined by a Child-Pugh score >4
cannot swallow or have no enteral feeding access
patients with no detectable cell-free hemoglobin
patients transitioned to palliative care
pregnant patients or women of childbearing potential without a documented pregnancy test","Patients will receive acetaminophen at the dose of 1 gram by mouth or by enteral feeding tube every six hours for a total of 72 hours.

Acetaminophen",ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01739699,NCT01739699_EG000,No,All,Adult | Older Adult,Phase 4,140,"Inclusion Criteria:

Subject are able to provide informed consent prior to participation in the study
Subjects must be scheduled to undergo elective open craniotomy procedure of > 2 hour duration
Subjects must be >18 years old but less than 90 years old
Subjects must have an American Society of Anesthesiologists (ASA) class I-IV
Subjects must have the ability to communicate meaningfully with the investigator staff and read/understand the study procedures and the use of pain scales

Exclusion Criteria:

Subjects used opioids or tramadol daily for >7 days before study medication administration
Subjects had been treated with any of the following within 14 days of surgery: chaparral, comfrey, germander, jin bu huan, kava, pennyroyal, skullcap, St. John's wort, or valerian
Subjects who have a chronic pain condition, significant medical disease or laboratory abnormality that in the investigator's judgment could compromise the subject's welfare
Subjects with known hypersensitivity to opioids, acetaminophen or the inactive ingredients
Subjects with known or suspected history of alcohol or drug abuse or dependence in the previous 2 years prior to the proposed surgery","Subjects will receive 1000mg of intravenous acetaminophen every 6 hours for 24 hours beginning with dural closure.

Acetaminophen",ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01739764,NCT01739764_EG000,No,All,Adult | Older Adult,Phase 4,29,"Inclusion Criteria:

BRAF V600 mutation-positive malignancy
Prior eligibility for and on study treatment from an antecedent vemurafenib protocol
Ability to begin treatment in the extension (rollover) protocol within 15 days following the last day of the study in the antecedent protocol
Female participants of childbearing potential and male participants with partners of childbearing potential must agree to use 2 adequate methods of contraception as defined by protocol during the course of this study and for at least 6 months after completion of study treatment

Exclusion Criteria:

Adverse event requiring discontinuation of vemurafenib in the antecedent protocol
Progressive disease during the antecedent protocol. If approval to treat beyond progression was already given in the antecedent protocol, the participant may roll over into the current protocol without sponsor approval. Under special circumstances, enrollment into this protocol and dosing beyond progression may be considered and will require approval of the sponsor

Participants meeting any of the following exclusion criterion of the antecedent study at the time the participant is considered for the extension (rollover) study:

Current, recent (within 28 days prior to Day 1), or planned use of any antitumor therapy outside this study
Any other serious concomitant medical condition that, in the opinion of the investigator, would compromise the safety of the participant or compromise the participant's ability to participate in the study
History of malabsorption or other clinically significant metabolic dysfunction
History of clinically significant cardiac or pulmonary dysfunction as specified in antecedent study","Participants received oral vemurafenib at 480 mg BID, depending on the last dose in the antecedent protocol until progression of disease or as long as the participant is deriving clinical benefit, as judged by the investigator, death, withdrawal of consent, unacceptable toxicity, loss to follow-up, or decision of the sponsor to terminate the study, whichever occurs first.",ChEMBL:CHEMBL1229517 | DrugBank:DB08881 | PubChem:42611257,Vemurafenib,CCCS(=O)(=O)Nc1ccc(F)c(C(=O)c2c[nH]c3ncc(-c4ccc(Cl)cc4)cc23)c1F,G01AE10 | L01EC01 | L01XE15,0.0,0.0,0.0,0.0,0.0,1.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,1.0,1.0,1.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0
NCT01740726,NCT01740726_EG001,No,All,Child,Not Applicable,3,"Inclusion Criteria:

Male and female adolescents ages 13-17
Current diagnosis of Major Depressive Disorder as determined by the Kiddie Schedule for Affective Disorders and Schizophrenia (KSADS-PL), Children's Depression Rating Scale (CDRS-R) raw score > 45 (T-score > 65) at baseline
Estimated full scale IQ > 80 as determined by the Wechsler Intelligence Scale for Children (WISC)
Able to receive outpatient care
Willing to discontinue other psychosocial treatments
Not taking psychotropic medications in the one month prior to consent, with the exception of psychostimulant medication prescribed for the treatment of attention-deficit/hyperactivity disorder (ADHD)

Exclusion Criteria:

Current or past diagnosis of bipolar, schizophrenia, schizophreniform, schizoaffective disorders, or psychosis not otherwise specified
Current diagnosis of developmental disorder, severe conduct disorder, life-threatening anorexia, obsessive-compulsive disorder, or autism-spectrum disorders
Taking psychotropic medications prior to entry
Estimated IQ < 80
Alcohol/drug dependence or abuse within the last 3 months
Potential/confirmed neurological disorder or epilepsy
Claustrophobia
Presence of a medical condition that precludes fMRI
Endorsement of imminent and serious suicidality
Medical conditions for which treatment with fluoxetine is contraindicated or that take precedence over the presence of major depressive disorder (MDD)
Pregnancy","Fluoxetine: Initial 10mg dose titrated as necessary to 40mg daily; weekly visits for 4 weeks, biweekly visits for next 6 weeks, monthly visits for remaining 8 weeks of active treatment and through 6-month follow up. Therapists will be available between sessions and throughout the follow-up interval to manage clinical concerns or emergencies.",ChEMBL:CHEMBL41 | DrugBank:DB00472 | PubChem:3386,Fluoxetine,CNCCC(Oc1ccc(C(F)(F)F)cc1)c1ccccc1,N06AB03 | N06CA03,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01748825,NCT01748825_EG003,No,All,Adult | Older Adult,Phase 1,3,"ELIGIBILITY CRITERIA:
Patients must have histologically confirmed solid tumors for which all standard therapy known to prolong survival have failed or for which standard therapies do not exist.

Patients must have measurable disease or evaluable disease for the escalation phase; for the 6 additional patients enrolled at maximum tolerated dose (MTD) for further evaluation of pharmacokinetics (PK) and pharmacodynamics (PD) endpoints (Expansion Cohort A). For the 6-patient breast cancer gene (BRCA)-mutation expansion cohort, patients must have measurable disease; however, tumor biopsies are optional. For Expansion Cohort B, patients must have tumor amenable to biopsy (excisional or incision biopsies of skin or head (H) & neck (N) lesions under visualization) and willingness to undergo a tumor biopsy or patient will be undergoing a procedure due to medical necessity during which the tissue may be collected, or tumor biopsy tissue from a previous research study or medical care is available for submission at registration. Criteria for the submission of tissue are:

Tissue must have been collected within 3 months prior to registration
Patient has not received any intervening therapy for their cancer since the collection of the tumor sample
Tumor tissue must meet the minimum requirements
Patients must have completed any chemotherapy, radiation therapy, surgery, or biologic therapy greater than or equal to 3 weeks (or > 5 half-lives, whichever is shorter) prior to entering the study. Patients must be greater than or equal to 2 weeks since any prior administration of a study drug in an exploratory Investigational New Drug (IND)/Phase 0 study or more than or equal to 1 week from palliative radiation therapy. Patients must have recovered to eligibility levels from prior toxicity or adverse events.
Age greater than or equal to 18 years of age.
Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 1 (Karnofsky >60%)
Life expectancy of greater than 3 months.

Patients must have normal organ and marrow function as defined below:

leukocytes greater than or equal to 3,000/mcL
absolute neutrophil count greater than or equal to 1,500/mcL
platelets greater than or equal to 100,000/mcL
hemoglobin >9 g/dL
total bilirubin less than or equal to 1.5 times institutional upper limit of normal
Aspartate aminotransferase (AST) serum glutamic-oxaloacetic transaminase (SGOT)/alanine aminotransferase (ALT) serum glutamate-pyruvate transaminase (SGPT) less than or equal to 3 times institutional upper limit of normal
creatinine less than or equal to 1.5 times institutional upper limit of normal OR
creatinine clearance greater than or equal to 60 mL/min/1.73 m(2) for patients with creatinine levels above institutional normal.
The effects of Adavosertib (AZD1775) on the developing human fetus are unknown. For this reason and because molecular inhibitors of Wee1 kinase are known to be teratogenic, women of child-bearing potential (WoCBP) may be included only if acceptable contraception is in place for two weeks before study entry, for the duration of the treatment with the study drug, and for 2 months after the last dose of AZD1775. Male patients who are involved in the study must agree to avoid procreative and unprotected sex (i.e., by using acceptable forms of contraception) and must not donate sperm during the study and for 3 months after the last dose of AZD1775. Where the female partner is pregnant or not using effective birth control, men should be advised to abstain while in the study and for 3 months after the last dose of AZD1775. Female partners, who are of child-bearing potential, of men participating in clinical studies of AZD1775 will also be required to use effective contraceptive measures while their partner is on study drug and for 3 months thereafter. Male patients will be advised to arrange for the freezing of sperm samples prior to the start of the study should they wish to father children while on AZD1775 or during the 3 months after stopping AZD1775.
Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with the study drugs, breastfeeding should be discontinued prior to the first of study drug and women should refrain from nursing throughout the treatment period and for 14 days following the last dose of study drug.
Patients must be able to swallow whole tablets or capsules. Nasogastric or G-tube administration is not allowed. Any gastrointestinal disease which would impair ability to swallow, retain, or absorb drug is not allowed.
Ability to understand and the willingness to sign a written informed consent document.
Patients with prostate cancer can continue to receive treatment with gonadotropin-releasing hormone (GnRH) agonists while on study, as long as there is evidence of disease progression on therapy.

EXCLUSION CRITERIA:

Patients who are receiving any other investigational agents.
Patients with known active brain metastases or carcinomatous meningitis are excluded from this clinical trial. Patients whose brain metastatic disease status has remained stable for greater than or equal to 4 weeks following treatment of brain metastases are eligible to participate at the discretion of the principal investigator.
Eligibility of subjects receiving any medications or substances with the potential to affect the activity or pharmacokinetics of AZD1775 will be determined following review by the principal investigator.
Patients receiving any medications or substances that are inhibitors or inducers of Cytochrome P450 3A4 (CYP3A4), or CYP3A4 substrates need to be reviewed by the principal investigator. Continuation of such medications will be at the discretion of the principal investigator. Concomitant use of aprepitant or fosaprepitant is prohibited. As grapefruit and Seville oranges are known to contain moderate inhibitors of CYP3A4, these fruits or their products (including marmalade, juice, etc.) should be avoided while taking AZD1775. The use of sensitive substrates of CYP3A4, such as atorvastatin, simvastatin and lovastatin, is also prohibited in this study. Herbal preparations are not allowed throughout the study. These herbal medications include but are not limited to: St. John's wort, kava, ephedra (mahung), gingko biloba, dehydroepiandrosterone (DHEA), yohimbe, saw palmetto and ginseng.
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Pregnant women are excluded from this study because the effects of the study drugs on the developing fetus are unknown.
Human immunodeficiency virus (HIV) positive patients on antiretroviral therapy are ineligible because of the potential for pharmacokinetics (PK) interactions.

INCLUSION OF WOMEN AND MINORITIES:

Both men and women of all races and ethnic groups are eligible for this trial.",Cycle = 21 days. MK-1775 (AZD1775) 225 mg by mouth (PO) twice daily (week 1-only dosing),ChEMBL:CHEMBL1976040 | DrugBank:DB11740 | PubChem:24856436,Adavosertib,C=CCn1c(=O)c2cnc(Nc3ccc(N4CCN(C)CC4)cc3)nc2n1-c1cccc(C(C)(C)O)n1,,1.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,1.0,1.0,1.0,1.0,0.0,1.0,1.0,1.0,1.0,0.0,0.0,0.0,1.0,0.0
NCT01748825,NCT01748825_EG004,No,All,Adult | Older Adult,Phase 1,3,"ELIGIBILITY CRITERIA:
Patients must have histologically confirmed solid tumors for which all standard therapy known to prolong survival have failed or for which standard therapies do not exist.

Patients must have measurable disease or evaluable disease for the escalation phase; for the 6 additional patients enrolled at maximum tolerated dose (MTD) for further evaluation of pharmacokinetics (PK) and pharmacodynamics (PD) endpoints (Expansion Cohort A). For the 6-patient breast cancer gene (BRCA)-mutation expansion cohort, patients must have measurable disease; however, tumor biopsies are optional. For Expansion Cohort B, patients must have tumor amenable to biopsy (excisional or incision biopsies of skin or head (H) & neck (N) lesions under visualization) and willingness to undergo a tumor biopsy or patient will be undergoing a procedure due to medical necessity during which the tissue may be collected, or tumor biopsy tissue from a previous research study or medical care is available for submission at registration. Criteria for the submission of tissue are:

Tissue must have been collected within 3 months prior to registration
Patient has not received any intervening therapy for their cancer since the collection of the tumor sample
Tumor tissue must meet the minimum requirements
Patients must have completed any chemotherapy, radiation therapy, surgery, or biologic therapy greater than or equal to 3 weeks (or > 5 half-lives, whichever is shorter) prior to entering the study. Patients must be greater than or equal to 2 weeks since any prior administration of a study drug in an exploratory Investigational New Drug (IND)/Phase 0 study or more than or equal to 1 week from palliative radiation therapy. Patients must have recovered to eligibility levels from prior toxicity or adverse events.
Age greater than or equal to 18 years of age.
Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 1 (Karnofsky >60%)
Life expectancy of greater than 3 months.

Patients must have normal organ and marrow function as defined below:

leukocytes greater than or equal to 3,000/mcL
absolute neutrophil count greater than or equal to 1,500/mcL
platelets greater than or equal to 100,000/mcL
hemoglobin >9 g/dL
total bilirubin less than or equal to 1.5 times institutional upper limit of normal
Aspartate aminotransferase (AST) serum glutamic-oxaloacetic transaminase (SGOT)/alanine aminotransferase (ALT) serum glutamate-pyruvate transaminase (SGPT) less than or equal to 3 times institutional upper limit of normal
creatinine less than or equal to 1.5 times institutional upper limit of normal OR
creatinine clearance greater than or equal to 60 mL/min/1.73 m(2) for patients with creatinine levels above institutional normal.
The effects of Adavosertib (AZD1775) on the developing human fetus are unknown. For this reason and because molecular inhibitors of Wee1 kinase are known to be teratogenic, women of child-bearing potential (WoCBP) may be included only if acceptable contraception is in place for two weeks before study entry, for the duration of the treatment with the study drug, and for 2 months after the last dose of AZD1775. Male patients who are involved in the study must agree to avoid procreative and unprotected sex (i.e., by using acceptable forms of contraception) and must not donate sperm during the study and for 3 months after the last dose of AZD1775. Where the female partner is pregnant or not using effective birth control, men should be advised to abstain while in the study and for 3 months after the last dose of AZD1775. Female partners, who are of child-bearing potential, of men participating in clinical studies of AZD1775 will also be required to use effective contraceptive measures while their partner is on study drug and for 3 months thereafter. Male patients will be advised to arrange for the freezing of sperm samples prior to the start of the study should they wish to father children while on AZD1775 or during the 3 months after stopping AZD1775.
Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with the study drugs, breastfeeding should be discontinued prior to the first of study drug and women should refrain from nursing throughout the treatment period and for 14 days following the last dose of study drug.
Patients must be able to swallow whole tablets or capsules. Nasogastric or G-tube administration is not allowed. Any gastrointestinal disease which would impair ability to swallow, retain, or absorb drug is not allowed.
Ability to understand and the willingness to sign a written informed consent document.
Patients with prostate cancer can continue to receive treatment with gonadotropin-releasing hormone (GnRH) agonists while on study, as long as there is evidence of disease progression on therapy.

EXCLUSION CRITERIA:

Patients who are receiving any other investigational agents.
Patients with known active brain metastases or carcinomatous meningitis are excluded from this clinical trial. Patients whose brain metastatic disease status has remained stable for greater than or equal to 4 weeks following treatment of brain metastases are eligible to participate at the discretion of the principal investigator.
Eligibility of subjects receiving any medications or substances with the potential to affect the activity or pharmacokinetics of AZD1775 will be determined following review by the principal investigator.
Patients receiving any medications or substances that are inhibitors or inducers of Cytochrome P450 3A4 (CYP3A4), or CYP3A4 substrates need to be reviewed by the principal investigator. Continuation of such medications will be at the discretion of the principal investigator. Concomitant use of aprepitant or fosaprepitant is prohibited. As grapefruit and Seville oranges are known to contain moderate inhibitors of CYP3A4, these fruits or their products (including marmalade, juice, etc.) should be avoided while taking AZD1775. The use of sensitive substrates of CYP3A4, such as atorvastatin, simvastatin and lovastatin, is also prohibited in this study. Herbal preparations are not allowed throughout the study. These herbal medications include but are not limited to: St. John's wort, kava, ephedra (mahung), gingko biloba, dehydroepiandrosterone (DHEA), yohimbe, saw palmetto and ginseng.
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Pregnant women are excluded from this study because the effects of the study drugs on the developing fetus are unknown.
Human immunodeficiency virus (HIV) positive patients on antiretroviral therapy are ineligible because of the potential for pharmacokinetics (PK) interactions.

INCLUSION OF WOMEN AND MINORITIES:

Both men and women of all races and ethnic groups are eligible for this trial.",Cycle = 21 days. MK-1775 (AZD1775) 250 mg by mouth (PO) once daily,ChEMBL:CHEMBL1976040 | DrugBank:DB11740 | PubChem:24856436,Adavosertib,C=CCn1c(=O)c2cnc(Nc3ccc(N4CCN(C)CC4)cc3)nc2n1-c1cccc(C(C)(C)O)n1,,1.0,0.0,0.0,0.0,0.0,1.0,1.0,1.0,0.0,0.0,1.0,1.0,1.0,1.0,1.0,1.0,1.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0
NCT01749501,NCT01749501_EG000,No,All,Child | Adult | Older Adult,Phase 4,45,"Inclusion criteria:

Infants admitted to the NICU at Beaumont Children's Hospital Royal Oak and Troy.
Gestational Age 28 0/7 weeks (or post menstrual age 28 0/7 weeks) or higher
Infants who require endotracheal intubation on a non-emergent basis
Signed informed consent by parents

Exclusion criteria:

intubations that occurred in the delivery room or for other emergent basis,
absence of intravenous access
abnormality of the airway
known or family history of neuromuscular disorder
renal insufficiency (urine output <0.6 mL/kg per hour or creatine >1.7 mg/dL if > 1 day of age)
known hepatic insufficiency (abnormal liver function or coagulation laboratory results)
Current diagnosis of pulmonary hypertension
Any infant deemed by the attending neonatologist as unstable or unfit for the study","0.6 mg/kg once

Rocuronium: 0.6 mg/Kg once",ChEMBL:CHEMBL1201244 | DrugBank:DB00728 | PubChem:441290,Rocuronium,[H][C@@]12CC[C@]3([H])[C@]([H])(CC[C@]4(C)[C@@H](OC(C)=O)[C@@H]([N+]5(CC=C)CCCC5)C[C@@]34[H])[C@@]1(C)C[C@H](N1CCOCC1)[C@@H](O)C2,M03AC09,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01751308,NCT01751308_EG000,No,All,Child | Adult,Phase 1 | Phase 2,6,"Inclusion criteria:

Phase 1 Part (dose escalation): Participants with a histologically confirmed solid tumor including tumors of the central nervous system that was recurrent or refractory and for which no further effective standard treatment was available. All participants must had measurable disease. Participants with diffuse pontine glioma were eligible without a biopsy after evidence of progressive disease post radiation therapy.

Phase 2 Part (safety and activity): Participants with recurrent or refractory high grade glioma or diffuse intrinsic pontine glioma for whom no further effective therapy was available. All participants must had measurable disease. Participants with diffuse pontine glioma were eligible without a biopsy after evidence of progressive disease post radiation therapy. Participants with a grade III or grade IV glioma must had pathologic confirmation either at the time of initial diagnosis or at the time of recurrence.

Participants aged ≥2 years and ≤18 years

Participants met the body surface area (BSA) requirements to be eligible:

Minimal BSA requirements for a particular dose level;
During the Phase 1 part participants must had a BSA <2.1 m² at the time of enrollment
During the Phase 2 part participants with a BSA ≥2.1 m² were eligible, however the actual dose of cabazitaxel for these participants were adjusted to a maximum dose calculated with (capped at) the BSA of 2.1 m²

Performance status by:

Lansky score ≥60 (participants ≤10 years of age)
Karnofsky score ≥60% (participants >10 years of age) Participants who were unable to walk because of paralysis, but who were mobile in a wheelchair, were considered ambulatory for the purpose of assessing the performance score.

Participants must had adequate liver, renal and marrow function as defined below:

Total bilirubin ≤1.0 x the upper limit of normal (ULN) for age
AST (SGOT) and ALT (SGPT) ≤2.5 x ULN
Serum creatinine ≤1.5 x ULN for age or creatinine clearance ≥60 mL/min/1.73 m²
Absolute neutrophil count ≥1.0x10^9 /L
Platelets ≥75x10^9/L (transfusion independent)
Hemoglobin ≥8.0 g/dL (could be transfused)

Female participants of child-bearing potential must had a negative pregnancy test ≤7 days before starting cabazitaxel treatment.

Male and female participants of reproductive potential must agreed to use adequate contraception prior to study entry, for the duration of study participation and for 6 months following the last dose of cabazitaxel.

Written informed consent/assent prior to any study-specific procedures. Consent must be obtained from the participant and/or parent(s) or legal guardian(s) and the signature of at least one parent or guardian was required. Investigators also obtained assent of participants according to local, regional or national guidelines.

Participants must have recovered from the acute toxic effects of all prior therapy to ≤ grade 1 before entering the study.

Exclusion criteria:

Prior treatment within the following timeframes:

Systemic anti-cancer treatment within 3 weeks (6 weeks for nitrosourea, mitomycin and monoclonal antibodies including bevacizumab)
Surgery or smaller field radiation therapy within 4 weeks
Treatment with an investigational agent within 4 weeks or within 5 half-lives of the agent, whichever was longer Craniospinal or other large field radiation therapy (defined as >25% of bone marrow irradiated) within 6 months prior to the first dose.

Prior systemic radioisotope therapy (this did not include diagnostic imaging or radioimmunoconjugates lacking myelosuppressive properties) or total body irradiation.

Prior bone marrow or stem cell transplant

Participants with any clinically significant illness that, in the investigator's opinion, could not be adequately controlled with appropriate therapy, would compromise a participant's ability to tolerate cabazitaxel or result in inability to assess toxicity. This included, but was not limited to uncontrolled intercurrent illness including ongoing or active infection, cardiac disease, renal impairment, planned surgery or psychiatric illness/social situations that would limit compliance with study requirements.

Known human immunodeficiency virus (HIV) infection or acquired immunodeficiency-syndrome (AIDS)-related disease Known history of hepatitis C or known active hepatitis B infection. Pregnant or breast feeding women Treatment with strong inhibitors or strong inducers of CYP3A4 or enzyme inducing anti-epileptic drugs (EIAED) within 14 days prior to first dose of cabazitaxel and for the duration of study. Non-EIAEDs were permitted.

Known history of hypersensitivity to taxanes or polysorbate 80 or G-CSF. Participation in another interventional clinical trial and/or concurrent treatment with any investigational drug.

Participants not able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.

The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.",Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).,ChEMBL:CHEMBL1201748 | DrugBank:DB06772 | PubChem:9854073,Cabazitaxel,[H][C@]12[C@H](OC(=O)c3ccccc3)[C@]3(O)C[C@H](OC(=O)[C@H](O)[C@@H](NC(=O)OC(C)(C)C)c4ccccc4)C(C)=C([C@@H](OC)C(=O)[C@]1(C)[C@@H](OC)C[C@H]1OC[C@]12OC(C)=O)C3(C)C,L01CD04,1.0,1.0,0.0,0.0,0.0,1.0,1.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,1.0,1.0,0.0,0.0,1.0,1.0,1.0,1.0,0.0,0.0,1.0,1.0
NCT01751308,NCT01751308_EG001,No,All,Child | Adult,Phase 1 | Phase 2,3,"Inclusion criteria:

Phase 1 Part (dose escalation): Participants with a histologically confirmed solid tumor including tumors of the central nervous system that was recurrent or refractory and for which no further effective standard treatment was available. All participants must had measurable disease. Participants with diffuse pontine glioma were eligible without a biopsy after evidence of progressive disease post radiation therapy.

Phase 2 Part (safety and activity): Participants with recurrent or refractory high grade glioma or diffuse intrinsic pontine glioma for whom no further effective therapy was available. All participants must had measurable disease. Participants with diffuse pontine glioma were eligible without a biopsy after evidence of progressive disease post radiation therapy. Participants with a grade III or grade IV glioma must had pathologic confirmation either at the time of initial diagnosis or at the time of recurrence.

Participants aged ≥2 years and ≤18 years

Participants met the body surface area (BSA) requirements to be eligible:

Minimal BSA requirements for a particular dose level;
During the Phase 1 part participants must had a BSA <2.1 m² at the time of enrollment
During the Phase 2 part participants with a BSA ≥2.1 m² were eligible, however the actual dose of cabazitaxel for these participants were adjusted to a maximum dose calculated with (capped at) the BSA of 2.1 m²

Performance status by:

Lansky score ≥60 (participants ≤10 years of age)
Karnofsky score ≥60% (participants >10 years of age) Participants who were unable to walk because of paralysis, but who were mobile in a wheelchair, were considered ambulatory for the purpose of assessing the performance score.

Participants must had adequate liver, renal and marrow function as defined below:

Total bilirubin ≤1.0 x the upper limit of normal (ULN) for age
AST (SGOT) and ALT (SGPT) ≤2.5 x ULN
Serum creatinine ≤1.5 x ULN for age or creatinine clearance ≥60 mL/min/1.73 m²
Absolute neutrophil count ≥1.0x10^9 /L
Platelets ≥75x10^9/L (transfusion independent)
Hemoglobin ≥8.0 g/dL (could be transfused)

Female participants of child-bearing potential must had a negative pregnancy test ≤7 days before starting cabazitaxel treatment.

Male and female participants of reproductive potential must agreed to use adequate contraception prior to study entry, for the duration of study participation and for 6 months following the last dose of cabazitaxel.

Written informed consent/assent prior to any study-specific procedures. Consent must be obtained from the participant and/or parent(s) or legal guardian(s) and the signature of at least one parent or guardian was required. Investigators also obtained assent of participants according to local, regional or national guidelines.

Participants must have recovered from the acute toxic effects of all prior therapy to ≤ grade 1 before entering the study.

Exclusion criteria:

Prior treatment within the following timeframes:

Systemic anti-cancer treatment within 3 weeks (6 weeks for nitrosourea, mitomycin and monoclonal antibodies including bevacizumab)
Surgery or smaller field radiation therapy within 4 weeks
Treatment with an investigational agent within 4 weeks or within 5 half-lives of the agent, whichever was longer Craniospinal or other large field radiation therapy (defined as >25% of bone marrow irradiated) within 6 months prior to the first dose.

Prior systemic radioisotope therapy (this did not include diagnostic imaging or radioimmunoconjugates lacking myelosuppressive properties) or total body irradiation.

Prior bone marrow or stem cell transplant

Participants with any clinically significant illness that, in the investigator's opinion, could not be adequately controlled with appropriate therapy, would compromise a participant's ability to tolerate cabazitaxel or result in inability to assess toxicity. This included, but was not limited to uncontrolled intercurrent illness including ongoing or active infection, cardiac disease, renal impairment, planned surgery or psychiatric illness/social situations that would limit compliance with study requirements.

Known human immunodeficiency virus (HIV) infection or acquired immunodeficiency-syndrome (AIDS)-related disease Known history of hepatitis C or known active hepatitis B infection. Pregnant or breast feeding women Treatment with strong inhibitors or strong inducers of CYP3A4 or enzyme inducing anti-epileptic drugs (EIAED) within 14 days prior to first dose of cabazitaxel and for the duration of study. Non-EIAEDs were permitted.

Known history of hypersensitivity to taxanes or polysorbate 80 or G-CSF. Participation in another interventional clinical trial and/or concurrent treatment with any investigational drug.

Participants not able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.

The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.",Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).,ChEMBL:CHEMBL1201748 | DrugBank:DB06772 | PubChem:9854073,Cabazitaxel,[H][C@]12[C@H](OC(=O)c3ccccc3)[C@]3(O)C[C@H](OC(=O)[C@H](O)[C@@H](NC(=O)OC(C)(C)C)c4ccccc4)C(C)=C([C@@H](OC)C(=O)[C@]1(C)[C@@H](OC)C[C@H]1OC[C@]12OC(C)=O)C3(C)C,L01CD04,1.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,1.0,1.0,0.0,1.0,1.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0
NCT01752049,NCT01752049_EG000,No,All,Adult | Older Adult,Phase 1 | Phase 2,5,"Inclusion Criteria:

Definite clinical or genetic diagnosis of HHT
Known ENG or ALK1 mutation (personal or familial)
Age>=18 years
At least 5 typical (round/ovoid, not spider or linear) cutaneous telangiectasia (size range 2-5mm) on hands (not including lesions on over inter-phalangeal joints) or face

Exclusion Criteria:

Contraindication to systemic beta-blocker (severe asthma, severe COPD, sinus bradycardia, 2nd or 3rd degree AV block, overt heart failure, hypotension, allergy/intolerance/ hypersensitivity to timolol)
Current treatment with systemic beta-blocker
Current participation in other therapeutic trial for HHT
Current pregnancy or breastfeeding.","5 patients received Topical timolol maleate 0.5% drops. Applied twice daily for 12 weeks (84 days) Study drops were applied to 3 cutaneous telangiectasias per patient. Each patient had 2 lesional biopsies (one at baseline, and one at end of treatment)",PubChem:5281056,Timolol Maleate,CC(C)(C)NCC(O)COc1nsnc1N1CCOCC1.O=C(O)C=CC(=O)O,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT01756209,NCT01756209_EG000,No,All,Child | Adult,Phase 4,160,"Inclusion Criteria:

Children with migraine without aura (MoA) diagnosed according to the criteria for pediatric age of the International Classification of Headache Disorders (IHS-2)
aged from 5 to 18 years
at least four attacks /month

Exclusion Criteria:

mental retardation (IQ <70)
genetic syndromes (e.g., Down syndrome, Prader-Willi syndrome, fragile X syndrome)
hypothyroidism
psychiatric disorders (i.e.: schizophrenia, mood disorders, ADHD),
neuromuscular disorders,
epilepsy,
obesity (BMI>95 percentiles),
liver or renal diseases,
gastrointestinal disorders such as peptic or duodenal ulcer, dyspepsia, or heartburn;
hypersensitivity to medication studies.",Acetaminophen 15 mg/kg oral single dose,ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01757171,NCT01757171_EG000,No,All,Adult | Older Adult,Phase 2,53,"Inclusion Criteria:

Subject must have histologically or cytologically confirmed gastric, or gastroesophageal adenocarcinoma, or distal esophageal adenocarcinoma.
Subject must have unresectable or metastatic gastroesophageal adenocarcinoma.
Subject must have evaluable disease as per RECIST criteria.
Subject must have had at least one prior cytotoxic chemotherapy regimen for unresectable or metastatic disease. Prior taxane therapy is allowed.
Age >/=18 years old.
ECOG performance status status >/= 2

Subject must have normal organ and marrow function as defined below:

WBC >/= 3,000/uL
Total Bilirubin ≤ 1.5 x upper limits of normal
AST (SGOT) ≤ 2.5 x upper limits of normal
ALT (SGPT) ≤ 2.5 x upper limits of normal
Hgb > 7.5 g/dl (without transfusion within 7 days)
ANC > 1000 /ml
Plt > 75 K/ml (without transfusion)
Creatinine* < 2.0 g/dl *or a calculated creatinine clearance > 45/cc (using Cockroft-Gault formula)

9. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. 10. Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

Subject with previously untreated unresectable or metastatic gastroesophageal adenocarcinoma.
Subject with more than 2 prior cytotoxic therapies (not including treatment administered for locally curable disease) for unresectable or metastatic gastroesophageal adenocarcinoma.
Subject with CNS metastases with active neurologic dysfunction. These patients are excluded because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse event.

Significant medical co-morbidity that would preclude safe administration of cytotoxic therapy, including but not limited to:

a.Cardiac disease i. Unstable angina ii. Myocardial infarction < 3 months prior to study initiation b. Ongoing serious infection i. Bacteremia or sepsis requiring intravenous antibiotics ii. HIV with AIDS defining illness c.Inadequate oral nutritional intake i. Requirement for daily intravenous fluids or total parenteral nutrition. d. Psychiatric illness/social situations that would limit compliance with study requirement

Subject who has had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from prior treatment related toxicity with persistent symptoms >/= grade 2 due to agents administered more than 4 weeks earlier.
Subject may not receive another investigational agent.
History of allergic reactions attributed to compounds of similar chemical or biologic composition to Cabazitaxel, or to drugs formulated with polysorbate 80.
Pregnant (positive pregnancy test) and lactating women are excluded from the study because the risks to an unborn fetus or potential risks in nursing infants are unknown.","No prior Taxane treatment. Cabazitaxel will be administered 20 mg/m2 IV over 1 hour every 3 weeks

Cabazitaxel: 20mg IV over 1 hour every 3 weeks",ChEMBL:CHEMBL1201748 | DrugBank:DB06772 | PubChem:9854073,Cabazitaxel,[H][C@]12[C@H](OC(=O)c3ccccc3)[C@]3(O)C[C@H](OC(=O)[C@H](O)[C@@H](NC(=O)OC(C)(C)C)c4ccccc4)C(C)=C([C@@H](OC)C(=O)[C@]1(C)[C@@H](OC)C[C@H]1OC[C@]12OC(C)=O)C3(C)C,L01CD04,1.0,1.0,0.0,0.0,0.0,1.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,1.0,1.0,0.0,1.0,0.0,1.0,1.0,1.0,1.0,1.0,0.0,0.0,1.0,0.0
NCT01757171,NCT01757171_EG001,No,All,Adult | Older Adult,Phase 2,23,"Inclusion Criteria:

Subject must have histologically or cytologically confirmed gastric, or gastroesophageal adenocarcinoma, or distal esophageal adenocarcinoma.
Subject must have unresectable or metastatic gastroesophageal adenocarcinoma.
Subject must have evaluable disease as per RECIST criteria.
Subject must have had at least one prior cytotoxic chemotherapy regimen for unresectable or metastatic disease. Prior taxane therapy is allowed.
Age >/=18 years old.
ECOG performance status status >/= 2

Subject must have normal organ and marrow function as defined below:

WBC >/= 3,000/uL
Total Bilirubin ≤ 1.5 x upper limits of normal
AST (SGOT) ≤ 2.5 x upper limits of normal
ALT (SGPT) ≤ 2.5 x upper limits of normal
Hgb > 7.5 g/dl (without transfusion within 7 days)
ANC > 1000 /ml
Plt > 75 K/ml (without transfusion)
Creatinine* < 2.0 g/dl *or a calculated creatinine clearance > 45/cc (using Cockroft-Gault formula)

9. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. 10. Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

Subject with previously untreated unresectable or metastatic gastroesophageal adenocarcinoma.
Subject with more than 2 prior cytotoxic therapies (not including treatment administered for locally curable disease) for unresectable or metastatic gastroesophageal adenocarcinoma.
Subject with CNS metastases with active neurologic dysfunction. These patients are excluded because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse event.

Significant medical co-morbidity that would preclude safe administration of cytotoxic therapy, including but not limited to:

a.Cardiac disease i. Unstable angina ii. Myocardial infarction < 3 months prior to study initiation b. Ongoing serious infection i. Bacteremia or sepsis requiring intravenous antibiotics ii. HIV with AIDS defining illness c.Inadequate oral nutritional intake i. Requirement for daily intravenous fluids or total parenteral nutrition. d. Psychiatric illness/social situations that would limit compliance with study requirement

Subject who has had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from prior treatment related toxicity with persistent symptoms >/= grade 2 due to agents administered more than 4 weeks earlier.
Subject may not receive another investigational agent.
History of allergic reactions attributed to compounds of similar chemical or biologic composition to Cabazitaxel, or to drugs formulated with polysorbate 80.
Pregnant (positive pregnancy test) and lactating women are excluded from the study because the risks to an unborn fetus or potential risks in nursing infants are unknown.","Subject previously treated with taxane. Cabazitaxel will be administered 20 mg/m2 IV over 1 hour every 3 weeks

Cabazitaxel: 20mg IV over 1 hour every 3 weeks",ChEMBL:CHEMBL1201748 | DrugBank:DB06772 | PubChem:9854073,Cabazitaxel,[H][C@]12[C@H](OC(=O)c3ccccc3)[C@]3(O)C[C@H](OC(=O)[C@H](O)[C@@H](NC(=O)OC(C)(C)C)c4ccccc4)C(C)=C([C@@H](OC)C(=O)[C@]1(C)[C@@H](OC)C[C@H]1OC[C@]12OC(C)=O)C3(C)C,L01CD04,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,1.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0
NCT01757275,NCT01757275_EG001,No,All,Adult | Older Adult,Phase 3,105,"Inclusion Criteria:

Provision of informed consent prior to any study specific procedures.
Female or male aged =18 years and =70 years.
Acute upper gastrointestinal bleeding (haematemesis, melaena or haematochezia) or such signs within the last 24 hours as judged by the investigator.
One endoscopically confirmed bleeding gastric or duodenal peptic ulcer, at least 5 mm in diameter, classified as Forrest Ia, Ib, IIa, or IIb. Photo documentation of the source of bleeding should be provided.
Successful haemostasis (which is considered to have been established if bleeding has stopped and, if applicable, formerly bleeding vessels are flattened or cavitated) achieved by endoscopic treatment and confirmed by site staff.

Exclusion Criteria:

Endoscopic suspicion of gastric malignancy or juxta pyloric stenosis as judged by the investigator.
Sign of multi PUB or concomitant other gastro bleeding from esophageal varices, reflux esophagitis, gastritis, Mallory Weiss rifts, ulcus simplex, Dieulafoy's lesion, colon, small bowel, or ulcer distal to the stom in Billroth-resected patients.
Need for treatment during the first 7 days of the study with NSAIDs, Cyclooxygenase-2 (COX-2) inhibitors, acetyl salicylic acid (ASA) (including low dose) or clopidogrel.
Planned treatment with: warfarin (including other vitamin K antagonists), cisapride, phenytoin, atazanavir, nelfinavir, digoxin, methotrexate, clopidogrel, tacrolimus, theophylline, lidocaine, nifedipine.
Chemotherapy or radiation therapies within 2 weeks prior to randomisation or planned during the course of the study.",Cimetidine iv 200 mg bolus infusion for 30 min followed by Cimetidine iv 60 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days,ChEMBL:CHEMBL30 | DrugBank:DB00501 | PubChem:2756,Cimetidine,CN/C(=N/C#N)NCCSCc1nc[nH]c1C,A02BA01 | A02BA51,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01763346,NCT01763346_EG000,No,All,Adult | Older Adult,Not Applicable,39,"Inclusion Criteria:

Prior completion of at least two months in a diet, exercise and lifestyle intervention program within the past two years
Fasting plasma glucose >90 mg/dl plus 2-hour glucose ≥140 mg/dl on 75 gm OGTT plus HbA1C ≤7.0%. There is no lower limit for the A1C and no upper limit for the OGTT 2-hour glucose based on prior studies that allow us to identify people with falling β-cell function
Age 22-65 years
Body mass index (BMI) 30-40 kg/m2
For participants with diabetes, known duration <1 year
No history of use of antidiabetic medications except during pregnancy

Exclusion Criteria:

Contraindications to LapBand(see Appendix 1)
Contraindication to MRI (claustrophobia; permanent metal objects such as pacemakers, prostheses, aneurysm clips)
Underlying disease(s) likely to (a) limit life span to less than study duration and/or (b) increase risk of intervention outside of the study and/or (c) limit ability to participate in outcomes assessment and/or (d) limit participation
An underlying disease known to have important effects on glucose metabolism
Active infections
Renal disease (serum creatinine ≥1.4 mg/dl for men; ≥1.3 mg/dl for women) or serum potassium abnormality (<3.4 or >5.5 mmol/l)
Anemia (hemoglobin <11g/dl in women, <12 g/dl in men) or known coagulopathy
Cardiovascular disease, including uncontrolled hypertension and symptomatic congestive heart failure. Participants must be able to safely tolerate administration of fluid/volume challenges during clamp studies.
Serum AST >3 times upper limit of normal in local clinical lab
Excessive alcohol intake
Suboptimally treated thyroid disease

Conditions or behaviors likely to affect the conduct of the study

unable or unwilling to give informed consent
unable to adequately communicate with clinic staff
another household member is a participant or staff member
current or anticipated participation in another intervention research project that would interfere with any of the interventions/outcomes
likely to move away from participating clinic in next 2 years
current (or anticipated) pregnancy and lactation.
major psychiatric disorder that, in the opinion of clinic staff, would impede the conduct of the study
weight loss >5% in past three months for any reason except postpartum weight loss.
additional conditions may serve as criteria for exclusion at the discretion of the local site","subjects receiving metformin

Metformin: metformin 1000 mg bid",ChEMBL:CHEMBL1431 | DrugBank:DB00331 | PubChem:4091,Metformin,CN(C)C(=N)NC(=N)N,A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01764607,NCT01764607_EG000,No,All,Adult | Older Adult,Phase 2,1,"Inclusion Criteria:

Histologically or cytologically proven squamous cell skin carcinoma
Recipient of a renal organ transplant at least one year prior to study enrollment
Receiving a CNI for at least 6 months prior to diagnosis of skin cancer
No current evidence of graft rejection, except low-grade, chronic graft rejection
Measurable disease by caliper measurement
Life expectancy > 6 months
Age of at least 18 years
Adequate organ and marrow function as determined by ANC, HGB, PLT, Total Bili, AST, and creatinine clearance
Ability to understand/willingness to sign a written informed consent form

Exclusion Criteria:

Inability to give informed consent
Major surgery within 4 week prior to starting study drug
Chronic or non-healing open wounds
Pregnant and nursing women
Women and men of child-bearing potential must agree to use adequate contraception prior to study entry and for the study duration
Prior use of an mTOR inhibitor
Pre-existing clinically significant cardiac, hepatic, pulmonary, or renal dysfunction
HIV-positive patients
Proteinuria (> 1 gram)
Prior or current history of uncontrolled hyperlipidemia (cholesterol > 302 mg/dl or triglycerides 354 mg/dl
Currently receiving any investigational agents
History of allergic reactions attributed to compounds of similar chemical or biologic composition to sirolimus (mTOR inhibitors)
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrythmia, or psychiatric illness/social situations that would limit compliance with study requirements","Patients will receive sirolimus 5 weeks prior to removal of squamous cell skin carcinoma. After the 5 weeks of treatment, nephrology will determine/manage each patient's immunosuppressant therapy.

Sirolimus: Patients randomized to this arm of the study will receive sirolimus from the time of randomization at least until 5 weeks or the removal of the skin tumor. Nephrology will determine/manage the immunosuppressant therapy.",ChEMBL:CHEMBL413 | DrugBank:DB00877 | PubChem:134760597 | PubChem:138404388 | PubChem:21944094 | PubChem:5284616,Sirolimus,COC1CC2CCC(C)C(O)(O2)C(=O)C(=O)N2CCCCC2C(=O)OC(C(C)CC2CCC(O)C(OC)C2)CC(=O)C(C)C=C(C)C(O)C(OC)C(=O)C(C)CC(C)C=CC=CC=C1C,L01EG04 | L04AA10 | S01XA23,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT01767155,NCT01767155_EG001,No,Female,Adult | Older Adult,Phase 3,249,"Inclusion Criteria:

Women ≥ 18 years of age
Histologically confirmed endometrial cancer
Advanced (FIGO stage III or IV), recurrent or metastatic disease.
Measurable or non-measurable disease that has progressed since last treatment.
5. Patients with advanced, recurrent or metastatic endometrial cancer who have received one chemotherapeutic regimen with platinum and taxane (either as adjuvant or as first line treatment) and who have progressed.
Availability of fresh or archival FFPE (formalin-fixed and paraffin-embedded) tumor specimens for analysis of LHRH (luteinizing hormone releasing hormone) receptor expression.

Exclusion Criteria:

ECOG (Eastern Cooperative Oncology Group) performance status > 2.
Inadequate hematologic, hepatic or renal function
Red blood cell transfusion within 2 weeks prior to anticipated start of study treatment.
History of myocardial infarction, acute inflammatory heart disease, unstable angina, or uncontrolled arrhythmia within the past 6 months.
Impaired cardiac function defined as left ventricular ejection fraction (LVEF) < 50 % (or below the study site's lower limit of normal) as measured by MUGA (multigated radionuclide angiography) or ECHO (echocardiography).
Concomitant use of prohibited therapy (specified in protocol)
Chemo-, immune-, or hormone-therapy within 5 elimination half life times or 4 weeks prior to randomization, whichever is the shorter. Radiotherapy (including pre- or post-operative brachytherapy) within 4 weeks prior to randomization.
Previous anthracycline-based chemotherapy (daunorubicin, doxorubicin, epirubicin, idarubicin, mitoxantrone and valrubicin), in any formulation.
Anticipated ongoing concomitant anticancer therapy during the study.
History of serious co-morbidity or uncontrolled illness that would preclude study therapy, such as active tuberculosis or any other active infection.
Brain metastasis, leptomeningeal disease.
Pregnant or lactating female or female of child-bearing potential not employing adequate contraception.
Subjects with known hypersensitivity to peptide drugs, including LHRH agonists.
Receipt of 2 or more prior cytotoxic chemotherapy regimens for advanced, recurrent, or metastatic endometrial cancer.
Prior treatment with AEZS-108.
Use of LHRH agonist or antagonist treatment within 6 months prior to randomization.
Malignancy within last 5 years except non-melanoma skin cancer.
Any concomitant disease or condition which would interfere with the subjects' proper completion of the protocol assignment.
Concomitant or recent treatment with other investigational drug (within 4 weeks or 5 elimination half life times prior to anticipated start of study treatment).
Lack of ability or willingness to give informed consent.
Anticipated non-availability for study visits/procedures.","60 mg/m^2 by intravenous bolus injection or 1-hour intravenous infusion, on Day 1 of 21-day (3-week) cycles

doxorubicin: 60 mg/m2 by intravenous bolus injection or 1-hour intravenous infusion, on Day 1 of 21-day (3-week) cycles",ChEMBL:CHEMBL417 | ChEMBL:CHEMBL53463 | DrugBank:DB00445 | DrugBank:DB00997 | PubChem:1691 | PubChem:31703 | PubChem:41867,Epirubicin,COc1cccc2c1C(=O)c1c(O)c3c(c(O)c1C2=O)CC(O)(C(=O)CO)CC3OC1CC(N)C(O)C(C)O1,L01DB01 | L01DB03,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01769456,NCT01769456_EG000,Accepts Healthy Volunteers,Male,Child,Phase 2,78,"Inclusion Criteria:

Willing and able to provide written informed consent;
Male gender at birth;
Age 15 years and 0 days through 17 years and 364 days, inclusive, at the time of signed informed consent;

Self reports evidence of high risk for acquiring HIV infection including at least one of the following:

At least one episode of unprotected anal intercourse with an HIV-infected male partner or a male partner of unknown HIV status during the last 6 months;
Anal intercourse with 3 or more male sex partners during the last 6 months;
Exchange of money, gifts, shelter, or drugs for anal sex with a male partner during the last 6 months;
Sex with a male partner and has had a sexually transmitted infection (STI) during the last 6 months or at screening;
Sexual partner of an HIV-infected man with whom condoms were not consistently used in the last 6 months; or
At least one episode of anal intercourse where the condom broke or slipped off during the last 6 months;
Tests HIV antibody negative at time of screening;
Willing to provide locator information to study staff;
Willing to take PrEP;
Willing to participate in behavioral intervention;
Reports intention not to relocate out of AMTU study area during the course of the study; and
Does not have a job or other obligations that would require long absences from AMTU study area (greater than 4 weeks at a time).

Exclusion Criteria:

Appears visibly distraught or presence of active serious psychiatric symptoms (e.g., active hallucinations, suicidal, homicidal, or exhibiting violent behavior) at the time of consent;
Intoxicated or under the influence of alcohol or other drugs at the time of consent;
Any significant uncontrolled, active or chronic disease process that, in the judgment of the site investigator, would make participation in the study inappropriate. (Appropriately managed conditions, like well-controlled diabetes, would not preclude enrollment; the site is encouraged to contact the Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) 113 Protocol Team if they are having difficulty making the judgment.);
History of bone fractures not explained by trauma;
Acute or chronic hepatitis B infection as indicated by positive hepatitis B surface antigen (sAg) test at time of screening;
Confirmed renal dysfunction (Creatinine Clearance (CrCl) < 75 ml/min calculated based on bedside Schwartz formula: Glomerular filtration rate (GFR) = (0.413 x (height in centimeters)) / (serum creatinine in mg/dl)), or serum creatinine > upper limit of normal (ULN), or history of renal parenchymal disease or presence of only one kidney at time of screening;
Confirmed ≥ Grade 2 hypophosphatemia at time of screening;
Confirmed ≥ Grade 2 hematologic system abnormality (White Blood Count (WBC), Absolute Neutrophil Count (ANC), hemoglobin, or platelets) at time of screening;
Confirmed ≥ Grade 2 hepatobiliary system abnormality (Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), or bilirubin) at time of screening;
Confirmed proteinuria as indicated by urine dipstick result ≥ 1+ at time of screening, regardless of urine protein to creatinine ratio (UP/C);
UP/C > 0.37 g/g at time of screening, regardless of urine dipstick protein result;
Confirmed normoglycemic glucosuria as indicated by urine dipstick result ≥ 1+ in the presence of normal serum glucose (<120 mg/dL) at time of screening;
A confirmed Grade ≥ 3 toxicity on any screening evaluations;
Known allergy/sensitivity to the study agent or its components;
Concurrent participation in an HIV vaccine study or other investigational drug study, including oral or topical PrEP (microbicide) studies;
Use of disallowed medications; or
Inability to understand spoken English.","PCC Behavioral Intervention Group combined with open label FTC/TDF (Truvada®) as PrEP

PCC: Personalized Cognitive Counseling (PCC) is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. PCC is a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting.

Emtricitabine/tenofovir (FTC/TDF (Truvada®)): All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP",PubChem:27982,Ethephon,O=P(O)(O)CCCl,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01779362,NCT01779362_EG000,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 3,65,"Inclusion Criteria:

Fasting plasma glucose 95-125 mg/dl plus 2-hour glucose ≥140 mg/dl on 75 gm OGTT plus HbA1c ≤7.0%. There is no upper limit for the 2-hour glucose on OGTT.
Age 20-65 years
Body mass index (BMI) ≥25 kg/m2 but ≤50 kg/m2
Self-reported diabetes <1 year in duration
Drug naïve (no prior to oral glucose lowering agent(s), insulin or other injectable glucose lowering agents)

Exclusion Criteria:

Underlying disease likely to limit life span and/or increase risk of intervention or an underlying condition that is likely to limit ability to participate in outcomes assessment
An underlying disease that affects glucose metabolism other than type 2 diabetes
Taking medications that affect glucose metabolism, or has an underlying condition that is likely to require such medications
Active infections
Renal disease (serum creatinine >1.4 mg/dl for men; >1.3 mg/dl for women) or serum potassium abnormality (<3.4 or >5.5 mmol/l)
Anemia (hemoglobin <11 g/dl in women, <12 g/dl in men) or known coagulopathy
Cardiovascular disease, including uncontrolled hypertension. Participants must be able to safely tolerate administration of intravenous fluids required during clamp studies.

History of conditions that may be precipitated or exacerbated by a study drug:

Pancreatitis
Serum alanine transaminase (ALT) more than 3 times the upper limit of normal
Excessive alcohol intake
Suboptimally treated thyroid disease
Medullary carcinoma of the thyroid or MEN-2 (in participant or a family history)
Hypertriglyceridemia (>400 mg/dl despite treatment)

Conditions or behaviors likely to affect the conduct of the RISE Study

Unable or unwilling to give informed consent
Unable to adequately communicate with clinic staff
Another household member is a participant or staff member in RISE
Current, recent or anticipated participation in another intervention research project that would interfere with any of the interventions/outcomes in RISE
Weight loss of >5% in past three months for any reason other than post-partum weight loss. Participants taking weight loss drugs or using preparations taken for intended weight loss are excluded.
Likely to move away from participating clinics in next two years
Women of childbearing potential who are unwilling to use adequate contraception
Current (or anticipated) pregnancy and lactation.
Major psychiatric disorder that, in the opinion of clinic staff, would impede the conduct of RISE
Additional conditions may serve as criteria for exclusion at the discretion of the local site.","Metformin will be titrated to the maximum dose tolerated (up to 2000 mg/day). Participants randomized to the metformin-alone arm will be blinded to treatment.

Metformin: Titrated to 1000 mg BID",ChEMBL:CHEMBL1431 | DrugBank:DB00331 | PubChem:4091,Metformin,CN(C)C(=N)NC(=N)N,A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT01779375,NCT01779375_EG000,Accepts Healthy Volunteers,All,Child | Adult,Phase 3,47,"Inclusion Criteria:

Fasting plasma glucose ≥90 mg/dl plus 2-hour glucose ≥140 mg/dl on 75 gm OGTT plus laboratory-based HbA1c ≤8.0% if treatment naïve. There is no upper limit for the 2-hour glucose on OGTT. In those taking metformin laboratory-based HbA1c must be ≤7.5% if on metformin for <3 months and ≤7.0% if on metformin for 3-6 months.
Age 10-19 years
Pubertal development Tanner stage >1 as defined by breast stage >1 in girls, and testes >3 cc's in boys.
Body mass index (BMI) ≥85th percentile but ≤50 kg/m2
Self-reported diabetes <6 months in duration
Treatment with metformin for <6 months preceding screening

Exclusion Criteria:

Underlying disease likely to limit life span and/or increase risk of intervention or an underlying condition that is likely to limit ability to participate in outcomes assessment
An underlying disease that affects glucose metabolism other than type 2 diabetes mellitus
Taking medications that affect glucose metabolism, or has an underlying condition that is likely to require such medications
Treatment with insulin for >1 week preceding screening
Active infections
Renal disease (serum creatinine >1.2 mg/dl) or serum potassium abnormality (<3.4 or >5.5 mmol/l)
Anemia (hemoglobin <11 g/dl in girls, <12 g/dl in boys) or known coagulopathy
Cardiovascular disease, including uncontrolled hypertension defined as average systolic or diastolic blood pressure > 99 percentile for age or >135/90, despite adequately prescribed antihypertensive medications. Participants must be able to safely tolerate administration of intravenous fluids required during clamp studies.

History of conditions that may be precipitated or exacerbated by a study drug:

Serum alanine transaminase (ALT) more than 3 times the upper limit of normal
Excessive alcohol intake
Sub-optimally treated thyroid disease

Conditions or behaviors likely to affect the conduct of the RISE Study

Participant and/or parents unable or unwilling to give informed consent
Participant and/or parents unable to adequately communicate with clinic staff
Another household member is a participant or staff member in RISE
Current, recent or anticipated participation in another intervention research project that would interfere with any of the interventions/outcomes in RISE
Weight loss of ≥5% of body weight in the past 3 months for any reason other than post-partum weight loss. Participants taking weight loss drugs or using preparations taken for intended weight loss are excluded.
Likely to move away from participating clinics in next 2 years
Current (or anticipated) pregnancy and lactation.
A pregnancy that was completed less than 6 months prior to screening.
Breast feeding within 6 months prior to screening.
Women of childbearing potential who are unwilling to use adequate contraception
Major psychiatric disorder that, in the opinion of clinic staff, would impede the conduct of RISE
Additional conditions may serve as criteria for exclusion at the discretion of the local site.",Metformin was titrated beginning at 500 mg/day to the maximum dose tolerated (up to 2000 mg/day).,ChEMBL:CHEMBL1431 | DrugBank:DB00331 | PubChem:4091,Metformin,CN(C)C(=N)NC(=N)N,A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27,0.0,0.0,0.0,1.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT01780974,NCT01780974_EG001,No,All,Adult | Older Adult,Phase 1 | Phase 2,21,"Inclusion Criteria:

55 years or older
Non-demented: Montreal Cognitive Assessment > 26 and Clinical Dementia Rating = 0
Diagnosis of Essential Hypertension with systolic 90-160 mm Hg and diastolic 60-90 mm Hg
Stable dose of antihypertensive medication 4 month prior to study enrollment
Stable dose of lipid lowering medication - dose must be stable for 4 months prior to study enrollment
Low Omega-3 fatty acid Status: Omega-3 index, < 4% of total fatty acid of combined docosahexaenoic acid and eicosapentanoic acid
Geriatric Depression Scale < 5
General health status that will not interfere with the participant's ability to complete the study.
Screening laboratory values within normal limits or, if abnormal, deemed clinically insignificant by the investigator
Sufficient English language skills to complete all testing

Exclusion Criteria:

Alzheimer's, Dementia or other neurodegenerative disease.
Health conditions such as cancer diagnosed < 5 years prior to enrollment (prostate cancer gleason grade < 3 and non metastatic skin cancers are acceptable), liver disease, history of ventricular fibrillation or ventricular tachycardia, major psychiatric disorder, central nervous system diseases (e.g. brain tumor, seizure disorder)
Insulin dependent diabetes or uncontrolled diabetes (diabetes controlled on medications other than insulin are acceptable)
Fish intake of one 6 ounce serving > once a week less than 4 months prior to enrollment
Omega-3 fatty acid supplement intake (e.g. fish oil capsules, cod liver oil) less than 4 months prior to enrollment
Lipoic Acid supplementation less than 1 month prior to enrollment
Taking systemic corticosteroids, neuroleptics, antiparkinsonian agents, and/or narcotic analgesics. Low dose sinemet and dopamine agonist taken once a day for restless leg syndrome is not an exclusion.
Contraindications to MRI, including: subjects with intrathecal pumps, stimulators, pacemakers, aneurysm clips, non-removable hearing aids, or metal fragments in the eyes. Other exclusion criteria include the inability to lie flat on the back for 40 minutes at a time or a self-reported history of claustrophobia. Subjects with a history of hip replacement and those with well-documented, verifiable, MRI-safe cardiac stents will not be excluded from the study.
Enrollment in another treatment study",Lipoic Acid plus Omega-3 Fatty Acids: alpha lipoic acid (racemic) and fish oil concentrate,ChEMBL:CHEMBL33864 | DrugBank:DB00166 | PubChem:6112 | PubChem:864,Lipoic acid,O=C(O)CCCCC1CCSS1,A16AX01,0.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0
NCT01781026,NCT01781026_EG000,No,All,Adult | Older Adult,Phase 2,2,"Inclusion Criteria:

Biopsy proven metastatic melanoma with the B-raf V600E or V600K mutations.
Untreated brain metastases
At least one cerebral metastasis that is not amenable to stereotactic radiosurgery (SRS) or surgical resection based on size or location OR four or more lesions
Patients may be symptomatic at the time of enrollment, but after any necessary local therapy and/or corticosteroids, the patient should be asymptomatic when vemurafenib is initiated.
Age >18
Adequate organ function
ECOG performance status < 3
No prior therapies with selective inhibitors of mutated BRAF; other prior therapies must have been administered at least 4 weeks before administration of vemurafenib
Life expectancy of at least 3 months
Understanding and willingness to consent
The use of corticosteroids to control cerebral edema or treat symptoms will be allowed
A history of whole brain radiotherapy for brain metastases is allowed, but any stable lesion that was present at the time of WBRT will NOT be considered evaluable. A minimum of 1 week break will be required between prior WBRT and initiation of vemurafenib therapy.

Exclusion Criteria:

Presence of leptomeningeal disease based on positive CSF cytology.
History or presence of clinically significant ventricular or atrial dysrhythmias ≥ Grade 2 (NCI CTCAE, v4.0), Corrected QT (QTc) interval >450 ms at baseline or history of congenital long QT syndrome
Uncontrolled medical illness, such as uncontrolled infection, congestive heart failure and MI within 2 months.
Second active, untreated malignancy, which is likely to result in the patient's demise prior to death from uncontrolled melanoma CNS metastases. This will be determined on a case by case basis by the PIs.
Unwillingness to undergo monitoring for a secondary malignancy including clinical dermatologic examinations and head and neck examinations and serial CT scans.","Vemurafenib 960 mg orally, twice a day",ChEMBL:CHEMBL1229517 | DrugBank:DB08881 | PubChem:42611257,Vemurafenib,CCCS(=O)(=O)Nc1ccc(F)c(C(=O)c2c[nH]c3ncc(-c4ccc(Cl)cc4)cc23)c1F,G01AE10 | L01EC01 | L01XE15,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01782885,NCT01782885_EG000,No,All,Adult | Older Adult,Not Applicable,32,"Inclusion Criteria:

Older than 18 years old
Patients who haven't received steroids injection or medical treatment 1 month before the study
Patients with knee osteoarthritis grade I and II (Kellgren-Lawrence scale)
Indistinct gender
Patients who accept to participate in the study with previous signed informed consent

Exclusion Criteria:

Patients with knee osteoarthritis grade III and IV (Kellgren-Lawrence scale)
Patients with prosthesis
Pregnancy
Patients with rheumatic diseases
Patients with diabetes, hepatic diseases, coagulopathy, cardiovascular diseases, immunosuppression, infections
Patients taking anticoagulants
Patients with concentrations of hemoglobin under 11 g/dL and platelets under 150,000/uL",Patients from this arm will receive a dose of acetaminophen (500 mg/8 hours) during 6 weeks.,ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01786174,NCT01786174_EG000,No,All,Adult | Older Adult,Phase 2,18,"Inclusion Criteria:

Age 18 years or older.
Sporadic or familial ALS diagnosed as possible, laboratory-supported probable, probable, or definite as defined by revised El Escorial criteria (Appendix 1).
Onset of weakness or spasticity due to ALS ≤ 2 years (24 months) prior to Baseline Visit.
Slow vital capacity (SVC) measure ≥65% of predicted for gender, height, and age at the screening visit.
Subjects must not have taken riluzole for at least 30 days, or be on a stable dose of riluzole for at least 30 days, prior to randomization (riluzole-naïve subjects are permitted in the study).
Subjects must be able to swallow oral medication at the Screening Visit and expected to be able to swallow the capsule throughout the course of the study.
Capable of providing informed consent and following trial procedures.
Geographically accessible to the site.
Women must not be able to become pregnant (e.g. post menopausal, surgically sterile, or using adequate birth control methods) for the duration of the study and three months after study completion. Adequate contraception includes: abstinence, hormonal contraception (oral contraception, implanted contraception, injected contraception or other hormonal (patch or contraceptive ring, for example) contraception), intrauterine device (IUD) in place for ≥ 3 months, barrier method in conjunction with spermicide, or another adequate method.
Subjects must agree not to take live attenuated vaccines (including seasonal flu vaccine) 30 days before randomization, throughout the duration of the trial and for 60 days following the trial.

Exclusion Criteria:

Prior use of fingolimod (Gilenya®).

History or presence of cardiac conditions including:

Cardiovascular or cerebrovascular disease in the previous 6 months (eg. myocardial infarction, unstable angina, or stroke)
Congestive heart failure
First, second- or third-degree atrioventricular block, sick sinus syndrome, or other serious cardiac rhythm disturbances
Any history of Torsades de Pointes

Treatment with a prohibited medication within 30 days of the Baseline Visit:

a. Class Ia or III antiarrhythmic medications: i.e., Quinidine, Sotalol Includes Nuedexta b. QT interval prolonging medications c. Ketoconazole d. Beta-blockers e. Calcium channel blockers f. Immunosuppressant medication g. Chemotherapeutic (anti-neoplastic) medications

Evidence on examination or ECG of bradycardia (<55 bpm), QTc >450ms for women or >430 msec for men, or 1st degree or higher conduction block.
History of unexplained syncope or cardiac syncope.
Serum AST and ALT value >2.0 times the upper normal limit.
Active infection (acute or chronic).
History of diabetes.
History of macular edema or uveitis.
History of lymphopenia.
History of acquired or inherited immune deficiency syndrome, including leukopenia.
History of severe untreated chronic obstructive sleep apnea.
Exposure to any other agent currently under investigation for the treatment of patients with ALS (off-label use or investigational) within 30 days of the Baseline Visit.
Presence of tracheostomy.
Use of non-invasive ventilation for hypoventilation due to ALS (such as BiPAP).
Presence of feeding tube.
Presence of diaphragmatic pacing system.
The presence of unstable psychiatric disease, cognitive impairment, or dementia that would impair ability of the subject to provide informed consent, according to PI judgment, or a history of active substance abuse within the prior year.
Clinically significant history of unstable or severe cardiac, oncologic, hepatic, or renal disease, or other medically significant illness.
Pregnant women or women currently breastfeeding.","0.5mg Gilenya (fingolimod) orally once daily for 28 days +/- 3 days

Gilenya: 0.5mg Gilenya orally by mouth once daily for approximately 28 days",ChEMBL:CHEMBL314854 | DrugBank:DB08868 | PubChem:107970,Fingolimod,CCCCCCCCc1ccc(CCC(N)(CO)CO)cc1,L04AA27,0.0,1.0,0.0,0.0,0.0,1.0,1.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0
NCT01787240,NCT01787240_EG001,No,All,Adult,Phase 4,5,"Inclusion Criteria:

Meets diagnostic criteria for Major Depressive Disorder
Written informed consent
Men or women aged 18-60 years old
A score of 18 or greater on the HAMD-28
Patient must continue to meet criteria for current MDD at baseline. Patients must have Clinical Global Impression Improvement (CGI) scores ≥ 3 (i.e. minimally improved or less) from the screen to the baseline visit
Agreeing to, and eligible for all procedures (only patients 18-45 will be eligible for MR-PET study)

Exclusion Criteria:

Pregnant women or women of child bearing potential not using a medically accepted means of contraception
Patients who are a serious suicide or homicide risk
Unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease, uncontrolled seizure disorder
The following DSM-IV diagnoses: a) organic mental disorders b) substance use disorders, including alcohol, active within the last year; c) schizophrenia; d) delusional disorder; e) psychotic disorders not elsewhere classified; f) bipolar disorder; g) acute bereavement; h) borderline or antisocial personality disorder i) current primary diagnoses of panic disorder, social phobia, GAD, or OCD (disorders that present as chief complaint and/or have their onset preceding the onset of MDD), l) Patients with mood congruent or mood incongruent psychotic features
Currently taking any of the following exclusionary medications: antipsychotics, anticonvulsants, mood stabilizers, stimulants, antidepressants, potential antidepressant augmenting agents (e.g., T3, SAMe, St. John's Wort, lithium, buspirone, Omega 3 fatty acids). If it is determined that it is safe to discontinue a medication, the patient will be required to wait a period equivalent to at least 5 half lives of the drug before the screening
Patients who have taken an investigational psychotropic drug within the last year
Patients who have not responded to one or more antidepressant trials of adequate doses (e.g., fluoxetine 40 mg/day or higher) and duration (e.g., for six weeks or more) over the past five years, as defined by the MGH-ATRQ
History of inadequate response or poor tolerability to citalopram or escitalopram
Any concomitant form of psychotherapy (depression-focused)
Receiving or have received during the index episode Vagal nerve stimulation, ECT or rTMS, or other somatic antidepressant treatments
Any reason not listed, determined by the site PI or study clinician, constituting good clinical practice and making participation in the study hazardous
Contraindications to fMRI scanning and MR-PET scanning (including presence of a cardiac pacemaker or pacemaker wires, metallic particles in the body, vascular clips in the head or previous neurosurgery, prosthetic heart valves, claustrophobia)
MR-PET-specific exclusion criteria: Patients who are younger than 18 or older than 45 years of age","After a screening visit, the patient will undergo a baseline assessment and will be randomized to escitalopram 10mg or placebo.

Escitalopram 10mg",PubChem:146571,Escitalopram Oxalate,CN(C)CCCC1(c2ccc(F)cc2)OCc2cc(C#N)ccc21.O=C(O)C(=O)O,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01795495,NCT01795495_EG001,No,All,Child | Adult,Phase 2,63,"Inclusion Criteria:

Patients older than 12, and younger than 19 years of age undergoing posterior spinal fusion for idiopathic scoliosis
American Society of Anesthesiologist (ASA) physical status I or II
Parents/Guardian willing and able to authorize informed consent
Patients willing and able to authorize assent

Exclusion Criteria:

Patients presenting with neuromuscular scoliosis
Patients deemed at increased risk of adverse reactions due to the presence of pre-existing severe organ system dysfunction, including debilitating lung disease, severe obstructive sleep apnea, severe congenital or acquired heart disease, and/or severe renal impairment
Patients who are both being currently treated for a psychological disorder and have a history of hospitalization for said disorder","This arm will receive the current analgesic remifentanil plus and adjunct dose of methadone hydrochloride.

Methadone hydrochloride: This drug will be used in conjunction with remifentanil as an adjunct analgesic. Remifentanil + methadone (0.1 mg/kg IV over 15 minutes) just after induction of anesthesia",ChEMBL:CHEMBL350719 | ChEMBL:CHEMBL651 | DrugBank:DB00333 | DrugBank:DB15198 | PubChem:4095 | PubChem:643985,Methadone,CCC(=O)C(CC(C)N(C)C)(c1ccccc1)c1ccccc1,N02AC52 | N07BC02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01798316,NCT01798316_EG000,No,All,Adult | Older Adult,Phase 4,52,"Inclusion Criteria:

Subject is undergoing pre-scheduled laparoscopic cholecystectomy;
American Society of Anesthesiology patient classification status I-II

Exclusion Criteria:

Regular preoperative use of or opioids,
Subjects admitted after surgery for postoperative complications other than postoperative pain or PONV.
Subjects converted to open laparoscopic cholecystectomy
Known allergy/hypersensitivity to acetaminophen
Use of opioids prior to commencement of the study (<7 days)
Patients with chronic pain conditions or disease requiring pain control
Abnormal liver function
Known or suspected alcohol, drug or opiate abuse or dependence
Patients with a BMI of greater than 35
Other physical, mental or medical conditions that could effect participation.
Abnormal renal function; serum creatinine>2gm/dl","IV Acetaminophen administered on admission to PACU

IV Acetaminophen: Single dose, 1000g mg infusion over 15 minutes plus standard of care",ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01804049,NCT01804049_EG001,No,All,Older Adult,Phase 1 | Phase 2,77,"Inclusion Criteria:

The investigators will enroll 120 sedentary, weight-stable, ambulatory Veterans aged 65 years and older with prediabetes identified with fasting glucose values 100 mg/dL or greater but under 126 mg/dL with no use of diabetes medications.
Participants must demonstrate that they are able to ambulate 400 meters without assistance.

Exclusion Criteria:

Chronic medical conditions affecting muscle mass or function like active non-skin cancer and hypogonadism
Medications affecting muscle mass or function like glucocorticoids and androgen/antiandrogens
Contraindications to metformin such as renal dysfunction defined as creatinine >= 1.5 mg/dL for men or >=1.4 mg/dL for women or estimated glomerular filtration rate (eGFR)<60 mL/min; liver dysfunction defined as alanine aminotransferase (ALT)>48 U/L, aspart aminotransferase (AST)>41 U/L or alkaline phosphatase (AlkPhos)>141 U/L; B12 deficiency defined as B12 level <180 pg/dL; congestive heart failure; known hypersensitivity to metformin; excessive alcohol intake (average of 2 or more alcoholic beverages/day over a month)

For the muscle biopsy substudy, additional exclusion criteria include:

Conditions that include bleeding risk such as the use of warfarin, clopidogrel/ticlopidine, aggrenox, dabigatran or anagrelide; laboratory results showing platelets<150 billion/L or international normalized ratio (INR)>1.2 or activated partial thromboplastin time (aPTT)>36 seconds
Allergy to lidocaine","60 enrolled participants were to be randomized to metformin.

metformin: Metformin will be given at a dose of 850 mg orally once daily for 1 month with titration up to 850 mg orally twice daily for the remainder of the study.

77 participants were allocated to the metformin group.",ChEMBL:CHEMBL1431 | DrugBank:DB00331 | PubChem:4091,Metformin,CN(C)C(=N)NC(=N)N,A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27,0.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0
NCT01804075,NCT01804075_EG000,No,All,Child,Phase 4,31,"Inclusion Criteria:

i. Evidence of opioid withdrawal clinically defined by at least 2 NAS scores > 8 in an 8 hour time period, AND

ii. Gestation => 35 weeks at entry defined by best obstetrical and physical exam criteria, AND

iii. Medically stable condition in the opinion of the attending neonatologist, other than opiate withdrawal, AND

iv. Mother on opiate replacement treatment therapy - methadone or buprenorphine.

Exclusion Criteria:

i. Gestation < 35 weeks at entry defined by best obstetrical and physical exam criteria.

ii. Hypoglycemia, hypomagnesaemia, or hypocalcemia until corrected,

iii. Serious medical illness such as sepsis, pneumonia, thyroid dysfunction, meningitis, intracranial hemorrhage, perinatal depression, or respiratory failure requiring admission to the NICU.

iv. Evidence of major congenital anomalies or genetic syndromes that impact the neonatal course

v. Mother consistently taking prescribed benzodiazepine at the time of delivery","Methadone (1 mg/mL) administered orally every 4 hours. The following is a dosing guide:

NAS Score Methadone 8-12 0.05 mg/kg/dose >=13 0.1 mg/kg/dose

Maximum dose of methadone will be 0.2 mg/kg/dose. (NeoFax)
Additional doses, 0.05 mg/kg, may be given every 4 hours as needed and added to the next 24 hour's doses divided every 4 hours, until NAS scores are consistently <8 for 48 hours.
If the maximum dose of methadone is reached and if withdrawal is not controlled, the infant will be started on clonazepam (0.005 mg/kg/dose q 12h) per current treatment.

Methadone, Morphine: To compare the duration of opiate medication treatment for babies on methadone versus those on morphine.",ChEMBL:CHEMBL350719 | ChEMBL:CHEMBL651 | DrugBank:DB00333 | DrugBank:DB15198 | PubChem:4095 | PubChem:643985,Methadone,CCC(=O)C(CC(C)N(C)C)(c1ccccc1)c1ccccc1,N02AC52 | N07BC02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01808690,NCT01808690_EG000,No,All,Child | Adult,Phase 3,25,"Inclusion Criteria:

Adolescents 12-21 years of age with type 1 diabetes (defined as having positive antibodies as well as insulin requirement)
Willing to consent for participation in study
Body Mass Index (BMI) >5% on growth charts

Exclusion Criteria:

Current use of medications known to affect insulin sensitivity: oral glucocorticoids within 10 days, atypical antipsychotics, immunosuppressant agents, metformin or thiazolidinediones.
Currently pregnant or breastfeeding women
Use of a thiazolidinedione within 12 weeks
Severe illness or Diabetic Ketoacidosis within 60 days
Macroalbuminuria
Hemoglobin A1c > 12%
Weight > 136.4 kg or < 42 kg, BMI < 5%
Creatinine > 1.2
Hemoglobin < 9
Major psychiatric or developmental disorder limiting informed consent
Implanted metal devices
Inability to tolerate ≥500mg twice a day of metformin","Metformin will be given at a dose of 1000 mg twice a day orally for three months to assess changes in insulin resistance compared to placebo.

Metformin",ChEMBL:CHEMBL1431 | DrugBank:DB00331 | PubChem:4091,Metformin,CN(C)C(=N)NC(=N)N,A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01809327,NCT01809327_EG000,No,All,Adult | Older Adult,Phase 3,237,"Inclusion Criteria:

Must have type 2 diabetes mellitus with inadequate glycemic control on diet and exercise
Not on antihyperglycemic agent therapy (at least 12 weeks before screening) and have a screening visit fingerstick glycated hemoglobin (HbA1c) of more than or equal to 7 percent and less than or equal to 12.5 percent
Have a screening visit HbA1c of more than or equal to 7.5 percent and less than or equal to 12 percent as determined by the central laboratory
Must have a fasting plasma glucose of less than or equal to 300 mg/dL (16.7 mmol/L) prior to randomization
Must have a fasting fingerstick glucose of greater than 120 mg/dL (6.7 mmol/L) performed at home or at the study center prior to randomization

Exclusion Criteria:

History of diabetic ketoacidosis, type 1 diabetes mellitus (T1DM), pancreas or beta-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy
Fasting C-peptide less than 0.70 ng/mL (0.23 nmol/L) in participants for whom the investigator cannot reasonably exclude T1DM based upon clinical evaluation
Repeated (2 or more over a 1 week period) fasting self-monitored blood glucose measurements more than 300 mg/dL (16.7 mmol/L) prior to randomization, despite reinforcement of diet and exercise counseling
History of hereditary glucose-galactose malabsorption or primary renal glucosuria
Has history of, or currently active, illness considered to be clinically significant by the Investigator or any other illness that the Investigator considers should exclude the patient from the study or that could interfere with the interpretation of the study results","Participants received metformin extended release (XR) tablets (in doses titrated over 9 weeks) once daily with the evening meal, plus one placebo capsule before the morning meal and one placebo capsule with the evening meal (to match the canagliflozin capsules administered in other treatment arms) for 26 weeks.",PubChem:44573417,metformin XR,CN=C(N)N(C)C(=N)N.Cl,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01809327,NCT01809327_EG002,No,All,Adult | Older Adult,Phase 3,238,"Inclusion Criteria:

Must have type 2 diabetes mellitus with inadequate glycemic control on diet and exercise
Not on antihyperglycemic agent therapy (at least 12 weeks before screening) and have a screening visit fingerstick glycated hemoglobin (HbA1c) of more than or equal to 7 percent and less than or equal to 12.5 percent
Have a screening visit HbA1c of more than or equal to 7.5 percent and less than or equal to 12 percent as determined by the central laboratory
Must have a fasting plasma glucose of less than or equal to 300 mg/dL (16.7 mmol/L) prior to randomization
Must have a fasting fingerstick glucose of greater than 120 mg/dL (6.7 mmol/L) performed at home or at the study center prior to randomization

Exclusion Criteria:

History of diabetic ketoacidosis, type 1 diabetes mellitus (T1DM), pancreas or beta-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy
Fasting C-peptide less than 0.70 ng/mL (0.23 nmol/L) in participants for whom the investigator cannot reasonably exclude T1DM based upon clinical evaluation
Repeated (2 or more over a 1 week period) fasting self-monitored blood glucose measurements more than 300 mg/dL (16.7 mmol/L) prior to randomization, despite reinforcement of diet and exercise counseling
History of hereditary glucose-galactose malabsorption or primary renal glucosuria
Has history of, or currently active, illness considered to be clinically significant by the Investigator or any other illness that the Investigator considers should exclude the patient from the study or that could interfere with the interpretation of the study results",Participants received one 300 mg canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.,DrugBank:DB08907 | PubChem:24812758,Canagliflozin,[H][C@@]1(c2ccc(C)c(Cc3ccc(-c4ccc(F)cc4)s3)c2)O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O,A10BD16 | A10BK02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01813214,NCT01813214_EG000,No,All,Adult | Older Adult,Phase 2,3,"Patients must have histological or cytological confirmed melanoma that is metastatic or that is unresectable stage III and clearly progressive.
Melanoma must be documented to contain a BRAFV600 mutation by a FDA approved assay
Age > 18 years
ECOG PS 0,1, or 2
Participants must have measurable melanoma. Measurable disease is defined as at least one lesion that can be measured accurately in at least one dimension (longest diameter to be recorded) as ≥ 20 mm with conventional techniques or as ≥ 10 mm with spiral CT scan. Cutaneous or subcutaneous lesions may be considered measurable if they can be measured reliably as ≥ 10 mm by direct physical exam measurement.

In addition, participants must also have separate disease, which may or may not be measurable as defined by RECIST, but must be readily accessible for core needle biopsy, excisional biopsy, and/or surgical resection. This disease may include one large tumor tissue deposit from which biopsies can be harvested multiple times or may include multiple deposits which can be biopsied, or excised individually, on different dates. Please see below for suggested minimum size requirements of tumor tissue to be used for biopsy for research:

1 lesion ≥ 5 cm3 or
2 lesions ≥ 3 cm3 each
3 lesions ≥ 2 cm3each OR
≥ 3 skin lesions, such that the surface area is approximately 1 cm^2 each (or in aggregate for several lesions) and the total volume of tumor I s approximately 260-325 mm^3 or greater for each biopsy time point. These subjects will need ≥ 3 such epidermal/dermal tumor lesions; excisional tumor tissue biopsies will be performed on one or more lesions at each time point. It is acceptable to biopsy more than one lesion, that may be less than 1 cm^2 in surface area, as long as the total tissue removed has a surface area of approximately 1 cm^2 or greater.
A combination of these may be acceptable, as long as there appears to be enough tumor tissue to remove approximately 325 mm^3 or more of tissue at each time point.

Lesion volume can be calculated based on the formula for volume of a sphere (4/3 r3). An acceptable approximation for lesions approaching spherical shape is to multiply the diameters in three perpendicular directions and divide by 2. [Volume ~ ½(D1xD2xD3); e.g.: volume of a 2 x 2 x 3 cm lesion is approximately 6 cm3. Lesion measurements are based on length X width X depth (height) of sample.]

Women must not be pregnant due to the fact that the effects of vemurafenib and/or cobimetinib on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation and for 6 months after completion of study treatment. See Appendix H for acceptable and unacceptable forms of contraception. Should a woman become pregnant while participating in this study, she should inform her treating physician immediately.
All females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy. A female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with vemurafenib and/or cobimetinib, breastfeeding must be discontinued prior to treatment Day 1 of the study.
Patients must have measurable disease as defined in Section 9.1. Cutaneous lesions or lymph nodes measuring at least 1 cm will be considered measurable. Baseline CT or MRI scans of measurable disease sites must be performed within 4 weeks of study entry.

Patients may have received any number of prior systemic treatment regimens for distant metastatic disease or advanced regional disease. The following prior therapy is permitted in either the adjuvant or metastatic disease setting:

No prior therapy
Immunotherapy consisting of interferon-alpha, interleukin-2, GM-CSF, ipilimumab, anti-PD1, cancer vaccines, or other experimental agent.
Cytotoxic chemotherapy consisting of dacarbazine, temozolomide, carboplatin, or paclitaxel alone or in combination.
Targeted therapy with temsirolimus, bevacizumab, or sorafenib.
Patients who have had prior therapy with a MEK inhibitor or an inhibitor of mutant BRAF are ineligible. Because sorafenib has low efficacy as a BRAF inhibitor, prior therapy with it is allowed.
Patients must have discontinued cytotoxic therapy agents at least 4 weeks and cytokine and immunoregulatory antibody based immunotherapy at least 6 weeks prior to entering the study and have recovered from adverse events due to those agents.
Patients must be completed radiation therapy at least 4 week previously
Patients must have an ECOG performance status of 0, 1 or 2.

Patients must have the following baseline laboratory values:

White Blood Count > 3,000/mm3
Absolute Granulocyte Count > 1,500/mm3
Platelet Count > 100,000/mm3
Hemoglobin > 9 g/dL
Serum creatinine < 1.5 x upper limit of normal (ULN) or serum creatinine clearance (CrCl) > 40ml/min (CrCl= Wt (kg) x (140-age)*/72 x Cr. level, *female x 0.85)
AST and ALT < 3 x ULN (< 5 x ULN for patients with documented liver metastases)
Alkaline Phosphatase ≤ 2 x ULN (≤ 5x ULN for patients with known liver involvement and ≤ 7x ULN for patients with known bone involvement)
INR < 1.5 and aPTT within 1.1 x ULN. Patients on warfarin therapy are not eligible due to the requirement for multiple biopsies.
Total Bilirubin < 1.5 x ULN
Patients must not receive any other investigational agents during the period on study or the four weeks prior to entry.
Patients will be evaluated with a head CT or MRI within 4 weeks of enrollment. Patients must have no clinical evidence of active brain metastasis. Patients with a history of brain metastases must have had them treated greater than 4 weeks previously with the CNS lesions confirmed to be stable or regressing on imaging since the time of the last CNS treatment. Patients must have no residual neurologic symptoms while taking either no steroids or a stable dose of steroids for the 2 weeks prior to enrollment. Patients are allowed to be on a stable dose of anti-seizure meds.

Patients who have had brain metastases will be eligible only if all of the following are true:

the total number of brain metastases ever is ≤ 3
all are less than or equal to 2 cm
they have been resected surgically or have been treated with gamma-knife or stereotactic radiosurgery
the patient has not taken any steroids or has not increased the dose of steroids ≤ 14 days prior to registration.

Patients must not have another cancer diagnosis with a few exceptions- the following diagnoses will be allowed:

squamous cell cancer of the skin without known metastasis. Note, patients with suspected cuSCCs should have them excised prior to study registration.
basal cell cancer of the skin without known metastasis
carcinoma in situ of the breast (DCIS or LCIS)
carcinoma in situ of the cervix
any cancer without distant metastasis that has been treated successfully, without evidence of recurrence or metastasis for over 3 years

Patients must not have a serious intercurrent illness including, but not limited to:

Ongoing or active infection requiring parental antibiotics on Day 1
History of congenital long QT syndrome or mean corrected QTc interval > 450 msec at baseline
Clinically significant cardiovascular disease:

Myocardial infarction within 6 months Unstable angina New York Heart Association grade II or greater congestive heart failure (see Appendix E) Serious cardiac arrhythmia requiring medication Uncontrolled hypertension ≥ Grade 2 (patients with a history of hypertension controlled with anti-hypertensives to ≤ Grade 1 are eligible) Left ventricular ejection fraction (LVEF) below institutional lower limit of normal or below 50%

Serious, non-healing wound, active ulcer, or untreated bone fracture

Psychiatric illness/social situations that would limit compliance with study requirements.

Participants must not be known to be HIV positive (testing is not required)
Participants must be Hepatitis C negative < 6 months prior to screening
Participants must not have a history of malabsorption or other condition that would interfere with absorption of vemurafenib or cobimetinib
Patients must be able to comply with study and follow-up procedures.
Patients must not have following foods/supplements at least 7 days prior to initiation of and during study treatment: St. John's wort or hyperforin (potent cytochrome P450 CYP34A enzyme inducer) or Grapefruit juice (potent cytochrome P450 CYP34A enzyme inhibitor).
Patients must not have significant ocular issues including history of or evidence of retinal pathology on ophthalmologic examination that is considered a risk factor for neurosensory retinal detachment, RVO, or neovascular macular degeneration.

The risk factors for RVO are listed below. Patients should be excluded if they have the following conditions:

Uncontrolled glaucoma with intra-ocular pressures > 21mmHg
Serum cholesterol ≥ Grade 2
Hypertriglyceridemia ≥ Grade 2

Hyperglycemia (fasting) ≥ Grade 2

Patients must have the ability to understand and the willingness to sign a written informed consent document.","Vemurafenib 960 mg po BID until unacceptable toxicity or progression of disease

Vemurafenib",ChEMBL:CHEMBL1229517 | DrugBank:DB08881 | PubChem:42611257,Vemurafenib,CCCS(=O)(=O)Nc1ccc(F)c(C(=O)c2c[nH]c3ncc(-c4ccc(Cl)cc4)cc23)c1F,G01AE10 | L01EC01 | L01XE15,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT01813929,NCT01813929_EG000,No,All,Adult,Phase 4,23,"Inclusion Criteria:

Age 20-59 years of age,
Type 1 diabetes based on antibody-positivity, rapid persistent conversion to insulin requirement after diagnosis, absent C-peptide, or DKA at diagnosis, or a clinical course consistent with T1D,
HbA1c 6.0 - 9.5, and
Willing and able to commit to two 6 week-long periods of blinded medication followed by hyperinsulinemic euglycemic clamp, vascular testing, and muscle biopsies.

Exclusion Criteria:

Any comorbid condition associated with:

inflammation,
insulin Resistance, or

dyslipidemia including:

cancer,
heart failure,
active or end stage liver disease,
kidney disease, or
rheumatological disease;
Tobacco use;
Pregnancy or women who are breastfeeding;
Steroid use;
Scheduled strenuous physical activity >3 days a week;
Angina, known CAD, or any other cardiovascular or pulmonary disease;
A history of COPD or asthma;
Presence of systolic blood pressure >190 at rest or >250 with exercise, or diastolic pressure >95 at rest or >105 with exercise;
Untreated thyroid disease;
Proteinuria (urine protein >200 mg/dl) or a creatinine > 1.5 mg/dl (males) or 1.4 mg/dL (females), suggestive of severe renal disease;
Severe Proliferative retinopathy;
Niacin treatment;
Administration of experimental agent for T1D within 30 days prior to screening;
Recent (prior 6 months) or current metformin or thiazolidenedione use;
Hypoglycemia unawareness or recurrent severe hypoglycemia (no symptoms of hypoglycemia with FSBS<40 and episodes of this severity >1 per week);
Weight instability (weight change >5% in last 6 months);
History of any organ transplant, including islet cell transplant;
Current or prior infection with HIV, hepatitis B or hepatitis C or hepatic -insufficiency (AST or ALT > 2x the upper limits of normal);
Any condition, medical or otherwise that would, in the opinion of the investigator, prevent complete participation in the study, or that would pose a significant hazard to the subject;
History of substance abuse within the 12 months prior to screening.","Metformin: Six week intervention: Study drug/placebo will be given in a forced uptitration with 500 mg once daily for one week, 500 mg twice daily for one week, 500/1000 for one week, and then 1000mg twice daily for the remainder of the 6 week intervention. If uptitration is not tolerated, max dose will be max tolerated dose of at least 500 mg twice daily.",ChEMBL:CHEMBL1431 | DrugBank:DB00331 | PubChem:4091,Metformin,CN(C)C(=N)NC(=N)N,A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01815918,NCT01815918_EG001,No,All,Adult | Older Adult,Phase 4,60,"Inclusion Criteria:

All patients undergoing unilateral or bilateral total knee replacement
Age 50-90

Exclusion Criteria:

All patients on steroid therapy regardless of dose or duration of treatment or those requiring stress-dose steroids preoperatively
Patients who are smokers
Patients under 50 years of age
Patients over 90 years of age
Patients with diabetes
Patients with a prior history of corticosteroid intolerance
Patients with previous complications of steroid use","Patients receive 3 100 mg of hydrocortisone: prior to surgery, 8 hours after the first dose and 16 hours after the first dose.

Hydrocortisone: Patients randomized to treatment arm will three doses of 100 mg of hydrocortisone at the following times: prior to surgery, 8 hours after the first dose and 16 hours after the first dose.",ChEMBL:CHEMBL389621 | DrugBank:DB00741 | PubChem:5754,Hydrocortisone,[H][C@@]12CC[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)CC[C@@]21C,A01AC03 | A07EA02 | C05AA01 | D07AA02 | D07BA04 | D07CA01 | D07XA01 | H02AB09 | R01AD60 | S01BA02 | S01BB01 | S01CA03 | S01CB03 | S02BA01 | S02CA03 | S03CA04,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01816477,NCT01816477_EG000,No,All,Adult | Older Adult,Not Applicable,30,"Inclusion Criteria:

Patients who are scheduled for repair of their pectus excavatum with minimally invasive (MIRPE) placement of steel or titanium braces at Mayo Clinic Arizona
Must be able to take oral medications preoperatively and postoperatively.

Exclusion Criteria:

American Society of Anesthesiology class IV or higher
Allergic to Ropivacaine or other local anesthetics
NSAID allergy
Specific epidural contraindication
Currently using opioids, sedatives, or hypnotics
Are pregnant as verified by preoperative pregnancy testing
Inability to place an epidural, patient refusal for epidural, or failure of an epidural to be properly placed or maintain proper placement for adequate pain control.",Thoracic epidural with Ropivicaine 0.25% placed pre-operatively by the anesthesiologist. Epidurals will remain in place for 72 hours and discontinued by the anesthesia pain management team.,PubChem:53262281,Naropin,CCC[NH+]1CCCCC1C(=O)Nc1c(C)cccc1C.O.[Cl-],,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01823679,NCT01823679_EG000,No,All,Adult | Older Adult,Phase 2,2,"INCLUSION CRITERIA

Squamous cell carcinoma of the skin or ""unknown primary lesions"" at the time of diagnosis if metastatic disease present with a history of plausible primary skin site removed in the past. Example: squamous cell carcinoma in neck or parotid lymph nodes with no identifiable mucosal primary but with a history of the removal of one or more early stage squamous cell carcinomas of the skin in an anatomically relevant lymphatic drainage region would be eligible
Measurable disease, defined as at least 1 lesion that can be accurately measured in at least 1 dimension as ≥ 10 mm with computed tomography (CT) scan; magnetic resonance imaging (MRI); or calipers during clinical exam
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%)
Life expectancy greater than 3 months
Absolute neutrophil count ≥ 1,000/mcL
Platelets ≥ 100,000/mcL

Total bilirubin

Within normal institutional limits OR
≤ 2 x upper limit of normal (ULN) if participant has Gilbert's syndrome (elevated unconjugated bilirubin from decreased UDP glucuronosyltransferase 1 family, polypeptide A1 [UGT1A1] activity)
Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) ≤ 2.5 x institutional ULN or up to 5 X ULN if known to be caused by liver metastases

Creatinine OR

< 1.3 mg/dL OR
Creatinine clearance ≥ 30 mL/min/1.73 m2 for patients with creatinine levels above institutional normal (Note creatinine clearances between 30 and 49 mg/dL necessitate dose modification)
For participants with a history of coronary artery disease (CAD)/myocardial infarction (MI) or congestive heart failure (CHF), ejection fraction (EF) ≥ 50% by multi-gated acquisition (MUGA) or echocardiogram (exceptions by PI discretion)

EXCLUSION CRITERIA

Prior treatment with systemic capecitabine or prodrugs
Prior treatment with systemic fluorouracil (5-FU) or prodrugs (prior topical treatment with 5FU is permitted if recovered from any toxicities > grade 1, and after at least 5 half-lives of the last systemically administered agent have passed)
Receiving any other investigational agents or anti-cancer treatments
Candidates for curative locoregional treatment (patients with recurrent locoregional disease following surgery and/ or radiation for which a resection is unacceptably morbid and unlikely to be curative are eligible)
History of allergic reactions attributed to compounds of similar chemical or biologic composition to capecitabine

Uncontrolled concurrent illness including, but not limited to:

Ongoing or active infection
Symptomatic congestive heart failure
Unstable angina pectoris
Cardiac arrhythmia
Psychiatric illness/social situations that would limit compliance with study requirements
Pregnant
Lactating","Participants are to receive 500 mg/m² of capecitabine orally (PO) twice daily (BID) on days 1 to 14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 2 years.",ChEMBL:CHEMBL1773 | DrugBank:DB01101 | PubChem:42066809 | PubChem:60953,Capecitabine,CCCCCOC(=O)Nc1nc(=O)n([C@@H]2O[C@H](C)[C@@H](O)[C@H]2O)cc1F,L01BC06,1.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,1.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT01827475,NCT01827475_EG001,No,All,Adult | Older Adult,Phase 2,30,"Inclusion Criteria:

Adult patients who presented to the emergency department with pain (a verbal numeric pain score greater than 0 on a scale of 0 to 10 from none to greatest) secondary to an acute musculoskeletal injury of less than 24 hours of duration when one of the study investigators was present were eligible for enrollment

Exclusion Criteria:

Patients who had taken an opioid containing analgesic as well as those with a prior history of allergy or contraindications to ibuprofen or acetaminophen.",Acetaminophen 1 gm,ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01837277,NCT01837277_EG001,No,All,Adult | Older Adult,Phase 2 | Phase 3,92,"Inclusion Criteria:

Patients with confirmed HIV-1 infection (positive Western blot or plasma HIV-1 RNA >1,000 copies/ml)
No previous use of any ARV drug (drug-naïve patients)
Presence of clinical symptoms according to Rio de Janeiro / Caracas´ AIDS definition (Asthenia, Cachexia/Wasting, Cough, Dermatitis, persistent, Diarrhea, Fever, Lymphadenopathy, Candidiasis, oral, or hairy leukoplasia, Central nervous system dysfunction, Herpes zoster in individual younger than 60 years of age)), and/or any active AIDS-defining condition
Baseline CD4+ cells count equal or lower than 50 cells/mm3
Age equal or higher than 18 years
HIV-1 plasma viral load ≥ 1,000 copies of HIV-1 RNA/ml

Exclusion Criteria:

Undetectable plasma viral load at screening
CD4 cells count>50 cells/mm3
Asymptomatic individuals",Patients treated with Efavirenz,ChEMBL:CHEMBL223228 | DrugBank:DB00625 | PubChem:64139,Efavirenz,O=C1Nc2ccc(Cl)cc2[C@@](C#CC2CC2)(C(F)(F)F)O1,J05AG03 | J05AR06 | J05AR11,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01844076,NCT01844076_EG000,No,All,Adult | Older Adult,Phase 1 | Phase 2,1,"Inclusion Criteria:

Patients much have histologically confirmed adenocarcinoma of the colon or rectum.
Patients must have measurable recurrence or metastases in the liver and/or lungs.
Patients must have prior chemotherapy for advanced colorectal cancer and have previously received both an oxaliplatin and an irinotecan based regimen.
Age > 18 years.
Life expectancy greater than 4 weeks.
ECOG performance status <3.
Patients must have normal organ and marrow function.
Patients must be able to swallow capsules.
Patients must be able to understand and willing to sign a written informed consent document.
Patients are included regardless of KRAS/BRAF status.

Exclusion Criteria:

Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
Patients may not be receiving any other investigational agent.
Patients with know brain metastases should be excluded from this clinical trial because they often develop progressive neurological dysfunction that would confound the evaluation of neurologic and other adverse events.
History of allergic reactions attributed to compounds of similar chemical or biologic composition to quinacrine, capecitabine or fluorouracil.
The concomitant use of quinacrine and primaquine is contraindicated.
Uncontrolled intercurrent illness including but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Pregnant women are excluded from this study.
Patients with a baseline creatinine clearance of < 50 mL/min.
Patients must be currently not treated with quinacrine or drugs related to quinacrine.
Patients who require anti-arrhythmic treatment with amiodarone or any drug with a quinidine-like effect on the heart or who have history of a malignant ventricular arrhythmia unless they have a functioning automatic implantable cardio defibrillator implanted.
Patients who have a history of noninfectious hepatitis or alcoholism.
Patients with a lifetime history of porphyria or psoriasis because it can exacerbate these conditions.
Patients with documented glucose-6-phosphate dehydrogenase deficiency.
Patients with a lifetime history of seizure disorder.
Patients with a lifetime history of dermatitis as an allergic/toxic reaction to any medication.
Patients with know dihydropyrimidine dehydrogenase deficiency.","Phase I (Quinacrine and Capecitabine): The Phase I portion of the study will aim to determine the tolerability of both agents in combinations when used at established clinical doses. This portion of the study will more closely resemble a pilot study or feasibility study rather than a dose escalation.

Each group will have 1 to 6 patients enrolled in it. If the patients in a lower group do not have any significant side effects the next patient will start at the next group dose.

Group 1: capecitabine at a dose of 1000 mg/m^2 twice per day (days 1-14), and quinacrine at a dose of 100 mg once per day (days 1-21) for a 21 day cycle",ChEMBL:CHEMBL1773 | DrugBank:DB01101 | PubChem:42066809 | PubChem:60953,Capecitabine,CCCCCOC(=O)Nc1nc(=O)n([C@@H]2O[C@H](C)[C@@H](O)[C@H]2O)cc1F,L01BC06,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0
NCT01845792,NCT01845792_EG001,No,All,Adult | Older Adult,Phase 2,2,"Inclusion Criteria:

Written informed consent has been obtained.
Adults over 18 years of age.
Histologically or cytologically proven adenocarcinoma of the prostate.
Stage IV disease as evidenced by soft tissue, visceral and/or bony metastasis must be Response Evaluation Criteria in Solid Tumors (RECIST) evaluable on CT scan and/or bone scan

Progressive disease while receiving hormonal therapy or after surgical castration documented by at least one of the following:

Increase in measurable disease per RECIST 1.1,
Appearance of new lesions on bone scan consistent with progressive prostate cancer (>2 new lesions on bone scans if this is the only measure of PD),

rising PSA defined as 2 sequential increases above a previous lowest reference value.

Each value must be obtained at least 1 week apart.
PSA at least 2 ng/mL
Received prior docetaxel chemotherapy
Received prior abiraterone acetate, but not within the 3 months prior to study drug dosing.
Testosterone level <50 ng/mL. Patients receiving Leutinizing Hormone Releasing Hormone (LHRH) agonists or antagonists must be continued to maintain castrate levels of testosterone while on study.
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.

Adequate hematologic function:

platelet >100, 000/uL;
neutrophil count of >1500 cell/mm3;
hemoglobin >9.0 g/dL)
Adequate renal function (Creatinine clearance > 50 mL/min)
Adequate potassium level (> 3.5 mEq/dL)

Adequate hepatic function

bilirubin < 1.5 X upper limit of normal (ULN),
alanine aminotransferase (ALT) < 1.5 X ULN,
aspartate aminotransferase (AST) < 1.5 X ULN.
serum albumin of ≥ 3.0 g/dL.
Controlled blood pressure, defined as blood pressure ≤ 140/90 on average (3 separate readings taken at screening visit in a relaxed clinical environment and averaged)
Must be able to take oral medication without crushing, dissolving or chewing tablets

Willing to take abiraterone acetate on empty stomach;

(1) no food should be consumed at least two hours before and for at least one hour after the dose of abiraterone acetate is taken.

Patients must be willing and able to adhere to the prohibitions and restrictions specified in this protocol.
Written authorization for use and release of health and research study information has been obtained.
Patients who have partners of childbearing potential must be willing to use a method of birth control with adequate barrier protection during the study and for 1 week after the last dose of abiraterone acetate.

Exclusion Criteria:

Surgery or radiation therapy within 2 weeks, or
Cytotoxic anti-cancer therapy within 3 weeks, or
Non-cytotoxic anti-cancer therapy within 2 weeks, or 5 half-lives (whichever is shorter) of Study Day 1.
Prior radiotherapy to ≥ 40% of bone marrow.
Prior treatment with Radium 223.
Use of an investigational therapeutic agent within 30 days.
Have a history of gastrointestinal disorders (medical disorders or extensive surgery) that may interfere with the absorption of the study agents.
Prior treatment with cabazitaxel.
Known chronic infection with human immunodeficiency virus (HIV).
Known active, or symptomatic, brain metastasis.
Blood pressure >140/90 on average (3 separate readings taken at screening visit in a relaxed clinical environment and averaged).
History of autoimmune disorder requiring daily corticosteroid therapy of greater than prednisone 10mg daily, or its equivalent.
Baseline peripheral edema > grade 3.
Pre-existing diarrhea uncontrolled with supportive care;
Prior hemorrhagic diarrhea due to ulcerative colitis, inflammatory bowel disease or other cause;
Active, uncontrolled peptic ulcer disease even in the setting of proton-pump inhibitor or Histamine2-blocker use.
Pre-existing peripheral neuropathy grade > 2.
Documented hypersensitivity (CTCAE grade > 2) to any drug containing polysorbate 80.
Have known allergies or hypersensitivity to abiraterone acetate or prednisone or their excipients.
Contraindications to steroid use.
Need for medications that strongly induce or inhibit cytochrome P450 3A4 (CYP3A4) or cytochrome P450 2D6 (CYP2D6) activity. (see section 7.2.3 for details)
Serious infection requiring parenteral antibiotics within 14 days of enrollment.
Poorly controlled diabetes (Hgb A1C >9).
Active or symptomatic viral hepatitis or Chronic liver disease, including Child-Pugh Class B and C liver disease.
History of pituitary or adrenal dysfunction.

Clinically significant heart disease as evidenced by:

myocardial infarction, or
arterial thrombotic events in the past 6 months,
severe or unstable angina, or
New York Heart Association Class III-IV heart disease, or
cardiac ejection fraction measurement of <50% at baseline.
Consumption of food or beverages containing grapefruit juice within 7 days of study drug dosing

Use of a first-generation anti-androgen such as:

bicalutamide within 6 weeks of study drug dosing, or
flutamide within 4 weeks of study dosing.
Have any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study or prevent the subject from meeting or performing study requirements.","Cabazitaxel administered as a single intravenous dose every 3 weeks

Cabazitaxel: Cabazitaxel intravenously every 3 weeks",ChEMBL:CHEMBL1201748 | DrugBank:DB06772 | PubChem:9854073,Cabazitaxel,[H][C@]12[C@H](OC(=O)c3ccccc3)[C@]3(O)C[C@H](OC(=O)[C@H](O)[C@@H](NC(=O)OC(C)(C)C)c4ccccc4)C(C)=C([C@@H](OC)C(=O)[C@]1(C)[C@@H](OC)C[C@H]1OC[C@]12OC(C)=O)C3(C)C,L01CD04,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01846221,NCT01846221_EG001,No,Female,Adult | Older Adult,Phase 4,101,"Inclusion Criteria:

women in labor at term pregnancy
healthy
epidural analgesia in place
breakthrough pain in advanced labor

Exclusion Criteria:

chronic pain syndrome
receiving systemic opioids within 4 hours
receiving chronic antidepressants, clonidine, opioids","Participants randomized to this arm of study will receive 100 mcg fentanyl with the bupivacaine in their epidural when requesting pain relief in advanced labor

Fentanyl: Subjects randomized to fentanyl will receive 100 mcg fentanyl and 12.5 mg bupivacaine in 10 ml of volume.",ChEMBL:CHEMBL596 | DrugBank:DB00813 | PubChem:3345,Fentanyl,CCC(=O)N(c1ccccc1)C1CCN(CCc2ccccc2)CC1,N01AH01 | N01AH51 | N02AB03,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01853553,NCT01853553_EG000,No,All,Adult,Phase 3,61,"Inclusion Criteria:

Aged 20-55 years;
Adults with ADPKD diagnosis based on Ravine criteria aged ≥ 30 years
Estimated glomerular filtration rate ≥ 60 ml/min/1.73m2
Hypertension defined as a systolic BP > 130 mm Hg and/or diastolic BP > 80 mmHg based on 3 separate measurements within the past year and currently on a minimum dose of an angiotensin converting enzyme inhibitor (minimum dose 10 mg P.O qd) or angiotensin receptor blocker (i.e., Losartan 25 mg P.O qd)
If using antioxidants and/or omega-3 fatty acids, must discontinue 4 weeks prior to participation
Free from alcohol dependence or abuse
Mini-mental state examination score ≥ 24; ability to provide informed consent
BMI < 40 kg/m2 (FMD measurements can be inaccurate in severely obese patients)
Not taking medications that interact with agents administered during experimental sessions (e.g., sildenafil interacts with nitroglycerin)

Exclusion Criteria:

• Average serum potassium >5.5 millequivalents or any single serum potassium > 6.0 millequivalents within the previous 6 months

Receiving an aldosterone antagonist within the previous 6 months
Use of a potassium sparing diuretic or any other drug that could contribute to hyperkalemia
Uncontrolled hypertension
Current smokers or history of smoking in the past 12 months
History of liver disease
History of heart failure (EF < 35%)
History of hospitalizations within the last 3 months
Active infection or antibiotic therapy
Warfarin use
Immunosuppressive therapy within the last year
Pregnancy","Active arm

Spironolactone 25 mg once daily.",ChEMBL:CHEMBL1393 | DrugBank:DB00421 | PubChem:5833,Spironolactone,[H][C@]12CC[C@]3(C)[C@]4(CCC(=O)O4)CC[C@@]3([H])[C@]1([H])[C@]([H])(SC(C)=O)CC1=CC(=O)CC[C@@]12C,C03DA01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01856114,NCT01856114_EG000,No,All,Adult | Older Adult,Phase 2,9,"Inclusion Criteria:

Diagnosis of cancer with evidence of active disease
Breakthrough dyspnea, defined in this study as dyspnea on exertion with an average intensity level >/=3/10 on the numeric rating scale
Outpatient at MD Anderson Cancer Center seen by the Supportive Care Service, Thoracic Medical Oncology or Cardiopulmonary Center
Ambulatory and able to walk with or without walking aid
On strong opioids with morphine equivalent daily dose of 60-130 mg for at least one week, with stable (i.e. +/- 30%) regular dose over the last 24 hours
Karnofsky performance status >/=50%
Age 18 or older
Able to complete study assessments
Must speak and understand English.

Exclusion Criteria:

Dyspnea at rest >/=7/10 at the time of enrollment
Supplemental oxygen requirement >6 L per minute
Delirium (i.e. Memorial delirium rating scale >13)
History of unstable angina or myocardial infarction 1 month prior to study enrollment
Resting heart rate >120 at the time of study enrollment
Systolic pressure >180 mmHg or diastolic pressure >100 mmHg at the time of study enrollment
History of active opioid abuse within the past 12 months
History of allergy to fentanyl
Severe anemia (Hb <7g/L) if documented in the last month and not corrected prior to study enrollment*
Bilirubin >5X Upper limit of normal if documented in the last month and not lowered to <5x normal prior to study enrollment*
Diagnosis of acute pulmonary embolism within past 2 weeks
Diagnosis of pulmonary hypertension
Unwilling to provide informed consent","Received Fentanyl Buccal Tablet 30 minutes before 2nd 6 minute walk test, dose equivalent to 20-50% of their total opioid dose over the past 24 hours.",ChEMBL:CHEMBL596 | DrugBank:DB00813 | PubChem:3345,Fentanyl,CCC(=O)N(c1ccccc1)C1CCN(CCc2ccccc2)CC1,N01AH01 | N01AH51 | N02AB03,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01856907,NCT01856907_EG002,No,Female,Adult,Phase 4,12,"Inclusion Criteria:

Females 18 years to 42 years of age who experienced gestational diabetes mellitus (GDM) during recent (within 12 months) pregnancy with prediabetic hyperglycemia determined by an oral glucose tolerance test (OGTT) with 75 g glucose postpartum. Study subjects will be inclusive of prior GDM women with impaired fasting glucose (IFG), impaired glucose tolerance (IGT), or both (IFG/IGT) postpartum.
Written consent for participation in the study

Exclusion Criteria:

Cholestasis during the past pregnancy
Any hepatic diseases in the past (viral hepatitis, toxic hepatic damage, jaundice of unknown etiology)
Serum aspartate transaminase (AST) and/or alanine aminotransferase (ALT) level exceeding more than twice normal lab values
Presence of hypersensitivity to sitagliptin or other DPP-4 inhibitor
Current use of metformin, thiazolidinediones, GLP-1 receptor agonists, DPP-4 inhibitors, or weight loss medications (prescription or over the counter [OTC])
Prior use of medication to treat diabetes except gestational diabetes
Use of drugs known to exacerbate glucose tolerance
History of diabetes or prior use of medications to treat diabetes except GDM
Creatinine clearance less than 60 ml/min
Pregnancy planned during the coming two years
Currently lactating
Patient not willing to use adequate contraception during study period (unless sterilized)","1000 mg BID

Metformin: Biguanide- insulin sensitizer",ChEMBL:CHEMBL1431 | DrugBank:DB00331 | PubChem:4091,Metformin,CN(C)C(=N)NC(=N)N,A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01859013,NCT01859013_EG000,No,All,Child,Phase 2,34,"Inclusion Criteria:

BMI ≥1.2 times the 95th percentile (based on gender and age) or BMI ≥35 kg/m2
12-18 years old
Tanner stage IV or V by physical exam

Exclusion Criteria:

Tanner stage I, II, or III
Type 1 or 2 diabetes mellitus
Previous (within 6-months) or current use of weight loss medication (patients may undergo washout)
Previous (within 6-months) or current use of drugs associated with weight gain (e.g. steroids/anti-psychotics)
Previous bariatric surgery
Recent initiation (within 3-months) of anti-hypertensive or lipid medication
Previous (within 6-months) or current use of medication to treat insulin resistance or hyperglycemia (patients may undergo washout)
Major psychiatric disorder
Females: Pregnant, planning to become pregnant, or unwilling to use 2 or more acceptable methods of contraception when engaging in sexual activity throughout the study
Tobacco use

Liver/renal dysfunction

ALT or AST >2.5 times the upper limit of normal
Bicarbonate <18 mmol/L
Creatinine >1.2 mg/dL
Glaucoma
Obesity associated with genetic disorder (monogenetic obesity)
Hyperthyroidism or uncontrolled hypothyroidism
History of suicidal thought/attempts
History of kidney stones
History of cholelithiasis
Current use of other carbonic anhydrase inhibitor","Four (4) weeks of meal replacement therapy, followed by 28-weeks of topiramate therapy. Topiramate will be initiated at a dose of 25 mg (taken orally once daily in the evening), escalated to 50 mg (taken orally once daily in the evening) after 1 week, and escalated to 75 mg (taken orally 25 mg in the morning and 50 mg in the evening) after 2 weeks.

Topiramate: Topiramate will be initiated at a dose of 25 mg (taken orally once daily in the evening), escalated to 50 mg (taken orally once daily in the evening) after 1 week, and escalated to 75 mg (taken orally 25 mg in the morning and 50 mg in the evening) after 2 weeks. Patients who do not tolerate dose escalation will be reduced to the highest tolerated dose for the remainder of the trial.",ChEMBL:CHEMBL220492 | DrugBank:DB00273 | PubChem:5284627,Topiramate,[H][C@@]12OC(C)(C)O[C@]1([H])CO[C@@]1(COS(N)(=O)=O)OC(C)(C)O[C@]12[H],A08AA51 | N03AX11,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01859715,NCT01859715_EG000,No,All,Adult | Older Adult,Not Applicable,502,"Inclusion Criteria:

self-reported pain or nausea identified by the initial nursing assessment

Exclusion Criteria:

unable to speak English,
< 18 y.o.,
previously diagnosed with chronic pain or cyclic vomiting","Subjects given either oxycodone 5mg or hydrocodone/acetaminophen 5mg/500 mg by ED provider decision or by triage nurse randomization.

Oxycodone: Subjects given either oxycodone 5mg or hydrocodone/acetaminophen 5mg/500 mg by ED provider decision or by triage nurse randomization.

Hydrocodone: Subjects given either oxycodone 5mg or hydrocodone/acetaminophen 5mg/500 mg by ED provider decision or by triage nurse randomization.",ChEMBL:CHEMBL656 | DrugBank:DB00497 | PubChem:5284603,Oxycodone,COc1ccc2c3c1O[C@H]1C(=O)CC[C@@]4(O)[C@@H](C2)N(C)CC[C@]314,N02AA05 | N02AA55 | N02AA56 | N02AJ17 | N02AJ18 | N02AJ19,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01859715,NCT01859715_EG001,No,All,Adult | Older Adult,Not Applicable,502,"Inclusion Criteria:

self-reported pain or nausea identified by the initial nursing assessment

Exclusion Criteria:

unable to speak English,
< 18 y.o.,
previously diagnosed with chronic pain or cyclic vomiting","Subjects given either oxycodone 5mg or hydrocodone/acetaminophen 5mg/500 mg by ED provider decision or by triage nurse randomization.

Oxycodone: Subjects given either oxycodone 5mg or hydrocodone/acetaminophen 5mg/500 mg by ED provider decision or by triage nurse randomization.

Hydrocodone: Subjects given either oxycodone 5mg or hydrocodone/acetaminophen 5mg/500 mg by ED provider decision or by triage nurse randomization.",ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01869699,NCT01869699_EG001,No,All,Adult | Older Adult,Phase 4,41,"Inclusion Criteria:

18 years of age and older
Patient in an intensive care unit
Weight greater or equal to 50 kgs
Fever: core body temperature greater than or equal to 38.3 degrees Celsius
Clinically stable: no active resuscitation with fluids, blood products, or dose increases of vasoactive medications within 1 hour of study drug administration

Exclusion Criteria:

Acetaminophen hypersensitivity
Acute liver failure or acute liver injury
Heat stroke, malignant hyperthermia, neuroleptic malignant syndrome
Therapeutic cooling, physical cooling, extracorporeal blood circuit therapies
Administration of acetaminophen-containing medications, non-steroidal anti-inflammatory drugs, or aspirin greater than 81 mg within specified times per drug prior to fever presentation","Acetaminophen 1 gram/100 mLs intravenous, single dose administered over 15 minutes

Acetaminophen: acetaminophen 1 gram/100mLs intravenously administered over 15 minutes",ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01872715,NCT01872715_EG000,No,All,Adult | Older Adult,Phase 4,24,"Inclusion Criteria:

Men and women
25-70 years
Diagnosis of papulopustular rosacea
Eligible for Oracea treatment

Exclusion Criteria:

Allergies to components of investigational product and/or hypersensitivity to tetracyclines
Taken systemic therapy directed at improving rosacea, including antibiotics, within 30 days prior to baseline visit
Used topical rosacea treatment within 30 days prior to baseline visit
Have active ocular rosacea and/or blepharitis/meibomianitis requiring systemic treatment by an opthalmologist
Previously failed to have improvement of rosacea with appropriate use of systemic tetracycline family of antibiotics
Exposed to intense/excessive ultraviolet (UV) radiation within one week prior to baseline and/or who forsee unprotected and intense/excessive UV exposure during the course of the study
Have planned surgical procedures during the course of the study
Have used tetracycline antibiotics within 30 days prior to baseline visit or during study
At risk in terms of precautions, warnings, and contraindications","Oracea (doxycycline USP, 40mg[30mg immediate release/ 10mg delayed release beads] taken once daily in the morning on an empty stomach, one hour before meals or two hours after.

Oral dose for 12 weeks

Oracea",PubChem:54684461,Doxycycline monohydrate,CC1c2cccc(O)c2C(O)=C2C(=O)C3(O)C(O)=C(C(N)=O)C(=O)C(N(C)C)C3C(O)C21.O,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT01873859,NCT01873859_EG000,No,All,Child | Adult | Older Adult,Not Applicable,166,"Inclusion Criteria:

Diabetic patients receiving metformin who were scheduled for:

coronary angiography
coronary angioplasty

Exclusion Criteria:

Patients who had contraindication for metformin administration, such as:

decompensated heart failure
severe liver disease
severe hypoxemia
GFR<60 mL/min per 1.73 m2","Diabetic patients receiving contrast media without discontinuing metformin.

Metformin: Incidence of lactic acidosis in diabetic patients receiving contrast media in the presence of metformin.",ChEMBL:CHEMBL1431 | DrugBank:DB00331 | PubChem:4091,Metformin,CN(C)C(=N)NC(=N)N,A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01876992,NCT01876992_EG000,Accepts Healthy Volunteers,All,Child | Adult | Older Adult,Not Applicable,10,"Pediatric Inclusion Criteria:

Children 10-17 years.
Both genders (male and female)
All children must have a Primary Care Physician and/or an Endocrinologist who must be aware that the child under their care will be part of the study.
All children must have a Primary Care Physician and/or an Endocrinologist who is considering initiating metformin therapy now or in the near future as part of standard clinical care.
Naïve to metformin.
Either: Prediabetic children Or diabetic children under good glycemic control

Pediatric Exclusion Criteria:

Children ages 10-17 who do not have parental consent and/or do not give assent
Children living in foster care
Children with allergies to foods in the breakfast menu
Children who currently consume any alcohol
Children on current antidiabetic medication or those who have been on any antidiabetic medication in the 3 months prior to enrolment
Children with a history of /or concurrent chronic disease (eg. heart, kidney, liver disease or any type of malignancy or pre-malignant condition) that required hospitalization within the last 6 months
Pregnancy
Refusal by a female participant who is of child bearing potential and sexually active to use contraceptive methods such as oral contraceptive pills, barrier methods and abstinence
Children weighing less than 36 kg
Children with any condition that increases the risk of lactic acidosis (e.g. cancer, infection, congestive heart failure, renal disease )
Children with history of recent hospitalization for surgery, dehydration, sepsis, hypoxemia (within the past 6 months)
Children with history of weight loss, polyuria and polydipsia
Children who are currently enrolled in a weight management program
Children with known hypersensitivity to metformin
Children with a fasting blood glucose of >180mg/dl
Children with a HbA1c level of ≥7%
Children with glycosuria
Children with clinical or laboratory evidence of hepatic disease- transaminase levels three times the upper normal range (Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT)) and/or a increased level of Gamma-glutamyltransferase (GGT), Prothrombin Time (PT), International Normalized Ratio (INR) from the reference normal range and a serum albumin less than the reference normal range of the Johns Hopkins Clinical Laboratories.
If iodinated contrast is used on a participant, due to possible acute alteration of renal function resulting in increased risk of lactic acidosis, the participant will be excluded.

Children with renal impairment

In children >50kg, renal impairment is defined by a serum creatinine 1.4 mg/dl or higher in females or 1.5mg/dl or higher in males OR estimated Glomerular Filtration Rates (eGFR) ≤60mL/min by the Schwartz formula.
In children <50kg, renal impairment is defined by eGFR <100 mL/min by the Schwartz formula.
Children with acid-base disturbance as defined by serum bicarbonate levels less than 20mEq/L or greater than 29mEq/L.

Adult Inclusion Criteria:

Adults 18-79 years
Both genders (male and female)
All participants must have a Primary Care Physician and/or an Endocrinologist who must be aware that the adult under their care will be part of the study
All participants must have a Primary Care Physician and/or an Endocrinologist who is considering initiating metformin therapy now or in the near future as part of standard clinical care.
Naive to metformin
EITHER: Prediabetic adults OR diabetic adults, under fair glycemic control:

Adult Exclusion Criteria:

Pregnancy
Adults who are not able to understand the Informed Consent document and who are unwilling to do the study
Adults with allergies to any of the foods in the breakfast menu
Adults on current antidiabetic medication or on any antidiabetic medication in the 3 months prior to enrolment.
Adults with a history of /or concurrent chronic disease (e.g. heart, kidney, liver disease or any type of malignancy or pre-malignant condition) that required hospitalization within the last 6 months
Refusal by a female participant who is of child bearing potential and sexually active to use contraceptive methods such as oral contraceptive pills, barrier methods and abstinence
Adults with excessive current intake of alcohol (>2 drinks/day for males and >1 drink/day for females)
Adults who have engaged in binge drinking (>5 drinks within a 2 hour period) in the last 3 months
Adults with history of recent hospitalization for surgery, dehydration, sepsis, hypoxemia (past 6 months)
Hypersensitivity to metformin.
Adults with fasting blood glucose of >180mg/dl.
Adults with HbA1c level of ≥8%
Adults with glycosuria.
Adults with any condition that increases the risk of lactic acidosis (e.g. cancer, infection, congestive heart failure, renal disease )
Adults with clinical or laboratory evidence of hepatic disease- transaminase levels three times the upper normal range (AST and ALT) and/or a increased level of GGT, PT, INR from the reference normal range and a serum albumin less than the reference normal range of the Johns Hopkins Clinical Laboratories.
If iodinated contrast is used on a participant, due to possible acute alteration of renal function resulting in increased risk of lactic acidosis, the adult participant will be excluded.
Adults with renal impairment as defined by a serum creatinine 1.4 mg/dl or higher in females or 1.5mg/dl or higher in males OR estimated Glomerular Filtration Rates (eGFR) ≤60mL/min by Modification of Diet in Renal Disease (MDRD) formula.
Adults with acid-base disturbance as defined as serum bicarbonate levels less than 20mEq/L or greater than 29mEq/L.

Adult Obese Control Inclusion Criteria:

Age 18-79
Both genders (male and female)
BMI > 30 kg/m2

Adult Obese Control Exclusion Criteria:

Subjects previously or currently on any diabetes medication, including metformin, will be excluded.
Pregnancy
Subjects with history of or concurrent chronic disease (e.g. heart, kidney, liver disease or any type of malignancy or pre-malignant condition) that required hospitalization within the last 6 months will be excluded.
Adults with allergies to any of the foods in the breakfast menu
Adults with excessive current intake of alcohol (>2 drinks/day for males and >1 drink/day for females)
Adults who have engaged in binge drinking (>5 drinks within a 2 hour period) in the last 3 months","Doses will be increased incrementally. Decisions to escalate the metformin dose will be made based upon tolerability of side effects as described in the schedule of evaluations to follow. All subjects will be monitored for safety while receiving metformin. Any participant with blood glucose of <60mg/dl at any time while receiving metformin will have therapy stopped and will be withdrawn from the study.

For children <50kg:

Baseline:250mg po qd, Week 2:250mg po bid, Week 4:500mg po AM/250mg po PM, Week 8:500mg po bid.

For children ≥50kg:

Baseline:500mg po qd, Week 2:500mg po bid, Week 4:1000mg po AM/500mg po PM, Week 8:1000mg po bid.

For adults:

Baseline:500mg po qd,Week2:500mg po bid,Week 4:1000mg po AM/500mg po PM,Week 8:1000mg po bid.

Metformin",ChEMBL:CHEMBL1431 | DrugBank:DB00331 | PubChem:4091,Metformin,CN(C)C(=N)NC(=N)N,A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01877564,NCT01877564_EG000,No,Female,Adult | Older Adult,Phase 2,6,"Inclusion Criteria:

Histological confirmed diagnosis of grade I or II adenocarcinoma of the endometrium
Must be obese as defined by a body mass index (BMI) greater than or equal to 30 kg/m2
Candidate for surgical removal of their uterus as part of their endometrial cancer treatment
Subjects must have signed informed consent
Age 42 - 65 years of age
Electrocorticogram (ECOG) Performance status of 0 - 2

History of adequate renal, liver, and bone marrow function:

Hb: (adequate for surgical intervention, with transfusion if necessary) White Blood Cell (WBC): (normal range)
Platelets: (180K/cmm)
Liver Function Test(LFTs): Normal bilirubin (<2.0mg/dL), AST/ALT (2xULN)
Renal function: creatinine less than 1.4
Female subjects must either not be of child-bearing potential or must have a negative urine pregnancy test within 7 days of randomization to Metformin. Subjects are considered not of child-bearing potential if they are surgically sterile or they are postmenopausal for greater than 12 months.

Exclusion Criteria:

Poorly differentiated cancer or any of the high-risk subtypes of endometrial cancer including serous, clear cell, or carcinosarcoma
History of diabetes mellitus Type 1 or Type 2.
Receiving metformin prior to enrollment
Known hypersensitivity to metformin.
Unable to swallow and retain oral medication.
Pregnant or lactating.
Previous or concurrent malignancies, except non-melanoma skin cancers, unless curatively treated and with no evidence of recurrence for > 5 years
If the physician feels that the candidate is not suitable for the study, he/she will be excluded.
Currently taking biguanides, sulfonylurea drugs, thiazolidinediones, insulin, or mTOR or DPP-4 inhibitors or having taken any of these medications during the 12 weeks prior to study participation.
Clinical symptoms of gastrointestinal obstruction or bleeding and consideration for immediate surgery or immediate neoadjuvant chemoradiation.
History of lactic or other metabolic acidosis.
Uncontrolled infectious disease.
History of positivity for human immunodeficiency virus (HIV).
History of congestive heart failure requiring pharmacologic treatment.
History of excessive alcohol abuse, defined by a habitual intake of more than three drinks daily.
Mal-absorption syndrome, disease affecting gastrointestinal function, or previous resection of the stomach or small bowel.
Current use of medications for weight loss.
Currently taking cimetidine, thiazide diuretics or cephalexin. If a patient needs some of these agents, alternative agents should be substituted.","oral metformin at 500 mg twice a day for 14-21 days followed by surgery

Metformin",ChEMBL:CHEMBL1431 | DrugBank:DB00331 | PubChem:4091,Metformin,CN(C)C(=N)NC(=N)N,A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01880515,NCT01880515_EG000,No,All,Adult | Older Adult,Phase 2,107,"Inclusion Criteria:

Diagnosis of non-operable, locally advanced, recurrent or metastatic, histologically or cytologically documented non-small cell lung cancer (stage IIIB or IV).

Patients should have an evidence of measurable disease.
18 years or older
Eastern Cooperative Oncology Group - Performance Status 0-3
At least 12 weeks of life expectancy
Patients with non-small cell lung cancer stages IIIB/IV who have received at least one cycle of platinum-based, first or second line systemic standard chemotherapy, and have a documented failure for this treatment.
More than 2 previous chemotherapy regimens are not allowed. The patients should have recovered from any toxic effect and at least 2 weeks should have elapsed from last dose before their entry (14 days for vinorelbine and other vinca alkaloids or gemcitabine). Patients who in the investigator's opinion are fully recovered from surgery for at least 4 weeks may also be considered for the study. Patients should have recovered from any severe toxicity (CTC > 1) caused by any previous therapy.
Granulocyte count > 1.5x 109/L and platelet count > 100x 109/L.
Serum bilirubin > 1.5 upper limit of normal (ULN)
AST and/or ALT > 2 ULN (or >5 x ULN when clearly attributable to presence of hepatic metastases).
Serum creatinine > 1.5 ULN or creatinine clearance < 60 mL/min
Capability to fulfill the study and follow-up procedures.
A negative pregnancy test should be obtained from all women of childbearing potential within 72 hours previous to therapy beginning.
Patients of reproductive potential should use effective contraceptive methods.
Written (signed) informed consent to participate in the study

Exclusion Criteria:

Patients allergic to the antibiotic therapy used.
Any unsteady systemic disease (including active infection, uncontrolled hypertension, unsteady angina, congestive cardiac failure, hepatic, renal or metabolic disease).
A previous treatment using a systemic anti-tumor therapy with EGFR inhibitors (tyrosine kinase inhibitors).
Any other malignant pathology within 5 previous years (except for carcinoma in situ of cervix or basal-cell type skin cancer appropriately treated).
Patients with cerebral metastases or spinal marrow compression recently diagnosed and/or definitely surgery and/or radiation naïve-treatment patients are excluded. Those with previously diagnosed and treated metastasis to Central Nervous System (CNS) or spinal marrow compression, having an evidence of steady disease (clinically steady in imaging studies) are accepted for at least 2 months.
Any significant ophthalmologic abnormality, especially severe dry-eye syndrome, keratoconjunctivitis sicca, Sjögren's syndrome, severe exposure keratitis and any other disorder that may increase the risk for corneal epithelial injure. Contact lens use during the study is not recommended. The decision to continue to use contact lens should be discussed with the oncologist responsible for patient treatment and the ophthalmologist.
Patients who cannot take oral medication, requiring intravenous nutrition, who underwent previous surgical procedures affecting absorption, or with active peptic ulcer.
Nursing women.","Patients will receive tetracycline 250mg every 12 hours for 1 month plus general dermatological recommendations (sunscreen and emollient cream)

Tetracycline: The experimental group will receive tetracycline 250mg every 12 hours for 1 month the same day at initiation of BIBW 2992",ChEMBL:CHEMBL1440 | DrugBank:DB00759 | PubChem:54675776,Tetracycline,[H][C@]12C[C@@]3([H])[C@H](N(C)C)C(O)=C(C(N)=O)C(=O)[C@@]3(O)C(O)=C1C(=O)c1c(O)cccc1[C@@]2(C)O,A01AB13 | A02BD02 | A02BD08 | D06AA04 | J01AA07 | J01AA20 | J01RA08 | S01AA09 | S02AA08 | S03AA02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01881828,NCT01881828_EG000,No,All,Child | Adult,Phase 3,71,"Inclusion Criteria:

Clinical diagnosis of presumed autoimmune type 1 diabetes (T1D) as indicated by age of diagnosis <10 years or documented positive diabetes-related autoantibodies.

a. Note: For randomization, presence of at least one of the diabetes-related autoantibodies [Insulin autoantibodies (IAA) at diagnosis prior to initiation of insulin, Islet cell antibodies (ICA), Anti-GAD (GAD65), Anti-IA2 (IA2), Zinc Transporter 8 (ZnT8)] must be documented either from medical records or new laboratory measurement (IAA and ICA not measured by central lab) sent to central lab for participants who were ≥10 years old at diagnosis.

Age: 12 to <20 years.
Duration of type 1 diabetes: ≥1 years.
Current insulin regimen involves either use of an insulin pump or multiple daily injections of insulin (at least 3 shots per day) for the last three months, with no plans to switch the modality of insulin administration during the next 6 months (e.g., injection user switching to a pump, pump user switching to injections).
Hemoglobin A1c: 7.5% - <10.0% from point of care measurement or local lab on day of screening visit or within 1 month prior.
BMI: ≥85th percentile adjusted for age and sex .
Total daily dose of insulin: ≥0.8 units per kg per day.
Average of ≥3 Self-Monitoring Blood Glucose (SMBG) tests per day prior to initiating study and from download of study-provided blood glucose meter following screening visit.
Available for at least 6 months of follow-up, has home phone (or access to phone), and willing to be contacted by clinical site staff.
Expected to comply with protocol in investigator's judgment.

Exclusion Criteria:

Use of non-insulin medications for blood glucose control within prior 6 months or planning to use within next 6 months (other than study drug).
Use of medications for weight reduction (such as: Belviq (lorcaserin), Qsymia (Phentermine + topiramate), Orlistat (xenical)) within the prior 6 months or planning to use within next 6 months.
Use of a medication such as stimulants, psychotropic agents and oral/inhaled glucocorticoids that could affect weight gain or glycemic control of T1D or planning to use within the next 6 months.
Any condition that in the judgment of the investigator will adversely affect the completion of the protocol.

Females: pregnant, lactating, or intending to become pregnant within the next 34 weeks

A negative urine pregnancy test will be required for all females An effective contraceptive method or abstinence will be required for all females who have experienced menarche
Requirements regarding pregnancy testing prior to enrollment and monitoring for pregnancy over the course of the study may be further defined by each individual Institutional Review Board (IRB)
Clinical diagnosis of celiac disease that is in poor control as defined by most recent tissue transglutaminase (tTG) that is in the abnormal range.
History of ≥1 diabetic ketoacidosis events in the past 3 months.
History of ≥1 severe hypoglycemic events (cognitive impairment that required assistance to treat) in the past 3 months.
History of anemia or vitamin B12 deficiency in the past 2 years.
Participation in an intervention study in the past 3 months.","Metformin 2000 mg per day

Metformin (glucophage): The strength of each tablet will be 500 mg. Participants will build up to a daily dose over four weeks by taking one tablet per day for 7 days, one tablet twice daily for 7 days, one tablet in morning and 2 tablets at night for 7 days, and then 2 tablets in the morning and 2 tablets at night, daily throughout the remainder of the study treatment period.",ChEMBL:CHEMBL1431 | DrugBank:DB00331 | PubChem:4091,Metformin,CN(C)C(=N)NC(=N)N,A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01882816,NCT01882816_EG000,No,All,Adult | Older Adult,Phase 2,27,"Inclusion Criteria:

Pathologically confirmed diagnosis of non-anaplastic non-medullary thyroid cancer that is either grossly recurrent after surgery or unresectable with or without metastatic disease.
Age ≥18 years
Karnofsky performance status ≥70%
Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months after treatment.
Patients must have ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

Women who are pregnant or lactating
Inability to comply with study and/or follow-up procedures","All patients will undergo radiation treatments using IMRT with concurrent low-dose radiosensitizing doxorubicin at 10 mg/m2 will be administered.

IMRT: Patients will receive intensity-modulated radiation therapy (IMRT) in once-daily fractions (Monday through Friday, excluding holidays). A total dose of 70Gy is planned. Patients will be seen weekly during radiation as per standard procedure at MSKCC

DWI MRI: The DW and multiparametric MRI will be recommended for 3 months, 6 months, and then every 6 months (all +/- 4 weeks) until 2 years post-RT unless contraindicated for main campus patients only. This schedule may be altered, as clinically indicated.

Doxorubicin: Low dose radiosensitizing doxorubicin at 10 mg/m2 will be administered weekly.

Modified Barium Swallow Impairment Profile (MBSImP): The MBSImP is a standardized tool which assesses swallowing impairment as it relates to oral, pharyngeal, and esophageal impairments.",ChEMBL:CHEMBL417 | ChEMBL:CHEMBL53463 | DrugBank:DB00445 | DrugBank:DB00997 | PubChem:1691 | PubChem:31703 | PubChem:41867,Epirubicin,COc1cccc2c1C(=O)c1c(O)c3c(c(O)c1C2=O)CC(O)(C(=O)CO)CC3OC1CC(N)C(O)C(C)O1,L01DB01 | L01DB03,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT01886690,NCT01886690_EG001,Accepts Healthy Volunteers,All,Adult,Phase 3,73,"Inclusion Criteria:

-Patients scheduled for LASIK surgery in both eyes.

Exclusion Criteria:

Any systemic medication use within 3 months of screening (including over the counter, herbal, prescription, or nutritional supplement) which may affect dry eye or vision
Use of topical eye medication other than prescribed for use in pre- or post-operative care
Use of RESTASIS® or other topical ophthalmic cyclosporine product within 6 months prior to Screening
Eye infection, inflammation, or allergy
Soft contact lenses in the previous 7 days or rigid contact lenses in the previous 30 days prior to LASIK surgery.",1 to 2 drops carboxymethylcellulose sodium based (REFRESH PLUS®) eye drops in each eye as per protocol for 90 days.,PubChem:6328154,Carmellose sodium,CC(=O)O.O=CC(O)C(O)C(O)C(O)CO.[Na],,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01888965,NCT01888965_EG000,No,All,Adult | Older Adult,Phase 2,9,"Inclusion Criteria:

Patients with a confirmed diagnosis of:

Stage 4 colon cancer either s/p metastasectomy or post-initial chemotherapy or maintenance ""standard of care"", either involving 5-fluorouracil/leucovorin (5-FU/LV) alone or continual bevacizumab alone. Patients in maintenance cohort must have had 2 consecutive CT scans showing stable disease and not be experiencing significant prior treatment-related toxicity above Grade 1.
Pancreas cancer, either s/p resection and adjuvant chemotherapy or locally advanced pancreas cancer s/p chemotherapy and radiation. Initial chemotherapy or radiation therapy may have been stopped between 2 weeks and 2 months prior to study start, and patients must have recovered from prior treatment related toxicity to grade 1 or less.
Prior surgery, including tumor resection or metastasectomy must have been performed at least 4 weeks prior to study enrollment.
No concomitant anti-cancer treatment is allowed
Age >/= 18 years
Performance status of 0-1
Adequate hepatic, bone marrow, and renal function
Partial thromboplastin time (PTT) must be </= 1.5 x upper normal limit of institution's normal range and INR (International Normalized Ratio) < 1.5.
Life expectancy >/= 4 months for maintenance cohorts and >/= 6 months for adjuvant cohorts
Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to initiation of treatment and must not be lactating.
Subject is capable of understanding and complying with protocol demands and able to sign and date the informed consent

Exclusion Criteria:

Women of child-bearing potential, who are biologically able to conceive, not employing two forms of highly effective contraception or who are pregnant.
Women who are breast-feeding
Fertile males unwilling to use contraception
Patients with brain metastases or any history of brain metastases
Patients who have undergone major surgery (e.g., intra-thoracic, -abdominal, or -pelvic) </= 4 weeks prior to starting study treatment or who have not recovered from such therapy
Patients with a history of pulmonary embolism, or untreated deep vein thrombosis within the past 6 months
Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of dovitinib
The subject has had another active malignancy within the past 5 years except for cervical cancer in situ, in situ carcinoma of the bladder or non-melanoma carcinoma of the skin.
Patients who have received the last administration of an anticancer therapy including chemotherapy, immunotherapy, hormonal therapy and monoclonal antibodies </= 2 weeks prior to starting the study drug, or who have not recovered from the side effects of such therapy
Cirrhosis, chronic active hepatitis or chronic persistent hepatitis
Patients who are currently receiving prasugrel
No concurrent use of isoniazid, labetolol, trovafloxacin, tolcapone, and felbamate
No concurrent use of other investigational drugs or antineoplastic therapies.
Patients with impaired cardiac function or clinically significant cardiac diseases.","Dovitinib 500 mg orally daily for 5 days followed by 2 days off (7 day cycles) for up to 2 years

Dovitinib: All patients in the study will receive Dovitinib, 500 mg orally daily for 5 days followed by 2 days off (7 day cycles) for up to 2 years.",DrugBank:DB05928 | PubChem:135398510,Dovitinib,CN1CCN(c2ccc3nc(-c4c(N)c5c(F)cccc5[nH]c4=O)[nH]c3c2)CC1,,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0
NCT01894607,NCT01894607_EG000,No,All,Adult | Older Adult,Not Applicable,11,"Inclusion Criteria:

Patients must have previous cross sectional imaging (CT or MRI) demonstrating renal mass or masses that is amenable to open partial nephrectomy.
Patient is scheduled for intraoperative ultrasound guided open partial nephrectomy.
Patient must sign informed consent, with risks and benefits of CEUS explained (see risks outlined on the following pages)

Exclusion Criteria:

Patients with known renal mass scheduled for total or laparoscopic partial nephrectomy.
Patients who are hypersensitive to Definity (Perflutren Lipid Microsphere)
Patients with known history of right-to-left, bidirectional or transient right-to-left cardiac shunts.
Pediatric patients less than 18 years of age.
Pregnant or nursing mothers.","During standard of care surgery, radiologist will take images and videos with an ultrasound machine before participant is given the contrast agent. Participant then receives the DEFINITY contrast by vein over about 1 minute. After receiving the injection of DEFINITY, radiologist will take more images and videos of the tumor and kidney(s) to compare to those recorded earlier.",ChEMBL:CHEMBL1663 | DrugBank:DB00556 | PubChem:6432,Perflutren,FC(F)(F)C(F)(F)C(F)(F)F,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01897727,NCT01897727_EG000,No,All,Adult | Older Adult,Not Applicable,41,"Inclusion Criteria:

Resistant hypertension defined as office BP that is uncontrolled with 3 or more antihypertensive medications
Moderate-severe OSA defined as AHI ≥15 events/hr
Self-reported adherence >80% with prescribed antihypertensive medications.

Exclusion Criteria:

Ongoing use of a potassium sparing diuretic
History of congestive heart failure (ejection fraction of <40%)
Chronic kidney disease (creatinine clearance <60 ml/min)
History of cardiovascular disease (stroke, TIA, myocardial infarction, or revascularization procedure)
Known or suspected history of secondary cause of hypertension other than primary aldosteronism
Severe nocturnal hypoxemia (O2 desaturation nadir <60%)
White coat hypertension defined as office BP >140/90 mm Hg and ambulatory daytime BP <135/85 mm Hg
Central sleep apnea (defined as 5% or more of the apneas as central apneas) and/or the presence of any Cheyne-Stokes breathing
Subjects working shift work or having other known circadian rhythm disorders such that their sleep-wake schedule is altered
Excessive daytime sleepiness as indicated by an Epworth score of >10
Pregnant Women",Spironolactone 25 mg administered following baseline measurements and uptitrated to 50 mg if BP > 140/90 mm Hg throughout the 3 month study.,ChEMBL:CHEMBL1393 | DrugBank:DB00421 | PubChem:5833,Spironolactone,[H][C@]12CC[C@]3(C)[C@]4(CCC(=O)O4)CC[C@@]3([H])[C@]1([H])[C@]([H])(SC(C)=O)CC1=CC(=O)CC[C@@]12C,C03DA01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01902303,NCT01902303_EG001,No,All,Adult | Older Adult,Phase 2,62,"Inclusion Criteria:

Clinical history of recurrent cold sores averaging 2 or more episodes per year
UV exposure is known to cause a cold sore outbreak

Exclusion Criteria:

History of abnormal reactions to sunlight
Used antiviral therapy directly prior to entering study
Any other condition which in the opinion of the Investigator may affect the results or place the subject at undue risk.",BTL-TML Safety Population - All subjects enrolled and allocated to active test article except for SAEs which includes all subjects that signed informed consent.,DrugBank:DB11590,Thimerosal,CC[Hg]Sc1ccccc1C(=O)[O-].[Na+],D08AK06,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01925170,NCT01925170_EG000,Accepts Healthy Volunteers,Female,Adult | Older Adult,Not Applicable,1638,"Inclusion Criteria:

Past prior SM interpreted as negative or benign [Breast Imaging Reporting and Data System (BI-RADS) Category 1 or 2]
Past prior SM interpreted as heterogeneously dense or extremely dense

Exclusion Criteria:

Subject is unable to understand and sign the consent form
Subject is pregnant or lactating
Subject is physically unable to sit upright and still for 40 minutes
Subject has self-reported signs or symptoms of breast cancer (palpable mass, bloody nipple discharge, axillary mass, etc.)
Subject has had needle biopsy within 3 months, or breast surgery within 1 year prior to the study
Subject is currently taking tamoxifen, Evista (raloxifene), Zoladex or an aromatase inhibitor for adjuvant therapy or chemoprevention.",Participants underwent conventional mammography and molecular breast imaging after a 740-millibecquerel (mBQ) (8-mCi) Technetium (99mTc) sestamibi injection.,PubChem:22617237,Technetium (99mTc) sestamibi,[C-]#[N+]CC(C)(C)OC.[C-]#[N+]CC(C)(C)OC.[C-]#[N+]CC(C)(C)OC.[C-]#[N+]CC(C)(C)OC.[C-]#[N+]CC(C)(C)OC.[C-]#[N+]CC(C)(C)OC.[Tc],,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01929980,NCT01929980_EG000,No,All,Child | Adult,Phase 2,4,"Inclusion Criteria:

All patients, having undergone allogeneic stem cell transplantation at our center.
Should have failed at least 2 standard treatments for autoimmune cytopenias. Standard treatments include corticosteroids, rituximab, IVIG, plasmapheresis, withdrawal of cyclosporine, cyclophosphamide and MMF. Definition of ""failed"" treatment will be no response of cytopenia after 2 weeks of continued treatment OR requirement of daily GCSF at 10 mcgs/kg/day for autoimmune neutropenia despite 2 weeks of treatment, transfusions of packed red blood cells or platelets 3 times weekly for 2weeks despite continued treatment OR 5days/week plasmapheresis for 2 weeks and inability to wean the duration.
Definition of autoimmune hemolytic anemia- development of anemia, where there is a hemoglobin drop of >2 g/dL/48 hours or an absolute value of hemoglobin < 8 g/dL, and evidence of hemolysis by positive direct Coombs test with compatible peripheral blood cell morphology, reticulocyte count and bilirubin level.
Definition of autoimmune neutropenia - absolute neutrophil counts < 500 for 2 weeks and presence of anti-neutrophil antibodies.
Definition of autoimmune thrombocytopenia- Platelet counts < 20,000 cells/uL for 2 weeks and presence of anti-platelet antibodies.

Exclusion Criteria:

Ongoing life threatening infections
Documented anaphylaxis to bortezomib
Failed engraftment
Relapse of primary malignancy
≥6/8 matched or haploidentical transplants","Four doses of bortezomib, 1.3mg/m2, will be given intravenously (through a needle in a vein) or subcutaneously (under the skin) on Days 1, 4, 8, 11.

The format of receiving medications is- Therapy Dose and Route Frequency Rituximab 375 mg/m2 intravenously Once on day 1. Plasmapheresis 2 hours prior to Bortezomib Day 1,4, 8 and 11 Bortezomib 1.3 mg/m2 intravenously Day 1,4,8 and 11

Bortezomib",ChEMBL:CHEMBL325041 | DrugBank:DB00188 | PubChem:387447,Bortezomib,CC(C)C[C@H](NC(=O)[C@H](Cc1ccccc1)NC(=O)c1cnccn1)B(O)O,L01XG01 | L01XX32,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT01930747,NCT01930747_EG000,No,All,Adult | Older Adult,Phase 4,16,"Inclusion Criteria:

1. Laparoscopic bariatric surgery in a patient older than 18 years of age without previous laparotomy. Examples of laparoscopic bariatric procedures are gastric band, sleeve gastrectomy, gastric bypass, gastric bypass after lap band, and revision of a gastric bypass

Exclusion Criteria:

Allergies or contraindications to the use of one or more of the following drugs: propofol, rocuronium, sugammadex, remifentanyl, or sevoflurane
History of a laparotomy
Emergency laparoscopy","deep neuromuscular block is given after first measurement of lap workspace one bolus dose of 1 mg/kg rocuronium is given

rocuronium: measure effect on laparoscopic workspace",ChEMBL:CHEMBL1201244 | DrugBank:DB00728 | PubChem:441290,Rocuronium,[H][C@@]12CC[C@]3([H])[C@]([H])(CC[C@]4(C)[C@@H](OC(C)=O)[C@@H]([N+]5(CC=C)CCCC5)C[C@@]34[H])[C@@]1(C)C[C@H](N1CCOCC1)[C@@H](O)C2,M03AC09,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01939496,NCT01939496_EG002,No,All,Adult | Older Adult,Phase 4,56,"Inclusion Criteria:

patients with a diagnosis of type 2 diabetes mellitus
patients with hypertension (seated office SBP of >=130 mmHg and <160 mmHg and seated office DBP of >= 70 mmHg at screening and at Week -2
patients on stable doses of 1 to 3 anti-hypertensive agents for at least 5 weeks before screening
patients on stable doses of 1 to 3 oral anti-hyperglycemic agents which must include metformin, for at least 8 weeks before screening

Exclusion Criteria:

a history of diabetic ketoacidosis
type 1 diabetes mellitus (T1DM)
pancreas or beta-cell transplantation
fasting C-peptide <0.70 ng/mL (0.23 nmol/L)
body mass index <30 kg/m2
has ongoing, inadequately controlled thyroid disorder
has a history of cardio-renal disease that required treatment with immunosuppressive therapy.",Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.,DrugBank:DB08907 | PubChem:24812758,Canagliflozin,[H][C@@]1(c2ccc(C)c(Cc3ccc(-c4ccc(F)cc4)s3)c2)O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O,A10BD16 | A10BK02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01941628,NCT01941628_EG000,No,Female,Adult | Older Adult,Phase 4,91,"Inclusion Criteria:

pregnant women undergoing Cesarean section under general anesthesia
at least 18 years of age
results of a physical and laboratory preoperative examination within normal limits or clinically acceptable limits for the study
written informed consent

Exclusion Criteria:

urgent Cesarean section
multiple pregnancy
abnormal placentation
prematurity (<34 weeks)
severe fetal hypoxia
history of severe pre-existing disease
hypersensitivity or allergy to rocuronium or sugammadex

Discontinuation Criteria:

a subject's choice to end participation in the study
a subject meets any exclusion criteria during the study or equivalent criteria
lost to follow up
the investigator feels that it's in the subject's best interest to discontinue the study",Rocuronium 0.6 mg/kg was used as muscle relaxant to allow intubation during induction into general anesthesia and to induce deep neuromuscular blockade for the surgery. Deep neuromuscular blockade was maintained thorough the surgery until the suture of fascia of musculus rectus abdominis.,ChEMBL:CHEMBL1201244 | DrugBank:DB00728 | PubChem:441290,Rocuronium,[H][C@@]12CC[C@]3([H])[C@]([H])(CC[C@]4(C)[C@@H](OC(C)=O)[C@@H]([N+]5(CC=C)CCCC5)C[C@@]34[H])[C@@]1(C)C[C@H](N1CCOCC1)[C@@H](O)C2,M03AC09,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01948063,NCT01948063_EG000,No,All,Adult | Older Adult,Phase 2,19,"Inclusion Criteria:

Over 18 years old
Suspected or confirmed infection
Presence of 2 or more systemic inflammatory response syndrome (SIRS) criteria
Admission to the ICU

Exclusion Criteria:

Under 18 years old
Current CoQ10 supplementation
Unable to receive enteral medications
Would need a nasogastric or orogastric tube solely for the purposes of the study
Pregnancy, incarceration, mentally disability
Patient confirmed Comfort measures only, Do not resuscitate (DNR) and/or Do not intubate. Patients with DNR but intubated and being provided full care are eligible","Depending on the patient's ability to swallow pills, patients in the experimental group will receive 200mg of Ubiquinol in either a pill or a liquid. The liquid form of the study med will be mixed with 50 milliliters of Ensure (a dietary supplement) to ensure blinding. This will be given every 12 hours for 7 days or until hospital discharge.",DrugBank:DB11340 | PubChem:9962735,Ubiquinol,COc1c(O)c(C)c(C/C=C(\C)CC/C=C(\C)CC/C=C(\C)CC/C=C(\C)CC/C=C(\C)CC/C=C(\C)CC/C=C(\C)CC/C=C(\C)CC/C=C(\C)CCC=C(C)C)c(O)c1OC,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01948505,NCT01948505_EG000,No,All,Adult | Older Adult,Phase 4,210,"Inclusion Criteria:

> 45 kg (amenable to adult dosing)
all traumatic brain injuries NPO for at least 12 hours
all post-operative craniotomy patients
all non-operative subarachnoid hemorrhage, intraparenchymal hemorrhage, and stroke patients
all carotid endarterectomy and carotid artery stenosis patients
all endovascular patients undergoing intracranial intervention
all post-op spine patients admitted to the NCCU

Exclusion Criteria:

documented allergy to acetaminophen
documented severe hepatic impairment (Child-Pugh score > 6) or severe hepatic disease (hepatitis)
documented severe renal impairment (CrCl < 30 ml/min) Blood tests will be performed prior to study procedures that will ensure patients do not have renal impairment.
patients who are pregnant or breast feeding","IV acetaminophen: 1000mg IV q 8 hrs (scheduled) until: a) tolerating PO and IV saline-locked or b) 48 hours reached on medication

Intravenous acetaminophen",ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01951651,NCT01951651_EG001,No,All,Adult | Older Adult,Phase 4,24,"Inclusion Criteria:

Patients must be able to communicate meaningfully with the investigator and must be legally competent to provide written informed consent.
Patients may be of either sex. Female patients must be non-lactating and must either be at least two years post-menopausal, or be using adequate contraceptive precautions.
Patients must range in age from 30 to 70 years, inclusive.
Patients must meet the American Diabetes Association (ADA) criteria (ADA 1997 Criteria: fasting plasma glucose greater than or equal to 126 mg/dl) for the diagnosis of type 2 diabetes mellitus.
Patients must be on diet therapy and/or metformin treatment for type 2 diabetes (stable dose)and have a fasting plasma glucose concentration between 126 and 260 mg/dl
Patients must have Hematocrit greater than 34 vol%.
Subjects whose body weight has been stable over the three months prior to study enrollment will be included.

Exclusion Criteria:

Patients must not have type 1 diabetes.
Patients must not have a fasting plasma glucose greater than 260 mg/dl.
Patients must not have received a thiazolidinedione for at least 3 months prior to randomization.
Patients must not be on insulin treatment or have received insulin for more than one week within the previous year prior to entry. Patients should not be on sulfonylureas, sitagliptin, or exenatide treatment.
Patients taking systemic glucocorticoids or other medications known to affect glucose tolerance are excluded.
Patients taking medications that affect gastrointestinal motility will be excluded.
Patients with a history of Congestive Heart Failure, or clinically significant cardiac, liver or kidney disease (creatinine greater than 1.5 mg/dl).","Glipizide 5 mg (tablet), one tablet twice daily orally for 6 months

Glipizide: Type 2 diabetic subjects will be randomized to receive either Exenatide 10 micrograms twice daily injected subcutaneously or glipizide 5 mg twice daily orally for 6 months. All subjects will receive baseline measurements of fasting plasma glucose, free fatty acids, plasma adipocytokines, plasma lipids, and glycosylated hemoglobin (HbA1c) as well as measurement of liver and myocardial fat content and left ventricular function with magnetic resonance imaging/spectroscopy. All subjects will also undergo measurements of monocyte inflammatory proteins at baseline. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, adipocytokines, HbA1c, monocyte inflammation, as well as hepatic/myocardial fat content determination and left ventricular function at the end of the 6 months.",ChEMBL:CHEMBL1073 | DrugBank:DB01067 | PubChem:3478,Glipizide,Cc1cnc(C(=O)NCCc2ccc(S(=O)(=O)NC(=O)NC3CCCCC3)cc2)cn1,A10BB07,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01954056,NCT01954056_EG000,No,All,Child | Adult | Older Adult,Phase 3,6,"Inclusion Criteria:

Gestational age greater than or equal to 34 weeks at birth
Admitted to the center NICU by 48 hours of age
Intubated and mechanically ventilated for a minimum of 2 hours before 72 hours postnatal age

Exclusion Criteria:

Receiving ECMO
Intubated for the sole purpose of anticipated surgery or airway anomalies
Treatment will be limited based on poor prognosis
Receiving dexamethasone or hydrocortisone
Receiving ibuprofen or indomethacin
Congenital heart disease
Hypotension thought to result from specific, immediately remediable factors including placental hemorrhage, acute hemorrhage or tension pneumothorax
Pituitary hypoplasia or congenital adrenal hyperplasia
Any chromosomal disorder
Hypertension in the absence of inotrope therapy as defined by mean arterial blood pressure > 95th percentile
Initiation of whole body cooling for moderate or severe neonatal encephalopathy
Brain disorders or any other known structural abnormality
Major anomalies","hydrocortisone (hydrocortisone sodium succinate, plain; will not have benzyl alcohol) given through intravenous line or by intramuscular injection if no intravenous line Hydrocortisone: • 7 day course of hydrocortisone (hydrocortisone sodium succinate, plain; will not have benzyl alcohol) given through intravenous line or by intramuscular injection if no intravenous line).

1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose",ChEMBL:CHEMBL389621 | DrugBank:DB00741 | PubChem:5754,Hydrocortisone,[H][C@@]12CC[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)CC[C@@]21C,A01AC03 | A07EA02 | C05AA01 | D07AA02 | D07BA04 | D07CA01 | D07XA01 | H02AB09 | R01AD60 | S01BA02 | S01BB01 | S01CA03 | S01CB03 | S02BA01 | S02CA03 | S03CA04,1.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01958073,NCT01958073_EG002,No,Female,Adult | Older Adult,Phase 4,35,"Inclusion Criteria:

Postmenopausal status as defined by amenorrhea for >12 months, OR history of bilateral salpingoophrectomy, OR if the patient has had a hysterectomy defined by menopausal symptoms for >1 year OR age >55
Documented recurrent UTIs (3 or more in the last year or 2 or more in the last 6 months)- one UTI must be documented by culture, others may be documented by urinalysis
Ability to provide informed consent

Exclusion Criteria:

Use of any investigational drug or device within thirty days of screening
Urologic surgery within the past 3 months of screening or plan for surgery within one year of screening
Diagnosis of Interstitial Cystitis/painful bladder syndrome
History of urinary tract infections which require the use of IV antibiotics or where only one oral antibiotic is available for treatment, or where the risk of treatment with vaginal estrogen only is deemed unacceptable by the principle investigator secondary to the severity of prior urinary tract infections
Known etiology of infection such as, but not limited to: kidney or bladder stones, enterovaginal/vesical fistula, fecal incontinence, intermittent catheterization, indwelling catheter, poorly controlled diabetes
Urothelial cancer
Actively treated estrogen sensitive tumor (breast or endometrial cancer)
Undiagnosed vaginal bleeding
Inability to use a vaginal ring (secondary to advanced prolapse or shortened vaginal length)
Any medical reason the investigator deems incompatible with treatment with vaginal estrogen
Prolapse requiring pessary use

Deferral Criteria

Undiagnosed hematuria - may enroll after malignancy is ruled out
Use of a progestin containing intrauterine device or use of any vaginal androgens, estrogens or progestins within 3 months of enrollment - may enroll after wash out
Use of drugs/supplements known to prevent UTIs (ie cranberry products, prophylactic antibiotics, methenamine hippurate) 1 month prior to enrollment - may enroll after wash out if still meets inclusion criteria.
History of estrogen sensitive tumor (breast or endometrial cancer) - requires approval by the subject's primary oncologist or primary care physician",Estradiol Ring per vagina every 3 months,PubChem:9960701,Nuvaring,C#CC1(O)CCC2C3CCC4=CC(=O)CCC4C3C(=C)CC21CC.C#CC1(O)CCC2C3CCc4cc(O)ccc4C3CCC21C,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01958073,NCT01958073_EG004,No,Female,Adult | Older Adult,Phase 4,35,"Inclusion Criteria:

Postmenopausal status as defined by amenorrhea for >12 months, OR history of bilateral salpingoophrectomy, OR if the patient has had a hysterectomy defined by menopausal symptoms for >1 year OR age >55
Documented recurrent UTIs (3 or more in the last year or 2 or more in the last 6 months)- one UTI must be documented by culture, others may be documented by urinalysis
Ability to provide informed consent

Exclusion Criteria:

Use of any investigational drug or device within thirty days of screening
Urologic surgery within the past 3 months of screening or plan for surgery within one year of screening
Diagnosis of Interstitial Cystitis/painful bladder syndrome
History of urinary tract infections which require the use of IV antibiotics or where only one oral antibiotic is available for treatment, or where the risk of treatment with vaginal estrogen only is deemed unacceptable by the principle investigator secondary to the severity of prior urinary tract infections
Known etiology of infection such as, but not limited to: kidney or bladder stones, enterovaginal/vesical fistula, fecal incontinence, intermittent catheterization, indwelling catheter, poorly controlled diabetes
Urothelial cancer
Actively treated estrogen sensitive tumor (breast or endometrial cancer)
Undiagnosed vaginal bleeding
Inability to use a vaginal ring (secondary to advanced prolapse or shortened vaginal length)
Any medical reason the investigator deems incompatible with treatment with vaginal estrogen
Prolapse requiring pessary use

Deferral Criteria

Undiagnosed hematuria - may enroll after malignancy is ruled out
Use of a progestin containing intrauterine device or use of any vaginal androgens, estrogens or progestins within 3 months of enrollment - may enroll after wash out
Use of drugs/supplements known to prevent UTIs (ie cranberry products, prophylactic antibiotics, methenamine hippurate) 1 month prior to enrollment - may enroll after wash out if still meets inclusion criteria.
History of estrogen sensitive tumor (breast or endometrial cancer) - requires approval by the subject's primary oncologist or primary care physician",Estradiol Ring per vagina every 3 months,PubChem:9960701,Nuvaring,C#CC1(O)CCC2C3CCC4=CC(=O)CCC4C3C(=C)CC21CC.C#CC1(O)CCC2C3CCc4cc(O)ccc4C3CCC21C,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01959204,NCT01959204_EG000,No,All,Child,Phase 4,97,"Inclusion Criteria:

Is male or female <17 years of age at the time of dosing.
Subject 2 to <17 years of age, be in at least the 25% for weight according to the Center for Disease Control pediatric growth charts and weighs at least 28 lb at the time of dosing with study drug.
Is generally healthy as documented by medical history (except for the condition for which the procedure is being performed); physical examination (including, but not limited to, the cardiovascular, gastrointestinal, respiratory, and central nervous systems); vital sign assessments; 12-lead electrocardiograms; clinical laboratory assessments; and general observations. Has a negative serum pregnancy test at Screening and predose check in for females of childbearing potential.
Is an outpatient for a surgical procedure and is expected to remain hospitalized for at least 24 hours after dosing with study drug.
Is anticipated to have postsurgical pain requiring a parenteral analgesic regimen using a short-acting opioid analgesic and is anticipated to be switched to an oral opioid for at least 1 dose (according to institution standard of care).
Has an indwelling access catheter for blood sampling.
Agrees to comply with all protocol requirements. If not old enough, the legally responsible parent(s) or legal guardian(s) must agree to comply with all protocol requirements.
Has been informed of the nature of the study and informed consent and assent (as appropriate) have been obtained from the legally responsible parent(s) or legal guardian(s) and the subject, respectively, in accordance with institutional review board requirements.

Exclusion Criteria:

Has the presence or history of a clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, or neurologic system(s) or psychiatric disease (except for the condition for which the procedure is being performed) as determined by the clinical investigator.
Has any clinical laboratory test result outside the normal range.
Has a positive test result for hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus antibody.
Had a clinically significant illness, except for the condition for which the procedure is being performed, in the 28 days before dosing with study drug as determined by the clinical investigator.
Is a lactating or breastfeeding female.
Uses any medication known to be an inhibitor or inducer of CYP3A4 within 14 days (for inhibitors such as the azole-antifungal agents voriconazole and ketoconazole, macrolide antibiotics such as erythromycin, and protease inhibitors such as ritonavir) or 28 days (for inducers such as rifampin, carbamazepine, and phenytoin) of dosing with study drug. Use of all other prescription medications, except required pre-op medications and birth control, is prohibited within 3 days of dosing with study drug. Use of any over-the-counter medications (including herbal or dietary supplements and therapeutic doses of vitamins), except for required pre-op medications, is prohibited within 24 hours of dosing with study drug, with the exception of topical spermicide. Use of St. John's wort is prohibited from 28 days before dosing until 14 days after dosing. Standard daily dose multivitamins (nontherapeutic doses) may be taken until enrollment into the study but will be restricted during the study.
Consumes alcohol-, caffeine-, or xanthine-containing products within 48 hours before dosing and during periods when blood samples are collected.
Consumes grapefruit, grapefruit products, Seville oranges, or pomelo-containing products within 14 days of dosing. Fruit juices, with the exception of apple and grape, will be prohibited during the study.
Is a smoker or has used nicotine or nicotine-containing products within 30 days of dosing.
Has a history of alcohol or drug addiction or abuse within the last year.
Subject 2 to <17 years of age, has a positive urine test result for drugs of abuse (amphetamines, barbiturates, cannabinoids, cocaine metabolites, opiates, phencyclidine, and benzodiazepines) or alcohol at Screening (not required for subjects less than 2 years of age).
Donated blood within 28 days or plasma within 14 days of dosing or plans to donate them within 4 weeks after completing the study.
Has a history of relevant drug allergies, food allergies, or both (i.e., allergy to oxycodone, allergy to related drugs, or any significant food allergy that could interfere with the study).
Is intolerant to direct venipuncture.
Received an investigational drug within 28 days of dosing.
Has taken oxycodone or oxymorphone within the 48 hours before anticipated dosing with study drug.
Is not suitable for entry into the study in the opinion of the investigator.","Open label pharmacokinetic study of oxycodone.

Oxycodone: Pain",ChEMBL:CHEMBL656 | DrugBank:DB00497 | PubChem:5284603,Oxycodone,COc1ccc2c3c1O[C@H]1C(=O)CC[C@@]4(O)[C@@H](C2)N(C)CC[C@]314,N02AA05 | N02AA55 | N02AA56 | N02AJ17 | N02AJ18 | N02AJ19,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT01960530,NCT01960530_EG003,Accepts Healthy Volunteers,Male,Adult,Phase 1,14,"Inclusion Criteria:

Healthy male volunteers between 18 and 60 years of age, inclusive (at screening).
Subjects with a Body Mass Index (BMI) of 21-28. Body Mass Index = Body weight (kg) / (Height (m))*2.
Subjects with no clinically significant abnormal serum biochemistry, haematology and urinalysis values within 14 days prior to Day 1 of Study Period 1.
Subjects with a negative urinary drugs of abuse screen, determined within 14 days prior to Day 1 of Study Period 1. A positive alcohol test may be repeated at the discretion of the Investigator.
Subjects with negative HIV and Hepatitis B and C results.
Subjects with no clinically significant abnormalities in 12-lead electrocardiogram (ECG) determined within 14 days prior to Day 1 of Study Period 1.
Subjects with no clinically-significant deviation outside the normal ranges for blood pressure and pulse measurements.

Subjects (unless anatomically sterile or where abstaining from sexual intercourse is in line with the preferred and usual lifestyle of the subject) and sexual partners must use effective contraception methods during the trial and for 3 months after the last dose, for example:

Oral contraceptive + condom
Intra-uterine device (IUD) + condom
Diaphragm with spermicide + condom
Subjects must be available to complete the study.
Subjects must satisfy a medical examiner about their fitness to participate in the study.
Subjects must provide written informed consent to participate in the study.

Exclusion Criteria:

A clinically significant history of gastrointestinal disorder likely to influence drug absorption.
Receipt of regular medication within 14 days prior to Day 1 of Study Period 1 (including high dose vitamins, dietary supplements or herbal remedies).
Receipt of any vaccination within 14 days prior to Day 1 of Study Period 1.
Evidence of renal, hepatic, central nervous system, respiratory, cardiovascular or metabolic dysfunction.
Presence of clinically significant infections (systemic fungal and viral infections, acute bacterial infections).
Current or previous history of tuberculosis.
A clinically significant history of previous allergy / sensitivity to Hydrocortisone and/or Dexamethasone.
A clinically significant history or family history of psychiatric disorders/illnesses.
A clinically significant history of drug or alcohol abuse.
Inability to communicate well with the Investigator (i.e., language problem, poor mental development or impaired cerebral function).
Participation in a New Chemical Entity clinical study within the previous 4 months or a marketed drug clinical study within the previous 3 months. (N.B. The washout period between trials is defined as the period of time elapsed between the last dose of the previous study and the first dose of the next study)
Subjects who have consumed more than 2 units of alcohol per day within seven (7) days prior to Day 1 of Study Period 1or have consumed any alcohol within the 48 hour period prior to Day 1 of Study Period 1.
Donation of 450ml or more of blood within the previous 3 months.
Subjects who smoke (or ex-smokers who have smoked within 6 months prior to Day 1 of Study Period 1).
Subjects who work shifts (i.e. regularly alternate between days, afternoons and nights).","20mg Hydrocortisone Tablet will be administered on Day 2 at 07:00. Dexamethasone is a challenge agent and will be taken to suppress endogenous ACTH and Cortisol. 1mg Dexamethasone will be administered at 22:00 on Day 1 and 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.

Hydrocortisone Tablet",ChEMBL:CHEMBL389621 | DrugBank:DB00741 | PubChem:5754,Hydrocortisone,[H][C@@]12CC[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)CC[C@@]21C,A01AC03 | A07EA02 | C05AA01 | D07AA02 | D07BA04 | D07CA01 | D07XA01 | H02AB09 | R01AD60 | S01BA02 | S01BB01 | S01CA03 | S01CB03 | S02BA01 | S02CA03 | S03CA04,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01965756,NCT01965756_EG000,No,All,Adult | Older Adult,Phase 2,20,"Inclusion Criteria:

• Ages 55-80.

2 Sex distribution: male and female
Diagnosis of MCI due to AD127 or early dementia due to AD128 with: a) age 55 - 80, b) complaint of cognitive decline, c) abnormal performance on the Logical Memory subtest of the Wechsler Memory Scale, d) MMSE > 21, e) CDR 0.5-1, f) positive topographic (MRI, FDG-PET) or molecular (CSF, amyloid imaging) biomarker consistent with AD, and g) no history of diabetes or other exclusions.
Fluent in English or Spanish
Education >5, literate, and/or good working history that precludes consideration of mental retardation
Visual and auditory acuity sufficient for neuropsychological testing and auditory evoked potential EEG
Geriatric Depression Scale < 6
Modified Hachinski Ischemic Score < 4
No major health issues or diseases expected to interfere with the study
Willing to complete all baseline assessments and study procedures
Stable on all permitted medications for 8 weeks
Not pregnant, lactating or of child-bearing potential (women must be >2 years post-menopausal or surgically sterile)
No history of diabetes
Fasting blood glucose <126 and/or HgbA1c < 6.4
Study partner with frequent contact with patient willing to accompany patient to visits and complete partner study forms
No contraindication to metformin

Exclusion Criteria:

• Any CNS disease other than suspected incipient AD, such as clinical stroke, brain tumor, normal pressure hydrocephalus, brain tumor, multiple sclerosis, significant head trauma with persistent neurological of cognitive deficits or complaints, Parkinson's disease, frontotemporal dementia, or other neurodegenerative diseases

Screening/baseline MRI scans with evidence of infarction or other focal lesions in critical memory structures that may be related to cognitive dysfunction
Major active psychiatric illness (e.g., depression, bipolar disorder, obsessive compulsive disorder, schizophrenia) within the previous year
History of alcohol or other substance abuse or dependence within the past two years
Pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in the eyes, skin or body or claustrophobia that would preclude MRI scanning
History of past or current diabetes, pancreatic or liver disease, renal disease
Any significant systemic illness or unstable medical condition that could affect compliance with study
Laboratory abnormalities in B12, TFTs, RPR, Lyme or other common lab parameters that might contribute to cognition or participation in study
Coagulopathy or anti-coagulant therapy (such as coumadin) increasing the risk for LP resulting in PT/PTT and INR within 1.5 standard deviations over the upper normal limit.
Compromised renal function at screening as determined by creatinine clearance <30mL/min based on Cockcroft-Gault calculation
Liver dysfunction at screening as evidenced by alanine transaminase (ALT/SGPT) values > 2X upper limit of normal or aspartate transaminase (AST/SGOT) values > 3X or total bilirubin > 2X.
Has received acetylcholinesterase inhibitor and/or memantine and/or any other medicine that affects the central nervous system for less than 4 months or has less than 2 months stable therapy on these treatments by baseline visit.
Current use of specified medications with psychoactive properties that deleteriously affect cognition (e.g., certain antidepressants, anticholinergics, anti-histamines, antipsychotics, sedative hypnotics, anxiolytics)
Use of investigational agents one month prior to entry and for the duration of the trial
Exceptions to these guidelines may be considered on a case-by-case basis at the discretion of the protocol director.","This group includes subjects treated with metformin for the first 8 weeks of the study, as well as subjects treated with metformin during the second 8 weeks of the study.",ChEMBL:CHEMBL1431 | DrugBank:DB00331 | PubChem:4091,Metformin,CN(C)C(=N)NC(=N)N,A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01968434,NCT01968434_EG001,No,All,Child,Phase 4,66,"Inclusion Criteria:

cough attributed to URTI such as the common cold
2-5 years of age
moderate to severe day cough according to questionnaire (score at least 3 on all 3 questions relating to day cough) considering the day prior to enrollment.
moderate to severe night cough score according to questionnaire (score at least 3 of 2 of the three questions relating to the evaluation of nocturnal cough (frequency of nocturnal cough, impact of the sleep of the child and impact on the sleep of the parent)
signature of informed consent

Exclusion Criteria:

Children with the diagnosis of diseases of the lower respiratory tract: inflammation of the larynx, trachea, bronchi, pneumonia, asthma, sinusitis, allergic rhinitis, as well as heart disease.
Children who received cough medicines or drugs containing antihistamines the day prior to study entry.
Known hypersensitivity to honey or any other component of the experimental product such as Grindelia, Helichrysum, essential oils natural flavourings of Lemon, Sweet Orange, Myrtle; Lemon natural flavouring
Children who received any steroid preparation (spray nozzle , or syrup , or other similar the day before study entry )
Known sensitivity to carbocysteine specifically to the comparator Mucolit
gastric ulcer","Dosage 20-25 mg/kg/day three times a day (3 days/4 nights)

carbocisteine cough syrup: Mucolytic",ChEMBL:CHEMBL396416 | DrugBank:DB04339 | PubChem:193653,CARBOCYSTEINE,N[C@@H](CSCC(=O)O)C(=O)O,R05CB03,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01969058,NCT01969058_EG000,No,All,Adult | Older Adult,Phase 2,50,"Inclusion Criteria:

- HIV-1 infection, documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen, plasma HIV-1 RNA viral load.

NOTE: The term ""licensed"" refers to a US FDA-approved kit, which is required for all IND studies.

CDC (Centers for Disease Control and Prevention) guidelines mandate that confirmation of the initial test result must use a test that is different from the one used for the initial assessment. A reactive initial rapid test should be confirmed by either another type of rapid assay or an E/CIA that is based on a different antigen preparation and/or different test principle (eg, indirect versus competitive), or a Western blot or a plasma HIV-1 RNA viral load.

Receiving ART therapy for at least 12 months prior to study entry.
No plans to change the ART regimen in the 6 months after study entry.
HIV-1 RNA below the lower limit of detection using an FDA-approved assay obtained within 30 days prior to study entry by any laboratory that has a CLIA certification or its equivalent (eg, <50 copies/mL on Roche Amplicor HIV-1 Monitor assay, <75 copies/mL on the Versant HIV-1 RNA assay by branched DNA, <40 copies/mL on the Abbott m2000sp/m2000rt real-time PCR test, < 20 copies/mL on the COBAS AmpliPrep/TAQMAN HIV-1 assay).
All measurements of HIV-1 RNA within the 12 months prior to study entry must be below the limit of detection with the following exception:

NOTE A: 1 viral blip (<200 copies/mL) is permitted if it is preceded and followed by viral loads below the limits of detection.

NOTE B: The virologic assay must have a lower limit of detection of ≤ 75 copies/mL.

CD4+ cell count <350 cells/mm3 obtained at screening within 30 days prior to entry at any laboratory that has a CLIA (Clinical Laboratory Improvement Amendments) certification or its equivalent.

The following laboratory values obtained within 30 days prior to entry by any laboratory that has a CLIA certification or its equivalent:

Hemoglobin A1c (HgbA1c) levels ≤ 6.5%
Hemoglobin ≥ 9.0 g/dL
Platelet count ≥ 50,000/mm3
Creatinine ≤1.5 mg/dl
CrCl ≥ 60 mL/min, calculated by the Cockcroft-Gault method
Aspartate aminotransferase (AST) (SGOT) ≤1.5x upper limit of normal (ULN)
Alanine aminotransferase (ALT) (SGPT) ≤1.5x ULN
Serum lipase ≤1.5x ULN
Fasting triglyceride level ≤200 mg/dL
Fasting glucose <126mg/dL
Karnofsky performance score >/=70 within 30 days prior to entry.
Men and post-menopausal females aged ≥ 18 years and ≤ 80 years at entry.

Note: Post-menopausal is defined as having either:

Appropriate medical documentation (see note) of prior complete bilateral oophorectomy (i.e., surgical removal of the ovaries, resulting in ""surgical menopause"" and occurring at the age at which the procedure was performed), OR
Permanent cessation (12 consecutive months or more of amenorrhea) of previously occurring menses as a result of ovarian failure with documentation of hormonal deficiency by a certified healthcare provider (i.e., ""spontaneous menopause"").

Hormonal deficiency should be properly documented (see note) in the case of suspected spontaneous menopause as follows:

If age >54 years and with the absence of normal menses: Serum FSH (Follicle Stimulating Hormone) level elevated to within the post-menopausal range based on the laboratory reference range where the hormonal assay is performed.
If age ≤ 54 years and with the absence of normal menses: Negative serum or urine HCG with concurrently elevated serum FSH (follicle stimulating hormone) level in the post-menopausal range, depressed estradiol (E2) level in the post-menopausal range, and absent serum progesterone level, based on the laboratory reference ranges where the hormonal assays are performed.

NOTE: ""Appropriate documentation"", and ""properly documented"" means written documentation or oral communication from a clinician or clinician's staff documented in source documents of an operative report, discharge summary, or

No active hepatitis B or C infection. NOTE: For subjects who have documentation of prior infection, but no active hepatitis infection, evidence of clearance must be greater than 1 year.
Ability and willingness of subject to provide informed consent.
Willingness to adhere to the iPLEDGE program requirements.
Indication of willingness to participate in the substudy A5330s. NOTE: In the event that 12 or fewer subjects have enrolled into A5330s by the time enrollment in the main study has reached 50% of the accrual target, A5330s enrollment will be required.

Exclusion Criteria:

Pre-existing diagnosis of diabetes.
Currently receiving treatment with fibrate, nicotinic acid, tetracycline, fish oil >1g/d, or methotrexate.
Known active healing fracture or any severe bone disorders. NOTE: does not include healed fractures or history of old fractures.
Receipt of any of the following medications within 30 days prior to entry: systemic steroids (including intra-articular steroids; inhaled or nasal steroid therapy is permitted), interleukins, systemic interferons (including intra-articular steroid injection; local injection of interferon alpha for treatment of human papilloma virus is permitted), or systemic chemotherapy.
Known allergy/sensitivity or any hypersensitivity to vitamin A, retinoids, or any of their derivatives.
Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
Acute or serious illness requiring systemic treatment and/or hospitalization within 60 days prior to entry.
Weight < 40 kg or > 150 kg.
History of major depression or suicide attempt requiring hospitalization, or psychotic episode requiring medication or hospitalization.
History of inflammatory bowel disease such as Crohn's disease, or Ulcerative colitis.","Participants received Isotretinoin at approximately 0.5 mg/kg orally once daily for 4 weeks, then increased to approximately 1.0 mg/kg orally once daily for 12 weeks.",ChEMBL:CHEMBL38 | ChEMBL:CHEMBL547 | ChEMBL:CHEMBL705 | DrugBank:DB00523 | DrugBank:DB00755 | DrugBank:DB00982 | PubChem:444795 | PubChem:449171 | PubChem:5282379,Tretinoin,CC(C=CC1=C(C)CCCC1(C)C)=CC=CC(C)=CC(=O)O,D10AD01 | D10AD04 | D10AD51 | D10AD54 | D10BA01 | D11AH04 | L01XF01 | L01XF02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT01970176,NCT01970176_EG000,No,All,Adult | Older Adult,Phase 1 | Phase 2,14,"Inclusion Criteria:

A total of 39 patients with PSD as defined by an ejection fraction of less than 40%, no clinical signs or symptoms of congestive heart failure, a minimal distance on 6-minute walk of equal or >450 meters will be recruited and calculated creatinine clearance of equal or less than 90 ml/min and greater than 30 ml/min, using the (MDRD-measurement of renal dysfunction, formula) assessed within the past 24 months. If the subject is not able to walk 450 meters due to pain in hips and knees and not fatigue or shortness of breath than they will still qualify for the protocol.

Exclusion Criteria:

Current or anticipated future need for nitrate therapy

Systolic blood pressure < 90 mmHg or > 180 mm Hg
Diastolic blood pressure < 40 mmHg or > 100 mmHg
Patients taking alpha antagonists or cytochrome P450 3A4 inhibitors (ketoconazole, itraconazole, erythromycin, saquinavir, cimetidine or serum proteases inhibitors for HIV) who cannot be taken off these medications for the duration of the study.
Patients taking the following selective alpha blockers and who are unable to stop for the duration of the study;
Alfuzosin
Prazosin
Doxazosin
Tamsulosin
Terazosin
Silodosin
Patients with retinitis pigmentosa, previous diagnosis of nonischemic optic neuropathy, untreated proliferative retinopathy or unexplained visual disturbance
Patients with sickle cell anemia, multiple myeloma, leukemia or penile deformities placing them at risk for priapism (angulation, cavernosal fibrosis or Peyronie's disease)
Patients with an allergy to iodine.
Patients on PDEV inhibition for pulmonary hypertension
Patients on PDEV inhibition for erectile dysfunction who are not willing to stop the medication for the duration of the study
Valve disease (> moderate aortic or mitral stenosis; > moderate aortic or mitral regurgitation)
Obstructive Hypertrophic cardiomyopathy
Infiltrative or inflammatory myocardial disease (amyloid, sarcoid)
Pericardial disease
Have experienced a myocardial infarction or unstable angina, or have undergone percutaneous transluminal coronary angiography (PTCA) or coronary artery bypass grafting (CABG) within 60 days prior to consent, or requires either PTCA or CABG at the time of consent
Severe congenital heart diseases
Sustained ventricular tachycardia or ventricular fibrillation within 14 days of screening
Second or third degree heart block without a permanent cardiac pacemaker
Stroke within 3 months of screening or other evidence of significantly compromised Central Nervous System (CNS) perfusion
Hemoglobin <9 g/dL
Patients with severe liver disease (AST > 3x normal, alkaline phosphatase or bilirubin > 2x normal)
Serum sodium of < 125 mEq/dL or > 150 mEq/dL
Serum potassium of < 3.2 mEq/dL or > 5.9 mEq/dL
Prior diagnosis of intrinsic renal diseases including renal artery stenosis of > 50%
Peritoneal or hemodialysis within 90 days or anticipation that dialysis or ultrafiltration of any form will be required during the study period
Less than 21 years of age
Pregnant or nursing women.
Women of child bearing potential who do not have a negative pregnancy test at study entry and who are not using effective contraception
Non-cardiac condition limiting life expectancy to less than one year, per physician judgment
Other acute or chronic medical conditions or laboratory abnormality which may increase the risks associated with study participation or may interfere with interpretation of the data
Received an investigational drug within 1 month prior to dosing
In the opinion of the investigator is unlikely to comply with the study protocol or is unsuitable for any reasons","Subject received Tadalafil daily for a total of 12 weeks

Tadalafil: Tadalafil 5 mg tablet. Daily. Tadalafil dose varies from 5 mg to 20 mg for 12 weeks. If blood pressure is >95 then subject dismissed from the Clinical Research Unit (CRU) on 2 (5 mg) tabs of tadalafil or placebo. If blood pressure is between 90 - 95 mmHg systolic, then dismiss on 1 (5 mg) tab of Tadalafil. At 2 weeks (± 5 days) if blood pressure is> 100 than add 1 (5 mg) tab of Tadalafil to make a total of 3 (5mg) tabs of Tadalafil. At 4 weeks(± 5 days) if blood pressure is > 100 add 1 (5 mg) tab to make a total of 4 (5 mg) tablets of Tadalafil.",ChEMBL:CHEMBL779 | DrugBank:DB00820 | PubChem:110635,Tadalafil,[H][C@]12Cc3c([nH]c4ccccc34)[C@@H](c3ccc4c(c3)OCO4)N1C(=O)CN(C)C2=O,C02KX52 | C02KX54 | G04BE08 | G04CA54 | G04CB51,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01978938,NCT01978938_EG000,No,All,Adult | Older Adult,Phase 3,455,"Inclusion Criteria:

1. Male and female participants with either:

a. Pyelonephritis and normal urinary tract anatomy (approximately 50% of the total population), OR b. cUTI with at least 1 of the following conditions associated with a risk for developing cUTI: i. Indwelling urinary catheter ii. Urinary retention (approximately 100 milliliters of residual urine after voiding) iii. Neurogenic bladder iv. Partial obstructive uropathy (such as, nephrolithiasis, bladder stones, and ureteral strictures) v. Azotemia of renal origin (not congestive heart failure or volume related) such that the serum blood urea nitrogen (BUN) is elevated (>20 mg/deciliters) AND the serum BUN: creatinine ratio is <15 vi. Surgically modified or abnormal urinary tract anatomy (such as, bladder diverticula, redundant urine collection system) EXCEPT surgery within the last month

Exclusion Criteria:

1. Concurrent use of non-study antibacterial drug therapy that would have a potential effect on outcome evaluations in participants with cUTI, including:

Participants with a history of a levofloxacin-resistant urinary tract infection
Likely to receive ongoing antibacterial drug prophylaxis prior to the late Post-Treatment visit (such as, participants with vesiculo-ureteral reflux)","Eravacycline was administered IV at a dose of 1.5 mg/kg of body weight q24h. At minimum, the first 3 doses were administered IV. After an IV-to-PO transition, provided adequate clinical improvement, participants were administered 200 mg PO BID for a total therapy of 7 dosing cycles.",ChEMBL:CHEMBL1951095 | DrugBank:DB12329 | PubChem:54726192,Eravacycline,[H][C@@]12Cc3c(F)cc(NC(=O)CN4CCCC4)c(O)c3C(=O)C1=C(O)[C@]1(O)C(=O)C(C(N)=O)=C(O)[C@@H](N(C)C)[C@]1([H])C2,J01AA13 | J01AA20,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01980342,NCT01980342_EG000,Accepts Healthy Volunteers,Female,Adult,Phase 4,1,"Inclusion Criteria:

Healthy women aged 18-40 years who have a Nexplanon®/Implanon® in place that is palpable on exam, had the device placed between 12 and 24 months prior to enrollment, and can provide documentation of when the implant was placed
Able to speak and read English
Documented HIV-negative status within 30 days of enrollment
BMI between 18.5 and 24.9 kg/m2
Willingness to take a two-week course of efavirenz
Willingness to comply with study visit schedule (as described below), including blood sampling, transvaginal ultrasounds, and cervical mucus assessment
Negative urine human chorionic gonadotropin pregnancy test at study entry

Normal laboratory values within 30 days of study entry, as specified below:

White blood cell count ≥ 4500 and ≤ 11000 cells/mm3
Platelet count ≥ 100,000 platelets/mm3
Hemoglobin ≥ 8.0 g/dL
International normalized ratio (INR) ≤ 1.8
Aspartate transaminase (SGOT) and alanine aminotransferase (SGPT) ≤ 3 times the upper limit of normal (ULN) (upper limit of normal)
Creatinine ≤ 1.5 x ULN
Serum amylase ≤ 1.5 x ULN
Total bilirubin ≤ 2.0 x ULN

Agree to use an additional reliable method of contraception while participating in the study. Acceptable methods include:

Abstinence
Condoms (male or female) with or without spermicide
Pre-existing sterilization of subject or her male partner
Willingness to abstain from alcohol consumption during the study period
Willingness to abstain from any grapefruit product or supplement for the duration of the study.

Exclusion Criteria:

Breastfeeding
Hypersensitivity to efavirenz
History of seizure disorder
Initiated, discontinued, or changed doses of drugs that are cytochrome P450 isoenzyme 3A4 (CYP3A4) inducers or inhibitors within 30 days of study entry.","Healthy, reproductive-age women using the etonogestrel contraceptive implant who will take a two-week course of efavirenz 400 mg orally each night.

Efavirenz: Healthy women who are using Nexplanon will be asked to take a 2-week course of reduced-dose efavirenz (400 mg daily).",ChEMBL:CHEMBL223228 | DrugBank:DB00625 | PubChem:64139,Efavirenz,O=C1Nc2ccc(Cl)cc2[C@@](C#CC2CC2)(C(F)(F)F)O1,J05AG03 | J05AR06 | J05AR11,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01984684,NCT01984684_EG000,No,All,Adult | Older Adult,Phase 3,417,"Inclusion Criteria:

Adult (≥ 18 years of age) men or women with a diagnosis of ABSSSI (cellulitis/erysipelas, wound infection, major cutaneous abscess, or burn infection) with surrounding redness of a minimum surface area of 75 cm^2 and at least two signs of systemic infection
In the opinion of the investigator, the subject must require and be a suitable candidate for IV antibiotic therapy, and the subject must be able and willing to comply with protocol requirements

Exclusion Criteria:

A medical history of significant hypersensitivity or allergic reaction to quinolones, beta-lactams, vancomycin, or vancomycin derivatives according to the judgment of the investigator.
Women who are pregnant or lactating.
Any chronic or underlying skin condition at the site of infection that may complicate the assessment of response, including infection involving a prosthetic joint, human or animal bite, osteomyelitis, decubitus ulcer, diabetic foot ulcer, septic arthritis, mediastinitis, necrotizing fasciitis, anaerobic cellulitis, or synergistic necrotizing cellulitis, myositis, tendinitis, endocarditis, sustained shock, gangrene or gas gangrene; burns covering ≥10% of body surface area; severely compromised immune system, severely impaired arterial blood supply to an extremity with an ABSSSI, deep vein thrombosis or superficial thrombophlebitis, and requiring either an amputation or multiple debridement procedures.

Receipt of systemic antibiotic therapy in the 14 days before enrollment unless 1 of the following was documented:

Received ≥ 48 hours of antibiotic therapy for ABSSSI AND clinical progression is documented (i.e., not by patient history alone).
Recently (within 14 days) completed a treatment course with an antibacterial drug for an infection other than ABSSSI and the drug does not have activity against bacterial pathogens that cause ABSSSI.
Received only 1 dose of either a single, potentially effective, short-acting antimicrobial drug or drug regimen for ABSSSI.
Any underlying disease that, in the opinion of the investigator, could interfere with the subject's ability to participate in the study including severe cardiac disease, known history of liver disease, end-stage renal disease, malignancy, psychiatric disorder, ongoing treatment for seizures or untreated history of seizures, or life expectancy of < 3 months.","300mg iv Q12H for 6 doses, 450mg oral tablet Q12H for a minimum of 10 up to a maximum of 28 doses total",ChEMBL:CHEMBL2105637 | DrugBank:DB11943 | PubChem:487101,Delafloxacin,Nc1nc(-n2cc(C(=O)O)c(=O)c3cc(F)c(N4CC(O)C4)c(Cl)c32)c(F)cc1F,J01MA23,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01984892,NCT01984892_EG000,No,All,Child | Adult | Older Adult,Phase 2,8,"Inclusion Criteria:

Histologically confirmed diagnosis of melanoma, squamous head and neck cancer, sarcoma, squamous cell carcinoma of the skin, basal cell skin cancer, or breast cancer
Sarcoma Patients must be @ least14 yrs of age; all others 18 yrs of age or older.
Un-resectable disease. Patients with resectable disease may be enrolled after having refused surgery and documented consultation with a surgeon.
Disease progressed through @ least 1 systemic therapy or through local irradiation within the preceding 6 mos.
Radiologically or visually measurable recurrent or metastatic disease and @ least 10mm in longest dimension.
At least 1 accessible primary or metastatic tumor site that can be readily injected IT with poly-ICLC with or without ultrasound guidance. Lesion can be superficial cutaneous, subcutaneous or within a readily accessible lymph node & must measure @ least 10mm in longest dimension.
Tumor site injection cannot have been irradiated within 8 wks of C1D1
ECOG performance status ≤ 2.
Normal hematologic, renal & liver function. INR<2 if off of anticoagulation. Patients on anticoagulation therapy with an INR>2 may be enrolled at the discretion of the investigator.
Patients able to provide informed consent.
Must agree to follow acceptable birth control methods and continue for @ least 2 mos. after last poly-ICLC dose. Women of childbearing potential must have a (-) pregnancy test.

Exclusion Criteria:

Serious concurrent infection or medical illness.
Bulky intracranial metastatic disease with shift of midline structures or progressive brain metastasis. Administration of immunotherapy or conventional chemotherapy treatments for metastatic cancer within 4 wks of C1D1
Radiation treatments within 4 wks of C1D1
AIDS defined as a CD4 count < then 200 in the context of HIV sero-positivity or chronically is taking immunosuppressive medication such as steroids or transplant related medications.
Life expectancy of < than 6 mos.","Enrolled patients received two cycles of Poly-ICLC treatment. Each priming (intratumoral injections - IT) and boosting (intramuscular injections - IM) treatment course will constitute one cycle.

Poly-ICLC: Cycle 1-Weeks 1 and 2: 1mg Poly-ICLC intratumoral (IT) injections (t=6) into same lesion over 2 weeks.

Weeks 3-9: 1mg Poly-ICLC 2x/week intramuscularly (IM) into thighs or upper arms.

Week 10: No treatment. CT scan of chest, abdomen, pelvis and extremities or neck; possible MRI brain scan.

Cycle 2-Weeks 11 and 12: 1mg Poly-ICLC IT injections (t=6) into same lesion over 2 weeks.

Weeks 13-19 - 1mg Poly-ICLC 2x/weekly IM in thighs or upper arms. Weeks 20-26: no treatment. Week 26, evaluate response in absence of inflammation.

Maintenance - Weeks 27-36: For patients with stable disease or response; IM poly-ICLC injections; evaluation of clinical and immune response. Week 38 repeat tumor assessment, optional biopsy",PubChem:136033680,Hiltonol,NCCCCNC(=O)O.Nc1ccn(C2OC(COP(=O)(O)O)C(O)C2O)c(=O)n1.O=C(O)CO.O=c1[nH]cnc2c1ncn2C1OC(COP(=O)(O)O)C(O)C1O,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT01989910,NCT01989910_EG000,No,All,Adult,Phase 4,51,"Inclusion Criteria:

Patients who are infected with HIV-1
Patients have not yet received any treatment for HIV
Patients with HIV viral RNA exceeds 5000 copies per ml
Ages at least 20 years

Exclusion Criteria:

Patients with acute or decompensated chronic hepatitis
Patients with chronic hepatitis and serum aminotransferase concentrations are more than five times the upper limit of the normal range
Patients with renal insufficiency (need dialysis or have serum creatinine concentrations of more than twice the upper limit of the normal range
Patients with any medical disorder that the use of study medications is contraindicated
Pregnant or breastfeeding women
Patients who are lack of expectation to maintain assigned study medication during study period
Patients who have received therapy with investigational drugs in the previous 3 months","Raltegravir 400mg oral twice daily

Efavirenz: Efavirenz 600mg oral at bedtime",ChEMBL:CHEMBL223228 | DrugBank:DB00625 | PubChem:64139,Efavirenz,O=C1Nc2ccc(Cl)cc2[C@@](C#CC2CC2)(C(F)(F)F)O1,J05AG03 | J05AR06 | J05AR11,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT01990352,NCT01990352_EG000,No,All,Adult | Older Adult,Phase 2,24,"Inclusion Criteria:

Metastatic breast cancer and have formalin-fixed, paraffin embedded primary tumor available for testing BRCA1 protein expression
Adults over 18 years of age
Have resolution of all acute toxic effects of any prior chemotherapy or radiotherapy to NCI CTC grade ≤ 1 prior to study registration.
Be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study specific screening procedures
Be willing and able to comply with the treatment plan, scheduled clinic visits, laboratory and oncological tests and other study procedures
Have a ECOG performance status of 0 - 2
Measurable disease by CT by RECIST 1.1 to evaluate response
Adequate bone marrow function defined as platelets 100 X 109 cells/L, neutrophils 1.5 x 109 cells/L, white blood cells (WBC) 3.0 x 109 cells/L and a hemoglobin 90 gm/L
Creatinine < 1.5 mg/dl or creatinine clearance > 40 ml/min
Liver function tests (AST and or ALT) should be 2 x upper limit of normal (ULN, defined as per laboratory where blood testing is done), total bilirubin 1.5 x ULN (except for patients with liver metastases, ALT and/or ALT 5 times the upper limit of normal is accepted)

Exclusion Criteria:

Myocardial infarction within 6 months of registration
Brain metastases unless documented to be controlled post completion of local therapy (surgery and/or radiation therapy) for at least four weeks prior to registration
Pregnant or breast feeding women. Women with child bearing potential must use effective measures to prevent pregnancy while receiving pegylated liposomal doxorubicin
Have a concurrent active non-breast malignancy except for non-melanoma skin cancer
Her2 positive tumors as defined by FDA guidelines(3+ immunohistochemical staining, defined as uniform, intense membrane staining of more than 10% of invasive tumor cells, and for cases with 2+ staining showing gene amplification by FISH, expressed as a ratio of more than 2 when comparing HER-2 gene and chromosome 17 fluorescent signals)","The enrolled patients will be treated with pegylated liposomal doxorubicin at 30mg/m2 every 21 days.

Pegylated liposomal doxorubicin: Doxil will be administered intravenously at 30mg/m2 on days 1 of a 21 day cycle.",ChEMBL:CHEMBL417 | ChEMBL:CHEMBL53463 | DrugBank:DB00445 | DrugBank:DB00997 | PubChem:1691 | PubChem:31703 | PubChem:41867,Epirubicin,COc1cccc2c1C(=O)c1c(O)c3c(c(O)c1C2=O)CC(O)(C(=O)CO)CC3OC1CC(N)C(O)C(C)O1,L01DB01 | L01DB03,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02009332,NCT02009332_EG000,No,All,Adult | Older Adult,Phase 1 | Phase 2,3,"Inclusion Criteria:

Patients must have a diagnosis of transitional cell carcinoma (TCC) of the urinary bladder confirmed at the study institution. The patient must have demonstrated nonmuscle-invasive bladder cancer refractory or recurrent to standard intravesical therapy. Refractory disease is defined as failure to achieve tumor-free status by 6 months of initiation of adequate BCG therapy. Recurrent disease is defined as reappearance of disease after achieving a tumor-free status by 6 months of initiation of adequate BCG therapy. Adequate BCG therapy includes at least 6 weeks induction plus 3 additional doses of either induction or maintenance. Patients with a history of other intravesical agents (except nab-rapamycin or gemcitabine) in addition to standard BCG will also be allowed to enroll. All grossly visible disease must be fully resected and pathologic stage will be confirmed at the institution where the patient is enrolled. This will include stage Ta, T1, Tis and exclude all patients with muscle invasion (T2).

For phase 1, patients with multifocal low-grade Ta histology will be eligible for participation
For phase 2, individuals with Ta disease only must have documentation of high-grade histology
For phase 2, prior intravesical treatment with nab-rapamycin or gemcitabine is not allowed
Age >18 and must be able to read, understand, and sign informed consent
Performance Status: ECOG 0, 1, and 2 (See Appendix III)

Hematologic inclusion within 2 weeks of start of treatment

Absolute neutrophil count >1,500/mm3
Hemoglobin >9.0 g/dl
Platelet count >100,000/mm3

Hepatic inclusion within 2 weeks of entry

Total bilirubin must be within normal limits.
Adequate renal function with serum creatinine ≤2.5 mg/dL
Aspartate transaminase (AST) and alanine transaminase (ALT) ≤2.5 x ULN for the institution, alkaline phosphatase ≤ 2.5 x ULN for the institution, unless bone metastasis is present in the absence of liver metastasis
Women of childbearing potential must have a negative pregnancy test.
All patients of childbearing potential must be willing to consent to using effective contraception, ie, intrauterine device, birth control pills, depo-provera, and condoms while on treatment and for 3 months after their participation in the study ends.

Exclusion Criteria:

Any other malignancy diagnosed within 1 year of study entry (except basal or squamous cell skin cancers or noninvasive cancer of the cervix) is excluded
Concurrent treatment with any chemotherapeutic agent
Women who are pregnant or lactating
History of vesicoureteral reflux or an indwelling urinary stent
Participation in any other research protocol involving administration of an investigational agent within 1 month prior to study entry
History of radiation to the pelvis
History of interstitial lung disease and/or pneumonitis
Evidence of metastatic disease","Phase 1, Cohort 1: ABI-009 injectable suspension, 100 mg in 80 mL 0.9% saline, administered intravesically and retained for 2 hours, once per week for 6 weeks",ChEMBL:CHEMBL413 | DrugBank:DB00877 | PubChem:134760597 | PubChem:138404388 | PubChem:21944094 | PubChem:5284616,Sirolimus,COC1CC2CCC(C)C(O)(O2)C(=O)C(=O)N2CCCCC2C(=O)OC(C(C)CC2CCC(O)C(OC)C2)CC(=O)C(C)C=C(C)C(O)C(OC)C(=O)C(C)CC(C)C=CC=CC=C1C,L01EG04 | L04AA10 | S01XA23,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT02009332,NCT02009332_EG001,No,All,Adult | Older Adult,Phase 1 | Phase 2,4,"Inclusion Criteria:

Patients must have a diagnosis of transitional cell carcinoma (TCC) of the urinary bladder confirmed at the study institution. The patient must have demonstrated nonmuscle-invasive bladder cancer refractory or recurrent to standard intravesical therapy. Refractory disease is defined as failure to achieve tumor-free status by 6 months of initiation of adequate BCG therapy. Recurrent disease is defined as reappearance of disease after achieving a tumor-free status by 6 months of initiation of adequate BCG therapy. Adequate BCG therapy includes at least 6 weeks induction plus 3 additional doses of either induction or maintenance. Patients with a history of other intravesical agents (except nab-rapamycin or gemcitabine) in addition to standard BCG will also be allowed to enroll. All grossly visible disease must be fully resected and pathologic stage will be confirmed at the institution where the patient is enrolled. This will include stage Ta, T1, Tis and exclude all patients with muscle invasion (T2).

For phase 1, patients with multifocal low-grade Ta histology will be eligible for participation
For phase 2, individuals with Ta disease only must have documentation of high-grade histology
For phase 2, prior intravesical treatment with nab-rapamycin or gemcitabine is not allowed
Age >18 and must be able to read, understand, and sign informed consent
Performance Status: ECOG 0, 1, and 2 (See Appendix III)

Hematologic inclusion within 2 weeks of start of treatment

Absolute neutrophil count >1,500/mm3
Hemoglobin >9.0 g/dl
Platelet count >100,000/mm3

Hepatic inclusion within 2 weeks of entry

Total bilirubin must be within normal limits.
Adequate renal function with serum creatinine ≤2.5 mg/dL
Aspartate transaminase (AST) and alanine transaminase (ALT) ≤2.5 x ULN for the institution, alkaline phosphatase ≤ 2.5 x ULN for the institution, unless bone metastasis is present in the absence of liver metastasis
Women of childbearing potential must have a negative pregnancy test.
All patients of childbearing potential must be willing to consent to using effective contraception, ie, intrauterine device, birth control pills, depo-provera, and condoms while on treatment and for 3 months after their participation in the study ends.

Exclusion Criteria:

Any other malignancy diagnosed within 1 year of study entry (except basal or squamous cell skin cancers or noninvasive cancer of the cervix) is excluded
Concurrent treatment with any chemotherapeutic agent
Women who are pregnant or lactating
History of vesicoureteral reflux or an indwelling urinary stent
Participation in any other research protocol involving administration of an investigational agent within 1 month prior to study entry
History of radiation to the pelvis
History of interstitial lung disease and/or pneumonitis
Evidence of metastatic disease","Phase 1, Cohort 2: ABI-009 injectable suspension, 200 mg in 80 mL 0.9% saline, administered intravesically and retained for 2 hours, once per week for 6 weeks",ChEMBL:CHEMBL413 | DrugBank:DB00877 | PubChem:134760597 | PubChem:138404388 | PubChem:21944094 | PubChem:5284616,Sirolimus,COC1CC2CCC(C)C(O)(O2)C(=O)C(=O)N2CCCCC2C(=O)OC(C(C)CC2CCC(O)C(OC)C2)CC(=O)C(C)C=C(C)C(O)C(OC)C(=O)C(C)CC(C)C=CC=CC=C1C,L01EG04 | L04AA10 | S01XA23,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02009332,NCT02009332_EG002,No,All,Adult | Older Adult,Phase 1 | Phase 2,1,"Inclusion Criteria:

Patients must have a diagnosis of transitional cell carcinoma (TCC) of the urinary bladder confirmed at the study institution. The patient must have demonstrated nonmuscle-invasive bladder cancer refractory or recurrent to standard intravesical therapy. Refractory disease is defined as failure to achieve tumor-free status by 6 months of initiation of adequate BCG therapy. Recurrent disease is defined as reappearance of disease after achieving a tumor-free status by 6 months of initiation of adequate BCG therapy. Adequate BCG therapy includes at least 6 weeks induction plus 3 additional doses of either induction or maintenance. Patients with a history of other intravesical agents (except nab-rapamycin or gemcitabine) in addition to standard BCG will also be allowed to enroll. All grossly visible disease must be fully resected and pathologic stage will be confirmed at the institution where the patient is enrolled. This will include stage Ta, T1, Tis and exclude all patients with muscle invasion (T2).

For phase 1, patients with multifocal low-grade Ta histology will be eligible for participation
For phase 2, individuals with Ta disease only must have documentation of high-grade histology
For phase 2, prior intravesical treatment with nab-rapamycin or gemcitabine is not allowed
Age >18 and must be able to read, understand, and sign informed consent
Performance Status: ECOG 0, 1, and 2 (See Appendix III)

Hematologic inclusion within 2 weeks of start of treatment

Absolute neutrophil count >1,500/mm3
Hemoglobin >9.0 g/dl
Platelet count >100,000/mm3

Hepatic inclusion within 2 weeks of entry

Total bilirubin must be within normal limits.
Adequate renal function with serum creatinine ≤2.5 mg/dL
Aspartate transaminase (AST) and alanine transaminase (ALT) ≤2.5 x ULN for the institution, alkaline phosphatase ≤ 2.5 x ULN for the institution, unless bone metastasis is present in the absence of liver metastasis
Women of childbearing potential must have a negative pregnancy test.
All patients of childbearing potential must be willing to consent to using effective contraception, ie, intrauterine device, birth control pills, depo-provera, and condoms while on treatment and for 3 months after their participation in the study ends.

Exclusion Criteria:

Any other malignancy diagnosed within 1 year of study entry (except basal or squamous cell skin cancers or noninvasive cancer of the cervix) is excluded
Concurrent treatment with any chemotherapeutic agent
Women who are pregnant or lactating
History of vesicoureteral reflux or an indwelling urinary stent
Participation in any other research protocol involving administration of an investigational agent within 1 month prior to study entry
History of radiation to the pelvis
History of interstitial lung disease and/or pneumonitis
Evidence of metastatic disease","Phase 1, Cohort 2b: ABI-009 injectable suspension, 100 mg in 80 mL 0.9% saline, administered intravesically and retained for 2 hours, twice per week (total dose 200 mg per week) for 6 weeks",ChEMBL:CHEMBL413 | DrugBank:DB00877 | PubChem:134760597 | PubChem:138404388 | PubChem:21944094 | PubChem:5284616,Sirolimus,COC1CC2CCC(C)C(O)(O2)C(=O)C(=O)N2CCCCC2C(=O)OC(C(C)CC2CCC(O)C(OC)C2)CC(=O)C(C)C=C(C)C(O)C(OC)C(=O)C(C)CC(C)C=CC=CC=C1C,L01EG04 | L04AA10 | S01XA23,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02009332,NCT02009332_EG003,No,All,Adult | Older Adult,Phase 1 | Phase 2,3,"Inclusion Criteria:

Patients must have a diagnosis of transitional cell carcinoma (TCC) of the urinary bladder confirmed at the study institution. The patient must have demonstrated nonmuscle-invasive bladder cancer refractory or recurrent to standard intravesical therapy. Refractory disease is defined as failure to achieve tumor-free status by 6 months of initiation of adequate BCG therapy. Recurrent disease is defined as reappearance of disease after achieving a tumor-free status by 6 months of initiation of adequate BCG therapy. Adequate BCG therapy includes at least 6 weeks induction plus 3 additional doses of either induction or maintenance. Patients with a history of other intravesical agents (except nab-rapamycin or gemcitabine) in addition to standard BCG will also be allowed to enroll. All grossly visible disease must be fully resected and pathologic stage will be confirmed at the institution where the patient is enrolled. This will include stage Ta, T1, Tis and exclude all patients with muscle invasion (T2).

For phase 1, patients with multifocal low-grade Ta histology will be eligible for participation
For phase 2, individuals with Ta disease only must have documentation of high-grade histology
For phase 2, prior intravesical treatment with nab-rapamycin or gemcitabine is not allowed
Age >18 and must be able to read, understand, and sign informed consent
Performance Status: ECOG 0, 1, and 2 (See Appendix III)

Hematologic inclusion within 2 weeks of start of treatment

Absolute neutrophil count >1,500/mm3
Hemoglobin >9.0 g/dl
Platelet count >100,000/mm3

Hepatic inclusion within 2 weeks of entry

Total bilirubin must be within normal limits.
Adequate renal function with serum creatinine ≤2.5 mg/dL
Aspartate transaminase (AST) and alanine transaminase (ALT) ≤2.5 x ULN for the institution, alkaline phosphatase ≤ 2.5 x ULN for the institution, unless bone metastasis is present in the absence of liver metastasis
Women of childbearing potential must have a negative pregnancy test.
All patients of childbearing potential must be willing to consent to using effective contraception, ie, intrauterine device, birth control pills, depo-provera, and condoms while on treatment and for 3 months after their participation in the study ends.

Exclusion Criteria:

Any other malignancy diagnosed within 1 year of study entry (except basal or squamous cell skin cancers or noninvasive cancer of the cervix) is excluded
Concurrent treatment with any chemotherapeutic agent
Women who are pregnant or lactating
History of vesicoureteral reflux or an indwelling urinary stent
Participation in any other research protocol involving administration of an investigational agent within 1 month prior to study entry
History of radiation to the pelvis
History of interstitial lung disease and/or pneumonitis
Evidence of metastatic disease","Phase 1, Cohort 3: ABI-009 injectable suspension, 300 mg in 80 mL 0.9% saline, administered intravesically and retained for 2 hours, once per week for 6 weeks",ChEMBL:CHEMBL413 | DrugBank:DB00877 | PubChem:134760597 | PubChem:138404388 | PubChem:21944094 | PubChem:5284616,Sirolimus,COC1CC2CCC(C)C(O)(O2)C(=O)C(=O)N2CCCCC2C(=O)OC(C(C)CC2CCC(O)C(OC)C2)CC(=O)C(C)C=C(C)C(O)C(OC)C(=O)C(C)CC(C)C=CC=CC=C1C,L01EG04 | L04AA10 | S01XA23,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02009332,NCT02009332_EG004,No,All,Adult | Older Adult,Phase 1 | Phase 2,4,"Inclusion Criteria:

Patients must have a diagnosis of transitional cell carcinoma (TCC) of the urinary bladder confirmed at the study institution. The patient must have demonstrated nonmuscle-invasive bladder cancer refractory or recurrent to standard intravesical therapy. Refractory disease is defined as failure to achieve tumor-free status by 6 months of initiation of adequate BCG therapy. Recurrent disease is defined as reappearance of disease after achieving a tumor-free status by 6 months of initiation of adequate BCG therapy. Adequate BCG therapy includes at least 6 weeks induction plus 3 additional doses of either induction or maintenance. Patients with a history of other intravesical agents (except nab-rapamycin or gemcitabine) in addition to standard BCG will also be allowed to enroll. All grossly visible disease must be fully resected and pathologic stage will be confirmed at the institution where the patient is enrolled. This will include stage Ta, T1, Tis and exclude all patients with muscle invasion (T2).

For phase 1, patients with multifocal low-grade Ta histology will be eligible for participation
For phase 2, individuals with Ta disease only must have documentation of high-grade histology
For phase 2, prior intravesical treatment with nab-rapamycin or gemcitabine is not allowed
Age >18 and must be able to read, understand, and sign informed consent
Performance Status: ECOG 0, 1, and 2 (See Appendix III)

Hematologic inclusion within 2 weeks of start of treatment

Absolute neutrophil count >1,500/mm3
Hemoglobin >9.0 g/dl
Platelet count >100,000/mm3

Hepatic inclusion within 2 weeks of entry

Total bilirubin must be within normal limits.
Adequate renal function with serum creatinine ≤2.5 mg/dL
Aspartate transaminase (AST) and alanine transaminase (ALT) ≤2.5 x ULN for the institution, alkaline phosphatase ≤ 2.5 x ULN for the institution, unless bone metastasis is present in the absence of liver metastasis
Women of childbearing potential must have a negative pregnancy test.
All patients of childbearing potential must be willing to consent to using effective contraception, ie, intrauterine device, birth control pills, depo-provera, and condoms while on treatment and for 3 months after their participation in the study ends.

Exclusion Criteria:

Any other malignancy diagnosed within 1 year of study entry (except basal or squamous cell skin cancers or noninvasive cancer of the cervix) is excluded
Concurrent treatment with any chemotherapeutic agent
Women who are pregnant or lactating
History of vesicoureteral reflux or an indwelling urinary stent
Participation in any other research protocol involving administration of an investigational agent within 1 month prior to study entry
History of radiation to the pelvis
History of interstitial lung disease and/or pneumonitis
Evidence of metastatic disease","Phase 1, Cohort 4: ABI-009 injectable suspension, 400 mg in 80 mL 0.9% saline, administered intravesically and retained for 2 hours, once per week for 6 weeks",ChEMBL:CHEMBL413 | DrugBank:DB00877 | PubChem:134760597 | PubChem:138404388 | PubChem:21944094 | PubChem:5284616,Sirolimus,COC1CC2CCC(C)C(O)(O2)C(=O)C(=O)N2CCCCC2C(=O)OC(C(C)CC2CCC(O)C(OC)C2)CC(=O)C(C)C=C(C)C(O)C(OC)C(=O)C(C)CC(C)C=CC=CC=C1C,L01EG04 | L04AA10 | S01XA23,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT02011945,NCT02011945_EG000,No,All,Adult | Older Adult,Phase 1,2,"For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

Confirmed diagnosis of Chronic Myeloid Leukemia in Chronic Phase or Accelerated Phase :

With historically documented Ph+ cells
≥2 prior Tyrosine Kinase Inhibitors (TKI) therapies for CML
Currently progressing, resistance to or with a suboptimal response to their most recent therapy
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Score 0 - 1

Exclusion Criteria:

Blast phase CML
Known Abl-kinase mutation resistant to Dasatinib (e.g. T315I or T315A)",dasatinib 100 mg QD(CP) or 140 mg QD (AP),ChEMBL:CHEMBL1421 | DrugBank:DB01254 | PubChem:3062316,Dasatinib,Cc1nc(Nc2ncc(C(=O)Nc3c(C)cccc3Cl)s2)cc(N2CCN(CCO)CC2)n1,L01EA02 | L01XE06,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02014129,NCT02014129_EG000,No,All,Adult | Older Adult,Phase 1,3,"Inclusion Criteria:

Have histological or cytological evidence of a diagnosis of cancer (either a solid tumor or a lymphoma) that is advanced and/or metastatic
Must be, in the judgment of the investigator, an appropriate candidate for the experimental therapy after available standard therapies have failed to provide clinical benefit for their disease
Have the presence of measurable or non-measurable disease as defined by the Response Evaluation Criteria in Solid Tumors Guideline Version 1.1, or the Revised Response Criteria for Malignant Lymphoma Guideline
Have adequate organ function
Have discontinued all previous therapies for cancer, including chemotherapy, radiotherapy, immunotherapy, and investigational therapy, for at least 21 days before the first dose of study drug and recovered from the acute effects of any such therapy
Males must agree to use medically approved barrier contraceptive precautions during the study and for 3 months following the last dose of study drug
Females with child bearing potential: must agree to use medically approved contraceptive precautions during the study and for 3 months following the last dose of study drug, must have had a negative serum or urine pregnancy test ≤7 days before the first dose of study drug.
A breastfeeding woman must not be breastfeeding. If a female who stops breastfeeding enters the study, the female must stop breastfeeding from the day of the first study drug administration until at least 3 months after the last administration
Have an estimated life expectancy of ≥12 weeks
Are able to swallow capsules

Exclusion Criteria:

Have received treatment within 21 days of the initial dose of study drug with an experimental agent for noncancer indications that has not received regulatory approval for any indication
Have a medical history of any of the following conditions: presyncope or syncope of either unexplained or cardiovascular etiology, ventricular arrhythmia (e.g., ventricular tachycardia and ventricular fibrillation) or sudden cardiac arrest
Have a baseline with any of the following findings on screening electrocardiogram (ECG): ventricular tachycardia, ventricular fibrillation, abnormal QTc using Bazett's formula (QTcB) (defined as ≥470 milliseconds), or evidence of acute myocardial ischemia
Have serious preexisting medical conditions that, in the judgment of the investigator, would preclude participation in this study (for example, history of major surgical resection involving the stomach or small bowel)
Have symptomatic central nervous system (CNS) malignancy or metastasis. For asymptomatic participants without history of CNS malignancy or metastases
Have evidence or history of a leukemia
Have received a stem-cell transplant. As an exception, a participant with lymphoma who received an autologous stem-cell transplant is eligible for the study, if more than 75 days have passed before the initial dose of study drug
Have active bacterial, fungal, and/or known viral infection (for example, human immunodeficiency virus [HIV], hepatitis B, or hepatitis C)",100 mg abemaciclib administered orally Q12H in 28 day cycles. (Cycle 1 = 32 days.) Participants remained on treatment until discontinuation criteria were met.,ChEMBL:CHEMBL3301610 | DrugBank:DB12001 | PubChem:46220502,Abemaciclib,CCN1CCN(Cc2ccc(Nc3ncc(F)c(-c4cc(F)c5nc(C)n(C(C)C)c5c4)n3)nc2)CC1,L01EF03,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,1.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT02014363,NCT02014363_EG000,No,All,Adult | Older Adult,Phase 2,55,"Inclusion Criteria:

Signed informed consent
Male or female
Age 18-65 years inclusive
Subjects with a current episode of moderate to severe Major Depressive Disorder meeting the criteria of Diagnostic and Statistical Manual of Mental Disorders (DSM) IV -TR and documented using the brief structured interview Mini International Neuropsychiatric Interview (MINI) version 5.0 and with a minimum duration of two weeks and a maximum of twelve months
Minimum Hamilton Depression Scale (HAM-D) 17 items total score of 18 at screening and ≥12 at the end of the lead-in phase prior to randomization.
Female subjects of childbearing potential must have a negative pregnancy test at the Screening Visit and must use an acceptable method of contraception throughout the study and for 30 days after. Male subjects with female partners of child-bearing potential must use an acceptable method of contraception throughout the study and for 30 days after.
Able to understand and comply with the requirements of the study as judged by the investigator

Exclusion Criteria:

Considered by the investigator to be at significant risk of suicide or scoring 5 or more on the Montgomery Asberg Depression Rating Scale (c) question 10
Significant other psychiatric illness which would interfere with trial assessments co-morbid generalized anxiety disorder (GAD) and panic disorder will be permitted where MDD is considered the primary diagnosis
Significant physical illness which would interfere with trial assessments
Recent (within 1 week of screening) antidepressants (except for fluoxetine [within 4 weeks of screening] and St John's Wort or Monoamine oxidase inhibitors (MAOI) [within 14 days of screening]),
Benzodiazepine or any other psychotropic medication including lithium or other mood stabilizers within 1 week of screening
Oral anticoagulant therapy within one month of screening
Formal psychotherapy or alternative treatments for one week prior to screening or during the study
Reduced hepatic function defined as liver enzyme levels ≥2.5 times upper limit of normal
Renal insufficiency defined as creatinine clearance <30 mL/min
Epilepsy
Uncontrolled hypothyroidism
Uncontrolled hypertension
Acute porphyria
Urinary retention, prostatic hypertrophy, narrow angle glaucoma or increased intraocular pressure or any other clinically relevant contraindication stated in the Summary of Product Characteristics (SmPC) for citalopram, tramadol or amitriptyline
History of significant cardiac dysrhythmia or history of myocardial infarction within 1 year prior to screening
Significant history of alcohol or substance abuse
Regular alcohol intake above the recommended United Kingdom (UK) guideline of 4 units per day for males or 3 units per day for females
Pregnant or lactating women
Known hepatitis B or C or human immunodeficiency virus (HIV) or syphilis seropositivity.
A corrected QT interval of >470ms for female subjects of >450ms for male subjects, calculated using the QTcB (Bazett Correction Formula) , or second degree or higher heart block on an electrocardiography (ECG) recording, at screening.
Allergy to the study drugs or excipients
Treatment with another investigational medicinal product within the 30 days prior to screening.","ETS6103 (low dose) extended release tablets (encapsulated) taken once daily orally for the duration of randomised phase of the study (8 weeks).

ETS6103 (low dose)",ChEMBL:CHEMBL1237044 | DrugBank:DB00193 | PubChem:33741,Tramadol,COc1cccc(C2(O)CCCCC2CN(C)C)c1,N02AJ13 | N02AJ14 | N02AJ16 | N02AX02,0.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT02014363,NCT02014363_EG001,No,All,Adult | Older Adult,Phase 2,54,"Inclusion Criteria:

Signed informed consent
Male or female
Age 18-65 years inclusive
Subjects with a current episode of moderate to severe Major Depressive Disorder meeting the criteria of Diagnostic and Statistical Manual of Mental Disorders (DSM) IV -TR and documented using the brief structured interview Mini International Neuropsychiatric Interview (MINI) version 5.0 and with a minimum duration of two weeks and a maximum of twelve months
Minimum Hamilton Depression Scale (HAM-D) 17 items total score of 18 at screening and ≥12 at the end of the lead-in phase prior to randomization.
Female subjects of childbearing potential must have a negative pregnancy test at the Screening Visit and must use an acceptable method of contraception throughout the study and for 30 days after. Male subjects with female partners of child-bearing potential must use an acceptable method of contraception throughout the study and for 30 days after.
Able to understand and comply with the requirements of the study as judged by the investigator

Exclusion Criteria:

Considered by the investigator to be at significant risk of suicide or scoring 5 or more on the Montgomery Asberg Depression Rating Scale (c) question 10
Significant other psychiatric illness which would interfere with trial assessments co-morbid generalized anxiety disorder (GAD) and panic disorder will be permitted where MDD is considered the primary diagnosis
Significant physical illness which would interfere with trial assessments
Recent (within 1 week of screening) antidepressants (except for fluoxetine [within 4 weeks of screening] and St John's Wort or Monoamine oxidase inhibitors (MAOI) [within 14 days of screening]),
Benzodiazepine or any other psychotropic medication including lithium or other mood stabilizers within 1 week of screening
Oral anticoagulant therapy within one month of screening
Formal psychotherapy or alternative treatments for one week prior to screening or during the study
Reduced hepatic function defined as liver enzyme levels ≥2.5 times upper limit of normal
Renal insufficiency defined as creatinine clearance <30 mL/min
Epilepsy
Uncontrolled hypothyroidism
Uncontrolled hypertension
Acute porphyria
Urinary retention, prostatic hypertrophy, narrow angle glaucoma or increased intraocular pressure or any other clinically relevant contraindication stated in the Summary of Product Characteristics (SmPC) for citalopram, tramadol or amitriptyline
History of significant cardiac dysrhythmia or history of myocardial infarction within 1 year prior to screening
Significant history of alcohol or substance abuse
Regular alcohol intake above the recommended United Kingdom (UK) guideline of 4 units per day for males or 3 units per day for females
Pregnant or lactating women
Known hepatitis B or C or human immunodeficiency virus (HIV) or syphilis seropositivity.
A corrected QT interval of >470ms for female subjects of >450ms for male subjects, calculated using the QTcB (Bazett Correction Formula) , or second degree or higher heart block on an electrocardiography (ECG) recording, at screening.
Allergy to the study drugs or excipients
Treatment with another investigational medicinal product within the 30 days prior to screening.","ETS6103 (high dose) extended release tablets (encapsulated) taken once daily orally for the duration of randomised phase of the study (8 weeks).

ETS6103 (high dose)",ChEMBL:CHEMBL1237044 | DrugBank:DB00193 | PubChem:33741,Tramadol,COc1cccc(C2(O)CCCCC2CN(C)C)c1,N02AJ13 | N02AJ14 | N02AJ16 | N02AX02,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT02014740,NCT02014740_EG001,No,All,Adult | Older Adult,Phase 4,45,"Inclusion Criteria:

Type 2 diabetes, as defined by ADA criteria
HbA1c < 8% measured at least 1 month prior to this study
BMI ≥27 kg/m2
Pre-treatment with Metformin
Age > 18 and < 65 years old

Exclusion Criteria:

• Known contra-indications to Liraglutide, such as previous history of pancreatitis or medullary thyroid carcinoma, personal or family history of MEN, in accordance with risks and safety information included in the latest updated Prescribing Information for Victoza®

Type 1 diabetes, as defined by American Diabetes Association (ADA) criteria
Insulin dependent or treated type 2 diabetes
Current use of other injectable incretins
History of diabetes ketoacidosis
Advanced Chronic Kidney Disease, as defined by Glomerular Filtration Rate (GFR) < 30 mL/min/1.73m2
Clinical signs or symptoms of New York Heart Association (NYHA) class III-IV heart failure
Clinical or laboratory evidences of chronic active liver diseases
Acute or chronic infective diseases
Cancer or chemotherapy
Current use of systemic corticosteroids or in the 3 months prior this study
Known or suspected allergy to Liraglutide, excipients, or related products
Pregnant, breast-feeding or the intention of becoming pregnant
Females of childbearing potential who are not using adequate contraceptive methods","M-group will be treated with Metformin for the duration of the study. Metformin (from 500 mg twice daily to a maximum of 1000 mg twice daily) regimen will be continued to achieve fasting glucose between 80 and 140 mg/dl

Metformin",ChEMBL:CHEMBL1431 | DrugBank:DB00331 | PubChem:4091,Metformin,CN(C)C(=N)NC(=N)N,A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02015637,NCT02015637_EG000,No,All,Child | Adult | Older Adult,Phase 3,304,"Inclusion Criteria:

Subject is a male or female 15 years of age or older.

Subject must have had 1 or more of the following occur:

gonorrhea with the nucleic acid amplification test (NAAT) or culture within the previous 14 days
unprotected genital contact within 14 days with a person confirmed to be infected with gonorrhea,
gram-negative present in urogenital gram strain or male subject must present with purulent urethritis or a female subject with must present with mucopurulent cervical discharge
Subject agrees to avoid unprotected sexual contact in order to minimize the risk of gonorrhea reinfection
Subject must be in good health (ie, based on medical history), as determined by the investigator.
In the opinion of the investigator, the subject must be able and willing to comply with protocol requirements. The subject must agree to provide reliable, verifiable contact information and agree to return for the Test-of-Cure Visit.
If a subject's age is 15 years to less than the legal age of consent,a written, voluntarily signed assent must be obtained from the subject and a written, voluntarily signed informed consent must be signed by the subject's parent or legal guardian before the initiation of any study related procedures, unless the Institutional Review Board (IRB)/Independent Ethics Committee (IEC) determines that parent/legal guardian consent is not required.

Exclusion Criteria:

Confirmed, or suspected, complicated or systemic gonococcal infection, such as pelvic inflammatory disease, arthritis, or endocarditis.
Subject has taken one of the following products within 6 hours of the Entry Visit that may interfere with the absorption of a quinolone antibiotic: magnesium/aluminum antacids; sucralfate; Videx® (didanosine) chewable/buffered tablets; other highly buffered drugs; or other products containing calcium, iron, or zinc.
Use of systemic or intravaginal antibiotics that are potentially effective against gonorrhea 4 weeks prior to study drug administration.
Subjects with a current or prior history of seizures, and subjects being treated with drugs that are known to have a sizable potential of or reduce the threshold for inducing seizures (eg, bupropion, theophylline, and tricyclic and tetracyclic antidepressants).
Current use of systemic corticosteroid or immunosuppressive drugs.
Known significant immunosuppression (eg, cluster of differentiation (CD4) cell count <200/mm3 or absolute neutrophil count <500/mL).
Cytotoxic chemotherapy or radiation therapy during the previous 3 months.
Subject is co-infected with an additional sexually transmitted disease (STD) for which treatment cannot be safely deferred until after the Test-of-Cure Visit unless the treatment is not potentially effective against gonorrhea.
Subject has used an investigational drug or product within 30 days before study drug dosing.
Medical history of Type 1 hypersensitivity to antibiotics of the quinolone or cephalosporin classes.
Hysterectomized subjects without a cervix are ineligible.","900mg orally (2 x 450 mg tablets) administered once

Delafloxacin: single dose",ChEMBL:CHEMBL2105637 | DrugBank:DB11943 | PubChem:487101,Delafloxacin,Nc1nc(-n2cc(C(=O)O)c(=O)c3cc(F)c(N4CC(O)C4)c(Cl)c32)c(F)cc1F,J01MA23,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02017327,NCT02017327_EG000,No,All,Adult | Older Adult,Phase 4,119,"Inclusion Criteria:

Male or female aged ≥18 years old.
Written informed consent.

Association of the 3 following criteria:

Both eyes have primary open angle glaucoma or ocular hypertension already treated and controlled by mono-therapy of Lumigan® 0.01% since at least 3 months (according to European Glaucoma Society guidelines).
Intra Ocular Pressure ≤ 18 mm Hg in both eyes.
With local intolerance signs in at least one eye defined by the association of:

3.1 Hyperaemia = Grade (2) or (3) or (4) following the photographic MacMonnies scale.

And 3.2.1 Presence of at least 2 symptoms with a level of severity ≥ 1 (= mild or moderate or severe) among the following 5 symptoms: irritation/burning, itching, tearing, eye dryness sensation, foreign body sensation.

And/Or 3.2.2 Presence of at least 2 signs with a level of severity ≥ 1 (= mild or moderate or severe) among the following 3 signs: superficial punctate keratitis, blepharitis, eyelid skin darkness.

Exclusion Criteria:

- Presence of at least one severe objective sign among the following:

Global ocular staining with Oxford (0-15) grading scheme >12.
Blepharitis (Grade 4: Very severe, i.e. eczematiform lesion).
Any ocular hypertension other than primary ocular hypertension or primary chronic open angle glaucoma (such as congenital, angle closure glaucoma, secondary glaucoma).
Visual field not performed or not available within the 6 months before inclusion visit.
Fundus not performed or not available within the 6 months before inclusion visit.

Advanced stage of glaucoma:

Absolute defect in the ten degrees central point of the visual field.
Severe visual field loss according to the investigator's best judgement.
Risk of visual field worsening as a consequence of participation in the trial according to the investigator's best judgement.
Best far corrected visual acuity ≤ 1/10.
History of trauma, infection, inflammation within the 3 months before inclusion visit.
Ongoing or known history of ocular allergy and/or uveitis and/or viral infection.
Severe dry eye (defined by severe epithelial erosions of the cornea and/or use of dry eye medication with a frequency exceeding 8 instillations / day).
Corneal ulceration.
Palpebral abnormalities not related to medical treatment study and incompatible with a good evaluation.
Any abnormality preventing accurate assessment e.g. reliable tonometry measurement, visual field examination.

Systemic/non ophthalmic/ exclusion criteria

Non-controlled diabetic patient.
Known or suspected hypersensitivity to one of the components of the study product.
Any medical or surgical history, disorder or disease such as acute or chronic severe organic disease: hepatic, endocrine, neoplastic, haematological; immunosuppressive, infectious diseases, severe psychiatric illness, relevant cardiovascular abnormalities, etc… and/or any complicating factor or structural abnormality, judged by the investigator to be incompatible with the study.

Specific exclusion criteria for women

Pregnancy, lactation.
Childbearing potential woman who is not using a reliable method of contraception (oral contraceptive, intra-uterine device, subcutaneous contraceptive implant, vaginal ring, patch) and is not surgically sterilised.","1 drop in each eye once daily at 9.00 pm (± 1 hour) for 3 months.

Monoprost: Monoprost®: Latanoprost 0.005% ophthalmic preparation is a sterile unpreserved oil-based solution for topical ophthalmic use. It is supplied in 0.30 ml single use polyethylene containers. The batch numbers and reanalysis dates will be stated in the certificate of analysis.",ChEMBL:CHEMBL1051 | DrugBank:DB00654 | PubChem:5311221,Latanoprost,CC(C)OC(=O)CCC/C=C\C[C@@H]1[C@@H](CC[C@@H](O)CCc2ccccc2)[C@H](O)C[C@@H]1O,S01EE01 | S01EE51,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02019667,NCT02019667_EG002,No,All,Child | Adult | Older Adult,Phase 2,19,"INCLUSION CRITERIA
Aged 4 years or older
4-hydroxybutyric aciduria (gamma-hydroxybutyric aciduria) on two separate tests
Documented succinic semialdehyde dehydrogenase enzyme deficiency
Patients must have clinical features consistent with SSADH deficiency including developmental delay especially deficit in expressive language, hypotonia, ataxia, seizures, and other neuropsychiatric symptoms including sleep disturbances , attention deficit, anxiety, obsessivecompulsive disorder, and autistic traits
During the study, women of child-bearing potential must use a reliable method of birth control until one month after the final drug taper is complete.

EXCLUSION CRITERIA

Current alcohol use (>14 drinks/wk in men and >7 drinks/wk in women or or recreational drug use
Contraindications to MRI: metal in the body including pacemakers, medication pumps, aneurysm clips, metallic prostheses (including metal pins and rods, heart valves or cochlear implants), shrapnel fragments, permanent eye liner or small metal fragments in the eye that welders and other metal workers may have
Claustrophobia
Cannot lie comfortably flat on the back for up to 2h in the MRI scanner
Patients with a history of other major medical disorders with clinical fluctuations, or requiring therapy that might affect study participation or drug response such as severe depression or psychoses, renal or hepatic disease.
Patients requiring treatment with drugs known to affect the GABAergic system, including vigabatrin and benzodiazepines.
Pregnant and lactating women","Participants with SSADH Deficiency receiving SGS-742 while on study drug for six months

SGS-742",DrugBank:DB05010 | PubChem:130021,SGS-742,CCCCP(=O)(O)CCCN,,0.0,0.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,1.0,0.0,1.0,1.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0
NCT02019875,NCT02019875_EG001,Accepts Healthy Volunteers,All,Adult,Early Phase 1,18,"Inclusion Criteria:

Subjects with no history of significant medical conditions including cardiac, pulmonary, gastrointestinal, or renal disease, HIV, diabetes mellitus or Hepatitis B or C
Subjects will be males or females 18-60 years of age
Subjects must read and understand English
Subjects must be able to provide informed consent
Subjects must be willing to avoid prescription medications, OTC drugs, dietary supplements and foods that are known to modulate CYP3A4 expression or activity
Subjects must be willing to maintain a consistent consumption of calcium and Vitamin D during the study and maintain a daily logbook of their dietary consumption
Women not currently pregnant or lactating. In addition, women participants of childbearing age must be willing to utilize a barrier method of birth control (sterilization will be acceptable)
Subjects will have no known allergies to the study drugs to be used
Subject's corrected QTc interval obtained by electrocardiogram will be ≤ 430 ms in men or ≤ 450 ms in women

Exclusion Criteria:

Subjects with any significant chronic medical condition, including cardiac, pulmonary, gastrointestinal, or renal disease, HIV, diabetes mellitus or Hepatitis B or C
Subjects less than 18 or greater than 60 years of age
Subjects unable to read and understand English
Subjects unable to provide informed consent
Subjects unable to avoid prescription medications, OTC drugs, dietary supplements and foods that are known to modulate CYP3A4 expression or activity
Subjects not willing to maintain a consistent consumption of calcium and Vitamin D during the study and maintain a daily logbook of their dietary consumption
Women who are pregnant or lactating and women participants of childbearing age not willing to utilize a barrier method of birth control (sterilization will be acceptable)
Subjects with allergies to rifampin, clarithromycin or grapefruit juice
Potential participants will be excluded if they are concurrently participating in another research study
Subjects with corrected QTc interval > 430 ms in men or > 450 ms in women on electrocardiogram","Rifampin 600 mg once a day for 14 days

Rifampin: P450 inducer",ChEMBL:CHEMBL374478 | DrugBank:DB01045 | PubChem:135398735 | PubChem:135403807 | PubChem:135441414 | PubChem:135449527 | PubChem:135476790 | PubChem:135512673 | PubChem:135550179 | PubChem:135876149 | PubChem:135900090 | PubChem:135921123 | PubChem:135921134 | PubChem:135925261 | PubChem:135925741 | PubChem:135932822 | PubChem:136122621 | PubChem:136136478 | PubChem:136246612 | PubChem:136601293 | PubChem:136619758 | PubChem:136709103 | PubChem:137016821 | PubChem:137086834 | PubChem:137225336 | PubChem:137270779 | PubChem:137286743 | PubChem:137287990 | PubChem:154825551 | PubChem:163059759,RIFAMPIN,COC1C=COC2(C)Oc3c(C)c(O)c4c(O)c(c(C=NN5CCN(C)CC5)c(O)c4c3C2=O)NC(=O)C(C)=CC=CC(C)C(O)C(C)C(O)C(C)C(OC(C)=O)C1C,J04AB02 | J04AM02 | J04AM05 | J04AM06 | J04AM07 | J04BA50 | J04BA51,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02019979,NCT02019979_EG000,No,All,Adult | Older Adult,Phase 2,14,"Inclusion Criteria:

Able to provide written consent and is amenable to compliance with protocol schedules and testing
Patient is > 18 years of age
Pathologically proven (either histologic or cytologic) diagnosis of Stage IIIB or IV non-squamous non-small cell lung cancer
No prior, palliative chemotherapy for stage IV lung cancer Patients who have received adjuvant chemotherapy post surgery for curative intent more than 12 months prior to development of stage IV disease are allowed.
Measurable disease as RECIST criteria 1.1 (Response Evaluation Criteria in Solid Tumors, Version 1.1)
CT Scan of the chest/abdomen/pelvis or PET Scan within 30 days of study entry
An MRI of the brain or Head CT Scan with contrast within 30 days of study entry if clinically indicated
ECOG Performance Status 0-2.

CBC/differential obtained within 2 weeks prior to registration on study, with adequate bone marrow function defined as follows:

Absolute neutrophil count (ANC) >1,500 cells/ul
Platelets > 100,000 cells/ul
Hemoglobin > 9.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb > g/dl is acceptable.)
Serum creatinine < 1.5 x ULN
Total bilirubin < 2.0 times the institutional Upper Limit of Normal (ULN)
AST and ALT < 3.0 x the ULN

Women of childbearing potential must have:

A negative serum or urine pregnancy test (sensitivity <= 25IU HCG/L) within 14 days prior to the start of study drug administration
Persons of reproductive potential must agree to use and utilize an adequate method of contraception throughout treatment and for at least 90 days after study drug is stopped prior to study enrollment, women of childbearing potential must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy.
Ability to take oral medication

Exclusion Criteria:

The patient has a diagnosis of squamous cell carcinoma. Adenosquamous (mixed) histologies are allowed
The patient has a history of type I or type II diabetes
Weight of less than 80% of (IBW) ideal body weight
Creatinine clearance less than 45 l/min as calculated by the Cockcroft-Gault equation
Known EGFR or ALK mutation in which targeted therapy with erlotinib or crizotinib would be the standard of care. Those patients whose tissue is not tested or have insufficient material are eligible
The patient is currently taking or has previously taken metformin in the past 6 months
The patient has received previous chemotherapy for NSCLC except in instances of adjuvant therapy post surgical resection more than 12 months prior to enrollment
The patient has undergone major surgery within four weeks prior to randomization.
The patient has undergone palliative radiation (chest, brain) to tumor sites within two weeks of randomization (except palliative radiation to the bone which can be within one week
Uncontrolled (untreated) brain metastasis.
Patient who has NCI-CTCAE Version 4 Grade >= 2 diarrhea
That patient has clinically relevant CAD or uncontrolled CHF
The patient has ongoing or active infection (requiring antibiotics) that would limit the administration of chemotherapy including active TB. HIV is allowed in this study
The patient has a history of neurological or psychological disorder that may interfere with the compliance of the protocol
Women who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 4 weeks after cessation of study drug, or have a positive pregnancy test at baseline, or are pregnant or breastfeeding","metformin and carbohydrate restricted diet added to platinum based chemotherapy regimen

metformin: Addition of metformin 1000 mg po bid to standard of care platinum based chemotherapy

carbohydrate restricted diet: addition of dietary counseling and metformin 1000 mg po bid to platinum based chemotherapy",ChEMBL:CHEMBL1431 | DrugBank:DB00331 | PubChem:4091,Metformin,CN(C)C(=N)NC(=N)N,A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02022007,NCT02022007_EG000,No,Female,Adult,Phase 3,13,"Inclusion Criteria:

Females 18 years to 42 years of age with polycystic ovary syndrome(NIH PCOS criteria) with prediabetic hyperglycemia determined by an 75 gram oral glucose tolerance test (OGTT). Study subjects will be inclusive of PCOS women with impaired fasting glucose (IFG), impaired glucose tolerance (IGT), or both (IFG/IGT).
Written consent for participation in the study

Exclusion Criteria:

Presence of significant systemic disease, heart problems including congestive heart failure, history of pancreatitis, or diabetes mellitus (Type 1 or 2)
Any hepatic diseases in the past (viral hepatitis, toxic hepatic damage, jaundice of unknown etiology), gallstones, abnormal liver function tests or renal impairment (elevated serum creatinine levels or abnormal creatinine clearance)
Uncontrolled thyroid disease (documented normal TSH), Cushing's syndrome, congenital adrenal hyperplasia or hyperprolactinemia
Significantly elevated triglyceride levels (fasting triglyceride > 400 mg %)
Untreated or poorly controlled hypertension (sitting blood pressure > 160/95 mm Hg)
Use of hormonal medications, drugs known to affect gastrointestinal motility, lipid-lowering (statins, etc.) and/or anti-obesity drugs or medications that interfere with carbohydrate metabolism (such as isotretinoin, hormonal contraceptives, gonadotropin releasing hormone (GnRH) analogues, glucocorticoids, anabolic steroids, C-19 progestins) for at least 8 weeks. Use of anti-androgens that act peripherally to reduce hirsutism such as 5-alpha reductase inhibitors (finasteride, spironolactone, flutamide) for at least 4 weeks
Prior history of a malignant disease requiring chemotherapy
Known hypersensitivity or contraindications to use of insulin sensitizers such as metformin or thiazolidinediones
History of hypersensitivity reaction to saxagliptin or other DPP-4 inhibitors (e.g. anaphylaxis, angioedema, exfoliative skin conditions)
Current use of metformin, thiazolidinediones, glucagon-like peptide -1 receptor agonists, DPP-4 inhibitors, or weight loss medications (prescription or OTC) Patients must stop use of insulin sensitizers or antidiabetic medicines such as metformin for at least 4 weeks or thiazolidinediones, GLP1 agonists or DPPIV inhibitors for 8 weeks.
Prior use of medication to treat diabetes except gestational diabetes
Use of drugs known to exacerbate glucose tolerance
Eating disorders (anorexia, bulimia) or gastrointestinal disorders
Suspected pregnancy (documented negative serum pregnancy test), desiring pregnancy during the study treatment interval, breastfeeding, or known pregnancy in last 2 months
Active or prior history of substance abuse (smoke or tobacco use within past 3 years) or significant intake of alcohol or history of alcoholism
Patient not willing to use adequate barrier contraception during study period (unless sterilized or have an IUD).
Debilitating psychiatric disorder such as psychosis or neurological condition that might confound outcome variables
Inability or refusal to comply with protocol
Not currently participating or having participated in an experimental drug study in previous three months","Metformin 2000 mg QD for 16 weeks

Metformin XR: Start 2 pills (2 pills of 500 mg =1000mg XR) for 3 weeks

Increase to 4 pills as tolerated (4 pills of 500 mg XR =2000 mg XR) for remainder of study",PubChem:44573417,metformin XR,CN=C(N)N(C)C(=N)N.Cl,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02022436,NCT02022436_EG000,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 2,66,"Inclusion Criteria:

Diagnosis of AAA with confirmation of diagnosis of any size aneurysm with imaging.
21 years of age or older
ability to give informed consent.

Exclusion Criteria:

Inability to provide an informed consent
Known allergy to Definity
Unstable cardiopulmonary conditions
pregnancy","Contrast ultrasound

contrast ultrasound: Definity® is the contrast agent that will be administered by intravenous injection by a registered nurse during the ultrasound (contrast enhanced ultrasound (CUS). The purpose is to assist in identifying differences in AAA characteristics based on gender and AAA stability and growth.

Contrast Ultrasound: Definity® is the contrast agent that will be administered by intravenous injection by a registered nurse during the ultrasound (contrast enhanced ultrasound (CUS). The purpose is to assist in identifying differences in AAA characteristics based on gender and AAA stability and growth.",ChEMBL:CHEMBL1663 | DrugBank:DB00556 | PubChem:6432,Perflutren,FC(F)(F)C(F)(F)C(F)(F)F,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02022436,NCT02022436_EG001,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 2,66,"Inclusion Criteria:

Diagnosis of AAA with confirmation of diagnosis of any size aneurysm with imaging.
21 years of age or older
ability to give informed consent.

Exclusion Criteria:

Inability to provide an informed consent
Known allergy to Definity
Unstable cardiopulmonary conditions
pregnancy","contrast enhanced ultrasound

contrast ultrasound: Definity® is the contrast agent that will be administered by intravenous injection by a registered nurse during the ultrasound (contrast enhanced ultrasound (CUS). The purpose is to assist in identifying differences in AAA characteristics based on gender and AAA stability and growth.

Contrast Ultrasound: Definity® is the contrast agent that will be administered by intravenous injection by a registered nurse during the ultrasound (contrast enhanced ultrasound (CUS). The purpose is to assist in identifying differences in AAA characteristics based on gender and AAA stability and growth.",ChEMBL:CHEMBL1663 | DrugBank:DB00556 | PubChem:6432,Perflutren,FC(F)(F)C(F)(F)C(F)(F)F,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02025075,NCT02025075_EG000,Accepts Healthy Volunteers,All,Adult | Older Adult,Not Applicable,37,"Inclusion Criteria:

Age 18 years or older
Elective patients scheduled to undergo laparoscopic surgery with expected duration > 2h
Physical status ASA I - III

Exclusion Criteria:

Pregnancy
Severe cardiac disease (NYHA class III or IV, acute coronary syndrome, or persistent ventricular tachyarrhythmia)
Previous lung surgery
History of severe chronic obstructive pulmonary disease
Gastro-esophageal pathology (including but not limited to recent gastric or esophageal surgery including bypass/banding, history of esophageal varices, known anatomical gastric or esophageal defects such as strictures, hernias or fistulas)
Mechanical ventilation within the last 30 days
Neuromuscular disease
Consented for another interventional study or refusal to participate in the present study
Hypersensitivity (e.g., anaphylaxis) to rocuronium bromide or other neuromuscular blocking agents","Muscle paralysis with rocuronium 0.6 - 1.2 mg/kg with the dose adjusted to achieve 1-2 post-tetanic counts (neuromuscular function monitor).

Rocuronium: Rocuronium 0.6 - 1.2 mg/kg with the dose adjusted to achieve 1-2 post-tetanic counts (Deep NMB) or 1-2 twitches in the train-on-four (Moderate NMB).",ChEMBL:CHEMBL1201244 | DrugBank:DB00728 | PubChem:441290,Rocuronium,[H][C@@]12CC[C@]3([H])[C@]([H])(CC[C@]4(C)[C@@H](OC(C)=O)[C@@H]([N+]5(CC=C)CCCC5)C[C@@]34[H])[C@@]1(C)C[C@H](N1CCOCC1)[C@@H](O)C2,M03AC09,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02025075,NCT02025075_EG001,Accepts Healthy Volunteers,All,Adult | Older Adult,Not Applicable,37,"Inclusion Criteria:

Age 18 years or older
Elective patients scheduled to undergo laparoscopic surgery with expected duration > 2h
Physical status ASA I - III

Exclusion Criteria:

Pregnancy
Severe cardiac disease (NYHA class III or IV, acute coronary syndrome, or persistent ventricular tachyarrhythmia)
Previous lung surgery
History of severe chronic obstructive pulmonary disease
Gastro-esophageal pathology (including but not limited to recent gastric or esophageal surgery including bypass/banding, history of esophageal varices, known anatomical gastric or esophageal defects such as strictures, hernias or fistulas)
Mechanical ventilation within the last 30 days
Neuromuscular disease
Consented for another interventional study or refusal to participate in the present study
Hypersensitivity (e.g., anaphylaxis) to rocuronium bromide or other neuromuscular blocking agents","Muscle paralysis with rocuronium 0.6 - 1.2 mg/kg with the dose adjusted to achieve 1-2 twitches in the train-on-four (neuromuscular function monitor).

Rocuronium: Rocuronium 0.6 - 1.2 mg/kg with the dose adjusted to achieve 1-2 post-tetanic counts (Deep NMB) or 1-2 twitches in the train-on-four (Moderate NMB).",ChEMBL:CHEMBL1201244 | DrugBank:DB00728 | PubChem:441290,Rocuronium,[H][C@@]12CC[C@]3([H])[C@]([H])(CC[C@]4(C)[C@@H](OC(C)=O)[C@@H]([N+]5(CC=C)CCCC5)C[C@@]34[H])[C@@]1(C)C[C@H](N1CCOCC1)[C@@H](O)C2,M03AC09,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02025634,NCT02025634_EG000,No,All,Adult | Older Adult,Phase 4,119,"Inclusion Criteria:

Is scheduled for knee arthroscopy with or without chondroplasty.
Scheduled arthroscopy procedure will not include ligament repairs or ligament reconstructions and/or bone cutting or fixation procedures.
Has not received any acetaminophen (IV, PR, PO) within at least 8 hours of the initiation of surgery.
Is willing and able to sign an informed consent.

Exclusion Criteria:

Is undergoing arthroscopy for ligament repairs/reconstructions and bone cutting or fixation procedures
Has self-reported and/or documented previous hypersensitivity to acetaminophen.
Has self-reported and/or documented history of hepatic disease or impairment.
Pre-operative calculated creatinine clearance (CrCL) less than 40 ml/min.
Has a medical history of alcohol abuse and/or currently drinks more than 3 alcoholic beverages per day.
Has a medical history of substance dependence (i.e. prescription analgesics or illegal drugs such as cocaine, heroin, etc…). May be self-reported or maybe per the judgment of the physician PI/Sub-I.","Infusion of Intravenous acetaminophen (Ofirmev)

Intravenous Acetaminophen: Participants randomized to intravenous acetaminophen (Ofirmev) will receive an infusion of Ofirmev in 100 ml of 0.9 NS according to manufacturer's recommendations related to subject's weight.",ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02028221,NCT02028221_EG001,No,Female,Adult,Phase 2,76,"Inclusion Criteria:

Premenopausal women
21-54 years of age
Have a BMI of 25 kg/m2 or greater
No change in menstrual patterns for the past 6 months preceding the time of registration
Waist circumference ≥ 35 inches or ≥ 31 inches for Asian Americans, individuals with polycystic ovary syndrome, or individuals with non-alcoholic fatty liver disease.

Have at least one other component of metabolic syndrome (103) reported below:

Elevated triglycerides (≥ 150 mg/dL (1.7 mmol/L) or on drug treatment for elevated triglycerides
Reduced HDL-C (< 50 mg/dL (1.3 mmol/L) or on drug treatment for reduced HDL-C
Elevated blood pressure (≥ 130 Hg systolic blood pressure or ≥85 mm Hg diastolic blood pressure or on antihypertensive drug treatment in a patient with a history of hypertension
Elevated fasting glucose (≥100 mg/dL)
Mammogram negative for breast cancer within the 12 months preceding the time of registration for women ≥ 50 years of age
Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

Postmenopausal women

Amenorrhea for at least 12 months (preceding the time of registration), or
History of hysterectomy and bilateral salpingo-oophorectomy, or
At least 55 years of age with prior hysterectomy with or without oophorectomy, or
Age 35 to 54 with a prior hysterectomy without oophorectomy OR with a status of ovaries unknown with documented follicle-stimulating hormone level demonstrating elevation in postmenopausal range
Women who are pregnant, planning pregnancy within the next year, or breastfeeding
On treatment with any drug for diabetes
Have uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or any illness that would limit compliance with study requirements
Have received chemotherapy and/or radiation for any malignancy (excluding non-melanoma skin cancer and cancers confined to organs with removal as only treatment) in the past 5 years (preceding the time of registration)
Have received other investigational agents within the past 3 months (preceding the time of registration)
Have a history of lactic acidosis or risk factors for lactic acidosis
Have significant renal disease or dysfunction (creatinine ≥ 1.4 mg/dL)
Have significant hepatic dysfunction (bilirubin ≥ 1.5 x ULN unless with Gilberts syndrome or AST/ALT ≥ 3 x ULN)
Have a history of alcoholism or high alcohol consumption (average of > 3 standard drinks/day)
Have a history of allergic reactions to metformin or similar drugs
Have a history of severe claustrophobia
Have electrically, magnetically, or mechanically activated implants including cardiac pacemaker, cochlear implants, magnetic surgical clips or prostheses
Have breast implants","metformin 850 mg 1 tablet taken by mouth daily X 4 weeks, then metformin 850 mg 1 tablet taken twice daily for the remaining duration of he intervention period.

Metformin: metformin 850 mg 1 tablet taken by mouth daily X 4 weeks, then metformin 850 mg 1 tablet taken twice daily for the duration of he intervention period.",ChEMBL:CHEMBL1431 | DrugBank:DB00331 | PubChem:4091,Metformin,CN(C)C(=N)NC(=N)N,A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0
NCT02028325,NCT02028325_EG000,No,All,Adult | Older Adult,Phase 4,136,"Inclusion Criteria:

Age 18 years or older.
Diagnosed by preoperative imaging modalities to have a brain tumor or vascular lesions (aneurysm, arteriovenous malformation or arteriovenous fistula) requiring surgical intervention.
The patient is determined by a board certified Neurosurgeon (above mentioned neurosurgeons) to benefit from the application of Fluorescein Sodium intraoperatively
Patient or legally authorized representative provides written informed consent to enroll in this study.

Exclusion Criteria:

Known allergic reaction to Fluorescein Sodium.
Children.
Prisoners.
Students.
Infection of the central nervous system or other sites.
Hemodynamic instability or significant impairments in circulation.
Concomitant treatment with other investigational drugs.
Any uncontrolled condition unrelated to the neurosurgical disease.
History of psychiatric, additive, or any other disorder that compromises the ability to provide informed consent or comply with study protocols.
Participation on other clinical trials during the last thirty days.
Pregnant patients.
Patients unable to discontinue medications that affect Fluorescein metabolism.","All patients enrolled in the study will prepare for surgery as per standard neurosurgical indications, procedures and institution protocols. At the time of the anesthesia induction, with the patient under general anesthesia, Fluorescein Sodium 10% (100mg/1mL) at a dose of 3-20 mg/kg will be administered intravenously (the optimal dosage will be determined within the study as the most minimal dose for adequate visualization will be used). For vascular lesions, fluorescein sodium 10% (100mg/1mL) will be injected and used to assess its application after the conventional methods have confirmed the exclusion of the aneurysm. No patient's care will be affected by the results of the Fluorescein angiography.",PubChem:10608,Fluorescein Sodium,O=C([O-])c1ccccc1-c1c2ccc(=O)cc-2oc2cc([O-])ccc12.[Na+].[Na+],,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02028715,NCT02028715_EG001,No,Female,Adult | Older Adult,Phase 4,34,"Inclusion Criteria:

-Female patients undergoing major gynecologic surgery via an open abdominal approach. The included surgeries would be exploratory laparotomy with or without removal of uterus, fallopian tubes, or ovaries.

Exclusion Criteria:

Patients with baseline preoperative liver function enzymes (AST and ALT) that are greater than twice the upper limit of normal would be excluded.
Patients with baseline CrCl <30.
Patients that require intensive postoperative care and delayed extubation will typically require additional sedation which would impede adequate evaluation of the two study pain regimens as they are designed to be patient controlled.
Patients with complications unrelated to the pain regimens that prolong their stay would be excluded from the evaluation of hospital stay and cost effectiveness analyses. Examples would include but are not limited to pre-renal azotemia and acute renal failure; pneumonia; venous thromboembolism; or need for re-exploration laparotomy.
Allergy to acetaminophen would exclude those patients set to enter the experimental IV acetaminophen study arm. One exception would be if the allergy were trivial and related to route of administration such as mild nausea with oral acetaminophen.
Patients that undergo a bowel resection during surgery as it may adversely effect return of bowel function
Patients that have required regular opioid intake for the 7 days preceding surgery.
NSAIDs within 8 hours of surgery.
Chronic steroid use with the exception of low-dose inhaled steroid formulations.
Chronic alcohol or drug abuse.
Patients currently pregnant.
Patients unable to provide informed consent.
Age >85
Any physical, medical, and mental condition that would make participation in the study inadvisable.","IV acetaminophen: IV acetaminophen (1,000mg) will be given every six hours for a total of eight doses with the first dose being given at time of anesthesia induction.

Morphine PCA for the initial 24 hours post-operation with low-dose basal rate (0.5mg/hr) with patient administered boluses prn. Oral oxycodone from 24-48 hours post-operation will be used prn and then patients will be transitioned to oral combined oxycodone/acetaminophen for the remainder of their hospital stay.",ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02029235,NCT02029235_EG001,No,All,Adult | Older Adult,Phase 4,31,"Inclusion Criteria:

Age greater than or equal to 18
Male or Female (non-pregnant)
Elective, soft tissue hand surgery indicated based on diagnosis made by either clinical exam or diagnostic studies (ie nerve conduction study, EMG) or a combination of the two (carpal tunnel release, trigger finger release, first dorsal compartment release, ganglion cyst excision, second extensor compartment release)
Subjects are capable of giving informed consent

Exclusion Criteria:

Allergy to study medication
Any pre-existing pain condition requiring analgesia
Fibromyalgia
Recent upper gastrointestinal bleeding
Coagulopathy (primary or medication-related)
Renal impairment
Liver disease
Pregnancy
Patients who consent to the study but require unexpected admission, including those requiring admission resulting from operative complications, will be excluded before randomization","Acetaminophen 325 mg and Hydrocodone 5 mg

Acetaminophen/Hydrocodone: Postoperatively, subjects will be given acetaminophen 325 mg / hydrocodone 5 mg every 4 hours, as needed, for one week or until essentially pain-free",ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02029846,NCT02029846_EG000,No,All,Older Adult,Phase 4,2,"Inclusion Criteria:

Type 2 diabetics diagnosed for at least 6 months
Patients ages ≥ 65 years and older
Active patients in the Bay West Endocrinology practice
Inadequately controlled on oral agents and/or basal insulin with HbA1c between 8.0% and 12%
Eligible for randomization to either treatment group
Patients willing to follow either treatment arm including regimen using one or more injectables
Patients to have an English Reading Level of Grade 6 or above
Patients residing at home

Exclusion Criteria:

Unwilling to use a regimen that may contain using one or more injections
Using short acting insulin prior to the study
Using GLP-1 in past 10 weeks
History of hypoglycemia unawareness or episodes needing emergency intervention
End-stage renal disease
Dementia
Blindness
Terminal illness","A regimen with traditional drugs only

Standard Treatment (insulin, metformin, sulfonylureas, TZDs): traditional drugs only",ChEMBL:CHEMBL1431 | DrugBank:DB00331 | PubChem:4091,Metformin,CN(C)C(=N)NC(=N)N,A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02038153,NCT02038153_EG000,No,All,Adult | Older Adult,Phase 1 | Phase 2,3,"Inclusion Criteria:

Patients must have a confirmed diagnosis of non-M3 AML; antecedent myelodysplastic syndrome (MDS) is acceptable
Post autologous stem cell transplant bone marrow biopsy core that is consistent with morphologic remission
Must have received induction and consolidation chemotherapy, and autologous stem cell transplant for AML
Life expectancy of greater than 12 months
Karnofsky performance status 70 or greater
Leukocytes >= 2,000/mcL
Absolute neutrophil count >= 1,000/mcL
Platelets >= 75,000/mcL
Total bilirubin =< 4 X institutional upper limit of normal unless 2nd to Gilbert's disease
Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 4 X institutional upper limit of normal
Creatinine < 1.5 X institutional upper limit of normal OR creatinine clearance >= 30 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal
Able to take aspirin, or warfarin, or low molecular weight heparin as prophylactic anticoagulation
Ability to understand and the willingness to sign a written informed consent document
Must be registered into the mandatory RevAssist® program and be willing and able to comply with the requirement of RevAssist®

Exclusion Criteria:

Patient received chemotherapy or radiotherapy within 2 weeks prior to entering the study or has not recovered from adverse events due to agents administered more than 4 weeks earlier
Patient received another investigational agent after post autologous stem cell transplant
Patient who will be receiving another investigational product during the study
Patient who is growth factor or transfusion dependent
Patient has central nervous system leukemia
History of allergic reactions attributed to thalidomide or lenalidomide
History of erythema nodosum, characterized by a desquamating rash while taking thalidomide or similar drugs
Prior history of metastatic malignancy
Uncontrolled illness including, but not limited to ongoing or active infection, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements; patients must not have suffered recent (< 6 months) myocardial infarction, unstable angina, uncontrolled hypertension, or difficult to control cardiac arrhythmias
Evidence of uncontrolled congestive heart failure
Active hepatitis B as defined by hepatitis B surface antigen positivity, unless able to start dual anti-hepatitis B (HepB) therapy, or already on dual anti-HepB therapy
Patients who are positive for hepatitis B core antibody, but negative for the hepatitis B surface antigen, should be on lamivudine 100 mg daily until at least 3 months post-transplant
Patient is positive for human immunodeficiency virus (HIV) or human T-cell lymphotropic virus-1 (HTLV-1)
Women of childbearing potential (defined as a sexually mature woman who has not undergone a hysterectomy or who has had menses at any time in the preceding 24 consecutive months)
Men who did not agree not to father a child and who refused to use a latex condom during any sexual contact with women of childbearing potential while taking lenalidomide and for 4 weeks after therapy is stopped, even if they have undergone a successful vasectomy","Patients receive lenalidomide PO QD on days 1-21. Courses repeat 4 weeks in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies

Lenalidomide: Given PO",ChEMBL:CHEMBL848 | DrugBank:DB00480 | PubChem:216326,Lenalidomide,Nc1cccc2c1CN(C1CCC(=O)NC1=O)C2=O,L04AX04,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02038829,NCT02038829_EG005,No,All,Adult | Older Adult,Phase 2,94,"Inclusion Criteria:

Male or female patients 40 to 65 years-old, inclusive.
A clinical diagnosis of moderate to severe COPD according to the GOLD 2011 guidelines.
Current smokers or ex-smokers with at least 10 pack year smoking history (eg, at least 1 pack/day for 10 years, or equivalent).
Post bronchodilator (following inhalation of ipratropium bromide) FEV1 ≥ 40% and ≤ 70% of predicted normal during Screening.
Post bronchodilator (following inhalation of ipratropium bromide) FEV1/FVC ratio ≤ 0.70 during Screening.
Post bronchodilator (following inhalation of ipratropium bromide) improvement in FEV1 ≥ 12% and ≥ 100 mL during Screening.
Ability to perform reproducible spirometry according to the American Thoracic Society (ATS) and European Respiratory Society (ERS) guidelines (2005).

Female of child bearing potential (only) must have a negative serum pregnancy test at Screening and be neither breastfeeding nor intending to become pregnant during study participation. Females of childbearing potential must be instructed to and agree to avoid pregnancy during the study. Female subjects of child bearing potential must use an adequate method of birth control from Screening until 30 days after receiving study drug and use contraception in addition to their partners using a barrier method. Acceptable forms of contraception are as follows:

Abstinence
Barrier methods: condoms, diaphragms, cervical caps; with a spermicide foam, gel, film, cream or suppository;
Oral contraceptives
Non hormone containing intrauterine methods: intrauterine devices or systems.
Willing and able to remain at the study site for at least 24 hours at Day 7 of each Treatment Period.
Willing and able to attend all study visits and adhere to all study assessments/procedures.
Willing and able to provide written informed consent

Exclusion Criteria:

Current evidence or recent history of any clinically significant and unstable disease (other than COPD) or abnormality in the opinion of the Investigator that would put the subject at risk or which would compromise the quality of the study data; including but not limited to cardiovascular disease, myocardial infarction, cardiac failure, uncontrolled hypertension, life threatening arrhythmias, uncontrolled diabetes, neurologic or neuromuscular disease, liver disease, gastrointestinal disease or electrolyte abnormalities.
Current evidence or history of a clinically significant abnormality of cardiac rhythm and/or conduction including Holter monitoring prior to randomization.
Primary diagnosis of asthma.
History of malignancy of any organ system, treated or untreated within the past 5 years, with the exception of localized basal cell carcinoma of the skin.
Recent history of COPD exacerbation requiring hospitalization or need for increased treatments for COPD within 6 weeks prior to Screening.
Use of daily oxygen therapy > 10 hours per day.
Use of systemic steroids within 3 months prior to Screening.
Respiratory tract infection within 6 weeks prior to or during Screening.
History of tuberculosis, bronchiectasis or other non-specific pulmonary disease.
History of urinary retention or bladder neck obstruction type symptoms.
History of narrow angle glaucoma.
Prolonged QTcF interval (males > 450 msec and females >470 msec) during Screening, or history of long QT syndrome.
Recent history (previous 12 months) of excessive use or abuse of alcohol or narcotic/illegal drugs.
History of hypersensitivity or intolerance to aerosol medications, beta-2 agonists, or anticholinergics.
Participation in another investigational drug study where drug was received within 30 days prior to Screening, or current participation in another investigational drug trial.
Subject is a staff member of the clinical site or a relative of a clinical site staff member.","Aclidinium 400 mcg bid

Aclidinium: Aclidinium 400 mcg bid",ChEMBL:CHEMBL1194325 | DrugBank:DB08897 | PubChem:11434515,Aclidinium,O=C(O[C@H]1C[N+]2(CCCOc3ccccc3)CCC1CC2)C(O)(c1cccs1)c1cccs1,R03AL05 | R03BB05,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02041325,NCT02041325_EG000,No,All,Adult | Older Adult,Phase 2,22,"Inclusion Criteria:

Understand and voluntarily sign an informed consent form.
Age > = 18 years at the time of signing the informed consent form.
Able to adhere to the study visit schedule and other protocol requirements.
Must have confirmed diagnosis of plasma cell disorder.
Patients with prior thalidomide or CC-5013 (lenalidomide) use are eligible but these agents must have been discontinued at least 4 weeks prior to treatment in this study.
All previous cancer therapy, including chemotherapy, and dexamethsone must have been discontinued at least 4 weeks prior to treatment in this study. Patients with recent radiation, hormonal therapy and surgery are eligible.
Patients must not have received prior Hepatitis B vaccination.
Patient should be negative for antibody against HbSAg.
ANC >= 1000, Platelets >= 75,000.
Women of childbearing potential (WCBP) must have a negative urine pregnancy test at screening (Visit 1). In addition, sexually active WCBP must agree to use two of the following adequate forms of contraception throughout the entire study (tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner). A WCBP must agree to have pregnancy tests 4 weeks after her last dose of lenalidomide. Due to the short duration of drug therapy, abstinence would also be a reasonable option.

Exclusion Criteria:

Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
Pregnant or lactating females.
Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
Use of any other experimental drug or therapy within 28 days of baseline.
Known hypersensitivity to thalidomide.
The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
Concurrent use of other anti-cancer agents or treatments.
Known HIV, HBV and HCV positivity.
Clinically significant autoimmune disease.
Serious intercurrent illness such as active infection requiring IV antibiotics, significant cardiac or pulmonary disease.
Psychiatric disorder, alcohol or illicit drug use.",Subjects will receive oral CC-5013 (lenalidomide) at 25 mg qd for 7 days prior to and 7 days after the vaccine.,ChEMBL:CHEMBL848 | DrugBank:DB00480 | PubChem:216326,Lenalidomide,Nc1cccc2c1CN(C1CCC(=O)NC1=O)C2=O,L04AX04,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02043704,NCT02043704_EG000,No,Female,Adult | Older Adult,Phase 4,100,"Inclusion Criteria:

Women between the ages of 18 and 70 years
Patients of the Division of Urogynecology at Good Samaritan and Bethesda North Hospitals in Cincinnati, Ohio
Scheduled to undergo major vaginal reconstruction
Must undergo total vaginal hysterectomy, anterior repair, posterior repair, enterocele repair, and intraperitoneal vault suspension. The addition of suburethral sling is not a cause for exclusion.

Exclusion Criteria:

Allergy to acetaminophen
Liver disease (chronic or active)
Chronic alcohol use (>1 drink/day)
Bleeding diathesis
Renal disease
Opiate dependent or daily use
History of chronic pain
Mental or cognitive disorder preventing patient to accurately verbalize pain levels
Undergoing abdominal or laparoscopic procedures at the time of surgery
Allergy to hydromorphone
Surgery is not performed under general anesthesia","Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.

IV Acetaminophen: Details covered in arm description.",ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02043704,NCT02043704_EG001,No,Female,Adult | Older Adult,Phase 4,100,"Inclusion Criteria:

Women between the ages of 18 and 70 years
Patients of the Division of Urogynecology at Good Samaritan and Bethesda North Hospitals in Cincinnati, Ohio
Scheduled to undergo major vaginal reconstruction
Must undergo total vaginal hysterectomy, anterior repair, posterior repair, enterocele repair, and intraperitoneal vault suspension. The addition of suburethral sling is not a cause for exclusion.

Exclusion Criteria:

Allergy to acetaminophen
Liver disease (chronic or active)
Chronic alcohol use (>1 drink/day)
Bleeding diathesis
Renal disease
Opiate dependent or daily use
History of chronic pain
Mental or cognitive disorder preventing patient to accurately verbalize pain levels
Undergoing abdominal or laparoscopic procedures at the time of surgery
Allergy to hydromorphone
Surgery is not performed under general anesthesia","Subjects will receive a 100mL dose of IV saline every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.

IV Acetaminophen: Details covered in arm description.",ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02044159,NCT02044159_EG000,No,All,Child,Phase 4,23,"Inclusion Criteria:

Children newborn to 17 years
On any dose of any vasoactive infusion for between 1 to 6 hours

Exclusion Criteria:

Patients who have known or suspected hypothalamic, pituitary or adrenal disease
Patients who are currently receiving steroids for the treatment of shock/suspected shock prior to randomization
Patients who are expected to have treatment withdrawn
Patients who are premature infants (<38 weeks corrected gestational age)
Patients who are pregnant
Patients post cardiac surgery
Patient who received their first dose of vasoactive infusion >24 hours after PICU admission
Patient who is no longer on vasoactive infusion at the time of study enrollment, and/or is expected to no longer be on vasoactive infusion at the time the first dose of study drug will be administered
Patients for whom primary cardiogenic shock is strongly suspected
Patients for whom spinal shock is strongly suspected
Patients for whom hemorrhagic or hypovolemic shock is strongly suspected
Patients who were previously enrolled in the STRIPES study
Patients who receive a vasoactive agent for reasons not related to shock
Physician refusal","Patients randomized to the hydrocortisone arm will receive a 2 mg/kg hydrocortisone IV bolus on enrolment followed by 1 mg/kg of hydrocortisone IV q6h until the patient has not had an escalation in therapy for at least 12 hours. If the patient meets these criteria their hydrocortisone will be weaned to 1 mg/kg every 8 hours which will be continued until they are off all vasoactive infusions for 12 hours. If following the initial hydrocortisone wean, the patient requires fluid boluses and/or an increase in their vasoactive infusion(s), their hydrocortisone will be increased back to 1 mg/kg of hydrocortisone IV q6h until they meet stability criteria again. Duration of treatment will range from a minimum of 20 hours to a maximum of 7 days of study drug.

Hydrocortisone: Hydrocortisone will be made up as a 10 mg/ml solution so the volume of added fluid will be very small (2 to 10 mls even for the initial dose of 2 mg/kg).",ChEMBL:CHEMBL389621 | DrugBank:DB00741 | PubChem:5754,Hydrocortisone,[H][C@@]12CC[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)CC[C@@]21C,A01AC03 | A07EA02 | C05AA01 | D07AA02 | D07BA04 | D07CA01 | D07XA01 | H02AB09 | R01AD60 | S01BA02 | S01BB01 | S01CA03 | S01CB03 | S02BA01 | S02CA03 | S03CA04,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02044419,NCT02044419_EG000,Accepts Healthy Volunteers,All,Adult,Phase 1,30,"Inclusion Criteria:

Subject is a non-smoking healthy male or female, aged between 18 and 40 years of age.
Subject has a BMI of 18.5 - 25 kg/m2.
Subject has total body weight between > 50 kg to ≤ 100 kg.
Subjects must agree to use acceptable methods of contraception.
All females, regardless of childbearing potential, must have a negative serum beta human chorionic gonadotropin pregnancy test at Screening and on admission.
In good health, determined by no clinically significant or relevant abnormalities identified by a detailed medical history & full physical examination.
No known history of hypersensitivity or previous intolerance to lomitapide, applesauce, and/or banana.
Subjects must be capable of understanding and complying with the requirements of the protocol and must have signed the informed consent form prior to undergoing any study-related procedures.

Exclusion Criteria:

Subject has a clinically significant disease or any condition or disease that might affect drug absorption, distribution or excretion.
History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs.
Any clinically significant abnormal laboratory, vital signs or other safety findings as determined by medical history, physical examination or other evaluations.
History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator;
Electrocardiogram (ECG) abnormalities in the standard 12-lead ECG (at screening) such as a QTcF interval of >450 msec, a history of a prolonged QTc interval or Brugada syndrome.
History or current evidence of any clinically relevant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, haematological, endocrinological, allergic, dermatological, metabolic, neurological, psychiatric or other disease.
History or laboratory evidence of Gilbert's syndrome.
Positive results in any of the serology tests for Hepatitis B Surface Antigen (HbsAg), anti-Hepatitis core antibody (anti-HBc Ig G [and anti-HBc IgM if IgG is positive], Hepatitis C antibodies (anti-HCV), and HIV 1 and 2 antibodies, (anti-HIV 1/2).
Use of any drugs of abuse within 6 months prior to admission.
Confirmed positive results from urine drug screen (amphetamines, benzodiazepines, cocaine, cannabinoids, opiates, barbiturates and methadone) or from the alcohol breath test at screening and on admission (Day -1).
History or clinical evidence of alcohol or drug abuse within one year prior to admission.
Mentally handicapped.
Participation in a drug trial within 90 days prior to first drug administration.
Use of any prescription medication within 2 weeks prior to admission (Day -1), with the exception of the oral contraceptive pill.
Use of any substance inducing or inhibiting CYP3A4 enzymes within 30 days prior to admission (Day -1).
Use of any over-the-counter (OTC) medication (including vitamins, minerals, and phytotherapeutic/herbal/plant-derived preparations) within 7 days prior to admission (Day -1), unless deemed acceptable by the Investigator and Sponsor.
Use of alcohol-, grapefruit-, starfruit-, or caffeine-containing foods or beverages within 72 hours prior to admission and through Study Completion.
Donation of more than 500 mL of blood within 90 days prior to drug administration.
Receipt of blood products within 2 months prior to admission.
Poor peripheral venous access.
Use of any tobacco- or nicotine-containing products within 6 months prior to admission (Day -1).
Any acute or chronic condition, scheduled hospitalisation (inclusive of elective surgery during study), or scheduled travel prior to completion of all study procedures.
Any circumstances or conditions, which, in the opinion of the PI, may affect full participation in the trial or compliance with the protocol.
Legal incapacity or limited legal capacity at screening.
Subjects who are vegetarians, vegans or have any dietary restrictions conflicting with the study standardised menus.",Contents of single 20 mg capsule of lomitapide sprinkled in applesauce,ChEMBL:CHEMBL354541 | DrugBank:DB08827 | PubChem:9853053,Lomitapide,O=C(NC1CCN(CCCCC2(C(=O)NCC(F)(F)F)c3ccccc3-c3ccccc32)CC1)c1ccccc1-c1ccc(C(F)(F)F)cc1,C10AX12,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02044419,NCT02044419_EG001,Accepts Healthy Volunteers,All,Adult,Phase 1,31,"Inclusion Criteria:

Subject is a non-smoking healthy male or female, aged between 18 and 40 years of age.
Subject has a BMI of 18.5 - 25 kg/m2.
Subject has total body weight between > 50 kg to ≤ 100 kg.
Subjects must agree to use acceptable methods of contraception.
All females, regardless of childbearing potential, must have a negative serum beta human chorionic gonadotropin pregnancy test at Screening and on admission.
In good health, determined by no clinically significant or relevant abnormalities identified by a detailed medical history & full physical examination.
No known history of hypersensitivity or previous intolerance to lomitapide, applesauce, and/or banana.
Subjects must be capable of understanding and complying with the requirements of the protocol and must have signed the informed consent form prior to undergoing any study-related procedures.

Exclusion Criteria:

Subject has a clinically significant disease or any condition or disease that might affect drug absorption, distribution or excretion.
History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs.
Any clinically significant abnormal laboratory, vital signs or other safety findings as determined by medical history, physical examination or other evaluations.
History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator;
Electrocardiogram (ECG) abnormalities in the standard 12-lead ECG (at screening) such as a QTcF interval of >450 msec, a history of a prolonged QTc interval or Brugada syndrome.
History or current evidence of any clinically relevant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, haematological, endocrinological, allergic, dermatological, metabolic, neurological, psychiatric or other disease.
History or laboratory evidence of Gilbert's syndrome.
Positive results in any of the serology tests for Hepatitis B Surface Antigen (HbsAg), anti-Hepatitis core antibody (anti-HBc Ig G [and anti-HBc IgM if IgG is positive], Hepatitis C antibodies (anti-HCV), and HIV 1 and 2 antibodies, (anti-HIV 1/2).
Use of any drugs of abuse within 6 months prior to admission.
Confirmed positive results from urine drug screen (amphetamines, benzodiazepines, cocaine, cannabinoids, opiates, barbiturates and methadone) or from the alcohol breath test at screening and on admission (Day -1).
History or clinical evidence of alcohol or drug abuse within one year prior to admission.
Mentally handicapped.
Participation in a drug trial within 90 days prior to first drug administration.
Use of any prescription medication within 2 weeks prior to admission (Day -1), with the exception of the oral contraceptive pill.
Use of any substance inducing or inhibiting CYP3A4 enzymes within 30 days prior to admission (Day -1).
Use of any over-the-counter (OTC) medication (including vitamins, minerals, and phytotherapeutic/herbal/plant-derived preparations) within 7 days prior to admission (Day -1), unless deemed acceptable by the Investigator and Sponsor.
Use of alcohol-, grapefruit-, starfruit-, or caffeine-containing foods or beverages within 72 hours prior to admission and through Study Completion.
Donation of more than 500 mL of blood within 90 days prior to drug administration.
Receipt of blood products within 2 months prior to admission.
Poor peripheral venous access.
Use of any tobacco- or nicotine-containing products within 6 months prior to admission (Day -1).
Any acute or chronic condition, scheduled hospitalisation (inclusive of elective surgery during study), or scheduled travel prior to completion of all study procedures.
Any circumstances or conditions, which, in the opinion of the PI, may affect full participation in the trial or compliance with the protocol.
Legal incapacity or limited legal capacity at screening.
Subjects who are vegetarians, vegans or have any dietary restrictions conflicting with the study standardised menus.",Contents of single 20 mg capsule of lomitapide sprinkled in mashed banana,ChEMBL:CHEMBL354541 | DrugBank:DB08827 | PubChem:9853053,Lomitapide,O=C(NC1CCN(CCCCC2(C(=O)NCC(F)(F)F)c3ccccc3-c3ccccc32)CC1)c1ccccc1-c1ccc(C(F)(F)F)cc1,C10AX12,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02044419,NCT02044419_EG002,Accepts Healthy Volunteers,All,Adult,Phase 1,31,"Inclusion Criteria:

Subject is a non-smoking healthy male or female, aged between 18 and 40 years of age.
Subject has a BMI of 18.5 - 25 kg/m2.
Subject has total body weight between > 50 kg to ≤ 100 kg.
Subjects must agree to use acceptable methods of contraception.
All females, regardless of childbearing potential, must have a negative serum beta human chorionic gonadotropin pregnancy test at Screening and on admission.
In good health, determined by no clinically significant or relevant abnormalities identified by a detailed medical history & full physical examination.
No known history of hypersensitivity or previous intolerance to lomitapide, applesauce, and/or banana.
Subjects must be capable of understanding and complying with the requirements of the protocol and must have signed the informed consent form prior to undergoing any study-related procedures.

Exclusion Criteria:

Subject has a clinically significant disease or any condition or disease that might affect drug absorption, distribution or excretion.
History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs.
Any clinically significant abnormal laboratory, vital signs or other safety findings as determined by medical history, physical examination or other evaluations.
History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator;
Electrocardiogram (ECG) abnormalities in the standard 12-lead ECG (at screening) such as a QTcF interval of >450 msec, a history of a prolonged QTc interval or Brugada syndrome.
History or current evidence of any clinically relevant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, haematological, endocrinological, allergic, dermatological, metabolic, neurological, psychiatric or other disease.
History or laboratory evidence of Gilbert's syndrome.
Positive results in any of the serology tests for Hepatitis B Surface Antigen (HbsAg), anti-Hepatitis core antibody (anti-HBc Ig G [and anti-HBc IgM if IgG is positive], Hepatitis C antibodies (anti-HCV), and HIV 1 and 2 antibodies, (anti-HIV 1/2).
Use of any drugs of abuse within 6 months prior to admission.
Confirmed positive results from urine drug screen (amphetamines, benzodiazepines, cocaine, cannabinoids, opiates, barbiturates and methadone) or from the alcohol breath test at screening and on admission (Day -1).
History or clinical evidence of alcohol or drug abuse within one year prior to admission.
Mentally handicapped.
Participation in a drug trial within 90 days prior to first drug administration.
Use of any prescription medication within 2 weeks prior to admission (Day -1), with the exception of the oral contraceptive pill.
Use of any substance inducing or inhibiting CYP3A4 enzymes within 30 days prior to admission (Day -1).
Use of any over-the-counter (OTC) medication (including vitamins, minerals, and phytotherapeutic/herbal/plant-derived preparations) within 7 days prior to admission (Day -1), unless deemed acceptable by the Investigator and Sponsor.
Use of alcohol-, grapefruit-, starfruit-, or caffeine-containing foods or beverages within 72 hours prior to admission and through Study Completion.
Donation of more than 500 mL of blood within 90 days prior to drug administration.
Receipt of blood products within 2 months prior to admission.
Poor peripheral venous access.
Use of any tobacco- or nicotine-containing products within 6 months prior to admission (Day -1).
Any acute or chronic condition, scheduled hospitalisation (inclusive of elective surgery during study), or scheduled travel prior to completion of all study procedures.
Any circumstances or conditions, which, in the opinion of the PI, may affect full participation in the trial or compliance with the protocol.
Legal incapacity or limited legal capacity at screening.
Subjects who are vegetarians, vegans or have any dietary restrictions conflicting with the study standardised menus.",Intact capsule of 20 mg lomitapide,ChEMBL:CHEMBL354541 | DrugBank:DB08827 | PubChem:9853053,Lomitapide,O=C(NC1CCN(CCCCC2(C(=O)NCC(F)(F)F)c3ccccc3-c3ccccc32)CC1)c1ccccc1-c1ccc(C(F)(F)F)cc1,C10AX12,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02046382,NCT02046382_EG000,No,Female,Adult | Older Adult,Phase 4,132,"Inclusion Criteria:

Age greater than or equal to 18 years
Scheduled cesarean section delivery
Patient of TriHealth's Faculty Medical Center or Tri-State Maternal Fetal Medicine Associates
Singleton pregnancy
Term delivery (greater than or equal to 37 weeks)
Spinal/epidural anesthesia with epidural analgesia (duramorph)
Use of pfannenstiel incision

Exclusion Criteria:

Weight less than 50 kg
Allergy to study drugs (acetaminophen, oxycodone, duramorph, NSAIDS)
Multiple gestation pregnancy
Cesarean section for pre-term delivery (less than 37 weeks)
Fetal anomalies
Inability to use epidural duramorph at time of procedure
General anesthesia used
Vertical skin incision
Opioid addiction
Liver dysfunction (hepatitis, HELLP (hemolysis, elevated liver enzymes, and low platelet count), preeclampsia)","Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 8 hours for 48 hours. The first dose will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given.

IV Acetaminophen: 1000mg dose of IV acetaminophen in 100mL solution every 8 hours for 48 hours. The first dose will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given.",ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02056288,NCT02056288_EG001,Accepts Healthy Volunteers,All,Child,Phase 4,78,"Inclusion Criteria:

1) Supracondylar fracture (2) Age 2-17 years (3) American Society of Anesthesiologists Status 1 -3 (4) Scheduled for closed reduction with percutaneous pinning under general anesthesia

Exclusion Criteria:

Pulseless extremity
Compromised neurologic status on exam (specifically assessment of radial, ulnar, and median nerve)
Known allergy to local anesthetics (7) Not scheduled for closed reduction with percutaneous pinning under general anesthesia
Bleeding diathesis
American Society of Anesthesiologist (ASA) status 4 or higher.
Sleep apnea by polysomnography","Patients randomized to the systemic analgesia group will receive 1mcg/kg of fentanyl IV after induction.

Fentanyl: Patients randomized to the systemic analgesia group will receive 1mcg/kg of fentanyl IV after induction.",ChEMBL:CHEMBL596 | DrugBank:DB00813 | PubChem:3345,Fentanyl,CCC(=O)N(c1ccccc1)C1CCN(CCc2ccccc2)CC1,N01AH01 | N01AH51 | N02AB03,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02057549,NCT02057549_EG000,No,All,Adult | Older Adult,Phase 4,36,"Inclusion Criteria:

Previous diagnosis of GP including those without formal gastric emptying studies.
Patients presenting with unresolving nausea, vomiting, and abdominal pain that is attributable to their GP.

Exclusion Criteria:

History of QT prolongation or presence on a 12 leads electrocardiogram.
Presence of concomitant acute abdominal pathology including but not limited to hepatobiliary disease, ischemia, and abdominal aneurysm.
Prisoners
Hypotension (systolic blood pressure below 90 mm Hg)
Pregnant women
Patients who are cognitively impaired and/or unable to consent for the study
Age <18
Allergy to haloperidol","Intravenous dose of haloperidol 5 mg in addition to conventional therapy. Conventional Therapy includes hydration via IV fluids, pain control with analgesics (usually opiates) frequently requiring multiple doses, also antiemetics (often requires multiple doses and different agents in attempts to control nausea and vomiting within this population), in addition to electrolytes abnormalities corrections as needed.",ChEMBL:CHEMBL54 | DrugBank:DB00502 | PubChem:3559,Haloperidol,O=C(CCCN1CCC(O)(c2ccc(Cl)cc2)CC1)c1ccc(F)cc1,N05AD01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02058095,NCT02058095_EG000,No,All,Adult | Older Adult,Phase 1 | Phase 2,15,"Inclusion Criteria:

- Inclusion Criteria:

A total of 39 patients with PDD as defined by an ejection fraction of greater than 50%, no clinical signs or symptoms of congestive heart failure, a minimal distance on 6-minute walk of equal or >450 meters will be recruited and calculated creatinine clearance of equal or less than 90 ml/min and greater than 30 ml/min, using the (MDRD-measurement of renal dysfunction, formula) assessed within the past 36 months. If the subject is not able to walk 450 meters due to pain in hips and knees and not fatigue or shortness of breath than they will still qualify for the protocol.

Exclusion Criteria:

• Current or anticipated future need for nitrate therapy

Systolic blood pressure < 90 mmHg or > 180 mm Hg
Diastolic blood pressure < 40 mmHg or > 100 mmHg
Patients taking alpha antagonists or cytochrome P450 3A4 inhibitors (ketoconazole, itraconazole, erythromycin, saquinavir, cimetidine or serum proteases inhibitors for HIV) who cannot be taken off these medications for the duration of the study.
Patients taking the following selective alpha blockers and who are unable to stop for the duration of the study;
Alfuzosin
Prazosin
Doxazosin
Tamsulosin
Terazosin
Silodosin
Patients with retinitis pigmentosa, previous diagnosis of nonischemic optic neuropathy, untreated proliferative retinopathy or unexplained visual disturbance
Patients with sickle cell anemia, multiple myeloma, leukemia or penile deformities placing them at risk for priapism (angulation, cavernosal fibrosis or Peyronie's disease)
Patients with an allergy to iodine.
Patients on PDEV inhibition for pulmonary hypertension
Patients on PDEV inhibition for erectile dysfunction who are not willing to stop the medication for the duration of the study
Valve disease (> moderate aortic or mitral stenosis; > moderate aortic or mitral regurgitation)
Obstructive Hypertrophic cardiomyopathy
Infiltrative or inflammatory myocardial disease (amyloid, sarcoid)
Pericardial disease
Have experienced a myocardial infarction or unstable angina, or have undergone percutaneous transluminal coronary angiography (PTCA) or coronary artery bypass grafting (CABG) within 60 days prior to consent, or requires either PTCA or CABG at the time of consent
Severe congenital heart diseases
Sustained ventricular tachycardia or ventricular fibrillation within 14 days of screening
Second or third degree heart block without a permanent cardiac pacemaker
Stroke within 3 months of screening or other evidence of significantly compromised Central Nervous System (CNS) perfusion
Hemoglobin <9 g/dL
Patients with severe liver disease (AST > 3x normal, alkaline phosphatase or bilirubin > 2x normal)
Serum sodium of < 125 mEq/dL or > 150 mEq/dL
Serum potassium of < 3.2 mEq/dL or > 5.9 mEq/dL
Prior diagnosis of intrinsic renal diseases including renal artery stenosis of > 50%
Peritoneal or hemodialysis within 90 days or anticipation that dialysis or ultrafiltration of any form will be required during the study period
Less than 21 years of age
Pregnant or nursing women.
Women of child bearing potential who do not have a negative pregnancy test at study entry and who are not using effective contraception
Non-cardiac condition limiting life expectancy to less than one year, per physician judgment
Other acute or chronic medical conditions or laboratory abnormality which may increase the risks associated with study participation or may interfere with interpretation of the data
Received an investigational drug within 1 month prior to dosing
In the opinion of the investigator is unlikely to comply with the study protocol or is unsuitable for any reasons","Subject received Tadalafil daily for a total of 12 weeks

Tadalafil: Tadalafil 5 mg tablet. Daily. Tadalafil dose varies from 5 mg to 20 mg for 12 weeks. If blood pressure is >95 then subject dismissed from the Clinical Research Unit (CRU) on 2 (5 mg) tabs of tadalafil or placebo. If blood pressure is between 90 - 95 mmHg systolic, then dismiss on 1 (5 mg) tab of Tadalafil.

At 2 weeks (± 5 days) if blood pressure is> 100 than add 1 (5 mg) tab of Tadalafil to make a total of 3 (5mg) tabs of Tadalafil.

At 4 weeks(± 5 days) if blood pressure is > 100 add 1 (5 mg) tab to make a total of 4 (5 mg) tablets of Tadalafil.",ChEMBL:CHEMBL779 | DrugBank:DB00820 | PubChem:110635,Tadalafil,[H][C@]12Cc3c([nH]c4ccccc34)[C@@H](c3ccc4c(c3)OCO4)N1C(=O)CN(C)C2=O,C02KX52 | C02KX54 | G04BE08 | G04CA54 | G04CB51,0.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT02059148,NCT02059148_EG000,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 1,23,"Inclusion Criteria:

Healthy sterile males or surgically sterile or postmenopausal females
Have a body mass index (BMI) of 18 to 32 kilogram per meter square (kg/m^2), inclusive, at screening
Are able to eat a high-fat, high-calorie meal

Exclusion Criteria:

Participated in a clinical trial involving investigational product within 30 days
Abnormal blood pressure
Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study
Have donated blood of more than 500 milliliter (mL) within the last month
Show evidence of human immunodeficiency virus, hepatitis B or hepatitis C","Single oral dose of LY2835219 given with a standard meal in one of three study periods.

LY2835219: Administered orally.",ChEMBL:CHEMBL3301610 | DrugBank:DB12001 | PubChem:46220502,Abemaciclib,CCN1CCN(Cc2ccc(Nc3ncc(F)c(-c4cc(F)c5nc(C)n(C(C)C)c5c4)n3)nc2)CC1,L01EF03,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02059148,NCT02059148_EG001,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 1,23,"Inclusion Criteria:

Healthy sterile males or surgically sterile or postmenopausal females
Have a body mass index (BMI) of 18 to 32 kilogram per meter square (kg/m^2), inclusive, at screening
Are able to eat a high-fat, high-calorie meal

Exclusion Criteria:

Participated in a clinical trial involving investigational product within 30 days
Abnormal blood pressure
Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study
Have donated blood of more than 500 milliliter (mL) within the last month
Show evidence of human immunodeficiency virus, hepatitis B or hepatitis C","Single oral dose of LY2835219 given with no food in one of three periods.

LY2835219: Administered orally.",ChEMBL:CHEMBL3301610 | DrugBank:DB12001 | PubChem:46220502,Abemaciclib,CCN1CCN(Cc2ccc(Nc3ncc(F)c(-c4cc(F)c5nc(C)n(C(C)C)c5c4)n3)nc2)CC1,L01EF03,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02059148,NCT02059148_EG002,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 1,24,"Inclusion Criteria:

Healthy sterile males or surgically sterile or postmenopausal females
Have a body mass index (BMI) of 18 to 32 kilogram per meter square (kg/m^2), inclusive, at screening
Are able to eat a high-fat, high-calorie meal

Exclusion Criteria:

Participated in a clinical trial involving investigational product within 30 days
Abnormal blood pressure
Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study
Have donated blood of more than 500 milliliter (mL) within the last month
Show evidence of human immunodeficiency virus, hepatitis B or hepatitis C","Single oral dose of LY2835219 given with a high fat meal in one of three periods.

LY2835219: Administered orally.",ChEMBL:CHEMBL3301610 | DrugBank:DB12001 | PubChem:46220502,Abemaciclib,CCN1CCN(Cc2ccc(Nc3ncc(F)c(-c4cc(F)c5nc(C)n(C(C)C)c5c4)n3)nc2)CC1,L01EF03,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02059278,NCT02059278_EG000,No,All,Adult | Older Adult,Phase 3,165,"Inclusion Criteria:

Age 18 years or older.
POAG or OH with IOP treated and adequately controlled (IOP ≤ 18 mm Hg) with latanoprost 0.005% ophthalmic solution monotherapy for at least 4 weeks prior to Screening.
Each eye being treated with latanoprost 0.005% ophthalmic solution monotherapy must have mean IOP ≤ 18 mm Hg at Screening and mean IOP ≤ 28 mm Hg at Baseline; measurements will be taken at each visit at 8 AM, 10 AM, and 4 PM (each ± 30 minutes) with AM measurements of IOP at least 2 hours apart. If only one eye qualifies but both eyes have glaucoma and the fellow eye will require antiglaucoma medications, the subject does not qualify for the trial.

Stable visual field (VF), defined as no sign of VF degradation between two consecutive 30-2 or two consecutive 24-2 VF examinations. For subjects with no VF defect (eg, those with OH), a single, normal VF examination performed ˂ 6 months prior to the screening visit is allowed to determine eligibility. For patients who have an abnormal VF examination, the following criteria apply:

Two VF (most recent VF and past VF) examinations performed at least ≥ 6 months and ≤ 18 months apart must be compared;
The most recent VF examination should be performed < 6 months prior to the Screening visit;
The past VF examination should be performed ≥ 6 months and ≤ 18 months prior to the most recent VF test.
Stable corrected Snellen visual acuity (VA) of better than 20/200 in the study eye. Patients must see ≥ 50% of the letters on a single line to accept that VA line.
Central corneal thickness 480-620 μm in the study eye.
Shaffer gonioscopic grade of ≥ 3 (in at least 3 quadrants) in both eyes.
Female subjects must be 1-year postmenopausal, surgically sterilized, or women of childbearing potential with a negative urine pregnancy test at Screening. Women of childbearing potential must use an acceptable form of contraception throughout the study. Acceptable methods include the use of at least one of the following: intrauterine (intrauterine device), hormonal (oral, injection, patch, implant, ring), barrier with spermicide (condom, diaphragm), or abstinence.
All subjects must provide signed written consent prior to participation in any study-related procedures.

Exclusion Criteria:

In the study eye:

A mean deviation of < -20 dB on VF examination.
A mean IOP ˃ 28 mm Hg at Baseline.
Presence of a scotoma within 5° of fixation on VF examination.
Aphakia.
Use of any antiglaucoma medication in addition to latanoprost 0.005% ophthalmic solution within 2 weeks prior to Screening and any antiglaucoma medication (other than latanoprost) during the study period other than the randomized study medication.
Use of any topical ophthalmic steroid within 2 weeks prior to Baseline. A short course of oral steroids is acceptable if the course is completed > 2 weeks prior to Screening. Inhaled and intranasal steroids are acceptable.
Use of topical nonsteroidal anti-inflammatory drug (NSAID) within 2 weeks prior to Baseline.
Use of any ophthalmic medications during the study period (nonpreserved artificial tears are allowed).
Ocular surgery or laser treatment of any kind in the study eye within 3 months prior to Baseline.
History of ocular allergy/inflammation and/or severe blepharitis and/or uveitis. Seasonal allergic conjunctivitis is acceptable (avoid enrollment of subjects who may experience seasonal flare-up during the study period). Mild blepharitis/blepharoconjunctivitis, typically associated with prostaglandin usage, on the lid is acceptable.
History of ocular trauma or ocular infection within 3 months of Screening.
History of herpes simplex keratitis.
Current proliferative diabetic retinopathy or age-related macular degeneration, unless deemed not clinically significant by the Investigator.
Severe dry eye (eg, clinically relevant superficial punctate keratitis, epithelial erosions of the cornea, and/or use of dry eye medication [including artificial tears] with a frequency exceeding 8 instillations per day).
Contact lens wear during the study period. Contact lens wear in an untreated fellow eye is allowed.
Any secondary glaucoma or OH (eg, congenital glaucoma, closed-angle glaucoma, uveitic glaucoma, or pseudoexfoliation syndrome).
Any severe glaucoma defined by cupping (cup-to-disc ratio ≥ 0.8).
Any non-laser glaucoma surgery.

Any abnormality preventing accurate assessment (eg, resulting in unreliable applanation tonometry or VF examination).

General:

Pregnancy or lactation.
Uncontrolled asthma (defined as asthma that does not respond to the maximum guideline-directed therapy).
Allergy to benzalkonium chloride.
History of moderate or severe renal or hepatic impairment.
Participation in any study of an investigational product within 30 days prior to Screening or at any time during the study period.",T-2345 Ophthalmic Solution,ChEMBL:CHEMBL1051 | DrugBank:DB00654 | PubChem:5311221,Latanoprost,CC(C)OC(=O)CCC/C=C\C[C@@H]1[C@@H](CC[C@@H](O)CCc2ccccc2)[C@H](O)C[C@@H]1O,S01EE01 | S01EE51,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02061384,NCT02061384_EG001,No,Male,Adult,Phase 2,10,"Inclusion Criteria:

Subjects will be infertile men (no pregnancy with partner with normal cycles and normal hysterosalpingogram despite >1 year of unprotected intercourse).
Abnormal sperm analyses with a total, motile sperm count of less than 10 million sperm as assessed by semen analysis on two occasions separated by one week.
In the opinion of the investigator, is able to comply with the protocol, understand and sign an informed consent and HIPAA (Health Insurance Portability and Accountability Act ) form.

Exclusion Criteria:

Men participating in another clinical trial
Men not living in the catchment area of the clinic
Clinically significant abnormal findings at screening
Known genetic infertility (e.g. Klinefelter syndrome or Y-chromosome microdeletions),
Hypogonadotropic hypogonadism (that might respond to gonadotropin injections),
The use of anabolic steroids, illicit drugs, or the consumption of more than 4 alcoholic beverages daily
Severe mental health problems requiring medications
Current therapy with retinoic acid (e.g. Accutane) or vitamin A.
Score of greater than 15 on the Patient health questionnaire (PHQ9).
Abnormal serum chemistry values according to local laboratory normal values which indicate liver or kidney dysfunction. Other abnormal lab values may also be exclusionary, at the discretion of the investigator
Men with a personal history of serious psychiatric disorders
Men currently receiving tetracycline containing medications
Men currently receiving phenytoin
Men with a history of inflammatory bowel disease
Men with a history of bone disease
Men who have used isotretinoin within eight weeks of the start of dosing
Men with elevated serum triglycerides",20 mg 13-cis retinoic acid twice daily (BID) with meals for 20 weeks,ChEMBL:CHEMBL38 | ChEMBL:CHEMBL547 | ChEMBL:CHEMBL705 | DrugBank:DB00523 | DrugBank:DB00755 | DrugBank:DB00982 | PubChem:444795 | PubChem:449171 | PubChem:5282379,Tretinoin,CC(C=CC1=C(C)CCCC1(C)C)=CC=CC(C)=CC(=O)O,D10AD01 | D10AD04 | D10AD51 | D10AD54 | D10BA01 | D11AH04 | L01XF01 | L01XF02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT02061774,NCT02061774_EG000,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 4,21,"Inclusion Criteria:

Age > 18 years old
Being scheduled to have elective primary minimally invasive 1 or 2 level transforaminal lumbar laminectomy interbody fusion
ASA I, II, or III
Informed consent form signed

Exclusion Criteria:

Anyone weighing less than 50kg (as this would require a dosing change).
Hypersensitivity or contraindication to intravenous acetaminophen or opioids
Allergy to Methocarbamol; morphine sulfate, sevoflourane, or fentanyl
Impairment of liver function-- defined as the inability to receive intravenous acetaminophen without dose adjustment as determined by the investigator; or history of chronic liver disease defined as history of hepatitis of any kind as recorded in the patient's chart
Mental retardation recorded as a diagnosis in the patient's chart
History of chronic pain (defined as currently receiving treatment from a specialist for pain)
History of pain recalcitrant to intravenous morphine
Impaired kidney function (defined as creatinine > 1.5)
Anyone who is not a candidate for general anesthesia or any other portion of the investigator's standard of","1g intravenous acetaminophen over a period of 15 minutes, 15 minutes (+/- 10 minutes) prior to the anticipated time of incision and every 6 hours (+/- 30 minutes) after the initial dose for 24 hours; maximum dose of 4 grams in 24 hours

Acetaminophen: 1 gram of intravenous Acetaminophen",ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02062944,NCT02062944_EG000,No,All,Adult | Older Adult,Not Applicable,15,"Inclusion Criteria:

Adult male and female recipients of all races, ≥ 18-75 years of age
Patients who underwent primary living or deceased donor liver transplantation ≥ 3 years (previous to screening ) and on ≥ 3 months of stable SRL monotherapy
Recipient of single organ transplant only
Liver transplant for non-immune, non-viral (no hepatitis B or hepatitis C virus unless currently non-viremic) causes
Ability to provide informed consent and to comply with the study protocol of IS withdrawal.

Exclusion Criteria:

Inability or unwillingness to provide informed consent
Acute cellular rejection within 12 months prior to enrollment
Viral (viremic hepatitis B virus [HBV] or hepatitis C virus [HCV]) or immune-mediated liver disease (Autoimmune hepatitis, primary sclerosing cholangitis, primary biliary cirrhosis) history
Abnormal liver function tests: Direct bilirubin ≥ 1 mg/dL; ([ALT, AST, GGT] or alkaline phosphatase [AlkPhos] ≥ 2x [ULN]); 5) Abnormal graft histology at enrollment: a) ≥ Grade 2 inflammation or stage 2 fibrosis; b) Acute or Chronic Rejection; c) De-novo Autoimmune Hepatitis; d) inflammation of >50% of portal tracts; e) Other pathology not-specified but deemed high risk per the PI and pathologist; 6) Ongoing or recurrent substance abuse

7) Retransplantation or combined liver-other organ 8) Human Immunodeficiency Virus(HIV) co-infection 9) Glomerular Filtration Rate (GFR)<30 ml/min by estimated glomerular filtration rate ([eGFR]-[MDRD-4])","SRL minimization will be performed if clinically, biochemically and histologically stable. Patients entering the minimization phases will be reduced every month by 50% of total dose of Sirolimus until they reach .5mg daily for one month. Then .5 mg every other day, then twice weekly, the once weekly dosing. This should take approximately 6 month to complete minimization. Liver function tests will be monitored every 2 weeks. For any patient developing liver dysfunction, liver biopsy will be performed. Patients will then be completely withdrawn and followed post-withdrawal for 12 months.

Sirolimus: SRL minimization will be performed if clinically, biochemically and histologically stable. Patients entering the minimization phases will be reduced every month by 50% of total dose of Sirolimus until they reach .5mg daily for one month. Then .5 mg every other day, then twice weekly, the once weekly dosing. This should take approximately 6 month to complete minimization. Liver function tests will be monitored every 2 weeks. For any patient developing liver dysfunction, liver biopsy will be performed. Patients will then be completely withdrawn and followed post-withdrawal for 12 months.",ChEMBL:CHEMBL413 | DrugBank:DB00877 | PubChem:134760597 | PubChem:138404388 | PubChem:21944094 | PubChem:5284616,Sirolimus,COC1CC2CCC(C)C(O)(O2)C(=O)C(=O)N2CCCCC2C(=O)OC(C(C)CC2CCC(O)C(OC)C2)CC(=O)C(C)C=C(C)C(O)C(OC)C(=O)C(C)CC(C)C=CC=CC=C1C,L01EG04 | L04AA10 | S01XA23,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02074904,NCT02074904_EG000,No,All,Adult,Phase 2,1,"Inclusion Criteria:

Physically healthy, as determined by a comprehensive physical examination and approval of the study physician, males or females who drink alcohol, ages 18-60.
Average weekly ethanol consumption of >24 standard drinks for men, or >18 standard drinks for women.
Females must be non-pregnant, non-lactating and either be of non-childbearing potential (i.e. sterilized via hysterectomy or bilateral tubal ligation or at least 2 years postmenopausal) or of child bearing potential but practicing a medically acceptable method of birth control. Examples of medically acceptable methods for this protocol include: the birth control pill, intrauterine device, injection of Depo-Provera, Norplant, contraceptive patch, contraceptive ring, double-barrier methods (such as condoms and diaphragm/spermicide), male partner sterilization, abstinence (and agreement to continue abstinence or to use an acceptable method of contraception, as listed above, should sexual activity commence), and tubal ligation.
Provide voluntary informed consent.
Must be able to read. [Subjects are required to be able to read because there are several self-administered measures that they must read, understand and provide written answers.]
Intelligence quotient of ≥ 80.

Exclusion Criteria:

Current, clinically significant physical disease or abnormality on the basis of medical history, physical examination, or routine laboratory evaluation.
History of head trauma or injury causing loss of consciousness, lasting more than five (5) minutes or associated with skull fracture or inter-cranial bleeding or abnormal MRI.
Current major DSM-IV Axis I diagnoses other than alcohol use disorder (except nicotine use disorder).
Presence of magnetically active irremovable prosthetics, plates, pins, permanent retainer, bullets, etc. (unless a radiologist confirms that it's presence is unproblematic). An x-ray may be obtained to determine eligibility given the possibility of a foreign body.
History of a serious psychiatric illness including psychosis, bipolar disorder, or suicidal or homicidal intent.
Current treatment with carbonic anhydrase inhibitors.
Claustrophobia or other medical condition preventing subject from lying in the MRI for approximately one (1) hour.
Current regular treatment with psychotropic medications (e.g., benzodiazepines, antidepressants), which affect neurotransmitter systems or a medication being used to treat alcohol use disorders (e.g., naltrexone, acamprosate).
Vision problems that cannot be corrected with glasses.
Body Mass Index (BMI) greater than or equal to 34, body girth greater than 52 inches and a head girth greater than 25 inches.
History of stroke and/or stroke related spasticity.
History of glaucoma or kidney stones.
HIV positive.
History of seizures.
History of topiramate treatment for alcohol use disorder and report no treatment response.
Current DSM-5 diagnosis of alcohol use disorder that is clinically too severe to permit them to participate in a research trial in which the goal is to stop or reduce drinking.","up to 200mg/day orally (over 8 weeks during which the dosage is gradually increased up to 200 mg orally and then maintained, and 1 week of medication taper)

Topiramate",ChEMBL:CHEMBL220492 | DrugBank:DB00273 | PubChem:5284627,Topiramate,[H][C@@]12OC(C)(C)O[C@]1([H])CO[C@@]1(COS(N)(=O)=O)OC(C)(C)O[C@]12[H],A08AA51 | N03AX11,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02076321,NCT02076321_EG000,No,All,Child,Phase 4,102,"Inclusion Criteria:

• Male aged 16 years or less or female aged 14 years or less

Open physis on radiographs
Fracture undergoing closed treatment or operative treatment or patient undergoing elective osteotomy

Exclusion Criteria:

• Regular use of NSAIDs

Allergy to NSAIDs
Inability to take breakthrough medications due side effects or allergy
Systemic illness
Renal impairment
Liver disease
Polytrauma
Uncontrolled diabetes
Regular use of corticosteroids
History of any skeletal dysplasia
History of neuromuscular disorder
History of bleeding disorder
History of liver disorder
Pathologic fracture
Closed physes
Male greater than 16 years old
Female greater than 14 years old
Pregnant or possibly pregnant females based on report and last menstrual period","control group

Acetaminophen: acetaminophen for pain control with dose and frequency of 10-15mg/kg/dose, Maximum dose 1000mg. Maximum amount per day: 75mg/kg (not to exceed 4g/day).",ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02076997,NCT02076997_EG000,No,All,Child | Adult,Not Applicable,23,"Inclusion Criteria:

Age: Patients must be greater than or equal to 365 days and less than 23 years of age at the time of enrollment.

Diagnosis: Patients with any malignancy who will receive high dose methotrexate (HDMTX) given as a 5 g/m2 infusion over 24 hours and a history of ≥ 1 of the following:

Documented decreased renal function, defined as Creatinine greater than 1.5 x baseline or glomerular filtration rate (GFR) <65ml/min/1.73m2.
History of prior nephrotoxicity with HDMTX as evidence by increased creatinine to 1.5 x baseline or need for dialysis or carboxypeptidase
History of Grade 3 adverse event (AE) related to HDMTX (mucositis, myelosuppression, nephrotoxicity, hepatotoxicity) based on the NIH Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Provider concern patient is at risk for MTX toxicity, such as a prior history of treatment with nephrotoxic chemotherapy, history of HDMTX-related neurotoxicity, or antimicrobial/antifungal therapy

Exclusion Criteria:

Unable to draw labs for HDMTX serum concentration
Enrollment on a protocol (COG or other) which restricts proposed dose modifications
Patients with Trisomy 21
Patients with greater than grade 1 neurologic toxicity at the time of enrollment that is attributed to unresolved prior methotrexate toxicity
Patients with greater than or equal to grade 3 chronic kidney disease at enrollment (eGFR or creatine clearance (CrCl) less than 30ml/min/1.73m2)","Individualized high dose methotrexate given as a 24-hour infusion.

Methotrexate: Patients will receive 5g/m^2 high dose methotrexate as a 24 hour infusion.

The methotrexate level in the blood will be checked at two times during the 24-infusion. The dose will be reduced based on the level in the blood.",ChEMBL:CHEMBL34259 | DrugBank:DB00563 | PubChem:126941,Methotrexate,CN(Cc1cnc2nc(N)nc(N)c2n1)c1ccc(C(=O)N[C@@H](CCC(=O)O)C(=O)O)cc1,L01BA01 | L04AX03,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02080273,NCT02080273_EG001,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 4,135,"Inclusion Criteria:

Subjects, ages 18-70, inclusive.
Availability for the six-month duration ofthe clinical research study.
Good general health.
Minimum of 20 uncrowned permanent natural teeth (excluding third molars).
Initial gingivitis index of at least 1.0 as determined by the use of the Loe and Silness Gingival Index.
Initial plaque index of at least 1.5 as determined by the use of the Quigley and Hein Plaque Index (Turesky Modification).
Signed Informed Consent Form.

Exclusion Criteria:

Presence of orthodontic bands.
Presence of partial removable dentures.
Tumor(s) of the soft or hard tissues of the oral cavity.
Advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone).
Five or more carious lesions requiring immediate restorative treatment.
Antibiotic use any time during the one month prior to entry into the study.
Participation in any other clinical study or test panel within the one month prior to entry into the study.
Dental prophylaxis during the past two weeks prior to baseline examinations.
History of allergies to oral care/personal care consumer products or their ingredients.
On any prescription medicines that might interfere with the study outcome.
An existing medical condition which prohibits eating or drinking for periods up to 4 hours.
History of alcohol or drug abuse.
Pregnant or lactating subjects.","Brush whole mouth 2x/day with Colgate Total toothpaste . This study treatment is currently marketed/sold in Poland

Colgate Total toothpaste: 0.32% sodium fluoride (1450 ppm NaF) and 0.3% triclosan. Colgate Total toothpaste is the active comparator toothpaste",PubChem:24848164,Sodium fluoride and triclosan,Oc1cc(Cl)ccc1Oc1ccc(Cl)cc1Cl.[F-].[Na+],,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02080819,NCT02080819_EG001,Accepts Healthy Volunteers,All,Adult,Phase 2,131,"Inclusion Criteria:

Male and female subjects
Age 18 to 50
Meet current DSM-IV criteria for cocaine dependence who are seeking treatment.

Exclusion Criteria:

Current DSM-IV diagnosis of any psychoactive substance dependence other than cocaine, marijuana, nicotine, or alcohol
Have a DSM-IV axis I psychiatric disorder or neurological disease or disorder requiring ongoing treatment and/or making study participation unsafe
Significant current suicidal or homicidal ideation
Medical conditions contraindicating levodopa/carbidopa or pharmacotherapy (e.g., evidence of any movement disorder, clinically significant pulmonary disease, cardiovascular disease, liver or kidney disease, seizure disorder)
Taking CNS active concomitant medications
Taking medications known to have significant drug interactions with the study medication (e.g., CYP P-450-2D6 inhibitors, such as tamoxifen, iron salts, pyridoxine, monoamine oxidase inhibitors, phenothiazines, selegiline, anesthetics)
Having conditions of probation or parole requiring reports of drug use to officers of the court
Impending incarceration
Pregnant or breast feeding for female patients
Inability to read, write, or speak English
Having plans to leave the immediate geographical area within 3 months
Unwillingness or not competent to sign a written informed consent form
Individuals who have pacemakers, metal or electromechanical implants or metallic foreign bodies
Patients who are known to be HIV positive will not be included due to possible CNS effects of HIV.
Alcohol withdrawal symptoms or history of significant previous alcohol withdrawal symptoms","Placebo BID for 7 weeks

levodopa/carbidopa 400/100 BID: Levodopa dose escalation (1 week): Days 1-2, one 50/12.5 mg tablet BID; Days 3-4, one 100/25 mg tablet BID; Days 5-6, one 200/50 mg tablet BID; Day 7, one 400/100 mg tablet BID.

Maintenance phase (7 weeks): One 400/100 mg Levodopa/Carbidopa tablet BID or placebo in conjunction with once weekly individual cognitive behavioral therapy plus contingency management for attendance.",DrugBank:DB00988 | PubChem:681,Dopamine,NCCc1ccc(O)c(O)c1,C01CA04,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02080819,NCT02080819_EG002,Accepts Healthy Volunteers,All,Adult,Phase 2,131,"Inclusion Criteria:

Male and female subjects
Age 18 to 50
Meet current DSM-IV criteria for cocaine dependence who are seeking treatment.

Exclusion Criteria:

Current DSM-IV diagnosis of any psychoactive substance dependence other than cocaine, marijuana, nicotine, or alcohol
Have a DSM-IV axis I psychiatric disorder or neurological disease or disorder requiring ongoing treatment and/or making study participation unsafe
Significant current suicidal or homicidal ideation
Medical conditions contraindicating levodopa/carbidopa or pharmacotherapy (e.g., evidence of any movement disorder, clinically significant pulmonary disease, cardiovascular disease, liver or kidney disease, seizure disorder)
Taking CNS active concomitant medications
Taking medications known to have significant drug interactions with the study medication (e.g., CYP P-450-2D6 inhibitors, such as tamoxifen, iron salts, pyridoxine, monoamine oxidase inhibitors, phenothiazines, selegiline, anesthetics)
Having conditions of probation or parole requiring reports of drug use to officers of the court
Impending incarceration
Pregnant or breast feeding for female patients
Inability to read, write, or speak English
Having plans to leave the immediate geographical area within 3 months
Unwillingness or not competent to sign a written informed consent form
Individuals who have pacemakers, metal or electromechanical implants or metallic foreign bodies
Patients who are known to be HIV positive will not be included due to possible CNS effects of HIV.
Alcohol withdrawal symptoms or history of significant previous alcohol withdrawal symptoms","Levodopa/carbidopa 400/100 BID for 7 weeks

levodopa/carbidopa 400/100 BID: Levodopa dose escalation (1 week): Days 1-2, one 50/12.5 mg tablet BID; Days 3-4, one 100/25 mg tablet BID; Days 5-6, one 200/50 mg tablet BID; Day 7, one 400/100 mg tablet BID.

Maintenance phase (7 weeks): One 400/100 mg Levodopa/Carbidopa tablet BID or placebo in conjunction with once weekly individual cognitive behavioral therapy plus contingency management for attendance.",DrugBank:DB00988 | PubChem:681,Dopamine,NCCc1ccc(O)c(O)c1,C01CA04,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02088034,NCT02088034_EG002,No,Female,Adult | Older Adult,Phase 4,92,"Inclusion Criteria:

Female gender
Latino ethnicity
Spanish fluency
Age ≥20 years
BMI ≥25 kg/m2
And ""increased risk of diabetes"" (ADA Diabetes Risk Score ≥4 as determine by 7-item questionnaire and hemoglobin A1C ≥ 5.6%)

Exclusion Criteria:

Hemoglobin A1C ≥ 6.5%
Current or planned pregnancy during the study period
Chronic conditions that could affect potential participants' ability to participate (osteoarthritis, heart disease, pulmonary disease requiring oxygen or daily bronchodilator use, and severe psychiatric disease)
Medical comorbidities that could influence weight loss or weight gain (thyroid disease, cancer, and HIV)
Medications that could affect weight or glucose metabolism (thiazide diuretics, β-blockers, and systemic glucocorticoids).","Participants randomized to the metformin arm of the study will receive this medication from months 1 through 12 after randomization. Subjects will receive 850 mg daily for 1 month and increase to 850 mg twice daily thereafter if no side effects are experienced.

Metformin Therapy: Participants in this group will receive metformin 850 mg bid for one year.",ChEMBL:CHEMBL1431 | DrugBank:DB00331 | PubChem:4091,Metformin,CN(C)C(=N)NC(=N)N,A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02096003,NCT02096003_EG000,Accepts Healthy Volunteers,Female,Adult,Phase 2,40,"Inclusion Criteria:

Elective primary cesarean section
Females age 18-40

Exclusion Criteria:

Emergency cesarean section
Anesthetic other than spinal
History of chronic pain or pre-op opioid use
Allergy to morphine or hydromorphone
BMI>40",0.25mg ( 250mcg) intrathecal morphine added to 1.5 mg 0.75% bupivicaine for single shot spinal anesthesia in primary cesarean sections,PubChem:6321225,Morphine sulfate pentahydrate,CN1CCC23c4c5ccc(O)c4OC2C(O)C=CC3C1C5.CN1CCC23c4c5ccc(O)c4OC2C(O)C=CC3C1C5.O.O.O.O.O.O=S(=O)(O)O,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT02105272,NCT02105272_EG001,No,All,Adult | Older Adult,Phase 3,119,"Inclusion Criteria:

Subjects with diagnosis of bilateral primary open-angle glaucoma or ocular hypertension

Exclusion Criteria:

Subjects with ocular conditions as defined by the protocol","Once daily

Latanoprost ophthalmic solution",ChEMBL:CHEMBL1051 | DrugBank:DB00654 | PubChem:5311221,Latanoprost,CC(C)OC(=O)CCC/C=C\C[C@@H]1[C@@H](CC[C@@H](O)CCc2ccccc2)[C@H](O)C[C@@H]1O,S01EE01 | S01EE51,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02107339,NCT02107339_EG000,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 4,120,"Inclusion Criteria:

All patients presenting for elective posterior lumbar or thoracic spinal fusion surgery will be eligible for enrollment.

Exclusion Criteria:

Preoperative renal failure (defined as a serum creatinine > 2.0 mg/dL.)
American Society of Anesthesiologists Physical Status IV or V
Pulmonary disease necessitating home oxygen therapy
Allergy to methadone or hydromorphone
Preoperative recent history of opioid or alcohol abuse
Inability to use a PCA device or speak the English language","Patient will receive methadone 0.2 mg/kg at induction of anesthesia (single dose)

Methadone: Methadone 0.2 mg/kg administered at induction of anesthesia",ChEMBL:CHEMBL350719 | ChEMBL:CHEMBL651 | DrugBank:DB00333 | DrugBank:DB15198 | PubChem:4095 | PubChem:643985,Methadone,CCC(=O)C(CC(C)N(C)C)(c1ccccc1)c1ccccc1,N02AC52 | N07BC02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02108288,NCT02108288_EG002,Accepts Healthy Volunteers,Male,Adult,Phase 1,10,"Inclusion Criteria:

Subjects who are considered medically healthy per investigator's judgment

Exclusion Criteria:

Subjects with ocular conditions as defined by the protocol
Subjects with intraocular pressure: <10 or ≥22 mmHg","Once daily

Latanoprost ophthalmic solution",ChEMBL:CHEMBL1051 | DrugBank:DB00654 | PubChem:5311221,Latanoprost,CC(C)OC(=O)CCC/C=C\C[C@@H]1[C@@H](CC[C@@H](O)CCc2ccccc2)[C@H](O)C[C@@H]1O,S01EE01 | S01EE51,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02110069,NCT02110069_EG001,No,All,Child | Adult,Phase 2,2,"Inclusion Criteria:

Diagnosis: All patients must have one of the following vascular anomalies as determined by clinical, radiologic and histologic criteria (when possible). Biopsy strongly recommended (but not required) with suggested immunostains: CD34, PROX-1 or D240, Glut-1 and MIB-1.

Kaposiform Hemangioendotheliomas
Tufted angioma

High Risk Stratification: In addition to the above diagnosis, all of the following criteria need to be met:

a. Kasabach Merritt Syndrome defined at a platelet counts less than 50,000 K/µl and/or fibrinogen level < 100 mg/dl at the time of diagnosis.

Age: Patients must be 0 - 31 years of age at the time of study entry. Enrollment includes patients of both genders and all ethnic groups.

Organ function requirements:

Adequate liver function defined as:

Total bilirubin ≤ 1.5 x ULN for age, and
SGPT (ALT) ≤ 5 x ULN for age, and
Serum albumin >/= 2 g/dL.
Fasting LDL cholesterol of <160 mg/dL
Fasting triglyceride <400 mg/dl

Adequate Bone Marrow Function defined as:

Peripheral absolute neutrophil count (ANC) >/= 1000/uL
Hemoglobin >/= 8.0 g/dL (may receive RBC transfusions)
No Platelet requirement

Adequate Renal Function Defined as:

A serum creatinine based on age as follows:

Age (Years) Maximum Serum Creatinine (mg/dL)

5 0.8 6 to ≤10 1.0 11 to ≤15 1.2 >15 1.5
Urine protein to creatinine ratio (UPC) < 0.3 g/l
Performance Status: Karnofsky >/= 50 (≥16 years of age) and Lansky >/= 50 for patients <16 years of age.

Prior therapy

Patients who have undergone surgical resection or interventional radiology procedures for disease control are eligible if they meet all inclusion criteria after surgery/procedure
Surgery: At least 2 weeks since undergoing any major surgery
Radiation: > 6 months from involved field radiation
Prior vincristine therapy is permitted. Patients may also have received up to 2 doses of vincristine prior to randomization.

Exclusion Criteria:

Concurrent severe and/or uncontrolled medical disease that could compromise participation in the study (e.g. uncontrolled diabetes, uncontrolled hypertension, severe infection, severe malnutrition, chronic liver or renal disease, active upper GI tract ulceration).
Patients who require medications that are strong inhibitors/inducers CYP3A4 enzyme activity, including anticonvulsants, (Appendix II) to control concurrent medical conditions are not eligible. Patients who discontinue use of prohibited medications with a one week washout prior to start of study treatment are eligible.
Known history of HIV seropositivity or known immunodeficiency. Testing is not required unless a condition is suspected.
Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of sirolimus (e.g. ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection). A gastric tube or nasogastric tube is allowed.
Females who are pregnant or breast feeding.
Males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method during the period they are receiving the study drug and for 3 months thereafter. Abstinence is an acceptable method of birth control. Females of childbearing potential will be given a pregnancy test within 7 days prior to administration of study treatment and must have a negative urine or serum pregnancy test.
Patients who have received prior treatment with an mTOR inhibitor.
Patients unwilling or unable to comply with the protocol or who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study.
Patients who currently have an uncontrolled infection, defined as receiving intravenous antibiotics.","Sirolimus will be administered at a dose of 0.8mg/m2/dose twice a day on a continuous dosing schedule throughout the trial for participants randomized to Sirolimus or for participants who fail vincristine may cross-over to the sirolimus arm.

Sirolimus trough levels will be maintained between 10-15 ng/ml.

Sirolimus: Continuous dosing to maintain trough level of 10-15ng/ml.",ChEMBL:CHEMBL413 | DrugBank:DB00877 | PubChem:134760597 | PubChem:138404388 | PubChem:21944094 | PubChem:5284616,Sirolimus,COC1CC2CCC(C)C(O)(O2)C(=O)C(=O)N2CCCCC2C(=O)OC(C(C)CC2CCC(O)C(OC)C2)CC(=O)C(C)C=C(C)C(O)C(OC)C(=O)C(C)CC(C)C=CC=CC=C1C,L01EG04 | L04AA10 | S01XA23,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02115607,NCT02115607_EG000,No,Female,Adult | Older Adult,Not Applicable,17,"Inclusion Criteria:

Females
Be diagnosed with T1 or greater LABC, any N and M0.
Be scheduled for neoadjuvant chemotherapy
Be at least 21 years of age.
Be medically stable.
If a female of child-bearing potential, must have a negative pregnancy test.
Have signed Informed Consent to participate in the study.

Exclusion Criteria:

Males
Females who are pregnant or nursing.
Patients with other primary cancers requiring systemic treatment.
Patients with any metastatic disease.
Patients undergoing neoadjuvant endocrine therapy.
Patients with known hypersensitivity or allergy to any component of Definity.
Patients with cardiac shunts or congenital heart defects.
Patients with unstable cardiopulmonary conditions or respiratory distress syndrome.
Patients with uncontrollable emphysema, pulmonary vasculitis, pulmonary hypertension or a history of pulmonary emboli.
Patients who have received any contrast medium (X-ray, MRI, CT or US) in the 24 hours prior to the research US exam.","Infusion of Definity (Perflutren Lipid Microspheres)

Definity infusion: 3 ml of Perflutren Lipid Microspheres (Definity) mixed in 50 ml of saline is infused at a rate of approximately 4ml/min",ChEMBL:CHEMBL1663 | DrugBank:DB00556 | PubChem:6432,Perflutren,FC(F)(F)C(F)(F)C(F)(F)F,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02116803,NCT02116803_EG001,No,All,Adult | Older Adult,Phase 2 | Phase 3,2,"Inclusion Criteria:

patient was currently enrolled in Novartis sponsored study, which had met its endpoint and was receiving single agent oral dovitinib or dovitinib and fulvestrant coadministration
patient was currently benefiting from treatment with single agent oral dovitinib or dovitinib and fulvestrant coadministration as determined by the guidelines of the parent protocol and according to the investigator's clinical judgment.
patient had demonstated compliance
patient had given written informed consent.

Exclusion Criteria:

patient had been permanently discontinued from oral dovitinib study treatment, either alone or in combination with fulvestrant, in the parent study
patient was pregnant or nursing at the time of entry
women of child-bearing potential and male patients with sexual partners of child-bearing potential unwilling to use highly effective methods of contraception during dosing and for a specified duration after stopping study treatment",Participants were given single agent dovitinib starting with last assigned dose and regimen which patient received in parent study. Additional dose modifications were given at the discretion of the investigator based on guidance provided in the protocol and investigative brochure (IB).,DrugBank:DB05928 | PubChem:135398510,Dovitinib,CN1CCN(c2ccc3nc(-c4c(N)c5c(F)cccc5[nH]c4=O)[nH]c3c2)CC1,,0.0,1.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0
NCT02120898,NCT02120898_EG000,No,All,Adult | Older Adult,Phase 3,187,"Inclusion Criteria:

Participant is a male or female, 18 years of age or older.
Participant has provided written informed consent.
Participant is willing and able to apply the test article as directed, comply with study instructions and commit to all follow-up visits for the duration of the study.
Participant has a clinical diagnosis of AK with at least 5 and no more than 20 clinically typical, visible or palpable AK lesions, each at least 4 millimeters (mm) in diameter, in an area greater than 25 cm^2 on the face (excluding ears) or balding scalp, but not both.
Participant is in good general health and free of any disease state or physical condition that might impair evaluation of AK lesions or which, in the investigator's opinion, exposes the participant to an unacceptable risk by study participation.
Females must be post-menopausal, surgically sterile or use an effective method of birth control, with a negative urine pregnancy test (UPT) at the Baseline visit.

Exclusion Criteria:

Participant is pregnant, lactating, or is planning to become pregnant during the study.
Participant has hyperkeratotic, hypertrophic or atypical AKs (for example, AK greater than [>] 1 cm^2 in size) in the treatment area.
Participant is currently enrolled in an investigational drug or device study.
Participant plans to be exposed to artificial tanning devices or excessive sunlight during the trial.
Participant is immunosuppressed (for example; human immunodeficiency virus [HIV], systemic malignancy, graft vs. host disease, etc.).
Participant has experienced an unsuccessful outcome from previous imiquimod therapy (an unsuccessful outcome is defined as after a reasonable therapeutic trial with no compliance issues and the topical drug do not work).
Participant has used an investigational drug or investigational device within 30 days prior to the Baseline visit.
Participant has had dermatologic procedures or surgeries such as: laser resurfacing, PUVA (Psoralen + ultraviolet A) therapy, UVB therapy, chemical peels or dermabrasion on the face or balding scalp within 6 months prior to the Baseline visit.
Participant has cryodestruction or chemodestruction, curettage, photodynamic therapy, surgical excision or other treatments for AK on the designated treatment area (face or scalp) within 1 month prior to the Baseline visit.
Participant has used oral corticosteroid therapy, interferon, cytotoxic drugs, immunomodulators, immunosuppressive therapies or retinoids within 1 month prior to the Baseline visit.
Participant has used topical medications; corticosteroids, alpha hydroxyl acids (for example; glycolic acid, lactic acid etc. >5%), beta hydroxy acid (salicylic acid >2%), urea >5%, 5-fluorouracil, diclofenac, imiquimod, ingenol mebutate or prescription retinoids (for example; tazarotene, adapalene, tretinoin) to the face or balding scalp within one month prior to the Baseline visit.
Participant has used topical creams, lotions or gels of any kind to the selected treatment area within one day prior to the Baseline visit.
Participant has lesions suspicious for skin cancer (skin cancer not ruled out by biopsy) or untreated skin cancers within the selected treatment area (face or scalp).
Participant has a history of sensitivity to any of the ingredients in the test articles.
Participant has any skin pathology or condition (for example; facial/scalp psoriasis, atopic dermatitis, acne, rosacea, etc.) that, in the investigator's opinion, could interfere with the evaluation of the test article, worsen due to the treatment or requires the use of interfering topical, systemic or surgical therapy.
Participant has any condition which, in the investigator's opinion, would make it unsafe or precludes the participant's ability to fully participate in this research study.
Participant is known to be noncompliant or is unlikely to comply with the requirements of the study protocol (for example; due to alcoholism, drug dependency, mental incapacity) in the opinion of the investigator.","Generic imiquimod cream 2.5% was applied once daily approximately 1 to 2 hours before bedtime to the skin of the treatment area (either full face [excluding the ears] or balding scalp) for two, 2-week treatment cycles separated by a 2-week no-treatment period. Participants applied test article for 14 consecutive days for each treatment cycle.",ChEMBL:CHEMBL1282 | DrugBank:DB00724 | PubChem:57469,Imiquimod,CC(C)Cn1cnc2c(N)nc3ccccc3c21,D06BB10,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02120898,NCT02120898_EG001,No,All,Adult | Older Adult,Phase 3,187,"Inclusion Criteria:

Participant is a male or female, 18 years of age or older.
Participant has provided written informed consent.
Participant is willing and able to apply the test article as directed, comply with study instructions and commit to all follow-up visits for the duration of the study.
Participant has a clinical diagnosis of AK with at least 5 and no more than 20 clinically typical, visible or palpable AK lesions, each at least 4 millimeters (mm) in diameter, in an area greater than 25 cm^2 on the face (excluding ears) or balding scalp, but not both.
Participant is in good general health and free of any disease state or physical condition that might impair evaluation of AK lesions or which, in the investigator's opinion, exposes the participant to an unacceptable risk by study participation.
Females must be post-menopausal, surgically sterile or use an effective method of birth control, with a negative urine pregnancy test (UPT) at the Baseline visit.

Exclusion Criteria:

Participant is pregnant, lactating, or is planning to become pregnant during the study.
Participant has hyperkeratotic, hypertrophic or atypical AKs (for example, AK greater than [>] 1 cm^2 in size) in the treatment area.
Participant is currently enrolled in an investigational drug or device study.
Participant plans to be exposed to artificial tanning devices or excessive sunlight during the trial.
Participant is immunosuppressed (for example; human immunodeficiency virus [HIV], systemic malignancy, graft vs. host disease, etc.).
Participant has experienced an unsuccessful outcome from previous imiquimod therapy (an unsuccessful outcome is defined as after a reasonable therapeutic trial with no compliance issues and the topical drug do not work).
Participant has used an investigational drug or investigational device within 30 days prior to the Baseline visit.
Participant has had dermatologic procedures or surgeries such as: laser resurfacing, PUVA (Psoralen + ultraviolet A) therapy, UVB therapy, chemical peels or dermabrasion on the face or balding scalp within 6 months prior to the Baseline visit.
Participant has cryodestruction or chemodestruction, curettage, photodynamic therapy, surgical excision or other treatments for AK on the designated treatment area (face or scalp) within 1 month prior to the Baseline visit.
Participant has used oral corticosteroid therapy, interferon, cytotoxic drugs, immunomodulators, immunosuppressive therapies or retinoids within 1 month prior to the Baseline visit.
Participant has used topical medications; corticosteroids, alpha hydroxyl acids (for example; glycolic acid, lactic acid etc. >5%), beta hydroxy acid (salicylic acid >2%), urea >5%, 5-fluorouracil, diclofenac, imiquimod, ingenol mebutate or prescription retinoids (for example; tazarotene, adapalene, tretinoin) to the face or balding scalp within one month prior to the Baseline visit.
Participant has used topical creams, lotions or gels of any kind to the selected treatment area within one day prior to the Baseline visit.
Participant has lesions suspicious for skin cancer (skin cancer not ruled out by biopsy) or untreated skin cancers within the selected treatment area (face or scalp).
Participant has a history of sensitivity to any of the ingredients in the test articles.
Participant has any skin pathology or condition (for example; facial/scalp psoriasis, atopic dermatitis, acne, rosacea, etc.) that, in the investigator's opinion, could interfere with the evaluation of the test article, worsen due to the treatment or requires the use of interfering topical, systemic or surgical therapy.
Participant has any condition which, in the investigator's opinion, would make it unsafe or precludes the participant's ability to fully participate in this research study.
Participant is known to be noncompliant or is unlikely to comply with the requirements of the study protocol (for example; due to alcoholism, drug dependency, mental incapacity) in the opinion of the investigator.","Zyclara® (imiquimod) cream 2.5% was applied once daily approximately 1 to 2 hours before bedtime to the skin of the treatment area (either full face [excluding the ears] or balding scalp) for two, 2-week treatment cycles separated by a 2-week no-treatment period. Participants applied test article for 14 consecutive days for each treatment cycle.",ChEMBL:CHEMBL1282 | DrugBank:DB00724 | PubChem:57469,Imiquimod,CC(C)Cn1cnc2c(N)nc3ccccc3c21,D06BB10,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02123966,NCT02123966_EG000,No,All,Child | Adult | Older Adult,Phase 2,10,"Inclusion Criteria:

While there will be no restrictions on concurrent systemic medications, all subjects must be on a stable immunomodulatory medication regimen for 7 days prior to beginning the study without plans to adjust doses during the following four-week study period. Dose modifications to maintain therapeutic drug levels of immunosuppressants (i.e. tacrolimus and sirolimus) during the study intervention period are allowed and do not constitute a trial violation. Changes in medications for non-cGVHD medical conditions will not affect eligibility.
Age 4 years and older.
Patients with symptomatic oral chronic graft-versus-host disease (sensitivity score ≥ 4).
Stable topical steroid therapy with dexamethasone, clobetasol, or budesonide oral solutions (5 min, four times a day) for seven days prior to study enrollment.
Stable systemic cGVHD medication regimen for seven days prior to study enrollment. Dose modifications to maintain therapeutic drug levels of immunosuppressants (i.e. tacrolimus and sirolimus) for the month prior and during the study intervention period are allowed and do not constitute a trial violation.
The effects of sirolimus on the developing human fetus are unknown. For this reason and because immunosuppressants agents as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of topical sirolimus administration.
Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

Patients already using topical sirolimus therapy.
Patients who have an allergy/intolerance to sirolimus.
Sensitivity score ≤ 3.
Inability to comply with study instructions.
Pregnant or breastfeeding.
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Pregnant women are excluded due to the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants, breastfeeding should be discontinued if the mother is treated with sirolimus.
HIV-positive participants on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with sirolimus. In addition, these participants are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in participants receiving combination antiretroviral therapy when indicated.","A four week supply of topical sirolimus will be dispensed. The treatment instructions will be to rinse and spit (NOT swallow) with one teaspoon (5 mL) of sirolimus solution 0.1mg/mL, combined with one teaspoon (5 mL) of steroid solution (dexamethasone 0.1%, clobetasol 0.05%, or budesonide 0.03%, based on the ongoing topical steroid prescription at the time of study enrollment) four times a day for 5 minutes at a time, and not to eat or drink for 15 minutes afterwards. Subjects will maintain a diary and record each dose, the length of time rinsing, and any adverse effects (e.g. transient burning).

Sirolimus",ChEMBL:CHEMBL413 | DrugBank:DB00877 | PubChem:134760597 | PubChem:138404388 | PubChem:21944094 | PubChem:5284616,Sirolimus,COC1CC2CCC(C)C(O)(O2)C(=O)C(=O)N2CCCCC2C(=O)OC(C(C)CC2CCC(O)C(OC)C2)CC(=O)C(C)C=C(C)C(O)C(OC)C(=O)C(C)CC(C)C=CC=CC=C1C,L01EG04 | L04AA10 | S01XA23,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02128113,NCT02128113_EG001,No,All,Adult | Older Adult,Phase 2,102,"Inclusion Criteria:

Be male or female and ≥18 years of age and ≤80 years of age
Plan to undergo cataract extraction by phacoemulsification with the implantation of a posterior chamber intraocular lens
Have the potential, in the opinion of the investigator, to improve best-corrected visual acuity in the study eye after surgery
Have Grade 3, 4, or 5 nuclear cataract in the study eye, according to the LOCS III
Have corneal endothelium in the study eye that can be accurately assessed using specular microscopy
Have endothelial cell density of >1800 cells/mm2 in the study eye at the Screening Visit
Have a pinhole visual acuity (VA) of at least 1.0 logarithm of the minimum angle of resolution (logMAR) in the study eye and fellow eye as measured using an Early Treatment for Diabetic Retinopathy Study (ETDRS) chart

Exclusion Criteria:

Have a score >0 on the ocular pain assessment at the Screening Visit or the Randomization Visit in the study eye
Have an active immunosuppressive disease or an autoimmune disease that, in the opinion of the investigator, could affect the quality of the ocular surface
Have active or chronic/recurrent ocular or systemic disease that is uncontrolled and will likely affect wound healing
Have an intraocular pressure (IOP) ≤5 mmHg in either eye
Have had corneal or retinal surgery (laser or incisional) within the past 6 months, or be planning to have laser or incisional surgery during the study period in the study eye
Have the presence of guttae Stage 2 or greater or other abnormality in the study eye that does not allow for accurate corneal endothelial cell assessments","A single drop of Omaveloxolone Ophthalmic suspension 0.5% was instilled into the study eye twice daily (approximately 12 hours apart) for a maximum of 28 days, beginning 3 to 7 days prior to cataract surgery and continuing on the day of surgery and for 3 weeks after surgery

Omaveloxolone Ophthalmic Suspension 0.5%: 0.5% ophthalmic suspension of RTA 408",ChEMBL:CHEMBL4303525 | DrugBank:DB12513 | PubChem:71811910,Omaveloxolone,CC1(C)CC[C@]2(NC(=O)C(C)(F)F)CC[C@]3(C)[C@H](C(=O)C=C4[C@@]5(C)C=C(C#N)C(=O)C(C)(C)[C@@H]5CC[C@]43C)[C@@H]2C1,,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02128113,NCT02128113_EG002,No,All,Adult | Older Adult,Phase 2,102,"Inclusion Criteria:

Be male or female and ≥18 years of age and ≤80 years of age
Plan to undergo cataract extraction by phacoemulsification with the implantation of a posterior chamber intraocular lens
Have the potential, in the opinion of the investigator, to improve best-corrected visual acuity in the study eye after surgery
Have Grade 3, 4, or 5 nuclear cataract in the study eye, according to the LOCS III
Have corneal endothelium in the study eye that can be accurately assessed using specular microscopy
Have endothelial cell density of >1800 cells/mm2 in the study eye at the Screening Visit
Have a pinhole visual acuity (VA) of at least 1.0 logarithm of the minimum angle of resolution (logMAR) in the study eye and fellow eye as measured using an Early Treatment for Diabetic Retinopathy Study (ETDRS) chart

Exclusion Criteria:

Have a score >0 on the ocular pain assessment at the Screening Visit or the Randomization Visit in the study eye
Have an active immunosuppressive disease or an autoimmune disease that, in the opinion of the investigator, could affect the quality of the ocular surface
Have active or chronic/recurrent ocular or systemic disease that is uncontrolled and will likely affect wound healing
Have an intraocular pressure (IOP) ≤5 mmHg in either eye
Have had corneal or retinal surgery (laser or incisional) within the past 6 months, or be planning to have laser or incisional surgery during the study period in the study eye
Have the presence of guttae Stage 2 or greater or other abnormality in the study eye that does not allow for accurate corneal endothelial cell assessments","A single drop of Omaveloxolone Ophthalmic suspension 1.0% was instilled into the study eye twice daily (approximately 12 hours apart) for a maximum of 28 days, beginning 3 to 7 days prior to cataract surgery and continuing on the day of surgery and for 3 weeks after surgery

Omaveloxolone Ophthalmic Suspension 1%: 1% ophthalmic suspension of RTA 408",ChEMBL:CHEMBL4303525 | DrugBank:DB12513 | PubChem:71811910,Omaveloxolone,CC1(C)CC[C@]2(NC(=O)C(C)(F)F)CC[C@]3(C)[C@H](C(=O)C=C4[C@@]5(C)C=C(C#N)C(=O)C(C)(C)[C@@H]5CC[C@]43C)[C@@H]2C1,,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02129348,NCT02129348_EG000,No,All,Child | Adult | Older Adult,Phase 2,38,"Inclusion Criteria:

Male and female adults.
Diagnosis of possible or probable AD by standard NIA criteria (McKahnn et al, 1984; McKhann et all, 2011)
Folstein MMSE 5-26 out of 30
Neuropsychiatric Inventory (NPI) agitation/aggression subscale score > 4. On each subscale (frequency X severity), a score higher than 4 represents moderate to severe symptoms.
Female patients need to be post-menopausal
Availability of informant; patients without an informant will not be recruited. Patients who lack capacity must have a surrogate.

Exclusion Criteria:

Medical contraindication to lithium treatment or prior history of intolerability to lithium treatment.

Contraindications to lithium in this study include: resting tremor causing functional impairment, history of falls in the last month, untreated thyroid disease or any abnormal thyroid function test (T3, T4, or TSH), creatinine level greater than 1.5 mg/100ml or a glomerular filtration rate less than 44ml/min/ 1.73m2; blood pressure > 150/90 mm Hg; heart rate < 50 bpm; unstable cardiac disease based on history, physical examination, and ECG.

Medications, in combination with lithium, known to have adverse renal effects, including therapeutic or higher doses of diuretics, i.e. hydrochlorothiazide greater than 25mg daily or furosemide greater than 10mg daily. Whenever feasible, patients receiving concomitant antidepressants or antipsychotics will be washed off these medications for at least 24 hours before starting lithium. Patients who do not wish to discontinue antipsychotics or antidepressants, typically because of family member/caregiver objection, will be allowed to enter the trial provided there is no contraindication to concomitant lithium use with that specific psychotropic medication. During the trial, patients will be permitted to receive lorazepam as needed up to 1 mg/day for anxiety/insomnia, and non-benzodiazepine hypnotics, e.g., zolpidem.
Current clinical diagnosis of schizophrenia, schizoaffective disorder, other psychosis, or bipolar 1 disorder (DSM-IV TR criteria).
Current or recent (past 6 months) alcohol or substance dependence (DSM-IV TR criteria).
Current major depression or suicidality as assessed by the study psychiatrist.
Suicidal behavior or dangerous behavior with serious safety risk or risk of physical harm to self or others.
Parkinson's disease, Lewy body disease, multiple sclerosis, CNS infection, Huntington's disease, amyotrophic lateral sclerosis, other major neurological disorder.
Clinical stroke with residual neurological deficits. MRI findings of cerebrovascular disease (small infarcts, lacunes, periventricular disease) in the absence of clinical stroke with residual neurological deficits will not lead to exclusion.
Acute, severe, unstable medical illness. For cancer, patients with active illness or metastases will be excluded, but past history of successfully treated cancer will not lead to exclusion.
QTc interval > 460 ms at the time of baseline EKG is an exclusion criterion for treatment.
Hypernatremia as determined by serum sodium level > 150 meq/L.","The patient will be started on lithium 150mg/day, with subsequent dose titration to 300mg/day at the 2-week visit, 450mg/day at the 4-week visit, and 600mg/day (maximum daily dose) if tolerated and based on lithium blood level. Blood will be drawn at each study visit. This upward dose titration will occur only if clinically indicated (absence of response at lower doses without intolerable side effects).

Patients who develop side effects, e.g., tremor, falls, will have their dose reduced.

Lithium",ChEMBL:CHEMBL1200826 | DrugBank:DB14509 | PubChem:11125,LITHIUM CARBONATE,O=C([O-])[O-].[Li+].[Li+],,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,1.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT02133664,NCT02133664_EG000,No,All,Adult | Older Adult,Phase 1 | Phase 2,26,"Inclusion Criteria:

• A definite diagnosis of multiple sclerosis (MS) with relapsing remitting or secondary progressive course

Age 18 to 65 years, inclusive
A score two or more standard deviations below the mean in one or more of the following cognitive tests: PASAT, COWAT, CVLT -II, Stroop
Expanded Disability Status Scale (EDSS) 0-7.5, inclusive
Suboptimal omega-3 levels (plasma docosahexaenoic acid [DHA] + eicosapentaenoic acid [EPA] < 5.0% of total plasma fatty acids)
If taking MS disease modifying medications, on stable dose for > 6 months preceding enrollment
Able to read and write English

Exclusion Criteria:

• Moderate to severe depression (Beck Depression Inventory score > 19)

Any significant uncontrolled medical problem including diabetes requiring insulin.
MS relapse within the 30 days before screening
Abnormalities of coagulation or current use of prescription anticoagulants or antiplatelet agents. Aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs) are not excluded.
Fish intake of one 6 ounce serving > once a week less than 2 months prior to enrollment
Omega-3 fatty acid supplement intake (e.g. fish oil capsules, cod liver oil) less than 2 months prior to enrollment
Lipoic Acid supplementation less than 1 month prior to enrollment
Taking systemic corticosteroids, neuroleptics, antiparkinsonian agents, and/or narcotic analgesics. Low dose sinemet and dopamine agonist taken once a day for restless leg syndrome is not an exclusion.
Contraindications to MRI, including: subjects with intrathecal pumps, stimulators, pacemakers, aneurysm clips, non-removable hearing aids, or metal fragments in the eyes. Other exclusion criteria include the inability to lie flat on the back for 40 minutes at a time or a self-reported history of claustrophobia. Subjects with a history of hip replacement and those with well-documented, verifiable, MRI-safe cardiac stents will not be excluded from the study.
Epilepsy or history of seizures.
Pregnancy or women not using a reliable form of contraception
Corrected binocular visual acuity worse than 20/50 or more than one error on binocular color vision testing with the Ishihara Color plates or sustained nystagmus or diplopia on primary gaze
Inability to complete the neuropsychological test battery at the screening visit
Participation in another intervention study","lipoic acid and omega-3 fatty acids

Alpha lipoic acid and omega-3 fatty acids: alpha lipoic acid as racemic form at 1,200 mg per day omega-3 fatty acids as fish oil concentrate containing a daily dose of 1.35 grams docosahexanoic acid and 1.95 grams of eicosapentaenoic acid",ChEMBL:CHEMBL33864 | DrugBank:DB00166 | PubChem:6112 | PubChem:864,Lipoic acid,O=C(O)CCCCC1CCSS1,A16AX01,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02135016,NCT02135016_EG001,No,All,Adult,Phase 4,45,"Inclusion Criteria:

American Society of Anesthesiologists (ASA) I-II physical status,
aged 40-60 yr,
BMI 19-25 kg/m2,
undergoing elective gastrointestinal surgery

Exclusion Criteria:

patients with cardiovascular or neurological disease, drug or alcohol abuse and absolute contraindications for neuraxial blockade.",epidural anesthesia with 2% lidocaine 5ml before propofol TCI,DrugBank:DB11203 | PubChem:5462311,Boron,[B],,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02135432,NCT02135432_EG000,No,All,Adult | Older Adult,Early Phase 1,8,"Inclusion Criteria:

Male or Female age 40-65
A clinical diagnosis of COPD as defined by GOLD
At Least a 10 pack year smoking history
Exhibit symptoms of chronic bronchitis defined by MRC
FEV1% predicted ≥ 35% and ≤70% Post Bronchodilator
Clinically stable in the last 4 weeks with no evidence of COPD exacerbation
Weight of 40 kg-120 kg
Willingness to use at least one form of acceptable birth control including abstinence, condom with spermicide, or hormonal contraceptives
Willing to monitor blood glucose if known history of diabetes mellitus requiring insulin or medical therapy

Exclusion Criteria:

Current Diagnosis of Asthma
Daytime use of Oxygen Therapy
Documented history of drug abuse within the last year
Subjects should not have a pulmonary exacerbation or changes in therapy for pulmonary disease within 28 days before receiving the first dose of study drug.
Cirrhosis or elevated liver transaminases > 3X ULN
GFR < 50 estimated by Cockcroft-Gault
Any illness of abnormal lab finding that, in the opinion of the investigator or the subject's general practitioner, might confound the results of the study or pose an additional risk in administering study drug to the subject.
Pregnant or Breastfeeding
Subjects taking any inhibitors or inducers of CYP3A4, including certain herbal medications and grapefruit/grapefruit juice.
Uncontrolled Diabetes
Excluded medications and foods include the drugs and foods provided in the appendix document.
Clinically significant arrhythmias or conduction abnormalities that in the opinion of the investigator affect patient safety have been added as exclusion criteria and criteria for withdrawal.

Patients who have not been stable or have been hospitalized in the past 3 months with any clinically significant cardiac conditions.

Subjects with history of cancer (current or past, unless remote (>5years))except for localized non-melanomatous skin cancers History of Stroke/CVA History of myocardial infarction/acute coronary syndrome Cardiac Failure NYHC grade III-IV Diabetes Type I Uncontrolled Hypertension Primary or secondary pulmonary hypertension

-","twice a day administration of Ivacaftor: 150mg

Ivacaftor",ChEMBL:CHEMBL2010601 | DrugBank:DB08820 | DrugBank:DB15141 | PubChem:16220172 | PubChem:71470491,Ivacaftor,CC(C)(C)c1cc(C(C)(C)C)c(NC(=O)c2c[nH]c3ccccc3c2=O)cc1O,R07AX02 | R07AX30 | R07AX31 | R07AX32,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT02139943,NCT02139943_EG002,No,All,Adult | Older Adult,Phase 2,117,"Inclusion Criteria:

Must have type 1 diabetes mellitus (T1DM) for at least 1 year
Must have have inadequate glycemic control (as defined by glycosylated hemoglobin level of >= 7.0% to <= 9.0%) on basal plus bolus insulin at screening
Must have body mass index 21 to 35 kg/m2 inclusive
Must be on a total daily dose of insulin >= 0.6 IU/kg at screening
Must be on a stable insulin regimen for at least 8 weeks prior to screening

Exclusion Criteria:

History of T2DM, pancreas or β-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy
Severe hypoglycemia (defined as an event required assistance from another person, or which resulted in seizure or loss of consciousness) within 6 months prior to study start
Diabetic ketoacidosis within 6 months prior to study start
History of hereditary glucose-galactose malabsorption or primary renal glycosuria
An ongoing, inadequately controlled thyroid disorder",Participants received 300 mg of canagliflozin capsules once daily for 18 weeks.,DrugBank:DB08907 | PubChem:24812758,Canagliflozin,[H][C@@]1(c2ccc(C)c(Cc3ccc(-c4ccc(F)cc4)s3)c2)O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O,A10BD16 | A10BK02,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02140788,NCT02140788_EG000,No,All,Adult,Phase 4,34,"Inclusion Criteria:

male or female patients with clinical diagnoses of schizophrenia or schizo-affective disorder
between 18 and 60 years of age
patients whose treating clinicians have recommended treatment with clozapine (and the patients have agreed and provided signed informed consent for treatment with clozapine)

Exclusion Criteria:

patients who have contraindications to metformin use, such as:

a diagnosis of congestive heart failure
renal impairment (serum creatinine > 1.5 in males; > 1.4 in females)
hepatic disease (AST or ALT > 2.0 times upper limit of normal (ULN)
positive hepatitis B surface antigen or hepatitis C antibody
total bilirubin>1.2x ULN; majority conjugated
metabolic acidosis (serum CO2 < lower limit of normal),
known hypersensitivity to metformin,
recent (in the past 30 days) or scheduled radiological studies involving iodinated contrast material
alcohol abuse/dependence within the past month
concurrent treatment with drugs that are known to increase metformin blood levels including furosemide, nifedipine, and cationic drugs including cimetidine, amiloride, digoxin, morphine, procainamide, quinidine, ranitidine, triamterene, trimethoprim, and vancomycin
patients with blood dyscrasias that could be worsened by added fish oil
women who are pregnant or breastfeeding","Subjects will continue to take the clozapine prescribed as standard of care. Subjects assigned to added metformin will receive metformin 250 mg BID days 1-3, 500 mg BID days 4-7, and 1000 mg BID days 8-28 with breakfast and supper. Patients unable to tolerate a dose escalation will have the metformin dose reduced to the previously tolerated lower dose.

Metformin",ChEMBL:CHEMBL1431 | DrugBank:DB00331 | PubChem:4091,Metformin,CN(C)C(=N)NC(=N)N,A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02143141,NCT02143141_EG000,No,Female,Adult | Older Adult,Phase 4,13,"Inclusion Criteria:

anticipated pain level estimated to be in the lowest 20th percentile (calculated <34.3 utilizing our standard preoperative questionnaire)
age >/= 18
not allergic to any study medications to be utilized in this study
singleton pregnancy

Exclusion Criteria:

allergies to morphine or acetaminophen
diagnosis of a chronic pain disorder
weight >300 lbs
hepatic disease","duramorph 150 mcg administered spinally with placebo capsules administered by mouth every 6 hours x 4 doses during first 24 hours

duramorph: duramorph 150 mcg given with spinal anesthetic, then receipt of placebo capsules postoperatively. evaluation postoperative day 1 for measurement of itching, nausea, vomiting, pain and itching.",PubChem:6321225,Morphine sulfate pentahydrate,CN1CCC23c4c5ccc(O)c4OC2C(O)C=CC3C1C5.CN1CCC23c4c5ccc(O)c4OC2C(O)C=CC3C1C5.O.O.O.O.O.O=S(=O)(O)O,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02151851,NCT02151851_EG001,No,All,Adult | Older Adult,Phase 3,316,"Inclusion Criteria:

An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent form (ICF) is signed and dated by the subject or by the legal representative
Subject is considered reliable and capable of adhering to the protocol (eg, able to understand and complete questionnaires), visit schedule, and medication intake according to the judgment of the Investigator
Subject is male or female, and at least 18 years of age at the Screening Visit
Subjects must have a diagnosis of adult onset Rheumatoid Arthritis RA of at least 6 months duration as defined by the 1987 American College of Rheumatology (ACR) classification criteria (Arnett et al, 1988).

Subjects must have active RA disease as defined by:

≥6 tender joints at Screening and Baseline
≥6 swollen joints at Screening and Baseline
Fulfilling 1 of the following 2 criteria during the Screening Period:
European League Against Rheumatism (ESR) (Westergren) ≥30 mm/hour, or
C-reactive protein (CRP) >15 mg/L
Subjects must have a normal chest x ray within 3 months prior to the Baseline Visit
Female subjects with childbearing potential should have a negative pregnancy test at Screening and at Baseline and should have a medically accepted method of contraception used during the entire duration of the study and for 10 weeks after the last dose of Certolizumab Pegol (CZP).
Male subjects must agree to ensure they use adequate contraception during the study and for at least 10 weeks after the subject receives their last dose of study medication
Subjects must have received treatment with Methotrexate (MTX) (with or without folic acid) for at least 3 months prior to the Baseline Visit. The dose and route of administration of MTX must have been stable for at least 2 months prior to the Baseline Visit. The minimum stable dose of MTX allowed is 10 mg weekly

Exclusion Criteria:

Rheumatoid Arthritis disease-related exclusions:

Subjects have a diagnosis of any other inflammatory arthritis (eg, psoriatic arthritis or ankylosing spondylitis)
Subjects have a secondary, noninflammatory type of arthritis (eg, Osteoarthritis or Fibromyalgia) that in the Investigator's opinion is symptomatic enough to interfere with evaluation of the effect of study medication on the subject's primary diagnosis of Rheumatoid Arthritis (RA)
Subjects have a history of an infected joint prosthesis at any time with that prosthesis still in situ
Subjects have >3 arthroplasties due to RA and/or Steinbrocker IV functional capacity

Concomitant medication exclusions:

Subjects must be free of prohibited medication, Analgesics (including Paracetamol and Acetominophen), NSAIDs /COX-2 Inhibitors, Oral corticosteroids, DMARDs, etc. as detailed in protocol Previous clinical studies and previous biological therapy exclusions
Subjects have previously participated in this study or subject has previously been assigned to treatment in a study of the medication under investigation in this study
Subjects have participated in another study of an investigational medicinal product (or a medical device) within the previous 3 months or are currently participating in another study of an investigational medicinal product (or a medical device)
Subjects have received any experimental nonbiological therapy, within or outside a clinical study in the 3 months or within 5 half lives (whichever is longer) prior to Baseline Visit
Subjects have received any biological therapy for RA within 3 months or within 5 half lives (whichever is longer) prior to Baseline Visit, except for Etanercept and Anakinra where only a 1 month washout prior to the Baseline Visit is necessary
Subjects have received Rituximab or Tocilizumab
Subjects have received Yunke (technetium-99 conjugated with methylene diphosphonate) other than for diagnostic purpose within 5 years prior to Baseline
Subjects have received previous treatment with a biological therapy for RA that resulted in a severe hypersensitivity reaction or an anaphylactic reaction
Subjects who failed to respond to previous treatment with a Tumor Necrosis Factor (TNF) blocking drug are excluded. Subjects who initially responded to a maximum of 2 TNF blocking agents but who later discontinued the agent(s) due to loss of efficacy or other reasons may be included

Medical history exclusions:

Female subjects who are breast feeding, pregnant, or plan to become pregnant during the study or for 3 months following last dose of study medication
Subjects with a history of chronic infection, recent serious or life threatening infection (within 6 months, including herpes zoster), or a current sign or symptom that may indicate an infection (eg, fever, cough)
Subjects with a history or active systemic/respiratory infection due to fungal, parasitic, or mycotic pathogens including but not limited to histoplasmosis, coccidiosis, paracoccidiosis, pneumocystis, blastomyces, aspergillus, and nontuberculous mycobacteria (NTMB)
Radiographic evidence suggestive of any of these infections is sufficient grounds for exclusion
Subjects with known Tuberculosis (TB) infection, at high risk of acquiring TB infection, or Latent Tuberculosis (LTB) infection are excluded
Subjects at a high risk of infection (eg, leg ulcers, indwelling urinary catheter, persistent or recurrent chest infections, and subjects that are permanently bedridden or wheelchair bound)
Subjects with a positive Hepatitis B surface antigen (HBsAg) test and/or Hepatitis C virus antibody (anti HCV) test result
Subjects with positive human immunodeficiency virus (HIV) test
Subjects receiving any live (includes attenuated) vaccination within 56 days prior to Baseline (eg, injectable influenza and pneumococcal vaccines are allowed, but nasal influenza vaccine is not)
Subjects with a history of a lymphoproliferative disorder including lymphoma or signs and symptoms suggestive of lymphoproliferative disease at any time
Subjects with an active malignancy of any type or a history of malignancy (other than carcinoma of the cervix or basal cell carcinoma successfully treated more than 5 years prior to Screening)
Subjects with a history of blood dyscrasias, eg, leukemia or hemophilia where the blood constituents are abnormal or are present in abnormal quantity
Subjects with class III or IV congestive heart failure New York Heart Association (NYHA) 1994
Subjects with a history of, or suspected, demyelinating disease of the central nervous system (eg, multiple sclerosis or optic neuritis)
Subjects with a current or recent history, as determined by the Investigator, of severe, progressive, and/or uncontrolled renal, hepatic, hematological, GI, endocrine, pulmonary, cardiac, neurological, or cerebral disease which would interfere with the subject's participation in the study. Abnormal laboratory parameters as detailed in protocol that require exclusion of a subject
Subjects with a history of an adverse reaction to Polyethylene Glycol (PEG) or a protein based medicinal product or known hypersensitivity to any components of the study medication or comparative drugs as stated in this protocol","Subjects will receive loading doses of CZP 400 mg (200 mg / prefilled syringe [PFS], ie, 2 injections) at Baseline, and Weeks 2 and 4; then CZP 200 mg (1 injection) Q2W until Week 22.

All subjects will continue their treatment on Methotrexate (MTX), with or without folic acid, at the same dose and route of administration as at entry (unless there is a need to reduce the dose for reasons of toxicity, minimum dose permitted 10 mg per week).",ChEMBL:CHEMBL34259 | DrugBank:DB00563 | PubChem:126941,Methotrexate,CN(Cc1cnc2nc(N)nc(N)c2n1)c1ccc(C(=O)N[C@@H](CCC(=O)O)C(=O)O)cc1,L01BA01 | L04AX03,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02152007,NCT02152007_EG000,No,All,Child | Adult | Older Adult,Phase 1,15,"Inclusion Criteria:

Subjects must:

Be capable of understanding the purpose and risks of the study and sign a written Informed Consent Form (ICF)
Be male or female ≥ 16 years of age at the time of the screening visit
Have a confirmed diagnosis of PC by genotyping (e.g., familial) and clinically correlated painful keratoderma.
Have roughly symmetrical calluses of similar severity on the plantar surface of both feet
Women of childbearing potential must have a negative serum pregnancy test
Subjects, whether male or female, with reproductive potential and who are sexually active must agree to use double-barrier contraception methods

Exclusion Criteria:

A Subject with any of the following criteria is not eligible for inclusion in this study:

Use of other investigational drugs within 30 days of the screening visit and/or has not recovered from any side effects of prior investigational drugs or procedure in the affected area (e.g., a biopsy)
Significant condition in the dermatologic treatment area such as trauma, or nonhealing chronic wound
Pregnant or nursing (lactating) female, or a positive serum pregnancy test
Active infection either systemic or local near the site of treatment requiring chronic or prolonged use of antimicrobial agents
Known immunodeficiency including: Hepatitis A; Hepatitis B; Hepatitis C; Human Immunodeficiency Virus (HIV)

Prior and Current Treatment

Unable to be discontinued from drugs known to either be inducers or inhibitors of CYP3A4/5 enzymes
Unable to be discontinued from drugs known to be P-glycoprotein inhibitors","This is a split-body design. Subjects will self-administer 1% topical sirolimus cream or placebo cream (no drug, vehicle control) on the plantar surface of each foot. At least one foot will be treated with topical sirolimus at some time during the study. Application will be one time daily for a total of 26 weeks. There will be an additional follow-up visit 3 months after the last application of study drug. The total duration of the study is 39 weeks.

1% sirolimus cream (TD201 1%): 1% sirolimus cream (TD201 1%)",ChEMBL:CHEMBL413 | DrugBank:DB00877 | PubChem:134760597 | PubChem:138404388 | PubChem:21944094 | PubChem:5284616,Sirolimus,COC1CC2CCC(C)C(O)(O2)C(=O)C(=O)N2CCCCC2C(=O)OC(C(C)CC2CCC(O)C(OC)C2)CC(=O)C(C)C=C(C)C(O)C(OC)C(=O)C(C)CC(C)C=CC=CC=C1C,L01EG04 | L04AA10 | S01XA23,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT02155101,NCT02155101_EG001,No,All,Adult | Older Adult,Phase 3,81,"Inclusion Criteria:

Subjects with documented HIV-1 infection.
Male or female aged > 21 years old.
Subjects receiving ART with 2 NRTIs + LPV/r (or ATV/r) for at least 3 months at the time of Screening 1.
Nadir T lymphocyte cluster of differentiation 4 (CD4) >100 cells/mm3
Plasma HIV-1 RNA <50 copies/ml at Screening 1 confirmed ideally 4-6 weeks later at Screening 2 (two results must be documented; a first result obtained up to 12 weeks earlier will be accepted).
Subjects can comply with the protocol requirements. In particular, subjects should be willing to be followed up at least until week 24 (discontinuation prior to week 24) and for the DRV/r arm up to week 48 (discontinuation after week 24) even if they discontinue randomized treatment.
Subjects who have voluntarily signed and dated the consent form.

Exclusion Criteria:

Clinical or laboratory evidence of significantly decreased hepatic function or decompensation, irrespective of liver enzyme levels (liver insufficiency).
Co-infection with hepatitis B (HBsAg positive).

Grade 3 or 4 laboratory abnormality as defined by AIDS, including haemoglobin ≤8mg/dL; platelets ≤50 000/mm3; estimated creatinine clearance ≤60ml/ minute, aspartate aminotransferase; alanine aminotransferase and alkaline phosphatase >3 times the upper limit of normal; and total bilirubin >2.5 times the upper limit of normal; with the following exceptions unless clinical assessment foresees an immediate health risk to the subject:

Pre-existing diabetes or asymptomatic glucose grade 3 or 4 elevations.
Asymptomatic triglyceride or cholesterol elevations of grade 3 or 4.

Presence of any currently active AIDS defining illness (Category C conditions according to the Centers for Disease Control Classification System for HIV Infection 1993) with the following exceptions:

Stable cutaneous Kaposi's Sarcoma (i.e., no internal organ involvement other than oral lesions) that is unlikely to require any form of systemic therapy during the study.
Wasting syndrome due to HIV infection. Note: An AIDS defining illness that is not clinically stabilized for at least 30 days will be considered as currently active.
Pregnant or breastfeeding women.
Active substance abuse, including alcohol or recreational drugs.
Any clinically significant disease (e.g., tuberculosis, cardiac dysfunction, pancreatitis, acute viral infections) or life threatening disease in the previous 14 days, or findings during screening of medical history or physical examination that, in the investigator's opinion, would compromise the subject's safety or outcome of the study.
Any medical or psychiatric condition which, in the opinion of the investigator, could compromise the subject's safety or adherence to the trial protocol.

Previously demonstrated clinically allergy or hypersensitivity to any of the excipients of the investigational medication (DRV).

Note: DRV is a sulfonamide. Subjects who have previously experienced a sulfonamide allergy will be allowed to enter the trial. To date, no potential for cross sensitivity between drugs in the sulfonamide class and DRV has been identified in subjects participating in phase II trials.

Participation in any other clinical trials that involve administration of antiretrovirals or other drugs within the last 4 weeks and during the participation in this trial.","Dosage form: Darunavir (PREZISTA) is a film coated, oval shaped, light orange 19.1mm tablet, debossed with ""400 mg"" on one side and TMC on the other side.

Darunavir: Darunavir (PREZISTA) is a film coated, oval shaped, light orange 19.1mm tablet, debossed with 400 mg on one side and TMC on the other side.",ChEMBL:CHEMBL1323 | DrugBank:DB01264 | PubChem:213039,Darunavir,[H][C@]12OCC[C@@]1([H])[C@@H](OC(=O)N[C@@H](Cc1ccccc1)[C@H](O)CN(CC(C)C)S(=O)(=O)c1ccc(N)cc1)CO2,G01AE10 | J05AE10 | J05AR14 | J05AR22 | J05AR26,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02156154,NCT02156154_EG000,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 3,580,"Inclusion Criteria:

Written informed consent
18-85 years old
above 50 kg
American Society of Anaesthesiologists Physical Status 1-3
Scheduled for elective open or laparoscopic abdominal surgery, including colorectal, prostate, and hysterectomy surgeries
Patients with anticipated hospitalization of two nights
Expected to require parenteral opioids for at least 48 hours for postoperative pain
Able to use IV Patient-Controlled Analgesia systems

Exclusion Criteria:

Hepatic disease, e.g. twice the normal levels of liver enzymes
Kidney disease, e.g. twice the normal level of serum creatinine
Epidural analgesia or regional blocks (including Transverse abdominis plane block)
Acetaminophen sensitivity or known allergy
Female patients who are pregnant or breastfeeding
Patients taking warfarin","Acetaminophen infusion will be initiated before the surgical incision with 1 g and repeated every 6 hours for the earlier of 48 postoperative hours of hospital discharge.

Intravenous Acetaminophen",ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02156154,NCT02156154_EG001,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 3,580,"Inclusion Criteria:

Written informed consent
18-85 years old
above 50 kg
American Society of Anaesthesiologists Physical Status 1-3
Scheduled for elective open or laparoscopic abdominal surgery, including colorectal, prostate, and hysterectomy surgeries
Patients with anticipated hospitalization of two nights
Expected to require parenteral opioids for at least 48 hours for postoperative pain
Able to use IV Patient-Controlled Analgesia systems

Exclusion Criteria:

Hepatic disease, e.g. twice the normal levels of liver enzymes
Kidney disease, e.g. twice the normal level of serum creatinine
Epidural analgesia or regional blocks (including Transverse abdominis plane block)
Acetaminophen sensitivity or known allergy
Female patients who are pregnant or breastfeeding
Patients taking warfarin","0.9% sodium chloride infusion will be initiated before the surgical incision with 100 ml and repeated every 6 hours for the earlier of 48 postoperative hours of hospital discharge.

Intravenous Acetaminophen",ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02169089,NCT02169089_EG000,No,All,Adult | Older Adult,Phase 4,37,"Inclusion Criteria:

Male or female patients >45 or >40 years with known atherosclerotic events (examples include MI, Stroke) and able to provide informed consent (females must be either post-menopausal for one year, surgically sterile, or using effective contraception. Oral contraceptives are disallowed.
Patients with Type II Diabetes with HbA1c ≤ 9.0 on stable anti-glycemic regimen that may include oral and/or injectable therapy (GLP-1/Insulin etc.). Changes in dose of glycemic regimen is allowed during the course of the trial if felt to be clinically appropriate.
GFR <90 and evidence of proteinuria (Urine albumin/creatinine ratio of >30 mg/g or equivalent) in a urine specimen within 12 months OR GFR <60 mg/g regardless of proteinuria.
Patients must be on ACE and/or ARB therapy with no planned dose adjustments.

Exclusion Criteria:

Uncontrolled hypertension (SBP>160 and/or DBP>95 mmHg at visit 0 (screening) and SBP >145 mm Hg at visit 2).
GFR (MDRD) of <15 at Visit 0 (screening).
Hyperkalemia defined as serum K+≥ 5.1 meq/L at visit 0 (screening).
LDL cholesterol >150 mg/dl.
Plasma triglycerides >400 mg/dl.
Contraindications to MRI (metallic implants, severe claustrophobia).
Acute coronary syndrome, Transient ischemic attack, CVA or critical limb ischemia during the last 6 months or coronary/peripheral revascularization within the last 3 months.
Evidence of a secondary form of hypertension.
Initiation of new therapy with statins, ACEI/ARB, anti-oxidants, CCBs, diuretics, β blockers.
Type I diabetes mellitus
Known contraindication, including history of allergy to Spironolactone.
. Any surgical or medical condition which might alter pharmacokinetics of drug (e.g. renal transplant, liver failure, liver transplant).
Concurrent potentially life threatening arrhythmia or symptomatic arrhythmia.
Significant hyponatremia defined as Na <130 meq/L.
History of prior malignancy including leukemia and lymphoma (but not basal cell skin cancer, cured squamous cell cancer and localized Prostate cancer).
History of any severe, life-threatening disease.
Any surgical or medical conditions which places the patient at higher risk derived from his/her participation into the study, or likely to prevent patient from complying with requirements.
History of drug abuse within the last 2 years, noncompliance and unwillingness/inability to consent.
Pregnant women and nursing mothers.
Class III or IV Congestive Heart Failure.
Primary Hyperaldosteronism.","Spironolactone

Spironolactone: Patients will be given Spironolactone 12.5 mg on week 0 (visit 2). Patients will be escalated to 25 mg daily Spironolactone or maximal tolerated dose over a 4-week period. Patients will continue treatment for an additional 48 weeks.",ChEMBL:CHEMBL1393 | DrugBank:DB00421 | PubChem:5833,Spironolactone,[H][C@]12CC[C@]3(C)[C@]4(CCC(=O)O4)CC[C@@]3([H])[C@]1([H])[C@]([H])(SC(C)=O)CC1=CC(=O)CC[C@@]12C,C03DA01,1.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02169830,NCT02169830_EG001,No,All,Adult | Older Adult,Not Applicable,35,"Inclusion Criteria:

-Men and women aged 18 to 70 with untreated vestibular migraine variant as diagnosed by history.

Exclusion Criteria:

Patients with allergies to nortriptyline or topiramate and their analogs or medication interactions that preclude their use.
Patients under the care of a psychiatrist.
Patients who are pregnant or trying to become pregnant.
Patients taking more than 5 prescription medications.
Patients with cancer.
Patient has a history of immunodeficiency.
Patient has a history of substance abuse within the preceding 6 months prior to screening.
Patient has used an investigational drug or device in the the 3 months prior to screening.
Patient is using marijuana for medical or other uses.
Patient has any other clinically significant illness or medical condition that, in the investigator's opinion, would prohibit the subject from participating in the study.
Patient with traumatic brain injury.
Patients taking Nortriptyline, MAOIs
Patients with liver or kidney dysfunction or glaucoma

Due to know drug interactions, patients taking the following medications will be excluded.

Nortriptyline: monoamine oxidase inhibitors (MAO) such as phenelzine. Patients on oral contraceptives will be asked to use a secondary method as nortriptyline can reduce the effectiveness of oral contraceptives.

Topiramate: acetazolamide (kidney stones), digoxin

Exclude subjects with liver dysfunction, kidney dysfunction and glaucoma (per the risks associated with topiramate).","Diet Modification topiramate and then nortriptyline if necessary

Topiramate: Topiramate dosing will be 25 mg PO qhs for 1 week, followed by 25 mg BID for 1 week, followed by 25 mg in the morning and 50 mg qhs for 1 week, and finally 50 mg BID",ChEMBL:CHEMBL220492 | DrugBank:DB00273 | PubChem:5284627,Topiramate,[H][C@@]12OC(C)(C)O[C@]1([H])CO[C@@]1(COS(N)(=O)=O)OC(C)(C)O[C@]12[H],A08AA51 | N03AX11,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02170220,NCT02170220_EG000,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 1,6,"Inclusion Criteria:

General:

In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
Is aged 18 to 75 years, inclusive, at the time of informed consent and first study medication dose.
Weighs at least 50 kg and has a body mass index (BMI) between 19 and 38 kg/m^2, inclusive at Screening.
A male participant who is nonsterilized and sexually active with a female partner of childbearing potential agrees to use adequate contraception from signing of informed consent throughout the duration of the study and for 30 days after last dose.
A female participant of childbearing potential who is sexually active with a nonsterilized male partner agrees to use routinely adequate contraception from signing of informed consent throughout the duration of the study.
Has a resting pulse and heart rate (as read on electrocardiogram [ECG]) between 51 and 100 beats per minutes (bpm), inclusive. For healthy participants in good physical condition and aged 18 to 45 years, inclusive, the lower limit is 45 bpm.

Has a negative result at screening on the fecal occult blood screen.

Healthy Participants (Normal Hepatic Function):

The participant, in opinion of the investigator, is in good health as determined by a prestudy physical examination, medical history, vital signs, ECG, and the results of blood biochemistry, hematology, and serology tests, and urinalysis.

Participants with severe hepatic impairment:

Has been classified as having severe hepatic impairment as defined by the Child-Pugh classification system.
Has case record notes demonstrating stable biochemistry as judged by the investigator prior to Screening.
Has case record notes demonstrating physical signs consistent with a clinical diagnosis of liver impairment (eg, liver firmness to palpation, splenic enlargement, spider angiomas, palmar erythema, parotid hypertrophy, testicular atrophy, ascites, gynecomastia).
For participants with hepatic encephalopathy, the condition does not, in the investigator's opinion, interfere with the participant's ability to provide an appropriate informed consent. (Participants who have severe encephalopathy receive a score of 3 or 4. The score reflects the degree of encephalopathy off treatment. This will be documented in the source.)

Exclusion Criteria:

General:

Has received any investigational compound within 45 days prior to first dose of study medication.
Has received vortioxetine (Lu AA21004) in a previous clinical study or as a therapeutic agent.
Is an immediate family member, study site employee, or in a dependant relationship with a study site employee who is involved in the conduct of this study (eg, spouse, parent, child, sibling) or may consent under duress.
Has received or donated more than 400 mL of blood or blood products within the 45 days preceding the beginning of the study or planned to donate blood during the study.
Has a history of hypersensitivity or allergies to vortioxetine or related compounds with same mechanism of action including any associated excipients.
Has a medical history of, or presence of, gastric or duodenal ulceration, gastritis, recent head injury or any other trauma within 1 week of Screening, extensive ecchymoses, hemoptysis, gingival bleeding, hematemesis, repeated or significant nose bleeds, periorbital hematoma, retinal detachment, menorrhagia, hematuria, or melena.
Has had an acute, clinically significant illness within 30 days prior to the first dose of study medication.
Has a history of abdominal surgery (except laparoscopic cholecystectomy or uncomplicated appendectomy), thoracic, or nonperipheral vascular surgery within 6 months prior to the study medication.
Has a history of cancer, other than basal cell or Stage 1 squamous cell carcinoma of the skin that has not been in remission for at least 5 years prior to the first dose of study drug.
Has taken any medications, supplements or food products except for those allowed for hepatically impaired participants, or approved by Takeda on a case-by-case basis.
If female, the participant is pregnant or lactating or intending to become pregnant before, during, or within 30 days after participating in this study; or intending to donate ova during such time period.
If male, the participant intends to donate sperm during the course of this study or for 30 days thereafter.
Has poor peripheral venous access.
Has a serum creatinine level greater than 1.5 mg/dL at Screening or Day -1 (Check-in).
Has active stage 3 or 4 encephalopathy.
Has a diastolic blood pressure >100 mm Hg or a systolic blood pressure >160 mm Hg (supine) at Screening or Day -1.
Has an orthostatic blood pressure ≥25 mm Hg (based on the difference between supine and standing [1 minute] systolic blood pressure) at Screening or Day 1.
Has a known history of human immunodeficiency virus infection.
Has a positive test result for hepatitis B surface antigen.
The participant's corrected QT interval (QTc, Bazett correction) is >450 millisecond (msec) for men and >470 msec for women at Screening or at Check-in as read on the printout of the ECG and evaluated by the investigator.
Has a history or clinical manifestations of significant illness such as renal insufficiency, hematologic, pulmonary, cardiovascular, gastrointestinal, neurological, rheumatologic, urologic, immunologic, infectious, skin and subcutaneous tissue disorders, or psychiatric or mood disorders (including any past suicide attempt). For hepatically impaired participants, previously known conditions associated with liver disease are not excluded.
Exercises extensively in his/her normal life, that is, marathon running, triathlons, physical sports at a contest level, etc.
Answers positive to any suicidal ideation and/or suicidal behavior questions during administration of the Columbia-Suicide Severity Rating Scale (C-SSRS) [7-9] at Screening.
Is unwilling or unable to comply with the protocol or scheduled appointments.
Is unable to understand verbal and/or written English or any other language for which a certified translation of the approved informed consent is available.
The participant, in the opinion of the investigator, is unlikely to comply with the clinical trial protocol or deemed unsuitable for any other reason.

Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse (defined as regular or daily consumption of more than 2 alcoholic units per day) within 1 year prior to the Screening Visit (1 unit=250 mL of beer or 20 mL of spirits or 1 glass [118 mL] of wine). Participants with severe hepatic dysfunction who test positive on the urine drug screen due to prescription drug use will be allowed to participate if approved by the principal investigator and the sponsor's medical monitor.

Healthy Participants (Normal Hepatic Function):

Has any clinically significant abnormal findings on the medical history, physical exam, ECG, or clinical laboratory tests that, in the opinion of the investigator, preclude study participation.
Has a hepatic and/or endocrine disorder.
Has a positive test result for antibody to hepatitis C virus.
Has an alanine transaminase or aspartate transaminase level of greater than 1.5 × upper limit of normal (ULN) at Screening or Day -1 (Check-in), active liver disease, active gall bladder disease, or jaundice.
Has a predisposition to easy bruising or bleeding, anemia, thrombocytopenia, or a known history, or history in a first-degree relative, of bleeding disorders (including Von Willebrand's disease or hemophilia A and B).

Has a positive test for fecal occult blood.

Participants with severe hepatic impairment:

Has clinically significant laboratory abnormalities except for those parameters influenced by hepatic impairment.
Has any serious illness except for controlled hypertension or diabetes and those problems associated with the primary diagnosis of hepatic impairment or other diseases that are approved by the principal investigator and the sponsor's medical monitor.
Has a clinical exacerbation of liver disease (i.e, abdominal pain, nausea, vomiting, anorexia, or fever) within the 2-week period before the administration of study drug.
Has clinical demonstrable, massive, tense ascites.
Has evidence of acute viral hepatitis within 1 month prior to the administration of study medication.
Has evidence of hepatorenal syndrome.
Has a known history of bleeding disorders (including Von Willebrand's disease or hemophilia A and B).
Has active alcohol abuse or dependence as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition.","Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with normal hepatic function.",ChEMBL:CHEMBL2104993 | DrugBank:DB09068 | PubChem:9966051,Vortioxetine,Cc1ccc(Sc2ccccc2N2CCNCC2)c(C)c1,N06AX26,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02170220,NCT02170220_EG001,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 1,6,"Inclusion Criteria:

General:

In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
Is aged 18 to 75 years, inclusive, at the time of informed consent and first study medication dose.
Weighs at least 50 kg and has a body mass index (BMI) between 19 and 38 kg/m^2, inclusive at Screening.
A male participant who is nonsterilized and sexually active with a female partner of childbearing potential agrees to use adequate contraception from signing of informed consent throughout the duration of the study and for 30 days after last dose.
A female participant of childbearing potential who is sexually active with a nonsterilized male partner agrees to use routinely adequate contraception from signing of informed consent throughout the duration of the study.
Has a resting pulse and heart rate (as read on electrocardiogram [ECG]) between 51 and 100 beats per minutes (bpm), inclusive. For healthy participants in good physical condition and aged 18 to 45 years, inclusive, the lower limit is 45 bpm.

Has a negative result at screening on the fecal occult blood screen.

Healthy Participants (Normal Hepatic Function):

The participant, in opinion of the investigator, is in good health as determined by a prestudy physical examination, medical history, vital signs, ECG, and the results of blood biochemistry, hematology, and serology tests, and urinalysis.

Participants with severe hepatic impairment:

Has been classified as having severe hepatic impairment as defined by the Child-Pugh classification system.
Has case record notes demonstrating stable biochemistry as judged by the investigator prior to Screening.
Has case record notes demonstrating physical signs consistent with a clinical diagnosis of liver impairment (eg, liver firmness to palpation, splenic enlargement, spider angiomas, palmar erythema, parotid hypertrophy, testicular atrophy, ascites, gynecomastia).
For participants with hepatic encephalopathy, the condition does not, in the investigator's opinion, interfere with the participant's ability to provide an appropriate informed consent. (Participants who have severe encephalopathy receive a score of 3 or 4. The score reflects the degree of encephalopathy off treatment. This will be documented in the source.)

Exclusion Criteria:

General:

Has received any investigational compound within 45 days prior to first dose of study medication.
Has received vortioxetine (Lu AA21004) in a previous clinical study or as a therapeutic agent.
Is an immediate family member, study site employee, or in a dependant relationship with a study site employee who is involved in the conduct of this study (eg, spouse, parent, child, sibling) or may consent under duress.
Has received or donated more than 400 mL of blood or blood products within the 45 days preceding the beginning of the study or planned to donate blood during the study.
Has a history of hypersensitivity or allergies to vortioxetine or related compounds with same mechanism of action including any associated excipients.
Has a medical history of, or presence of, gastric or duodenal ulceration, gastritis, recent head injury or any other trauma within 1 week of Screening, extensive ecchymoses, hemoptysis, gingival bleeding, hematemesis, repeated or significant nose bleeds, periorbital hematoma, retinal detachment, menorrhagia, hematuria, or melena.
Has had an acute, clinically significant illness within 30 days prior to the first dose of study medication.
Has a history of abdominal surgery (except laparoscopic cholecystectomy or uncomplicated appendectomy), thoracic, or nonperipheral vascular surgery within 6 months prior to the study medication.
Has a history of cancer, other than basal cell or Stage 1 squamous cell carcinoma of the skin that has not been in remission for at least 5 years prior to the first dose of study drug.
Has taken any medications, supplements or food products except for those allowed for hepatically impaired participants, or approved by Takeda on a case-by-case basis.
If female, the participant is pregnant or lactating or intending to become pregnant before, during, or within 30 days after participating in this study; or intending to donate ova during such time period.
If male, the participant intends to donate sperm during the course of this study or for 30 days thereafter.
Has poor peripheral venous access.
Has a serum creatinine level greater than 1.5 mg/dL at Screening or Day -1 (Check-in).
Has active stage 3 or 4 encephalopathy.
Has a diastolic blood pressure >100 mm Hg or a systolic blood pressure >160 mm Hg (supine) at Screening or Day -1.
Has an orthostatic blood pressure ≥25 mm Hg (based on the difference between supine and standing [1 minute] systolic blood pressure) at Screening or Day 1.
Has a known history of human immunodeficiency virus infection.
Has a positive test result for hepatitis B surface antigen.
The participant's corrected QT interval (QTc, Bazett correction) is >450 millisecond (msec) for men and >470 msec for women at Screening or at Check-in as read on the printout of the ECG and evaluated by the investigator.
Has a history or clinical manifestations of significant illness such as renal insufficiency, hematologic, pulmonary, cardiovascular, gastrointestinal, neurological, rheumatologic, urologic, immunologic, infectious, skin and subcutaneous tissue disorders, or psychiatric or mood disorders (including any past suicide attempt). For hepatically impaired participants, previously known conditions associated with liver disease are not excluded.
Exercises extensively in his/her normal life, that is, marathon running, triathlons, physical sports at a contest level, etc.
Answers positive to any suicidal ideation and/or suicidal behavior questions during administration of the Columbia-Suicide Severity Rating Scale (C-SSRS) [7-9] at Screening.
Is unwilling or unable to comply with the protocol or scheduled appointments.
Is unable to understand verbal and/or written English or any other language for which a certified translation of the approved informed consent is available.
The participant, in the opinion of the investigator, is unlikely to comply with the clinical trial protocol or deemed unsuitable for any other reason.

Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse (defined as regular or daily consumption of more than 2 alcoholic units per day) within 1 year prior to the Screening Visit (1 unit=250 mL of beer or 20 mL of spirits or 1 glass [118 mL] of wine). Participants with severe hepatic dysfunction who test positive on the urine drug screen due to prescription drug use will be allowed to participate if approved by the principal investigator and the sponsor's medical monitor.

Healthy Participants (Normal Hepatic Function):

Has any clinically significant abnormal findings on the medical history, physical exam, ECG, or clinical laboratory tests that, in the opinion of the investigator, preclude study participation.
Has a hepatic and/or endocrine disorder.
Has a positive test result for antibody to hepatitis C virus.
Has an alanine transaminase or aspartate transaminase level of greater than 1.5 × upper limit of normal (ULN) at Screening or Day -1 (Check-in), active liver disease, active gall bladder disease, or jaundice.
Has a predisposition to easy bruising or bleeding, anemia, thrombocytopenia, or a known history, or history in a first-degree relative, of bleeding disorders (including Von Willebrand's disease or hemophilia A and B).

Has a positive test for fecal occult blood.

Participants with severe hepatic impairment:

Has clinically significant laboratory abnormalities except for those parameters influenced by hepatic impairment.
Has any serious illness except for controlled hypertension or diabetes and those problems associated with the primary diagnosis of hepatic impairment or other diseases that are approved by the principal investigator and the sponsor's medical monitor.
Has a clinical exacerbation of liver disease (i.e, abdominal pain, nausea, vomiting, anorexia, or fever) within the 2-week period before the administration of study drug.
Has clinical demonstrable, massive, tense ascites.
Has evidence of acute viral hepatitis within 1 month prior to the administration of study medication.
Has evidence of hepatorenal syndrome.
Has a known history of bleeding disorders (including Von Willebrand's disease or hemophilia A and B).
Has active alcohol abuse or dependence as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition.","Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with severe hepatic impairment.",ChEMBL:CHEMBL2104993 | DrugBank:DB09068 | PubChem:9966051,Vortioxetine,Cc1ccc(Sc2ccccc2N2CCNCC2)c(C)c1,N06AX26,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02174276,NCT02174276_EG000,No,All,Adult | Older Adult,Phase 2,27,"Key Inclusion Criteria:

Must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study
Documented evidence of chronic hepatitis B virus (HBV) infection, for example, hepatitis B surface antigen (HBsAg) positive for more than 6 months
Screening HBV DNA ≥ 2000 IU/mL
A negative serum pregnancy test is required for females (unless surgically sterile or > 2 years post-menopausal)

Key Exclusion Criteria:

Cirrhosis
Inadequate liver function
Co-infection with hepatitis C virus (HCV), HIV or hepatitis D virus (HDV)
Received antiviral treatment for HBV within 3 months of screening
Evidence of hepatocellular carcinoma (eg, as evidenced by recent imaging)
Significant cardiovascular, pulmonary, or neurological disease
Women who are pregnant or may wish to become pregnant during the course of the study
Received solid organ or bone marrow transplant
Received prolonged therapy with immunomodulators (eg, corticosteroids) or biologics (eg, monoclonal antibody, interferon) within 3 months of screening
Use of investigational agents within 3 months of screening
Current alcohol or substance abuse judged by the investigator to potentially interfere with individual's compliance
Receipt of immunoglobulin or other blood products within 3 months prior to enrollment
History of demyelinating disease (Guillain-Barre), Bell's Palsy, Crohn's disease, Ulcerative colitis, or autoimmune disease
Documented history of yeast allergy
Known hypersensitivity to study drugs, metabolites or formulation excipients
Malignancy within 5 years prior to screening, with the exception of specific cancers that are cured by surgical resection (basal cell skin cancer, etc). Individuals under evaluation for possible malignancy are not eligible

Note: Other protocol defined Inclusion/Exclusion criteria may apply.",Participants received TDF 300 mg tablet orally once daily for 48 weeks during the main study. Participants had the option to continue receiving TDF 300 mg tablet orally once daily for up to 144 weeks (in OTEP).,PubChem:5486830 | PubChem:6398764,Tenofovir Disoproxil Fumarate,CC(C)OC(=O)OCOP(=O)(COC(C)Cn1cnc2c(N)ncnc21)OCOC(=O)OC(C)C.O=C(O)C=CC(=O)O,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,1.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT02177838,NCT02177838_EG000,No,All,Adult | Older Adult,Not Applicable,8,"Inclusion Criteria:

Histologically proven squamous cell carcinoma of the oropharynx, hypopharynx or larynx
Stage III/IVa/b squamous cell carcinoma (SCC) by American Joint Committee on Cancer (AJCC) 7 criteria (advanced, but not metastatic)
Patients must give informed consent
Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status =< 2
Platelets >= 100,000/uL
Absolute neutrophil count (ANC) >= 1,500/uL
Hemoglobin > 8 g/dl (use of transfusion to achieve this is acceptable)
Total bilirubin < 2 X institutional upper limit of normal (ULN)
Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3 X institutional ULN
Serum creatinine < 2 x institutional ULN or creatinine clearance > 50 ml/min as determined by 24 hour collection or estimated by Cockcroft-Gault formula
Estimated life expectancy of at least 12 weeks
Negative pregnancy test

Exclusion Criteria:

Patients may not have received previous therapy for their head and neck SCC, including chemotherapy, radiation therapy, or surgery beyond biopsy
Second primary malignancy; exceptions are 1) patient had a second primary malignancy but has been treated and disease free for at least 3 years, 2) in situ carcinoma (e.g. in situ carcinoma of the cervix), 3) non-melanomatous carcinoma of the skin
Patients with metastatic disease beyond the neck and supraclavicular region will be excluded
Serious concomitant systemic disorders (including active infections) that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator; this includes scleroderma
History of allergic reactions attributed to compounds of similar chemical or biologic composition to cetuximab or cisplatinum or other agents used in the study
Women who are pregnant; women of childbearing age must agree to undergo a pregnancy test prior to therapy and to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation and for 6 months after; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
Patients with human immunodeficiency virus (HIV) infection are not automatically excluded, but must meet the following criteria: cluster of differentiation (CD)4 count is > 499/cu mm and their viral load is < 50 copies/ml; use of highly active anti-retroviral therapy (HAART) is allowed
Patients who have had either myocardial infarction, coronary artery bypass graft, coronary artery stenting, hospital admission for heart related issues such as congestive heart failure or arrhythmia within the last 3 months, will not be allowed on protocol

Grade 3-4 electrolyte abnormalities (Common Terminology Criteria for Adverse Events [CTCAE], version [v]. 4):

Serum calcium (ionized or adjusted for albumin) < 7 mg/dl (1.75 mmol/L) or > 12.5 mg/dl (> 3.1 mmol/L) despite intervention to normalize levels
Magnesium < 0.9 mg/dl (< 0.4 mmol/L) or > 3 mg/dl (> 1.23 mmol/L) despite intervention to normalize levels
Potassium < 3.5 mmol/L or > 6 mmol/L despite intervention to normalize levels
Sodium < 130 mmol/L or > 155 mmol/L despite intervention to normalize levels","Patients receive cetuximab IV over 60-120 minutes for 3 weeks. Patients then undergo EBRT over 6-7 weeks. Patients achieving response continue weekly doses of cetuximab until radiation therapy is completed. Patients unable to achieve response or progression receive cisplatin IV over 1-2 hours on days 1, 22, and 43 of radiation therapy.

cetuximab: Given IV

cisplatin: Given IV

external beam radiation therapy: Undergo EBRT

laboratory biomarker analysis: Correlative studies",DrugBank:DB00515 | PubChem:5460033 | PubChem:5702198,Cisplatin,Cl[Pt]Cl.N.N,L01XA01,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT02179788,NCT02179788_EG000,No,Female,Adult | Older Adult,Phase 1 | Phase 2,20,"Inclusion Criteria among mother-infant dyads:

Stage 1 Criteria (for participation in baseline measurement phase):

identified with low milk supply by a Cincinnati-area IBCLC
mother denies obvious cause of low milk supply such as pituitary disorder, breast surgery, severe lack of breast emptying (< 4 times per day), or failure to show any signs of lactogenesis
mother at least 20 years of age
infant is between 1 week and 2 calendar months old
mother gave birth to a single, healthy, term (>37 weeks gestation) infant
mother free of breast and nipple infections
mother lives within study catchment area
mother has not been diagnosed with Type 1 or Type 2 Diabetes Mellitus
mother willing to sustain consistent use of herbal galactogogues (such as fenugreek) during follow up measurements (2-4 weeks) as was consumed during the baseline measurements
mother not currently taking a prescription medication that may affect the hormones of lactation and not planning to initiate any such drug for at least the next 2-4 weeks.
mother has established pediatric care for the infant

Stage 2 maternal inclusion criteria (among those who meet Stage 1 criteria, to continue with enrollment into randomized controlled trial, goal, N=30 with replacement for non-completers to at least two weeks):

successful completion of baseline measurements (involving 24-hour test weighing of milk output and undergoing baseline measurements at the clinical research center, including providing fasting blood samples)
body mass index is >19.0 kg/m2 (i.e., not underweight)
evidence of likely insulin resistance, based on at least one of the following: mean fasting plasma glucose between 95.0 - 125.0 g/dL, inclusive; abdominal obesity; history of polycystic ovary syndrome; or history of gestational diabetes
estimated glomerular filtration rate > 60 mL/min
liver function in normal range (AST <= 37 U/L, ALT < 87 U/L, and total bilirubin <= 1.1 mg/dL
willingness to continue trying to lactate for the next 2-4 weeks
health history does not reveal illness/treatments for which metformin is contraindicated
participant is not currently being treated with metformin

Eligibility criteria for enrollment into abundant milk supply comparison group (goal, N=30, will be compared in baseline measurements).

Inclusion criteria:

exclusively feeding mother's own milk to infant, and presenting to Cincinnati area IBCLC with breastfeeding question or problem unrelated to milk supply
mother at least 20 years of age
infant is between 1 week and 2 calendar months old
mother gave birth to a single, term infant
mother free of breast and nipple infections
mother lives within study catchment area
mother has not been diagnosed with Type 1 or Type 2 Diabetes Mellitus
mother willing to sustain consistent use of herbal galactogogues (such as fenugreek) during baseline measurements
mother willing to avoid prescription medication that may affect the hormones of lactation","10 stage 2 eligible mothers were randomly allocated to this arm. Mothers were instructed to thoroughly empty their breasts at least 8 times per day and to take the assigned study drug.

Standard care: Mothers will be instructed to thoroughly empty their breasts at least 8 times per 24 hours by breastfeeding, followed by breast expression with a combination of hand -expression and the use of a hospital-grade electric breast pump.

Metformin: The metformin arm will be consuming Glucophage XR (metformin hydrochloride extended release, 750 or 500 mg, encapsulated in #00 opaque capsules for 4 weeks according to the following schedule:

Days 1-7, one 750 mg capsule with evening meal (750 mg/day)
Days 8-14, three 500 mg capsule with evening meal (1500 mg/day)
Days 14-28 (or through completion of post-intervention data collection),four 500 mg capsules with evening meal (2000 mg/day)

The trial duration was28 days (with a +/- 3 day cushion)",ChEMBL:CHEMBL1431 | DrugBank:DB00331 | PubChem:4091,Metformin,CN(C)C(=N)NC(=N)N,A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT02181387,NCT02181387_EG000,No,Female,Adult,Phase 4,33,"Inclusion Criteria:

>/= 18 years of age not allergic to study medications

Exclusion Criteria:

pre-eclampsia in labor AND with demonstrated significant abnormal liver enzyme function changes non-English speaking subjects","1000 mg every 6 hours during labor up to maximum 3 doses

Acetaminophen: administered every 6 hours by mouth up to 3 doses",ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02182492,NCT02182492_EG001,No,All,Child | Adult | Older Adult,Not Applicable,94,"Inclusion Criteria:

Meeting the CRS diagnostic criteria including CRSsNP and CRSwNP based on the EP3OS definition
Age ≥16 and ≤70 years
Chinese of either sex
Failure to conventional medical therapies according to EP3OS recommendation

Exclusion Criteria:

Pregnant or breast-feeding women
Cystic fibrosis
Congenital ciliary dyskinesia
Sinonasal fungal disease
Systemic vasculitis
Granulomatous disease
Tumor
Immunodeficiency
Allergic to clarithromycin or topical corticosteroid
With an upper respiratory tract infection within 4 weeks of entering the study
With serious metabolic, cardiovascular, autoimmune, neurology, blood, digestive, cerebrovascular, respiratory system disease, or any disease interfering with the evaluation of results or affecting subjects' safety such as glaucoma and tuberculosis
With emotional or mental problems
Have received immunotherapy within the previous 3 months
Have had a history of local or systemic medications, such as glucocorticoids and macrolides within 4 weeks
Have had an acute asthmatic within the 4 weeks before entering the study","Clarithromycin tablet

Clarithromycin: Clarithromycin 250 mg tablet once daily for 3 months",ChEMBL:CHEMBL1741 | DrugBank:DB01211 | PubChem:84029,Clarithromycin,[H][C@]1(O[C@H]2[C@H](C)[C@@H](O[C@]3([H])O[C@H](C)C[C@H](N(C)C)[C@H]3O)[C@](C)(OC)C[C@@H](C)C(=O)[C@H](C)[C@@H](O)[C@](C)(O)[C@@H](CC)OC(=O)[C@@H]2C)C[C@@](C)(OC)[C@@H](O)[C@H](C)O1,A02BD04 | A02BD05 | A02BD06 | A02BD07 | A02BD09 | A02BD11 | A02BD12 | A02BD14 | J01FA09,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02191579,NCT02191579_EG001,No,All,Adult | Older Adult,Phase 4,142,"Inclusion Criteria:

History of chronic migraine
More than 15 headache days in a 28 day period (headaches that last more than 4 hours and/or require treatment with prescription medication).

Exclusion Criteria:

Taking opioid-containing products for acute headache treatment more than 8 days during a 28-day period
Previous treatment with botulinum toxin of any serotype for any reason
Previous treatment with topiramate
On a ketogenic diet (high in fat, low in carbohydrates)
History of acute myopia or increased intraocular pressure
Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis or any other significant disease that might interfere with neuromuscular function
Acupuncture, transcutaneous electrical stimulation (TENS), cranial traction, dental splints for headache, or injection of anesthetics/steroids in the 4 weeks prior to screening.",Topiramate starting at a daily oral dose of 25 mg/day titrated up to a maximum dose of 100 mg/day for 36 weeks.,ChEMBL:CHEMBL220492 | DrugBank:DB00273 | PubChem:5284627,Topiramate,[H][C@@]12OC(C)(C)O[C@]1([H])CO[C@@]1(COS(N)(=O)=O)OC(C)(C)O[C@]12[H],A08AA51 | N03AX11,0.0,0.0,0.0,0.0,0.0,1.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02193165,NCT02193165_EG000,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 3,120,"Inclusion Criteria:

Male and female subjects, ages 21-70, inclusive.
Availability for the six-week duration of the study.
Good general health.
Minimum of 20 uncrowned permanent natural teeth (excluding third molars).
Initial gingivitis index of at least 1.0 as determined by the use of the Loe and Silness Gingival Index.
Initial plaque index of at least 1.5 as determined by the use of the Quigley and Hein Plaque Index (Turesky Modification).
Signed Informed Consent Form.

Exclusion Criteria:

Presence of orthodontic bands.
Presence of partial removable dentures.
Tumor(s) of the soft or hard tissues of the oral cavity.
Advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone).
Five or more carious lesions requiring immediate restorative treatment.
Use of antibiotics any time during the one month prior to entry into the study.
Participation in any other clinical study or test panel within the one month prior to entry into the study.
Pregnant women or women who are breast feeding.
Dental prophylaxis received in the past two weeks prior to baseline examinations.
History of allergies to oral care/personal care consumer products or their ingredients.
On any prescription medicines that might interfere with the study outcome.
An existing medical condition which prohibits eating or drinking for periods up to 4 hours.
History of alcohol or drug abuse","triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash

triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Total toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using a Total 360 toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of mouthwash for 30 seconds.",PubChem:24848164,Sodium fluoride and triclosan,Oc1cc(Cl)ccc1Oc1ccc(Cl)cc1Cl.[F-].[Na+],,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02194465,NCT02194465_EG006,No,All,Adult | Older Adult,Phase 2,26,"Inclusion Criteria:

Have a history of hypertension.

If participants are naïve to treatment of hypertension, or have not been treated with any antihypertensive medications within the 30 days immediately prior to screening:

Have seated systolic (SBP) of ≥140 and <170 millimeters of mercury (mmHg) at screening and at the end of the lead-in period.

If participants are currently being treated for hypertension:

Are taking a stable dose of 1 or 2 antihypertensive medications for at least the previous 30 days. A combination antihypertensive medication from 2 classes is considered as 2 antihypertensive medications.
Are willing to discontinue the antihypertensive medications during the study.
Have seated SBP of ≥140 and <170 mmHg at the end of the lead-in period.
Have a body mass index (BMI) ≥18.5 and <40 kilograms/m^2.

Exclusion Criteria:

Have a history of severe hypertension (defined as SBP ≥180 mmHg and/or diastolic (DBP) ≥120 mmHg), secondary hypertension, symptomatic postural hypotension, or hospitalization due to hypertension.
Have SBP ≥180 mmHg and/or DBP ≥110 mmHg at screening, lead-in period, or randomization.
Have a history of hospitalization due to hyperkalemia, or history of drug discontinuation due to elevated serum potassium levels.
Have a serum potassium ≤3.5 or >5.0 millimoles per liter (mmol/L).
Have an estimated glomerular filtration rate (eGFR) <50 milliliters/minute/1.73 m^2.",25 mg titrated to 50 mg as tolerated of spironolactone (open label) administered orally once daily for 4 weeks.,ChEMBL:CHEMBL1393 | DrugBank:DB00421 | PubChem:5833,Spironolactone,[H][C@]12CC[C@]3(C)[C@]4(CCC(=O)O4)CC[C@@]3([H])[C@]1([H])[C@]([H])(SC(C)=O)CC1=CC(=O)CC[C@@]12C,C03DA01,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02195518,NCT02195518_EG000,No,All,Adult | Older Adult,Phase 4,213,"Inclusion Criteria:

Aged between 18-65years (inclusive). Male or female; a female is eligible to enter and participate in this study if she is of: Non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is post-menopausal); or,
Child-bearing potential, has a negative serum pregnancy test at baseline, and agrees to one of the following methods for avoidance of pregnancy during the period of the study and until 30 days after last dose of study medication: Oral contraceptive, either combined or progestogen alone, Injectable progestogen, Implants of levonorgestrel, Oestrogenic vaginal ring, Percutaneous contraceptive patches., Intrauterine device (IUD) or intrauterine system (IUS) showing that the expected failure rate is less than 1% per year as stated in the IUD or IUS product label, Has a male partner who is sterilised, Double barrier method: condom and an occlusive cap (diaphragm or cervical/vault caps) with a vaginal spermicidal agent (foam/gel/film /cream/suppository).
The ability to understand and sign a written informed consent prior to any study-related procedure and comply with the requirements of the study.
Positive HBsAg for more than 6 months, and anti-HBs negative.
Serum HBV DNA level >=200 IU/mL at study screening (Use central lab results).
Experienced multiple NAs treatment failure which is defined as HBV DNA greater than 200 IU/mL after at least two NAs treatment (at least 6 months continuous treatment for each NA(s), total duration is no less than 12 months). In addition, subjects judged by the treating physician to have adhered to previous NA therapy.
Agreement not to participate in any other investigational trials or to undertake other HBV systemic antiviral or interferon (IFN) regimens during participation in this study.

Exclusion Criteria:

Hepatocellular carcinoma as evidenced by one of the following: Suspicious foci on ultrasound or radiological examination, Normal ultrasound but a history of rising serum alpha-fetoprotein and serum alpha-fetoprotein >20 nanogram (ng) per mL at screening.
Clinical signs of decompensated liver disease at baseline. These may include but are not limited to:Total serum bilirubin >1.5 x Upper limit of the normal range (ULN), International Normalized Ratio >1.3, Serum albumin <32grams per Liter (g/L), History of clinical hepatic decompensation (e.g., ascites, variceal bleeding, or encephalopathy).
Creatinine clearance less than 70 milliliter per minutes (mL/min).
Alanine aminotransferase >10 times ULN at screening or history of acute exacerbation leading to transient decompensation.
Haemoglobin <8 grams per deciliter (g/dL), absolute neutrophil count <1.0 x 10^9 per Liter, platelets <75 x 10^9 per Liter.
Documented co-infection with hepatitis A (HAV), hepatitis C (HCV), hepatitis delta virus (HDV), hepatitis E virus (HEV) or Human immunodeficiency virus (HIV). For HCV co-infection, subjects who are anti-HCV positive and in whom HCV RNA is undetectable are considered to be not eligible for enrolment.
Evidence of active liver disease due to autoimmune hepatitis (antinuclear antibody titre >1:160)
Any serious or active medical or psychiatric illnesses other than hepatitis B which, in the opinion of the Investigator, would interfere with subject treatment, assessment or compliance with the protocol. This would include any uncontrolled clinically significant renal, cardiac, pulmonary, vascular, neurogenic, digestive, metabolic (diabetes, thyroid disorders, adrenal disease), immunodeficiency disorders, pathological fractures or cancer.
Active alcohol or drug abuse or history of alcohol or drug abuse considered by the Investigator to be sufficient to hinder compliance with treatment, participation in the study or interpretation of results.
A female who is breastfeeding or plan to breast.
Use of immunosuppressive therapy, immunomodulatory therapy [including Pegylated interferon (PEG-IFN) and short-acting interferon or thymosin alpha], systemic cytotoxic agents within the previous 6 months prior to screening.
Planned for liver transplantation or previous liver transplantation.
Receipt of TDF within 6 months prior to screening.
Therapy with nephrotoxic drugs (e.g., aminoglycosides, amphotercin B, vancomycin, cidofovir, foscarnet, cis-platinum, pentamidine etc.) or competitors of renal excretion (e.g., probenecid) within 2 months prior to study screening or the expectation that subject will receive any of these during the course of the study.
History of hypersensitivity to nucleoside and/or nucleotide analogues and/or any component of study medication.
Inability to comply with study requirements as determined by the study Investigator.",Participants received an open-label treatment of Tenofovir Disoproxil Fumarate 300 mg orally once daily for 144-weeks.,PubChem:5486830 | PubChem:6398764,Tenofovir Disoproxil Fumarate,CC(C)OC(=O)OCOP(=O)(COC(C)Cn1cnc2c(N)ncnc21)OCOC(=O)OC(C)C.O=C(O)C=CC(=O)O,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02201251,NCT02201251_EG000,No,All,Child,Phase 3,28,"Inclusion Criteria:

Participant with a clinical diagnosis of new-onset or recent-onset epilepsy characterized by partial-onset seizures (POS) (with or without secondary generalization) or primary generalized tonic-clonic seizures (PGTCS) in accordance with criteria of the International League Against Epilepsy. The epilepsy diagnosis must be within the previous 2 years before screening
Caregivers (parents or legally acceptable representatives) of the participant must be able to accurately maintain the participant take-home record and seizure diary
At screening, participant must have weight and height values within the 5th to 95th percentile for chronological age (based on standard Child Height and Weight Charts from the Centers for Disease Control [CDC])
Participant must never have been treated for epilepsy (treatment-naïve) or have been treated with no more than 1 standard antiepileptic drug (AED) if temporary or urgent AED use was necessary. Previous AED exposure must not exceed either of the following: 1.)Thirty-one days immediately preceding enrollment, or 2.)A total of 6 months of previous AED exposure in the past if the AED has been discontinued for at least 1 year prior to enrollment
Parents (or legally acceptable representatives) of the participant must sign an informed consent/permission document, indicating that they understand the purpose of and procedures required for the study and are willing to give permission for their child to participate in the study. Participant 7 years of age and older, capable of understanding the nature of the study, must provide assent for their participation

Exclusion Criteria:

Participant has a surgically implanted and functioning vagus nerve stimulator
Participant has a history of seizures as a result of a correctable medical condition, such as metabolic disturbance, toxic exposure, neoplasm, or active infection within 2 weeks prior to the first day of Screening
Participant has had uncontrolled seizures while previously taking either topiramate or levetiracetam
Participant has a history of non-epileptic seizures within 2 weeks prior to the first day of Screening
Participant has myoclonic or absence seizures","Participants received topiramate weight-based sprinkle capsule and tablet, as tolerated (not to exceed 350 milligrams per day [mg/day] for participants 2 to less than [<] 10 years of age, and not to exceed 400 mg/day for participants 10 to 15 years of age), twice daily (BID) for up to 1 year during open-label treatment phase. Participants were to either continue on commercially available topiramate or were tapered off of study drug over a period of up to 2 weeks during post-treatment phase of 30 days.",ChEMBL:CHEMBL220492 | DrugBank:DB00273 | PubChem:5284627,Topiramate,[H][C@@]12OC(C)(C)O[C@]1([H])CO[C@@]1(COS(N)(=O)=O)OC(C)(C)O[C@]12[H],A08AA51 | N03AX11,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT02204579,NCT02204579_EG000,No,All,Adult | Older Adult,Phase 2,5,"Inclusion Criteria:

Subjects with a heterozygous activating mutation of the CaSR gene (ADH); if not previously confirmed, genetic testing will be performed at the screening visit
At least 18 years of age
Body mass index (BMI) ≥ 18.5 to < 39 kg/m2

Exclusion Criteria:

Diseases or conditions that might compromise any major body system or interfere with the pharmacokinetics of NPSP795
History of treatment with PTH 1-84 or 1-34 within the previous 6 months
History of hypocalcemia requiring frequent IV calcium infusions
History of hypocalcemic seizure within the past 3 months
Blood 25-hydroxy vitamin D level < 25 ng/mL. If subjects have a blood 25-hydroxy vitamin D level < 25 ng/mL at the outpatient screening visit, they will be prescribed vitamin D replacement. Once the 25-hydroxy vitamin D level is > 25 ng/mL, the subject will be eligible to continue on to the treatment phase of the study
Estimated glomerular filtration rate (GFR) < 25 mL/minute, and/or abnormal hepatic, hematologic, and/or clotting function
12 lead resting electrocardiogram (ECG) with clinically significant abnormalities
Concomitant medications with the potential to interfere with NPSP795 metabolism
History of thyroid or parathyroid surgery","NPSP795 administered Intravenous (IV) infusion for 10 min on Day 1 if certain criteria for ionized calcium and/or blood parathyroid hormone (PTH) were met, an infusion was administered for either 10 min or 3.5 hours on Days 2 & 3, according to a predefined dose escalation scheme. NPSP795 was administered as a 3.5-hour infusion on Day 4, or the participant underwent discharge procedures.",PubChem:9910902,SB-423562,CC(C)(CC1Cc2ccccc2C1)NCC(O)COc1cc(CCC(=O)O)ccc1C#N,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02204917,NCT02204917_EG000,No,All,Child | Adult,Phase 1 | Phase 2,30,"Inclusion criteria:

Children 2-18 years (first age cohort).
Children 0-18 years (second age cohort).
Referred to the Children's Hospital of Philadelphia (CHOP) for the performance of the clinically indicated Voiding Cystourethrography (VCUG) examination.
Parental/guardian permission (informed consent) and if appropriate, child's assent for additional performance of contrast enhanced Voiding Urosonography (ceVUS) examination.

Exclusion criteria:

Hypersensitivity to perflutren, blood, blood products or albumin.
Children requiring sedation for VCUG or ceVUS examinations.
Parents/guardians or subjects who, in the opinion of the principal investigator, may be non-compliant with study schedules or procedures.","OPTISON will be resuspended just before the performance of ceVUS examination, and 0.1%-0.5% of the bladder filling volume OPTISON / normal saline solution will be used for intravesical administration. The exact OPTISON dose (ml) will be adjusted according to the age-related bladder filling capacity with the maximum OPTISON dose (ml) range from 0.3 mL in newborns to 3 mL in 18 year-old children.

VCUG exam will be performed using the same bladder catheter with intravesical administration of the x-ray contrast agent.",ChEMBL:CHEMBL1663 | DrugBank:DB00556 | PubChem:6432,Perflutren,FC(F)(F)C(F)(F)C(F)(F)F,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02205983,NCT02205983_EG002,Accepts Healthy Volunteers,All,Adult,Not Applicable,50,"Inclusion Criteria:

Healthy adult volunteers

Exclusion Criteria:

any current medical condition requiring medication or abnormal electrocardiogram
current or past medical condition considered to be a contraindication for the study conditions
any current Axis I psychiatric disorder (APA, 1994) including Substance Use Disorder, or Anxiety Disorder or Major Depression in the past year, any history of psychosis
less than high school education
lack of fluency in English
night shift work
Pregnancy, lactation or plans to become pregnant.
Use of hormonal contraception.
Daily cigarette smokers i.e., >7 cigarettes per week","Healthy adult volunteers will receive 1000 mg acetaminophen. Acetaminophen is a COX inhibitor that is used clinically as an analgesic and antipyretic. The dose administered here has been shown to reduce neural and subjective responses to social rejection, and it also peaks about 60 min after ingestion.

1000 mg Acetaminophen: We are administering sublingual buprenorphine to healthy volunteers to measure its effects on the performance of a verbal task.",ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02206685,NCT02206685_EG000,Accepts Healthy Volunteers,All,Child,Phase 4,32,"Inclusion Criteria:

Patient age 10 - 17 years
Patients undergoing multilevel thoraco-lumbar spine surgery with instrumentation and fusion

Exclusion Criteria:

Preoperative methadone therapy
Inability to use the PCA
Allergy to methadone or morphine
Morbid obesity with a body mass index >36.0 kg/m2
Patients with chronic renal failure defined by serum creatinine >2.0 mg/dL
Liver failure defined as a history of cirrhosis or fulminant hepatic failure
Preoperative congenital heart disease or arrhythmias
Patient refusal to participate in study
Pregnancy (It is standard of care for all post menarche female patients to undergo a urine pregnancy test prior to surgery).","The treatment group will receive 0.2 mg/kg methadone diluted to a 20 ml infusion over 10 minutes.

Methadone: The treatment group will receive 0.2 mg/kg methadone diluted to a 20 ml infusion over 10 minutes",ChEMBL:CHEMBL350719 | ChEMBL:CHEMBL651 | DrugBank:DB00333 | DrugBank:DB15198 | PubChem:4095 | PubChem:643985,Methadone,CCC(=O)C(CC(C)N(C)C)(c1ccccc1)c1ccccc1,N02AC52 | N07BC02,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT02207608,NCT02207608_EG000,No,All,Adult | Older Adult,Phase 2,15,"Inclusion Criteria:

Histologically proven non-muscle invasive bladder cancer;
Indication to intravesical instillation of BCG according to EAU guidelines;
Age > 18 years;
Willingness, to participate to the study;
Written informed consent.

Exclusion Criteria:

Previous or ongoing BCG or different intravesical instillations;
Urinary tract infections (UTI) or other known pathologies of the lower urinary tract;
Indication for a radical cystectomy;
Severe systemic disorders, including neurological pathologies, kidney, liver or heart failure;
Contraindications to BCG use.","Group A receive BCG (Immucist® 81 mg, Sanofi-Aventis Group) alone

BCG (Immucist®)",ChEMBL:CHEMBL3989866 | DrugBank:DB11799 | PubChem:90311989,Bictegravir,O=C(NCc1c(F)cc(F)cc1F)c1cn2c(c(O)c1=O)C(=O)N1[C@H]3CC[C@H](C3)O[C@@H]1C2,J05AR20,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02212587,NCT02212587_EG000,No,All,Child | Adult | Older Adult,Phase 1,10,"Inclusion Criteria:

Age 6 years or older
Diagnosis of CF based on the following: sweat chloride>60 mEq/L or genotype with 2 identifiable mutations consistent with CF; and one or more clinical features consistent with CF.
Chronically infected with a Burkholderia cepacia complex species (>50% of respiratory specimens positive in the 24 months prior to screening).
Able to produce sputum (expectorated or induced).
Able to reproducibly perform pulmonary function testing.
Written informed consent provided.

Exclusion Criteria:

Post lung transplantation.
Pregnancy.
Acute exacerbation requiring IV or oral antibiotics within 14 days
Patients currently receiving inhaled tobramycin/TOBI
A septic or clinically unstable patient, as determined by the investigator.",TOBI: New inhalation devices such as the podhaler can administer tobramycin inhalation powder TIP/TOBI and achieve very high sputum drug levels. TOBI will be administered using the Podhaler,ChEMBL:CHEMBL1747 | DrugBank:DB00684 | PubChem:36294,Tobramycin,NC[C@H]1O[C@H](O[C@H]2[C@H](O)[C@@H](O[C@H]3O[C@H](CO)[C@@H](O)[C@H](N)[C@H]3O)[C@H](N)C[C@@H]2N)[C@H](N)C[C@@H]1O,J01GB01 | S01AA12,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02213900,NCT02213900_EG000,No,All,Adult | Older Adult,Phase 4,68,"Inclusion Criteria:

At least ≥ 18 years of age and older
Undergoing a possible or scheduled thoracotomy
English speaking

Exclusion Criteria:

History of Schizophrenia and Parkinson's disease
History of Severe Dementia
History of Alcohol Abuse
On Cholinesterase Inhibitors or Levodopa
Pregnant or Nursing
Corrected QT interval > 550 milliseconds at the time of randomization
History of Neuroleptic Malignant Syndrome or Haloperidol Allergy","Randomized patients will receive 0.5mg Haloperidol immediately after surgery and Q8H following the initial dose for a total of 4 days.

Haloperidol: 0.5mg IV Push immediately after surgery and Q8H following for a total of 4 days",ChEMBL:CHEMBL54 | DrugBank:DB00502 | PubChem:3559,Haloperidol,O=C(CCCN1CCC(O)(c2ccc(Cl)cc2)CC1)c1ccc(F)cc1,N05AD01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02223364,NCT02223364_EG001,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 4,55,"Inclusion Criteria:

Adult patients with an American Society of Anesthesiologists (ASA) physiological status I-III
Patients presenting for unilateral primary total knee replacement.
No focal neurologic deficit of the surgical lower extremity.
Cognitively intact with the ability to sign informed consent

Exclusion Criteria:

Chronic pain syndromes such as fibromyalgia or complex regional pain syndrome
History of long term use of daily opioids (>1 months) with oral morphine equivalent (OME) >5mg/day.
Body mass index (BMI) > 40 kg/m2
Allergies to medications used in this study such as: fentanyl, hydromorphone, ketorolac, ibuprofen, acetaminophen, local anesthetics, oxycodone, OxyContin, tramadol, ondansetron, droperidol, or dexamethasone, celecoxib

Major systemic medical problems such as:

Severe renal disorder defined as glomerular filtration rate (GFR) <50 units/m2
Cardiovascular disorders defined as congestive heart failure (CHF) New York Heart Association (NYHA) class III-IV
Severe hepatic disorder defined as current or past diagnosis of acute/subacute necrosis liver, acute hepatic failure, chronic liver disease, cirrhosis (primary biliary cirrhosis), fatty liver, chronic hepatitis/toxic hepatitis, liver abscess, hepatic coma, hepatorenal syndrome, other disorders of liver.
Impaired cognitive function or inability to understand the study protocol
Contraindication to a regional anesthesia technique (e.g., preexisting neuropathy in the operative extremity, coagulopathy [platelets < 100,000, International Normalized Ratio (INR) >1.5], refusal, etc.).
Previous contralateral knee replacement managed with regional or periarticular injection
Unable to follow-up at the 3 month interval at Mayo Clinic in Rochester, Minnesota
Pregnancy or breast feeding (women of child-bearing potential, must have a negative pregnancy test)","This group received intra articular injection with Ropivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.",PubChem:53262281,Naropin,CCC[NH+]1CCCCC1C(=O)Nc1c(C)cccc1C.O.[Cl-],,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02224456,NCT02224456_EG000,No,All,Adult,Phase 4,195,"Inclusion Criteria:

Age 18-60 years(inclusive);
Presence of HBsAg in serum at screening and for at least 6 months before screening assessment;
Serum HBV DNA>=2000 IU/mL if HBeAg positive at screening (with or without ALT elevation); or serum HBV DNA>=200IU/mL if HBeAg negative at screening (with or without ALT elevation);
Clinically diagnosed as advanced fibrosis or compensated cirrhosis defined as both of following : liver stiffness measure (LSM) >12.4 kiloPascals (kpa) (ALT> Upper limit of normal [ULN]) or LSM>9.0 kpa (ALT<=ULN); One of following: Liver biopsy showing advanced fibrosis or cirrhosis (Ishak score >=4, within the previous 6 months before screening and provided that no treatment likely to improve liver histology has been taken since). The slides must be available for review by an independent histopathologist; Endoscopy-proven gastroesophageal or gastric varices, non-cirrhotic portal hypertension excluded; Abdominal ultrasound or CT found changes indicating cirrhosis, irregular liver surface or nodularity, with/without splenomegaly (depth of spleen>4.0cm or spleen length>13cm); Blood platelets <100 x10^9/L (and other causes of thrombocytopenia excluded);
Ability to give written informed consent;
A female is eligible to enter and participate in this study if she is of: non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is post-menopausal), or Child-bearing potential, has a negative urine pregnancy test at screening, and agrees to one of the following methods for avoidance of pregnancy during the period of the study and until 30 days after last dose of study medication: Oral contraceptive, either combined or progestogen alone; Injectable progestogen; Implants of levonorgestrel; Oestrogenic vaginal ring; Percutaneous contraceptive patches; Intrauterine device (IUD) or intrauterine system (IUS) showing that the expected failure rate is less than 1% per year as stated in the IUD or IUS product label; Has a male partner who is sterilised; Double barrier method: condom and an occlusive cap (diaphragm orcervical/vault caps) with a vaginal spermicidal agent (foam/gel/film /cream/suppository).
Agreement not to participate in any other investigational trials or to undertake other HBV systemic antiviral or interferon (IFN) regimens during participation in this study.

Exclusion Criteria:

Hepatocellular carcinoma as evidenced by one of the following: Suspicious foci on ultrasound or radiological examination; Normal ultrasound serum alpha-fetoprotein >50 nanograms (ng)/mL at screening.
Serum ALT >10 times ULN at screening or history of acute exacerbation leading to transient decompensation;
Documented co-infection with hepatitis A (HAV), hepatitis C (HCV), hepatitis delta virus (HDV), hepatitis E virus (HEV) or human immunodeficiency virus (HIV). For HCV co-infection, subjects who are anti-HCV positive and in whom HCV ribonucleic acid (RNA) is undetectable are considered to be not eligible for enrolment.
Evidence of active liver disease due to autoimmune hepatitis (antinuclear antibody (ANA) titre >1:160).
Decompensated liver disease as indicated by any of the following: serum bilirubin >1.5 xULN prothrombin time activity <60% or International normalized ratio (INR)>1.5; serum albumin <32 grams per liter (g/L); history of previous clinical hepatic decompensation (e.g., ascites, variceal bleeding, or encephalopathy);
Planned for liver transplantation or previous liver transplantation;
Creatinine clearance less than 70 mL/minute (min);
Haemoglobin <10 g/deciliter (dL), white blood cell (WBC) count <1.5 x 10^9/liter (L), platelets <=50 x 10^9/L;
Any serious or active medical or psychiatric illnesses other than hepatitis B which, in the opinion of the Investigator, would interfere with subject treatment, assessment or compliance with the protocol. This would include any uncontrolled clinically significant renal, cardiac, pulmonary, vascular, neurogenic, digestive, metabolic (diabetes, thyroid disorders, adrenal disease), immunodeficiency disorders, pathological fractures or cancer;
Active alcohol or drug abuse or history of alcohol or drug abuse considered by the Investigator to be sufficient to hinder compliance with treatment, participation in the study or interpretation of results;
A female who is breastfeeding or plan to breastfeed;
Use of immunosuppressive therapy, immunomodulatory therapy (including IFN or thymosin alpha), systemic cytotoxic agents, chronic antiviral agents including Chinese herbal medicines known to have activity against HBV (e.g., lamivudine (LAM), adefovir, entecavir (ETV), telbivudine (LdT) or hepatitis B immunoglobulin (HBIg)) within the previous 6 months prior to screening into this study;
Have ever received TDF or any medicinal products containing the above mentioned antiviral agents or any investigative anti-HBV treatments (e.g., emtricitabine (FTC), (2R,4R)-4-(2,6-Diaminopurin-9-yl)-1,3-dioxolan-2-yl]methanol (DAPD) and 1-(2-fluoro-5-methyl-beta, Larabinofuranosyl) uracil (L-FMAU));
History of hypersensitivity to nucleoside and/or nucleotide analogues and/or any component of study medication;
Therapy with nephrotoxic drugs (e.g., aminoglycosides, amphotercin B, vancomycin, cidofovir, foscarnet, cis-platinum, pentamidine etc.) or competitors of renal excretion (e.g., probenecid) within 2 months prior to study screening or the expectation that subject will receive any of these during the course of the study;
Inability to comply with study requirements as determined by the study Investigator",Participants received Tenofovir Disoproxil Fumarate 300 mg tablet once daily (QD) orally for 240 weeks.,PubChem:5486830 | PubChem:6398764,Tenofovir Disoproxil Fumarate,CC(C)OC(=O)OCOP(=O)(COC(C)Cn1cnc2c(N)ncnc21)OCOC(=O)OC(C)C.O=C(O)C=CC(=O)O,,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,1.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT02224846,NCT02224846_EG000,No,Male,Adult | Older Adult,Phase 4,210,"Inclusion Criteria:

Have a history of erectile dysfunction for at least 3 months.
Are sexually active and willing to remain sexually active with the same female partner during the study.
Are willing to have 4 or more attempts of sexual intercourse with female partner between screening and first treatment start day.
Are willing to stay away from any other medicines that the participants were already taking for erectile dysfunction during this study period.

Exclusion Criteria:

Have erectile dysfunction, which is caused by any other primary sexual disorder.
Have certain problems with kidneys, liver, heart, blood sugar levels, eyes, or central nervous system (study doctor will discuss with participants).
Have a penis deformity or penile implant that in the opinion of the participants' doctor is significant.
Have human immunodeficiency virus (HIV) infection.
Are using certain kinds of medicines, which are not allowed in this study.
Are allergic to tadalafil.
Are planning to father a baby or are in a relationship with a pregnant partner.
Are participating or discontinued participation in the past 30 days from any another clinical trial, which is not compatible with this trial.
Have participated or discontinued from any other tadalafil clinical trial.
Have a history of drug, alcohol, or substance abuse within the past 6 months.",2.5 mg tadalafil orally once daily for 3 months (Period 1) and then 5 mg tadalafil orally once daily for 21 months (Period 2).,ChEMBL:CHEMBL779 | DrugBank:DB00820 | PubChem:110635,Tadalafil,[H][C@]12Cc3c([nH]c4ccccc34)[C@@H](c3ccc4c(c3)OCO4)N1C(=O)CN(C)C2=O,C02KX52 | C02KX54 | G04BE08 | G04CA54 | G04CB51,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02224846,NCT02224846_EG001,No,Male,Adult | Older Adult,Phase 4,421,"Inclusion Criteria:

Have a history of erectile dysfunction for at least 3 months.
Are sexually active and willing to remain sexually active with the same female partner during the study.
Are willing to have 4 or more attempts of sexual intercourse with female partner between screening and first treatment start day.
Are willing to stay away from any other medicines that the participants were already taking for erectile dysfunction during this study period.

Exclusion Criteria:

Have erectile dysfunction, which is caused by any other primary sexual disorder.
Have certain problems with kidneys, liver, heart, blood sugar levels, eyes, or central nervous system (study doctor will discuss with participants).
Have a penis deformity or penile implant that in the opinion of the participants' doctor is significant.
Have human immunodeficiency virus (HIV) infection.
Are using certain kinds of medicines, which are not allowed in this study.
Are allergic to tadalafil.
Are planning to father a baby or are in a relationship with a pregnant partner.
Are participating or discontinued participation in the past 30 days from any another clinical trial, which is not compatible with this trial.
Have participated or discontinued from any other tadalafil clinical trial.
Have a history of drug, alcohol, or substance abuse within the past 6 months.",5 mg tadalafil orally once daily for 24 months (Period 1 and Period 2).,ChEMBL:CHEMBL779 | DrugBank:DB00820 | PubChem:110635,Tadalafil,[H][C@]12Cc3c([nH]c4ccccc34)[C@@H](c3ccc4c(c3)OCO4)N1C(=O)CN(C)C2=O,C02KX52 | C02KX54 | G04BE08 | G04CA54 | G04CB51,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT02230384,NCT02230384_EG000,No,All,Adult | Older Adult,Phase 2,60,"Inclusion Criteria: List the specific criteria for inclusion of potential subjects.

Men or women of any race, ages 18 to 65 years, (≥18 years, ≤ 66 years)
Willing to provide written informed consent
MINI (Sheehan et al 1998, 2008) chart and/or clinician consensus affirmed DSM IV TR or (DSM -V) diagnoses of schizophrenia or schizoaffective disorder.
Patients whose PANSS total scores have been stable for ≥ 4 weeks (clinician and/or subject affirmed) and at ≤ 70
No recent ( ≤ 3months) hospitalization, aggression, or suicidal attempts
Stable doses of antipsychotic medication, ≥ 4 weeks

Smoking Inclusion Criteria:

Smoke ≥ 5 cigarettes/day
Smoking cigarettes ≥ 1 year

Exclusion Criteria:

Smoking/Nicotine Exclusions:

Use of smokeless tobacco or snuff or chewing tobacco
Use of e-cigarettes, or any non-tobacco nicotine products (e.g. nicotine gum, lozenges, patch, etc.)
Current enrollment or plans to enroll in another smoking cessation program. (Bupropion use for depression will be assessed on a case by case basis)

Alcohol/Illicit Substance Exclusion Criteria:

Recent alcohol or substance dependence (≤ 3 months)
Current alcohol consumption that exceeds 15 standard drinks/week or greater than 2 standard drinks daily

Medical Exclusion Criteria:

Women who are pregnant, planning a pregnancy, or lactating; all female participants shall undergo a pregnancy test at screening and will be excluded if positive.
Serious or unstable medical disorder within the past 3 months (assessed by the investigators)
Epilepsy
Current diagnosis (within last 6-months) of abnormal cardiac rhythms; unstable cardiovascular disease e.g. stroke, myocardial infarction in the last 6 months
Evidence impaired liver function test (LFT) defined as serum glutamate oxaloacetate transaminase (SGOT) (AST) or serum glutamate pyruvate transaminase (SGPT) (ALT) or alkaline phosphatase greater than 1x the upper limit of normal, or bilirubin 1x the upper limit of normal
Evidence of kidney failure defined as: Serum creatinine > 1.8 mg/dl for males and 1.6 mg/dl for females.
Any subject with a history of hematological cancers examples: leukemia, lymphoma etc. will be excluded.
Any clinically significant hematological laboratory abnormality (chronic low-grade laboratory values just above or below the reference range that are without clinical significance will be permitted) will be grounds for exclusion.

Medication Exclusion Criteria:

Current use or recent discontinuation (within last 14-days) of the following medications: any form of smoking cessation medication (Bupropion except when used for Depressive Disorders on a case by case basis, Varenicline, NRT); and (b) opiate-containing medications for chronic pain. Potent CYP 3A4 inhibitors will be reviewed for exclusion, see below.
In view of novel drug being a moderate CYP3A4 inhibitor, any subjects receiving the following narrow therapeutic index CYP3A4 substrates will be excluded: Alfentanil, astemizole, cisapride, cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, tacrolimus, terfenadine.
In view of the impact of clozapine on smoking cessation, patients receiving clozapine will be excluded.
Stable medical conditions examples: hypertension, diabetes, dyslipidemia etc that are treated and ongoing and patients are not receiving the exclusionary drugs noted above will be considered for inclusion on a case by case basis.",Period during which participants received Active JNJ Drug: 200 mg/day (100 mg b.i.d.),DrugBank:DB11867 | PubChem:16755766,JNJ-39393406,CN(C)C(=O)CCn1nc(Nc2ccc3c(c2)OC(F)(F)O3)nc1-c1ccncc1,,0.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT02232061,NCT02232061_EG000,No,All,Adult,Phase 4,6,"Inclusion Criteria:

Patients participating in study FTY720D2406 who experienced a serious cardiovascular event during their fingolimod treatment initiation or re-initiation which led to overnight monitoring or met seriousness criteria.
Patients still on fingolimod after the this first dose serious event

Exclusion Criteria:

-Treatment with any investigational drug unless it is received as part of a Novartis sponsored MS study lasting less than 1 month",Fingolimod 0.5mg/day tablets taken orally,ChEMBL:CHEMBL314854 | DrugBank:DB08868 | PubChem:107970,Fingolimod,CCCCCCCCc1ccc(CCC(N)(CO)CO)cc1,L04AA27,1.0,0.0,0.0,0.0,1.0,0.0,1.0,1.0,0.0,0.0,1.0,1.0,0.0,1.0,1.0,1.0,1.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0
NCT02232399,NCT02232399_EG000,No,All,Child,Phase 2,38,"Inclusion Criteria:

Provision of informed consent prior to any study specific procedures
Female and male children between 1 and 12 months of age
Non-restrictive VSD (corrective surgery)
Complete AVSD (biventricular repair)
Tetralogy of Fallot

Exclusion Criteria:

Unbalanced AtrioVentricular Septal Defect or AVSD with cyanosis
Age less than one month and more than one year
Acute operation that is unscheduled operation during the first 24 hours after presentation to the department for thoracic surgery
Mild, moderate, or severe kidney dysfunction and known anatomical anomalies of kidneys
Liver impairment or disease
Ongoing infection
Use of nephrotoxic drugs (like ibuprofen, angiotensin-converting-enzyme inhibitors, gentamicin, vancomycin) preoperative or postoperative until first post operative day. Contrast agents whithin 24 hours before operation.
Use of inhibitors of membrane transport proteins (cimetidine, cetirizine, trimethoprim, probenecid, rifampin and gemfibrosil).
Allergy to Levosimendan or substance included in the preparation or previous use of Levosimendan.
Severe arrhythmias needing pace-maker treatment prior to the operation
Severe cardiac dysfunction needing for treatment with extracorporeal membrane oxygenation (ECMO) prior to the operation.
Preoperative need for mechanical ventilation and/or inotropic agents.
Re-operation (open heart surgery). Earlier surgical closure of the arterial duct does not count as an exclusion criteria.
Prematurity: Gestational age < 30 weeks, irrespective of postpartum age. Gestational age 30-34 weeks if patient is included at postpartum age under 3 months.",Patients who received milrinone,ChEMBL:CHEMBL189 | DrugBank:DB00235 | PubChem:4197,Milrinone,Cc1[nH]c(=O)c(C#N)cc1-c1ccncc1,C01CE02,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02235077,NCT02235077_EG000,No,All,Adult | Older Adult,Phase 2,182,"Inclusion Criteria:

Male or female patient ≥21 years old
Admitted to hospital for AHF with at least 1 symptom (dyspnea, orthopnea, or fatigue) and 1 sign (rales on auscultation, peripheral edema, ascites, pulmonary vascular congestion on chest radiography) of congestion
Patient must be randomized within 24 hours of first IV diuretic dose administered for the current episode of decompensation (regardless of where the diuretic was given e.g. office, ED, ambulance, hospital etc.)
Estimated GFR of ≥30 mL/min/1.73m2 determined by the MDRD equation
Serum K+ ≤5.0 mmol/L at enrollment
NT-proBNP ≥1000 pg/mL or BNP ≥250 pg/mL, measured within 24h from randomization
Not on MRA or on low-dose spironolactone (12.5 mg or 25 mg daily) at baseline

Exclusion Criteria:

Taking eplerenone or >25 mg spironolactone at baseline
eGFR < 30 ml/min/1.73m2
Serum K+ >5.0 mmol/L. If a repeat measurement within the enrollment window is <5.0, the patient can be considered for inclusion.
Systolic blood pressure <90 mmHg
Hemodynamically significant arrhythmias or defibrillator shock within 1 week
Acute coronary syndrome currently suspected or within the past 4 weeks
Severe liver disease (ALT or AST >3 x normal, alkaline phosphatase or bilirubin >2x normal)
Active infection (current use of oral or IV antimicrobial agents)
Active gastrointestinal bleeding
Active malignancy other than non-melanoma skin cancers
Current or planned mechanical circulatory support within 30 days
Post cardiac transplant or listed for transplant and expected to receive one within 30 days
Current inotrope use
Complex congenital heart disease
Primary hypertrophic cardiomyopathy, infiltrative cardiomyopathy, acute myocarditis, constrictive pericarditis or tamponade
Previous adverse reaction to MRAs
Enrollment in another randomized clinical trial during index hospitalization","Spironolactone 25mg or 100 mg orally, once daily while in the hospital for 96 hours

Spironolactone: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.

Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours.",ChEMBL:CHEMBL1393 | DrugBank:DB00421 | PubChem:5833,Spironolactone,[H][C@]12CC[C@]3(C)[C@]4(CCC(=O)O4)CC[C@@]3([H])[C@]1([H])[C@]([H])(SC(C)=O)CC1=CC(=O)CC[C@@]12C,C03DA01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02236520,NCT02236520_EG000,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 2,16,"Inclusion Criteria:

Age 30 to 80 years old;
Systolic blood pressures between 110 to 150 mmHg and/or diastolic blood pressure between 80-99 mmHg;
Ability to give informed consent.

Exclusion Criteria:

Pregnancy;
Intolerance to study protocols;
Acute cardiovascular events within the previous 6 months;
Impaired renal function [estimated glomerular filtration rate (GFR) < 45 ml/min/1.73m^2];
Current or recent treatment with systemic glucocorticoid therapy (within 1 month of enrollment);
Current use of anti-hypertensive medication (except calcium channel blockers and beta blockers);
Diabetes mellitus requiring medical therapy;
Morbid obesity (BMI > 45);
Prior adverse reaction to a thiazide or spironolactone;
Claustrophobia preventing the patient from having an MRI or other contraindications to MRI;
Impaired hepatic function (aspartate amino transaminase and/or alanine amino transaminase > 1.5x upper limit of normal range);
Current illicit drug use;

Sexually active women of childbearing potential** who are unwilling to practice adequate contraception during the study [adequate contraceptive measures include stable use of oral contraceptives or other prescription pharmaceutical contraceptives for 2 or more menstrual cycles prior to screening; intrauterine device (IUD); bilateral tubal ligation; vasectomy; condom plus contraceptive sponge, foam, or jelly, or diaphragm plus contraceptive sponge, foam, or jelly].

Postmenopausal women must be amenorrheic for at least 12 months in order not to be considered of child bearing potential. Pregnancy testing and contraception are not required for women with documented hysterectomy or tubal ligation.","50 mg capsule of Spironolactone administered orally 1 per day for 8 weeks

Spironolactone",ChEMBL:CHEMBL1393 | DrugBank:DB00421 | PubChem:5833,Spironolactone,[H][C@]12CC[C@]3(C)[C@]4(CCC(=O)O4)CC[C@@]3([H])[C@]1([H])[C@]([H])(SC(C)=O)CC1=CC(=O)CC[C@@]12C,C03DA01,0.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02238977,NCT02238977_EG000,No,All,Adult | Older Adult,Phase 4,1,"Inclusion Criteria:

age 30-70 yrs;
have patent and non-infected arteriovenous fistula or graft;
are receiving maintenance HD 3 times per week lasting for 3-4 hours;
serum albumin of ≥ 3.2 g/dl, serum phosphate of <6.5 mg/dl, and serum hemoglobin of ≥9 mg/dl in consecutive two blood tests as per the National Kidney Foundation Disease Outcomes Quality Initiative (NKF KDOQI) guidelines [subjects failing screening due to blood test will be allowed to be re-screened in 30 days];
receiving stable or maintenance dose of iron or erythropoietin-stimulating agents, statins, angiotension receptor blockers and/or angiotension converting enzyme inhibitors, phosphate binders, vitamin D receptor analogs as these agents may influence cytokines proposed in the study;
meet the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria for MDD;
have a Ham-D score > 17

Exclusion Criteria:

meet DSM-IV criteria for Bipolar Disorder or other psychotic disorder in the month prior to screening;
are taking antidepressants, anti-anxiety medications, or hypnotics (including Zyban for smoking cessation);
having failed to respond to or tolerate bupropion or fluoxetine in the past
allergic to fluoxetine or bupropion
known history of HIV/AIDS; No testing will be conducted for screening purposes
known history of alcohol or drug abuse or dependence within the month prior to screening based on clinical records;
history of myocardial infarction or heart failure within one month of screening or a history of seizures or stroke at any point;
history of chronic liver disease and diagnosis of hepatic encephalopathy based on clinical records;
currently diagnosed with cancer or receiving any cancer treatment;
history of any infection within the last 2 weeks ;
currently taking any antibiotics, anti-inflammatory, and immune-modulator agents;
recorded noncompliance with dialysis schedules; and
currently participating in clinical or behavioral intervention studies.
recorded noncompliance with dialysis schedules; and
currently participating in clinical or behavioral intervention studies","Fluoxetine up to 20 mg orally daily for 12 weeks. Flexible dosing between a minimum of 10 mg daily and 20 mg daily as tolerated.

Fluoxetine: Antidepressant",ChEMBL:CHEMBL41 | DrugBank:DB00472 | PubChem:3386,Fluoxetine,CNCCC(Oc1ccc(C(F)(F)F)cc1)c1ccccc1,N06AB03 | N06CA03,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02241486,NCT02241486_EG000,No,All,Adult | Older Adult,Phase 3,2,"Inclusion Criteria:

Subject capable of giving consent
Age 18-65
Total burn surface area greater than or equal to 5%
Opioid tolerant
BMI less than or equal to 35

Exclusion Criteria:

Subjects with cognitive or psychiatric impairment that would preclude study participation or compliance with protocol
Allergy to fentanyl, morphine, naloxone
Pregnancy, intent to become pregnant or lactating
Evidence of burn injury to oral mucosa
Active illicit drug use or illicit drug abuse history","Examine the efficacy and safety of sublingual fentanyl spray (Subsys) for procedural pain (dressing changes/minor debridement) in patients with burn injury.

Sublingual Fentanyl Spray: Patients with burn injuries will receive sublingual fentanyl spray (Subsys) for procedural pain (dressing changes/minor debridement).",ChEMBL:CHEMBL596 | DrugBank:DB00813 | PubChem:3345,Fentanyl,CCC(=O)N(c1ccccc1)C1CCN(CCc2ccccc2)CC1,N01AH01 | N01AH51 | N02AB03,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02243046,NCT02243046_EG002,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 2,162,"Inclusion Criteria

Subjects, ages 18-70, inclusive.
Availability for the six-month duration of the clinical research study.
Good General health.
Minimum of 20 uncrowned permanent natural teeth (excluding third molars).
Initial gingivitis index of at least 1.0 as determined by the use of the Loe and Silness Gingival Index.
Initial plaque index of at least 1.5 as determined by the use of the Quigley and Hein Plaque Index (Turesky Modification).
Signed Informed Consent Form.

Exclusion Criteria

Presence of orthodontic bands.
Presence of partial removable dentures.
Tumor(s) of the soft or hard tissues of the oral cavity.
Advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone).
Five or more carious lesions requiring immediate restorative treatment.
Antibiotic use any time during the one-month period prior to entry into the study.
Participation in any other clinical study or test panel within the one month prior to entry into the study.
Dental prophylaxis during the past two weeks prior to baseline examinations.
History of allergies to oral care/personal care consumer products or their ingredients.
On any prescription medicines that might interfere with the study outcome.
An existing medical condition that prohibits eating or drinking for periods up to 4 hours.
History of alcohol or drug abuse.
Pregnant or lactating subjects.",1450 ppm sodium fluoride/triclosan toothpaste Active Comparator: 1450 ppm sodium fluoride/triclosan toothpaste - Subjects will brush their whole mouth with this toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study.,PubChem:24848164,Sodium fluoride and triclosan,Oc1cc(Cl)ccc1Oc1ccc(Cl)cc1Cl.[F-].[Na+],,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02244619,NCT02244619_EG000,No,All,Adult | Older Adult,Phase 4,515,"Inclusion Criteria:

18 years of age and older
Able to provide written consent
Able to read and write in English
Weighing over 50 kg
Will undergo total hip or total knee joint replacement

Exclusion Criteria:

Non-verbal patients
Unable to use numeric pain scale
Allergic to the test article
Documented hepatic impairment or failure
Current illicit drug use
Requires traumatic or emergent surgery
Pregnant women
Women who are breastfeeding
Prisoners
Cognitively impaired requiring Legally Authorized Representative (LAR) or Power of Attorney (POA)
Unable to swallow oral capsules","Subjects receive 2 capsules each containing Tylenol 500 mg caplets. The test article administration will be initiated 60 minutes (± 15 minutes) prior to the scheduled surgery start time.

Oral acetaminophen: Subjects randomized to the Oral acetaminophen arm will receive 2 Tylenol 500mg capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving Oral acetaminophen will also receive 100ml of IV Normal Saline similar to the delivery method of the IV acetaminophen arm. The Normal Saline IV placebo will be given not as an intervention but rather as a method to maintain study integrity.",ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02244619,NCT02244619_EG001,No,All,Adult | Older Adult,Phase 4,515,"Inclusion Criteria:

18 years of age and older
Able to provide written consent
Able to read and write in English
Weighing over 50 kg
Will undergo total hip or total knee joint replacement

Exclusion Criteria:

Non-verbal patients
Unable to use numeric pain scale
Allergic to the test article
Documented hepatic impairment or failure
Current illicit drug use
Requires traumatic or emergent surgery
Pregnant women
Women who are breastfeeding
Prisoners
Cognitively impaired requiring Legally Authorized Representative (LAR) or Power of Attorney (POA)
Unable to swallow oral capsules","Subjects receive Ofirmev 1000 mg in 100 ml Normal Saline IV infusion. The test article will be given perioperatively at the discretion of the attending anesthesiologist.

IV acetaminophen: Subjects randomized to the IV acetaminophen arm will receive Ofirmev 1000mg in 100ml Normal Saline IV plus 2 placebo capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving IV acetaminophen will also receive 2 placebo capsules similar to the delivery method of the oral acetaminophen arm. The placebo capsules will be given not as an intervention but rather as a method to maintain study integrity.",ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02247245,NCT02247245_EG001,No,All,Adult | Older Adult,Not Applicable,40,"Inclusion criteria:

We will only include patients able to give informed written consent, which will be obtained in all subjects, and those capable of performing a peak exercise test. Since we are performing the study on three groups of patients, further inclusion criteria for each group are outlined below.

Inclusion criteria - CRT-sinus rhythm group We will enrol 25 patients with severe CHF on otherwise optimally tolerated medical therapy who have undergone cardiac resynchronisation therapy at least 3 months previously. These individuals will be on optimal medical therapy for their heart failure with no change in medication or exacerbation for the preceding 3 months. They will not currently be taking ivabradine.

Inclusion criteria - CRT-atrial fibrillation group We will enrol 25 patients with severe CHF on otherwise optimally tolerated medical therapy who have undergone cardiac resynchronisation therapy at least 3 months previously. All patients will be previously pacemaker dependant or have 'blocked' atrial fibrillation either due to medical therapy or previous atrio-ventricular nodal ablation.

Inclusion criteria - control group The control subjects (n=25) will be recruited from the general pacemaker clinic. They will undergo echocardiography to exclude structural heart disease. They will have no contraindications to exercise testing or ivabradine.

Exclusion Criteria:

We will exclude subjects with musculoskeletal disorders limiting exercise capacity, patients with peripheral vascular disease, those with inflammatory disorders such as rheumatoid arthritis, and airways disease. Other exclusions include contraindications to ivabradine use such as severe hepatic impairment, significant renal impairment (creatinine clearance <15ml.min-1), and long QT syndrome. We will only include patients able to give informed written consent, which will be obtained in all subjects.

-","Subjects are given an ivabradine capsule (double-blinded) to take 90 minutes prior to the cardiopulmonary exercise test.

Ivabradine: Ivabradine 7.5mg",ChEMBL:CHEMBL471737 | DrugBank:DB09083 | PubChem:132999,Ivabradine,COc1cc2c(cc1OC)CC(=O)N(CCCN(C)C[C@H]1Cc3cc(OC)c(OC)cc31)CC2,C01EB17 | C07FX05 | C07FX06,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02249767,NCT02249767_EG000,Accepts Healthy Volunteers,All,Child | Adult,Phase 3,230,"Inclusion Criteria:

Normal, healthy male and female children and adults aged 12 to 40 years
Written and verbal informed consent had to be obtained. Subjects aged 12 to 17 years, had to sign an assent for the study and a parent or a legal guardian had to sign the informed consent
Women of childbearing potential had to be non-pregnant and non-nursing, and had to be willing to avoid pregnancy during the course of the study and during the menstrual cycle following completion of their participation in the study. Adequate contraception was defined as systemic birth control, such as oral contraceptives, for three months prior and implantable/injectable contraceptives (e.g., Norplant, intrauterine device [IUD]) for six months prior to study drug administration; or barrier methods, such as diaphragm plus spermicide or condom plus spermicide, consistently for at least 14 days prior to study drug administration; or abstinence.
On the face, having ≥ 20 inflammatory (i.e., papules and pustules) and ≥ 25 non-inflammatory (i.e., open and closed comedones) lesions with ≤ 2 nodulocystic lesions (i.e, nodules and cysts), as per FDA Draft Guidance on Tretinoin, dated March 20
Able to refrain from the use of all other topical acne medications or antibiotics during the treatment period
Considered reliable and capable of understanding their responsibility and role in the study

Exclusion Criteria:

Presence of any skin condition that would interfere with the diagnosis or assessment of acne vulgaris (e.g., on the face: rosacea, dermatitis, psoriasis, squamous cell carcinoma, eczema, acneform eruptions caused by medications, steroid acne, steroid folliculitis, or bacterial folliculitis). Note: Eczema and psoriasis on the body are not exclusions.
Subjects with active cystic acne as evidenced by more than 2 facial nodules. Nodules are defined as in 7.3.3 as: deep-seated in the skin (i.e., centered in the dermis or subcutis) and greater than 5 mm in diameter.
More than 40 papules and/or pustules (inflammatory lesions).
More than 60 open and/or closed comedones/milia (non-inflammatory lesions).
Overall severity grade of less than 2 or greater than 4.
History of allergy or hypersensitivity to tretinoin, retinoids, or any of the study medication ingredients.
Significant history or clinical evidence of auto-immune, cardiovascular, gastrointestinal, hematological, hepatic, neurological, pancreatic, or renal disease.
Use within 6 months prior to baseline of systemic retinoid (isotretinoin) treatment or therapeutic vitamin A supplements of greater than 10,000 units/day (multivitamins are allowed).
Oral contraceptives started or changed within 3 months prior to study initiation or planned to change during the study.
Use on the face within 1 month prior to baseline of 1) cryodestruction or chemodestruction, 2) dermabrasion, 3) photodynamic therapy, 4) acne surgery, 5) intralesional steroids, or 6) x-ray therapy.
Use within 1 month prior to baseline of 1) spironolactone, 2) systemic steroids, 3) systemic antibiotics, 4) systemic treatment for acne vulgaris (other than oral retinoids, which require a 6-month washout), or 5) systemic anti-inflammatory agents.
Use within 2 weeks prior to baseline of 1) topical steroids, 2) topical retinoids, 3) topical acne treatments including over-the-counter preparations, 4) topical anti-inflammatory agents, or 5) topical antibiotics.
Pregnant or breast-feeding.
Serious psychological illness.
Significant history (within the past year) of alcohol or drug abuse.","Treatment of acne once daily over 12 weeks

Tretinoin: Treatment of acne once daily in evening",ChEMBL:CHEMBL38 | ChEMBL:CHEMBL547 | ChEMBL:CHEMBL705 | DrugBank:DB00523 | DrugBank:DB00755 | DrugBank:DB00982 | PubChem:444795 | PubChem:449171 | PubChem:5282379,Tretinoin,CC(C=CC1=C(C)CCCC1(C)C)=CC=CC(C)=CC(=O)O,D10AD01 | D10AD04 | D10AD51 | D10AD54 | D10BA01 | D11AH04 | L01XF01 | L01XF02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT02249767,NCT02249767_EG001,Accepts Healthy Volunteers,All,Child | Adult,Phase 3,229,"Inclusion Criteria:

Normal, healthy male and female children and adults aged 12 to 40 years
Written and verbal informed consent had to be obtained. Subjects aged 12 to 17 years, had to sign an assent for the study and a parent or a legal guardian had to sign the informed consent
Women of childbearing potential had to be non-pregnant and non-nursing, and had to be willing to avoid pregnancy during the course of the study and during the menstrual cycle following completion of their participation in the study. Adequate contraception was defined as systemic birth control, such as oral contraceptives, for three months prior and implantable/injectable contraceptives (e.g., Norplant, intrauterine device [IUD]) for six months prior to study drug administration; or barrier methods, such as diaphragm plus spermicide or condom plus spermicide, consistently for at least 14 days prior to study drug administration; or abstinence.
On the face, having ≥ 20 inflammatory (i.e., papules and pustules) and ≥ 25 non-inflammatory (i.e., open and closed comedones) lesions with ≤ 2 nodulocystic lesions (i.e, nodules and cysts), as per FDA Draft Guidance on Tretinoin, dated March 20
Able to refrain from the use of all other topical acne medications or antibiotics during the treatment period
Considered reliable and capable of understanding their responsibility and role in the study

Exclusion Criteria:

Presence of any skin condition that would interfere with the diagnosis or assessment of acne vulgaris (e.g., on the face: rosacea, dermatitis, psoriasis, squamous cell carcinoma, eczema, acneform eruptions caused by medications, steroid acne, steroid folliculitis, or bacterial folliculitis). Note: Eczema and psoriasis on the body are not exclusions.
Subjects with active cystic acne as evidenced by more than 2 facial nodules. Nodules are defined as in 7.3.3 as: deep-seated in the skin (i.e., centered in the dermis or subcutis) and greater than 5 mm in diameter.
More than 40 papules and/or pustules (inflammatory lesions).
More than 60 open and/or closed comedones/milia (non-inflammatory lesions).
Overall severity grade of less than 2 or greater than 4.
History of allergy or hypersensitivity to tretinoin, retinoids, or any of the study medication ingredients.
Significant history or clinical evidence of auto-immune, cardiovascular, gastrointestinal, hematological, hepatic, neurological, pancreatic, or renal disease.
Use within 6 months prior to baseline of systemic retinoid (isotretinoin) treatment or therapeutic vitamin A supplements of greater than 10,000 units/day (multivitamins are allowed).
Oral contraceptives started or changed within 3 months prior to study initiation or planned to change during the study.
Use on the face within 1 month prior to baseline of 1) cryodestruction or chemodestruction, 2) dermabrasion, 3) photodynamic therapy, 4) acne surgery, 5) intralesional steroids, or 6) x-ray therapy.
Use within 1 month prior to baseline of 1) spironolactone, 2) systemic steroids, 3) systemic antibiotics, 4) systemic treatment for acne vulgaris (other than oral retinoids, which require a 6-month washout), or 5) systemic anti-inflammatory agents.
Use within 2 weeks prior to baseline of 1) topical steroids, 2) topical retinoids, 3) topical acne treatments including over-the-counter preparations, 4) topical anti-inflammatory agents, or 5) topical antibiotics.
Pregnant or breast-feeding.
Serious psychological illness.
Significant history (within the past year) of alcohol or drug abuse.","Treatment of Acne once daily over 12 weeks

Tretinoin: Treatment of acne once daily in evening",ChEMBL:CHEMBL38 | ChEMBL:CHEMBL547 | ChEMBL:CHEMBL705 | DrugBank:DB00523 | DrugBank:DB00755 | DrugBank:DB00982 | PubChem:444795 | PubChem:449171 | PubChem:5282379,Tretinoin,CC(C=CC1=C(C)CCCC1(C)C)=CC=CC(C)=CC(=O)O,D10AD01 | D10AD04 | D10AD51 | D10AD54 | D10BA01 | D11AH04 | L01XF01 | L01XF02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT02249767,NCT02249767_EG002,Accepts Healthy Volunteers,All,Child | Adult,Phase 3,115,"Inclusion Criteria:

Normal, healthy male and female children and adults aged 12 to 40 years
Written and verbal informed consent had to be obtained. Subjects aged 12 to 17 years, had to sign an assent for the study and a parent or a legal guardian had to sign the informed consent
Women of childbearing potential had to be non-pregnant and non-nursing, and had to be willing to avoid pregnancy during the course of the study and during the menstrual cycle following completion of their participation in the study. Adequate contraception was defined as systemic birth control, such as oral contraceptives, for three months prior and implantable/injectable contraceptives (e.g., Norplant, intrauterine device [IUD]) for six months prior to study drug administration; or barrier methods, such as diaphragm plus spermicide or condom plus spermicide, consistently for at least 14 days prior to study drug administration; or abstinence.
On the face, having ≥ 20 inflammatory (i.e., papules and pustules) and ≥ 25 non-inflammatory (i.e., open and closed comedones) lesions with ≤ 2 nodulocystic lesions (i.e, nodules and cysts), as per FDA Draft Guidance on Tretinoin, dated March 20
Able to refrain from the use of all other topical acne medications or antibiotics during the treatment period
Considered reliable and capable of understanding their responsibility and role in the study

Exclusion Criteria:

Presence of any skin condition that would interfere with the diagnosis or assessment of acne vulgaris (e.g., on the face: rosacea, dermatitis, psoriasis, squamous cell carcinoma, eczema, acneform eruptions caused by medications, steroid acne, steroid folliculitis, or bacterial folliculitis). Note: Eczema and psoriasis on the body are not exclusions.
Subjects with active cystic acne as evidenced by more than 2 facial nodules. Nodules are defined as in 7.3.3 as: deep-seated in the skin (i.e., centered in the dermis or subcutis) and greater than 5 mm in diameter.
More than 40 papules and/or pustules (inflammatory lesions).
More than 60 open and/or closed comedones/milia (non-inflammatory lesions).
Overall severity grade of less than 2 or greater than 4.
History of allergy or hypersensitivity to tretinoin, retinoids, or any of the study medication ingredients.
Significant history or clinical evidence of auto-immune, cardiovascular, gastrointestinal, hematological, hepatic, neurological, pancreatic, or renal disease.
Use within 6 months prior to baseline of systemic retinoid (isotretinoin) treatment or therapeutic vitamin A supplements of greater than 10,000 units/day (multivitamins are allowed).
Oral contraceptives started or changed within 3 months prior to study initiation or planned to change during the study.
Use on the face within 1 month prior to baseline of 1) cryodestruction or chemodestruction, 2) dermabrasion, 3) photodynamic therapy, 4) acne surgery, 5) intralesional steroids, or 6) x-ray therapy.
Use within 1 month prior to baseline of 1) spironolactone, 2) systemic steroids, 3) systemic antibiotics, 4) systemic treatment for acne vulgaris (other than oral retinoids, which require a 6-month washout), or 5) systemic anti-inflammatory agents.
Use within 2 weeks prior to baseline of 1) topical steroids, 2) topical retinoids, 3) topical acne treatments including over-the-counter preparations, 4) topical anti-inflammatory agents, or 5) topical antibiotics.
Pregnant or breast-feeding.
Serious psychological illness.
Significant history (within the past year) of alcohol or drug abuse.","Treatment of acne once daily over 12 weeks

Tretinoin: Treatment of acne once daily in evening",ChEMBL:CHEMBL38 | ChEMBL:CHEMBL547 | ChEMBL:CHEMBL705 | DrugBank:DB00523 | DrugBank:DB00755 | DrugBank:DB00982 | PubChem:444795 | PubChem:449171 | PubChem:5282379,Tretinoin,CC(C=CC1=C(C)CCCC1(C)C)=CC=CC(C)=CC(=O)O,D10AD01 | D10AD04 | D10AD51 | D10AD54 | D10BA01 | D11AH04 | L01XF01 | L01XF02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT02251938,NCT02251938_EG000,No,All,Adult | Older Adult,Phase 3,60,"Inclusion Criteria:

Participated in the SAKURA study
Received clinical benefit from treatment in the SAKURA study
Ability to sign informed consent and attend all study visits

Exclusion Criteria:

Uveitis of infectious etiology
Implanted device
Suspected or confirmed central nervous system or ocular lymphoma
Uncontrolled glaucoma
Significant ocular disease
Intravitreal injections in the past 60 days
Intraocular surgery or treatment
Ocular or periocular infection
History of herpetic infection
Toxoplasmosis or toxoplasmosis scar
Ocular malignancy
Vitrectomy
Allergy or hypersensitivity to study drug
Participation in other uveitis device clinical trials within 30 days
Any recent systemic condition/infection
Immunosuppressive therapy or immunocomprimised
Cytomegalovirus infection
Malignancy in remission
Females who are pregnant or lactating and who are not using adequate contraceptive
Medical marijuana or illegal drug use
Systemic saroidosis
Therapeutic radiation to the head or neck","Medium dose of DE-109

DE-109: Medium Dose of DE-109",ChEMBL:CHEMBL413 | DrugBank:DB00877 | PubChem:134760597 | PubChem:138404388 | PubChem:21944094 | PubChem:5284616,Sirolimus,COC1CC2CCC(C)C(O)(O2)C(=O)C(=O)N2CCCCC2C(=O)OC(C(C)CC2CCC(O)C(OC)C2)CC(=O)C(C)C=C(C)C(O)C(OC)C(=O)C(C)CC(C)C=CC=CC=C1C,L01EG04 | L04AA10 | S01XA23,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02252081,NCT02252081_EG000,No,All,Adult | Older Adult,Phase 2,30,"Inclusion Criteria:

Age 18 years old;
Ability to give informed consent;
Life expectancy greater than 6 months;
Estimated GFR 30-59 ml/min/1.73m^2;
Overweight (BMI >=25 to < 30 kg/m^2) or obese (BMI >=30 kg/m^2); or normal (BMI >=18.5 to <25 kg/m^2) if pre-diabetic or insulin resistant.

Exclusion Criteria:

Pregnancy or breast feeding;
Presence or history of Diabetes Mellitus type I or II
History of metformin use or any insulin sensitizer or any drug for the treatment of metabolic syndrome over the last one year;
Any acute kidney injury episode in the last 4 months due to the risk of recurrent AKI;
Proteinuria of > 5 g in 24 hours determined by a 24 hour urine collection or PCR > 4.5;
Uncontrolled hypertension with systolic blood pressure 160 mmHg and diastolic blood pressure 100 mmHg;
Patients with new changes to their antihypertensive regimen over the last 1 month;
Severe, unstable, or active inflammatory disease; active infection including seropositive HIV, Hepatitis B or C; active connective tissue disorder; or moderate to severe liver disease;
Decompensated heart failure;
Recent hospitalization or surgical procedure within 1 month prior to the study for any cause;
Current active malignancy or cancer history in the prior 5 years (excluding squamous cell and basal cell skin cancers);
Known intolerance to the study drug;
Patient receiving oral or injected steroids
Use of any investigational product or device within 30 days prior to screening, or requirement for any investigational agent prior to completion of all scheduled study assessments;","500 to 1500 mg orally per day for 16 weeks if eGFR > 45 ml/min; 500 to 1000 mg orally per day for 16 weeks if eGFR =< 45 ml/min

metformin: 500 to 1500 mg orally per day for 16 weeks if eGFR > 45 ml/min; 500 to 1000 mg orally per day for 16 weeks if eGFR =< 45 ml/min",ChEMBL:CHEMBL1431 | DrugBank:DB00331 | PubChem:4091,Metformin,CN(C)C(=N)NC(=N)N,A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT02252965,NCT02252965_EG001,No,All,Adult | Older Adult,Phase 4,264,"Inclusion criteria:

Diagnosis of Type 2 diabetes mellitus before the screening visit based on the World Health Organization (WHO) diagnostic and classification criteria
HbA1c value of 7.0-10.0%, inclusive
Age ranging from 18 to 79 years, inclusive
Treatment-naive for oral antidiabetic agents (that is, had not received antidiabetic medication previously, or had received antidiabetic medication for at least 14 days and not within 1 month of enrolment)
Male, or non-pregnant, non-breastfeeding females
Body mass index (BMI) greater than or equal to (>=) 18.5 and less than (<) 35 kilogram per square meter (kg/m^2)
In the opinion of the investigator, subjects are well-motivated, capable and willing to continue the study treatment as required during the whole study period, maintain a study dietary, as required for this protocol, attend scheduled visits and be willing to receive phone calls between visits, avoid pregnancy by using an adequate method of contraception throughout the duration of the study for the female subjects of child bearing potential (and if appropriate male subjects with female partners of childbearing potential)
Written informed consent given before any trial-related activities are carried out

Exclusion criteria:

Type 1 diabetes
Previous treatment with insulin or other antidiabetics (including Chinese traditional medicine) for more than 14 days continuously or within 1 month of enrolment
Any of the protocol-specified cardiovascular conditions within 3 months prior to the screening visit
Impaired liver function as defined in the protocol
Serum creatinine values as specified in the protocol
Known proliferative retinopathy or maculopathy requiring acute treatment, or recurrent major hypoglycemia or hypoglycemic unawareness as judged by the investigator
Persistent uncontrolled hypertension
Severe chronic gastrointestinal disease
Previous history of 1 or more episodes of ketoacidosis or hyperosmolar state/coma
Currently receiving chronic (>14 days) systemic glucocorticoid therapy (excluding topical, intraocular, inhaled or intranasal preparations) or have received such therapy within 4 weeks of the screening visit
Current use of beta-blockers, thiazide diuretic, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, nifedipine and isoniazid and cannot be replaced by any other treatment
Have any hematologic condition that may interfere with HbA1c measurement (for example, hemolytic anemia, sickle-cell disease)
Have any other condition (such as, known drug or alcohol abuse or a psychiatric disorder) that may prevent the subject from following and completing the protocol
Known hypersensitivity to Metformin Hydrochloride
Currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational product or non-approved use of a drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
Any contraindications to Metformin according to local package insert","Subjects received Metformin XR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for next 2 weeks and maintained at 2000 mg until Week 16.",PubChem:44573417,metformin XR,CN=C(N)N(C)C(=N)N.Cl,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02256267,NCT02256267_EG000,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 1,24,"Inclusion Criteria:

Overtly healthy sterile males or surgically sterile females or postmenopausal females
Have a body mass index (BMI) of 18 to 32 kilogram per meter square (kg/m^2)

Exclusion Criteria:

Have participated in a clinical trial involving investigational product within the last 30 days
Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study
Have an abnormal blood pressure
Show evidence of human immunodeficiency virus (HIV), hepatitis B or hepatitis C
Have donated blood of more than 500 milliliters (mL) within the last month
Have used or intend to use over-the-counter or prescription medication including herbal medications within 7 days prior to dosing or during the study","Single oral dose of 200 mg LY2835219 Day 1, period 1.",ChEMBL:CHEMBL3301610 | DrugBank:DB12001 | PubChem:46220502,Abemaciclib,CCN1CCN(Cc2ccc(Nc3ncc(F)c(-c4cc(F)c5nc(C)n(C(C)C)c5c4)n3)nc2)CC1,L01EF03,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT02260258,NCT02260258_EG000,No,All,Adult | Older Adult,Phase 2,83,"Inclusion Criteria:

Adult (≥ 18 years)
Cardiac arrest with sustained return of spontaneous circulation (ROSC)
Comatose (i.e., not following commands) following ROSC
Undergoing targeted temperature management (TTM)
Time of enrollment ≤ 6 hours from initiation of targeted temperature management
Serum Lactate ≥2

Exclusion Criteria:

Pre-existing dementia, severe brain injury, or dependence on others for activities of daily living (i.e. a modified Rankin scale (mRS) score of 4 or higher)
Traumatic etiology of the cardiac arrest
Protected population (pregnant, prisoner)","Patients will receive a bolus dose of 1 mg/kg, then a continuous I.V. infusion as per standard intensive care unit practice.

Of note, protocol allows for use of cistatracurium in place of rocuronium for either reasons of drug-shortage or clinical conditions (if institutional preferences for dose adjustment in liver or renal insufficiency arise).

Rocuronium: Neuromuscular Blockade",ChEMBL:CHEMBL1201244 | DrugBank:DB00728 | PubChem:441290,Rocuronium,[H][C@@]12CC[C@]3([H])[C@]([H])(CC[C@]4(C)[C@@H](OC(C)=O)[C@@H]([N+]5(CC=C)CCCC5)C[C@@]34[H])[C@@]1(C)C[C@H](N1CCOCC1)[C@@H](O)C2,M03AC09,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02264821,NCT02264821_EG000,No,Female,Adult | Older Adult,Phase 3,63,"Inclusion Criteria:

Patients aged 18 years and more, ASA 1 or ASA 2, pregnant with at least 34 weeks of gestational age, admitted for a planned caesarian with a Pfannenstiel incision and having signed the informed consent form.

Exclusion Criteria:

Refusal of the patient or contra-indication to locoregional anesthesia
Allergy to the products used
ASA 3
ASA 4
Sleep apnea syndrome and/or obesity (BMI > 35)
Size inferior to 155cm
existence of a language barrier","ropivacaine 2 mg/ml bolus 15 ml continuous 10 ml/h wound infusion and intrathecal saline

ropivacaine infiltration: wound infiltration",PubChem:53262281,Naropin,CCC[NH+]1CCCCC1C(=O)Nc1c(C)cccc1C.O.[Cl-],,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0
NCT02268058,NCT02268058_EG000,No,All,Child | Adult,Not Applicable,80,"Inclusion Criteria:

diagnosed with a first time concussion
english speaking
presenting to Emergency with headache 24-48 hours post concussion
normal Glascow Coma Scale
8-18 years of age

Exclusion Criteria

postive findings on CT scan
patient with cervical injury
history of multiple concussions
positive neurology","Patient took routinely acetaminophen every 4 hours when awake for a 72 hour period and documented their headaches for a week.

Patient and family received standard education on concussion management in the Emergency department.

Acetaminophen: routine administration of medication for a 72 hour period",ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02274948,NCT02274948_EG000,No,All,Child,Phase 4,166,"Inclusion Criteria:

Obese children (based on >+2SD of BMI to age on WHO 2007 standards)

Exclusion Criteria:

Children not of Sri Lankan origin
Children who are not planning to live in Sri Lanka during the next one year
Children with a secondary underlying cause for the overweight/obesity","8-10.99 year old children received metformin. Initially children were given 250mg of metformin daily for a week and increased to 250mg twice daily for a week and then to 500 mg twice daily there after. 11-16 year old children received 500mg of metformin daily initially for one week increased to 500mg twice daily for a week and then to 1g twice daily.

Children were asked to take medication with their morning and evening meals to reduce gastro intestinal side effects and risk of hypoglycaemia. Effects to medication were evaluated before each dose revision and was monitored for all possible adverse events.",ChEMBL:CHEMBL1431 | DrugBank:DB00331 | PubChem:4091,Metformin,CN(C)C(=N)NC(=N)N,A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02275065,NCT02275065_EG000,No,All,Adult | Older Adult,Phase 1,4,"Key Inclusion Criteria:

No current or prior anti-HIV treatment, including ART medications received for prevention (preexposure prophylaxis [PrEP]), or postexposure prophylaxis (PEP) within 12 weeks of screening
Plasma HIV-1 ribonucleic acid (RNA) ≥ 10,000 copies/mL but ≤ 400,000 copies/mL at screening
Cluster of differentiation 4+ (CD4+) cell count > 200 cells/mm^3

Key Exclusion Criteria:

Anticipated to start HIV-1 therapy during the study period
Active participation in another study of investigational or approved ART agents
A new acquired immunodeficiency syndrome (AIDS)-defining condition diagnosed within the 30 days prior to screening
Participants with positive hepatitis C antibody at screening
Chronic hepatitis B virus (HBV) infection
Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 42 days prior to Day 1 (baseline)

Note: Other protocol defined Inclusion/Exclusion criteria may apply.",Bictegravir 5 mg (1 × 5 mg tablet) administered orally once daily for 10 days,ChEMBL:CHEMBL3989866 | DrugBank:DB11799 | PubChem:90311989,Bictegravir,O=C(NCc1c(F)cc(F)cc1F)c1cn2c(c(O)c1=O)C(=O)N1[C@H]3CC[C@H](C3)O[C@@H]1C2,J05AR20,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02275065,NCT02275065_EG001,No,All,Adult | Older Adult,Phase 1,4,"Key Inclusion Criteria:

No current or prior anti-HIV treatment, including ART medications received for prevention (preexposure prophylaxis [PrEP]), or postexposure prophylaxis (PEP) within 12 weeks of screening
Plasma HIV-1 ribonucleic acid (RNA) ≥ 10,000 copies/mL but ≤ 400,000 copies/mL at screening
Cluster of differentiation 4+ (CD4+) cell count > 200 cells/mm^3

Key Exclusion Criteria:

Anticipated to start HIV-1 therapy during the study period
Active participation in another study of investigational or approved ART agents
A new acquired immunodeficiency syndrome (AIDS)-defining condition diagnosed within the 30 days prior to screening
Participants with positive hepatitis C antibody at screening
Chronic hepatitis B virus (HBV) infection
Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 42 days prior to Day 1 (baseline)

Note: Other protocol defined Inclusion/Exclusion criteria may apply.",Bictegravir 25 mg (1 × 25 mg tablet) administered orally once daily for 10 days,ChEMBL:CHEMBL3989866 | DrugBank:DB11799 | PubChem:90311989,Bictegravir,O=C(NCc1c(F)cc(F)cc1F)c1cn2c(c(O)c1=O)C(=O)N1[C@H]3CC[C@H](C3)O[C@@H]1C2,J05AR20,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02275065,NCT02275065_EG002,No,All,Adult | Older Adult,Phase 1,4,"Key Inclusion Criteria:

No current or prior anti-HIV treatment, including ART medications received for prevention (preexposure prophylaxis [PrEP]), or postexposure prophylaxis (PEP) within 12 weeks of screening
Plasma HIV-1 ribonucleic acid (RNA) ≥ 10,000 copies/mL but ≤ 400,000 copies/mL at screening
Cluster of differentiation 4+ (CD4+) cell count > 200 cells/mm^3

Key Exclusion Criteria:

Anticipated to start HIV-1 therapy during the study period
Active participation in another study of investigational or approved ART agents
A new acquired immunodeficiency syndrome (AIDS)-defining condition diagnosed within the 30 days prior to screening
Participants with positive hepatitis C antibody at screening
Chronic hepatitis B virus (HBV) infection
Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 42 days prior to Day 1 (baseline)

Note: Other protocol defined Inclusion/Exclusion criteria may apply.",Bictegravir 50 mg (2 × 25 mg tablets) administered orally once daily for 10 days,ChEMBL:CHEMBL3989866 | DrugBank:DB11799 | PubChem:90311989,Bictegravir,O=C(NCc1c(F)cc(F)cc1F)c1cn2c(c(O)c1=O)C(=O)N1[C@H]3CC[C@H](C3)O[C@@H]1C2,J05AR20,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT02275065,NCT02275065_EG003,No,All,Adult | Older Adult,Phase 1,4,"Key Inclusion Criteria:

No current or prior anti-HIV treatment, including ART medications received for prevention (preexposure prophylaxis [PrEP]), or postexposure prophylaxis (PEP) within 12 weeks of screening
Plasma HIV-1 ribonucleic acid (RNA) ≥ 10,000 copies/mL but ≤ 400,000 copies/mL at screening
Cluster of differentiation 4+ (CD4+) cell count > 200 cells/mm^3

Key Exclusion Criteria:

Anticipated to start HIV-1 therapy during the study period
Active participation in another study of investigational or approved ART agents
A new acquired immunodeficiency syndrome (AIDS)-defining condition diagnosed within the 30 days prior to screening
Participants with positive hepatitis C antibody at screening
Chronic hepatitis B virus (HBV) infection
Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 42 days prior to Day 1 (baseline)

Note: Other protocol defined Inclusion/Exclusion criteria may apply.",Bictegravir 100 mg (1 × 100 mg tablet) administered orally once daily for 10 days,ChEMBL:CHEMBL3989866 | DrugBank:DB11799 | PubChem:90311989,Bictegravir,O=C(NCc1c(F)cc(F)cc1F)c1cn2c(c(O)c1=O)C(=O)N1[C@H]3CC[C@H](C3)O[C@@H]1C2,J05AR20,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02276872,NCT02276872_EG001,No,All,Child,Phase 2,10,"Inclusion Criteria:

Legal guardian informed consent and subject assent, if appropriate, to participate in the study was voluntarily given.
The subject was between 7 and 17 years of age, inclusive, on the date informed consent was signed.
Cohort 3: The subject weighed a minimum of 22 kg at Screening.

The subject had a current diagnosis of PAH (WHO Group I) associated with:

IPAH or HPAH
Persistent PAH for at least 1 year following surgical repair of a congenital systemic-to-pulmonary cardiac shunt, congenital heart disease, or other congenital heart lesions with no clinically significant residual defects and condition was stabilized hemodynamically
PAH in subjects with unrepaired restricted atrial septal defect, ventricular septal defect, or patent ductus arteriosus; subject had a resting post-ductal oxygen saturation (off oxygen) of greater than 88%.

The subject had a current diagnosis of PAH confirmed by RHC prior to the Screening Visit with the following parameters:

PAPm of ≥25 mmHg
Pulmonary vascular resistance index (PVRi) of >3 Wood Units*m2
Left ventricular end-diastolic pressure (LVEDP) or pulmonary capillary wedge pressure (PCWP) of ≤15 mmHg.
Cohort 1: The subject had received IV/SC Remodulin for at least 90 days without dose change for at least 30 days prior to Baseline. The IV/SC Remodulin dose was between 25 to 75 ng/kg/min, inclusive, for the first 5 subjects in the cohort. Following safety review, the dose range was expanded to 25 to 125 ng/kg/min, inclusive, for the remaining subjects. Subjects must have received stable doses of all other PAH medications for at least 14 days prior to the baseline assessments; exception for diuretics and anticoagulants.
Cohort 2: The subject must have received inhaled prostacyclin for at least 90 days and had been at the current stable dose without changes for at least 30 days prior to Baseline. Subjects must have received stable doses of all other PAH medications for at least 14 days prior to the baseline assessments; exception for diuretics and anticoagulants.
All Cohorts: All subjects were optimally treated (as determined by the Investigator) with background PAH therapies (eg, phosphodiesterase type 5 inhibitor [PDE5-I], endothelin receptor antagonist [ERA], soluble guanylate cyclase [sGC]) for at least 90 days and had been on a stable dose without changes (except documented weight based adjustments) for at least 30 days prior to the first dose of oral treprostinil. Subjects must have received stable doses of all other PAH medications for at least 14 days prior to the first dose of oral treprostinil; exception for diuretics and anticoagulants.
The subject was willing and able to swallow intact tablets whole without chewing, breaking, or splitting.
The subject was willing and able to comply with the dietary requirements associated with the oral treprostinil dosing regimen.
The subject was on stable doses of other medical therapy for 14 days prior to the Baseline Visit with no dose adjustments, additions, or discontinuations. Dose changes of diuretics were allowed if within the usual dose adjustments prescribed for the subject. Anticoagulants could have been adjusted, but not discontinued or added, within 14 days of Baseline. Temporary discontinuation of anticoagulants when related to study-related procedures was allowed.
Females of childbearing potential include any female who had experienced menarche. Females of childbearing potential must have practiced true abstinence from intercourse, had an intrauterine device, or used 2 different forms of highly effective contraception for the duration of the study and for at least 30 days after discontinuing oral treprostinil. Medically acceptable forms of effective contraception included approved hormonal contraceptives (such as birth control pills) or barrier methods (such as a condom or diaphragm) used with a spermicide. For females of childbearing potential, a negative urine pregnancy test was required at Baseline prior to oral treprostinil administration. Males participating in the study must have used a condom during intercourse for the duration of the study and for at least 48 hours after discontinuing oral treprostinil.
Subjects with a history of metallic implants, prior neurosurgical clip placement, or other potential contraindications to cMRI were individually evaluated per site standard operating procedures for MRI performance.
In the opinion of the Principal Investigator, the subject and/or legal guardian was able to communicate effectively with study personnel, and was considered reliable, willing, and likely to be cooperative with protocol requirements, including attending all study visits.

Exclusion Criteria:

The subject had a diagnosis of large unrestrictive ventricular septal defect or patent ductus arteriosus, Eisenmenger syndrome, congenital diaphragmatic hernia, or a chronic lung disease, such as bronchopulmonary dysplasia or interstitial lung disease.
The subject had a current disease severity of Panama FC IIIb or IV.
The subject had previously been exposed to oral treprostinil.
Cohort 1: The subject had previous intolerance to treprostinil or epoprostenol due to systemic adverse effects that resulted in discontinuation of therapy. This did not include site pain reactions or central venous catheter-related blood stream infections.
Cohort 1 and 2: The subject was receiving IV/SC Remodulin or Tyvaso® (as the inhaled prostacyclin) for any other disease or condition other than the treatment of PAH in accordance with the IV/SC Remodulin or Tyvaso package inserts (ie, eligible subjects must have had a WHO Group I PAH classification as defined in inclusion criterion #4).
Cohort 3: The subject had been previously exposed to a prostacyclin within 30 days of Screening, with the exception of vasoreactivity testing.
The subject was pregnant or lactating.
The subject had a current diagnosis of uncontrolled sleep apnea as defined by their physician.
The subject had severe renal insufficiency as defined by an estimated creatinine clearance <30 mL/min (Schwartz Formula) or the requirement for dialysis at Screening.
The subject had moderate to severe hepatic dysfunction as defined by elevated liver function tests (aspartate aminotransferase or alanine aminotransferase) ≥3 times the upper limit of normal at Screening, or Child Pugh class B or C hepatic disease.
The subject had clinically significant anemia as defined by a hemoglobin and/or hematocrit level <75% of the lower limit of normal ranges according to age and gender.
The subject had Down Syndrome.
The subject had uncontrolled systemic hypertension as evidenced by a systolic or diastolic blood pressure greater than the 95th percentile for age, height, and gender at Screening or Baseline.
The subject and/or legal guardian had an unstable psychiatric condition or was mentally incapable of understanding the objectives, nature, or consequences of the study, or had any condition in which the Investigator's opinion would constitute an unacceptable risk to the subject's safety.
The subject had an active infection or any other cardiovascular, liver, renal, hematologic, gastrointestinal, immunologic, endocrine, metabolic, or central nervous system disease or condition that, in the opinion of the Investigator, might have adversely affected the safety of the subject or interfered with the interpretation of study assessments.
Subject was actively listed for transplantation.
The subject was receiving an investigational drug, had an investigational device in place, or had participated in an investigational drug or device study within 30 days prior to Baseline. Participation in an observational study did not disqualify a potential subject from study participation.",Transitioned from inhaled prostacyclin to oral treprostinil,PubChem:23663413,Treprostinil sodium,CCCCCC(O)CCC1C(O)CC2Cc3c(cccc3OCC(=O)[O-])CC21.[Na+],,0.0,1.0,0.0,0.0,0.0,1.0,1.0,1.0,0.0,1.0,1.0,1.0,1.0,1.0,1.0,0.0,1.0,0.0,1.0,0.0,1.0,1.0,1.0,0.0,0.0,1.0,0.0
NCT02278055,NCT02278055_EG000,No,Male,Adult | Older Adult,Phase 2,29,"Inclusion Criteria:

Males aged 18 years of age and above
Histological or cytological proof of prostate adenocarcinoma
Castrate serum testosterone level: ≤50 ng/dL (≤1.7 nmol/L)
Patients who have experienced disease progression despite initial hormonal therapy, either by orchiectomy or by using a GnRH agonist in combination with an anti-androgen, must first progress through anti- androgen withdrawal prior to being eligible. The minimum time frame to document failure of anti-androgen withdrawal will be four weeks. Patients on second-line (or beyond) hormonal maneuvers, and patients who had no PSA decline on combined androgen blockade as first line therapy, need not progress through AAW in order to be eligible.

Known progressive castration-resistant disease, defined as:

Serum PSA progression defined as two consecutive increases in PSA over a previous reference value within 6 months of first treatment, each measurement at least one week apart. Serum PSA at screening ≥ 2 ng/mL or
Documented appearance of new lesions by bone scintigraphy
ECOG Performance Status of 0-2 2 or more bone metastases demonstrated on bone scintigraphy
Pain at baseline as measured by a BPI worst pain score average of ≥ 3. The BPI worst pain score average will be based on the worst pain scores completed by the patient in the 7 consecutive pretreatment days. A minimum of 4 days of pain scores must be completed by the patient in the 7 day window in order to calculate the average worst pain score. The investigator will optimize the subject's pain regimen prior to study entry.

Normal organ function with acceptable initial laboratory values:

WBC ≥ 3 x 109 /L
ANC ≥ 1.5 x 109 /L
Platelets ≥ 100 x 109 /L
Hemoglobin ≥ 9.0 g/dL
Creatinine < 1.5 x institutional upper limit of normal (ULN)
Bilirubin ≤ 1.5 x ULN
AST/ALT ≤ 2.5 x ULN
Albumin > 25 g/L
All acute toxicities as a result of any prior treatment must have resolved to NCI-CTCAE v4.0 Grade 1 or less at the time of signing the Informed Consent Form (ICF) [Note: Ongoing grade 2 neuropathy as a result of treatment with a cytotoxic chemotherapy regimen is permitted]
Life expectancy of at least 6 months
Willing and able to provide written informed consent and HIPAA authorization for the release of personal health information NOTE: HIPAA authorization may be either included in the informed consent or obtained separately
Willing and able to comply with the protocol, including follow-up visits, examinations as well as having the ability to self-report pain and fatigue using a Patient Reported Outcome (PRO) instrument
Willingness to use adequate methods of contraception beginning at the signing of the ICF until at least 30 days after the last dose of study drug

Exclusion Criteria:

Prior exposure to Radium-223
Received an investigational therapy within the 4 weeks prior to registration or is scheduled to receive one during the treatment period
Received a new anti-cancer agent within 4 weeks prior to registration
Received external beam radiotherapy within 4 weeks prior registration
Received systemic therapy with radionuclides (e.g. strontium-89, samarium-153, rhenium-186 or rhenium-188) for the treatment of bone metastases
Treatment with cytotoxic chemotherapy within 4 weeks prior to registration
Symptomatic nodal disease, i.e. scrotal, penile or leg edema. Visceral metastases (including cerebral metastases) from CRPC (>2 lung and/or liver metastases [size ≥2cm]; Lymphadenopathy exceeding 6 cm in short-axis diameter or any size pelvic lymphadenopathy if it is thought to be a contributor to concurrent hydronephrosis), as assessed by CT, MRI or chest X-ray within the 8 weeks prior registration.
Concurrent chemotherapy. Patients may be on other non-chemotherapy anti-cancer treatments, per FDA labeling of Radium-223, provided that these are not changed during the primary pain assessment period Major surgery within 30 days prior to registration.
Imminent spinal cord compression based on clinical findings and/or magnetic resonance imaging (MRI). Treatment should be completed for spinal cord compression.
Patients with a, ""currently active,"" second malignancy other than non-melanoma skin cancers or non-invasive bladder cancers or other in-situ or non-invasive malignancies. Patients who have completed therapy for a prior malignancy and are free of disease for ≥3 years are eligible.

Any other serious illness or medical condition, such as but not limited to:

Any infection ≥ National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03 Grade 2
Cardiac failure New York Heart Association (NYHA) III or IV
Crohn's disease or ulcerative colitis
Bone marrow dysplasia
Fecal incontinence
Any other condition which, in the opinion of the Investigator, would make the subject unsuitable for trial participation
NOTE: Any patient found to be ineligible prior to treatment initiation will require re-screening.","Radium Ra 223 dichloride will be administered as a bolus intravenous (IV) injection (up to 1 minute) at intervals of every 4 weeks for up to 6 cycles. The dosage of Radium Ra 223 dichloride after implementation of the new 2015 NIST standard is 55kBq/kg body weight.

Radium-223",PubChem:6328144 | PubChem:6335825,Radium,[Ra],,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02280239,NCT02280239_EG001,No,All,Adult | Older Adult,Phase 4,10,"Generally to be considered for this study one must be critically ill, febrile, and can safely either receive acetaminophen or have acetaminophen withheld. Also one must not have conditions that would alter normal drug absorption or normal thermoregulation. Specifically the eligibility criteria are:

INCLUSION CRITERIA:

Adult patients (> 18 years) admitted to Intensive Care Unit at Vancouver Hospital with a core temperature > 38.3 °C for 2 or more consecutive hours, but not longer than 48 hours*
Continuous arterial pressure monitor in place at the time of intervention and data collection
Patients may only participate in the study once
To remain in the ICU for the entire study period (2 hours prior to drug administration to 4 hours post drug administration)

EXCLUSION CRITERIA:

Significant liver dysfunction
Acute neurological injury
Seizure disorder
Cardiomyopathy, elevated cardiac enzymes indicative of an acute cardiac injury, electrocardiogram (ECG) changes indicative of cardiac ischemia (i.e., ST segment elevation/depression)
Hemodynamic instability (requiring fluid boluses, or change/initiation of vasopressors. Patients receiving steady doses of vasopressor support may be included)
Severe hypoxemia, (fraction of inspired oxygen (FiO2) requirements of more than 60% to maintain hemoglobin oxygen saturation (SaO2) > 90% or partial pressure of oxygen in the blood (PaO2) > 70)
Temperature > 40.0 °C
Receiving external cooling
Haemodialysis, plasma exchange, or any treatment where the blood is taken out of the body and processed
Acute thermal injury to skin (i.e., burn)
Gut malabsorption (i.e., receiving < 40% required calories enterally)
Receiving medications that have known antipyretic effects (acetaminophen, ibuprofen, steroids, etc.)
Physician opposed to enrolment in the study

NOTE: in response to very low enrollment 2 exclusion criteria were changed on Nov 5, 2015. These were:

patients no longer needed to recieve 40% of required calories enterally, instead patients who were not receiving any caloric intake via the gut could be enrolled as long as they were still permitted to receive oral medications.
patients no longer had to have acetaminophen discontinued upon enrollment. They could not be receiving it regularly but could still receive acetaminophen on an as needed (PRN) basis as long as it could be safely withheld for up to 12 hours if they developed a fever.","This group consists of stable but febrile ICU patients (temp >38.3°C). Participants in this group will receive a one-time does of acetaminophen 650mg via the enteral route (via the gut), after which vital signs (including continuous measures of core temperature, heart rate, and blood pressure) will be monitored for 4 hours.

Acetaminophen: one-time dose of acetaminophen 650mg given via the enteral route (via the gut)",ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02281136,NCT02281136_EG000,No,All,Adult | Older Adult,Phase 2,29,"Inclusion Criteria:

At least 6 Grade 1/2 AKs on one upper extremity AND
At least 12 Grade 1/2 AKs on the OTHER upper extremity

Exclusion Criteria:

Pregnancy
history of cutaneous photosensitization, porphyria, hypersensitivity to porphyrins or photodermatosis
lesions suspicious for skin cancer (skin cancer not ruled out by biopsy) or untreated skin cancers within the Treatment Area
Body Mass Index (BMI) > 32.0 kg/m2
skin pathology or condition which could interfere with the evaluation of the test product or requires the use of interfering topical or systemic therapy
significant blood loss within 60 days or donated blood/plasma within 72 hours prior to Visit 2 (Baseline)
tested positive at screening for human immunodeficiency virus (HIV) or was known to be seropositive for HIV
a history of lead poisoning or a history of a significant exposure to lead or a screening lead level above 6μg/dl
tested positive at screening for hepatitis B surface antigen, hepatitis C antibody or had a history of a positive result
positive drug screen at Screening
Screening safety labs are clinically significant in the opinion of the investigator
major surgery within 30 days prior to Visit 2 (Baseline) or plans to have surgery during the study
Subject is immunosuppressed
currently enrolled in an investigational drug or device study
has received an investigational drug or been treated with an investigational device within 30 days prior to Visit 2 (Baseline)
known sensitivity to one or more of the vehicle components (ethyl alcohol, isopropyl alcohol, laureth 4, polyethylene glycol)

use of the following topical preparations on the extremities to be treated:

Keratolytics including urea (greater than 5%), alpha hydroxyacids [e.g.glycolic acid, lactic acid, etc. greater than 5%], salicylic acid (greater than 2%) within 2 days of initiation of treatment
Cryotherapy within 2 weeks of initiation of treatment
Retinoids, including tazarotene, adapalene, tretinoin, retinol, within 4 weeks of initiation of treatment
Microdermabrasion, laser ablative treatments, ALA-PDT, chemical peels, 5-FU, diclofenac, imiquimod or other topical treatments for AK within 8 weeks of initiation of treatment
use of systemic retinoid therapy within 6 months of initiation of treatment","20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment

Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light

BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2",PubChem:123608,Aminolevulinic Acid Hydrochloride,Cl.NCC(=O)CCC(=O)O,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02281591,NCT02281591_EG002,Accepts Healthy Volunteers,All,Adult,Phase 1,8,"Inclusion Criteria

Male or female subjects aged between 18 and 45 years, inclusive.
Subjects of body mass index (BMI) between 19 and 30 kg/m2, inclusive.
Subjects who were healthy as determined by pre-study medical history, physical examination, vital signs, neurological examination, and 12-lead ECG.
Subjects who had clinical laboratory tests clinically acceptable at screening and admission.
Subjects who had negative tests for HBsAg, anti-HCV Ab and HIV-1 and HIV-2 Ab at screening.
Subjects who were negative for drugs of abuse and alcohol at screening and admission.
Subjects who were non-smokers or who smoke < 10 cigarettes or equivalent per day.
Subjects who are able and willing to give written informed consent.
(If female) She was not of childbearing potential by reason of surgery or, if of childbearing potential, she used one of the following methods of contraception: double barrier, intrauterine device or abstinence.
(If female) She had a negative pregnancy test at screening and admission to Phase A.

Exclusion Criteria:

Subjects who did not conform to the above inclusion criteria, OR
Subjects who had a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine, connective tissue diseases or disorders.
Subjects who had a clinically relevant surgical history.
Subjects who had a clinically relevant family history.
Subjects who had a history of relevant atopy.
Subjects who had a history of relevant drug hypersensitivity (especially carbamazepine or oxcarbazepine).
Subjects who had a history of alcoholism or drug abuse.
Subjects who consumed more than 14 units of alcohol a week.
Subjects who had a significant infection or known inflammatory process on screening or admission.","450 mg of S-licarbazepine

S-licarbazepine: capsules containing 225 mg",ChEMBL:CHEMBL1067 | ChEMBL:CHEMBL315985 | DrugBank:DB14575 | PubChem:114709 | PubChem:9816485 | PubChem:9881504,Eslicarbazepine,NC(=O)N1c2ccccc2CC(O)c2ccccc21,N03AF04,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0
NCT02281591,NCT02281591_EG003,Accepts Healthy Volunteers,All,Adult,Phase 1,8,"Inclusion Criteria

Male or female subjects aged between 18 and 45 years, inclusive.
Subjects of body mass index (BMI) between 19 and 30 kg/m2, inclusive.
Subjects who were healthy as determined by pre-study medical history, physical examination, vital signs, neurological examination, and 12-lead ECG.
Subjects who had clinical laboratory tests clinically acceptable at screening and admission.
Subjects who had negative tests for HBsAg, anti-HCV Ab and HIV-1 and HIV-2 Ab at screening.
Subjects who were negative for drugs of abuse and alcohol at screening and admission.
Subjects who were non-smokers or who smoke < 10 cigarettes or equivalent per day.
Subjects who are able and willing to give written informed consent.
(If female) She was not of childbearing potential by reason of surgery or, if of childbearing potential, she used one of the following methods of contraception: double barrier, intrauterine device or abstinence.
(If female) She had a negative pregnancy test at screening and admission to Phase A.

Exclusion Criteria:

Subjects who did not conform to the above inclusion criteria, OR
Subjects who had a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine, connective tissue diseases or disorders.
Subjects who had a clinically relevant surgical history.
Subjects who had a clinically relevant family history.
Subjects who had a history of relevant atopy.
Subjects who had a history of relevant drug hypersensitivity (especially carbamazepine or oxcarbazepine).
Subjects who had a history of alcoholism or drug abuse.
Subjects who consumed more than 14 units of alcohol a week.
Subjects who had a significant infection or known inflammatory process on screening or admission.","450 mg of Rlicarbazepine

R-licarbazepine: capsules containing 225 mg",ChEMBL:CHEMBL1067 | ChEMBL:CHEMBL315985 | DrugBank:DB14575 | PubChem:114709 | PubChem:9816485 | PubChem:9881504,Eslicarbazepine,NC(=O)N1c2ccccc2CC(O)c2ccccc21,N03AF04,0.0,0.0,0.0,0.0,0.0,1.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02285855,NCT02285855_EG000,No,All,Adult | Older Adult,Phase 2,14,"Inclusion Criteria:

Patients with pathologic diagnosis of lung NSCLC or squamous cell carcinoma.
Patients are to be treated with hypofractionated RT.
Patient is not a surgical candidate due to medical comorbidities determined by a thoracic surgeon or patient refusal
Patient plans to receive treatment at MD Anderson
Patients must sign informed consent
Patient must have adequate renal function within 30 days prior to registration, defined as serum creatinine within normal institutional limits or creatinine clearance at least 60 ml/min

Exclusion Criteria:

Patient has: random glucose >200 mg/dl or is taking an oral hypoglycemic agent or insulin at the time of study entry
Patient has a history of lactic acidosis, chronic kidney disease or a creatinine >/= 1.2 mg/dl
Women who are pregnant or breast feeding, as treatment involves unforeseeable risks to the participant, embryo, fetus, or nursing infant
Patients with history of allergic reaction to metformin","Patients randomized to metformin arm will receive 3 weeks of daily metformin (500 mg, am, 1000 mg, noon, 500 mg, pm) and then SBRT to a total dose of 50-70 Gy in 4-15 daily treatment fractions with metformin.",ChEMBL:CHEMBL1431 | DrugBank:DB00331 | PubChem:4091,Metformin,CN(C)C(=N)NC(=N)N,A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02289989,NCT02289989_EG000,No,All,Child,Not Applicable,1,"Inclusion Criteria:

Male or non-pregnant female subjects aged 2-17 years of age.
Individuals must be diagnosed with acute-subacute AD regardless of the study.
Written informed consent must be obtained from all patients or caregivers.
Women of childbearing potential (WOCBP) must be willing to practice effective contraception for the duration of study treatment.
Subjects must be willing and able to comply with study conditions, properly apply or have caregivers apply topical medications to the selected body sites, as well as return to the clinic for required visits.
Subject caregivers must be willing and able to perform ADQ assessment test.

Exclusion Criteria:

Individuals who are immune-compromised or suffering from infectious disease, malignant disease, are known to be HIV+ or present with a general reduced level of health.
Individuals diagnosed with underlying dermatological conditions in addition to AD.
Individuals with a chronic pre-existing disease such as diabetes mellitus or others that in the opinion of the investigator would preclude their participation in the study.
Individuals who are pregnant, nursing mothers, or subjects planning a pregnancy during the course of the study.
Subjects/caregivers who are unable to communicate or comply with study conditions due to language disability, poor mental development, or impaired cerebral function.
Individuals who are simultaneously enrolled in another clinical drug or device research study.
Individuals with a history of chronic steroid use.
Individuals needing to concurrently use topical agents, medicinal products containing corticosteroids, or immunosuppressants.
Individuals who have received systemically administered corticosteroids and/or antihistamines 2 weeks prior to the start of study.
Individuals undergoing light therapy.
Individuals who have been treated with another investigation device or drug within 30 days prior to study enrollment.
Individuals with a known allergy to oregano.","Intervention: hydrocortisone 1% ointment will be applied to one patient's forearm

Hydrocortisone: An experimental cream will be applied to one of the arms of the patient which will be an oregano extract and will be compared to the standard treatment which will be hydrocortisone 1% ointment",ChEMBL:CHEMBL389621 | DrugBank:DB00741 | PubChem:5754,Hydrocortisone,[H][C@@]12CC[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)CC[C@@]21C,A01AC03 | A07EA02 | C05AA01 | D07AA02 | D07BA04 | D07CA01 | D07XA01 | H02AB09 | R01AD60 | S01BA02 | S01BB01 | S01CA03 | S01CB03 | S02BA01 | S02CA03 | S03CA04,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02292784,NCT02292784_EG001,No,All,Child,Phase 3,44,"Inclusion Criteria:

Mother is randomly assigned and dosed (retosiban or comparator) in 1 of the Phase III SPTL retosiban clinical studies.
Infant is alive at 28 days post EDD.
Written informed consent is obtained from the parent(s) or legal guardian(s) of the infant. The parent/legal guardian of subjects aged 12 to 17 years must also provide written agreement for the infant to participate in the study where required by applicable regulatory and country or state requirements.

Exclusion Criteria:

There are no formal exclusion criteria for participation.","All infants and children born to women who received atosiban (in 3 successive stages; an initial bolus dose of 6.75 milligram [mg] using atosiban 6.75 mg per 0.9 milliliter [mL] solution for injection, followed by continuous high dose infusion at 18 mg per hour for 3 hours, then a lower 6 mg per hour infusion for the remainder of the 48-hour using the atosiban 37.5 mg per 5 mL concentrate for solution) in 200721 study. Current study did not require any medical interventions or study visits to an investigational site.",ChEMBL:CHEMBL382301 | DrugBank:DB09059 | PubChem:5311010,Atosiban,[H][C@@]1([C@@H](C)O)NC(=O)[C@]([H])([C@@H](C)CC)NC(=O)[C@@H](Cc2ccc(OCC)cc2)NC(=O)CCSSC[C@@H](C(=O)N2CCC[C@H]2C(=O)N[C@@H](CCCN)C(=O)NCC(N)=O)NC(=O)[C@H](CC(N)=O)NC1=O,G02CX01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02294682,NCT02294682_EG000,No,All,Adult | Older Adult,Phase 2,52,"Inclusion Criteria:

The subject is an adult male or female at least 18 years of age at the time of signing informed consent who meets one of the following criteria:

A non-pregnant, non-lactating female of childbearing potential who 1) is sexually inactive by abstinence, 2) has a sole male partner who has been sterilized, or 3) uses a contraceptive method with a failure rate of <1% through the Test-of-Cure Visit. Females of childbearing potential must not become pregnant during the study.
A female of non-childbearing potential, which includes the following: Females who are surgically sterile with a documented hysterectomy and/or bilateral oophorectomy; Females with documented tubal ligation. If the procedure was done hysteroscopically, the effectiveness of tubal occlusion must have been documented by hysterosalpingogram after the procedure (typically 3 months after the procedure); Females who are post-menopausal, defined as amenorrhoeic for greater than 1 year. For women whose menopausal status is in doubt, documented previous confirmatory blood samples with follicle-stimulating hormone >40 milli international units (mIU)/millilitre (mL) and estradiol <40 picograms (pg)/mL (<140 picomoles [pmol]/litre [L]) will need to be confirmed, or they will be required to use one of the acceptable contraception methods. Note: For the purposes of these criteria, ""documented"" includes information obtained via a verbal interview with the subject or from the subject's medical records.
There is clinical suspicion that the subject has a urogenital gonococcal infection (e.g., prior culture, nucleic acid amplification test [NAAT] or Gram stain presumptive or positive for the presence of N. gonorrhoeae, or sexual contact with a partner diagnosed with gonorrhea within the past 14 days, as reported by the subject). Note: All subjects will be tested for N. gonorrhoeae, but these results will not be used to determine subject eligibility for enrollment in the study.
The subject has provided written, dated, informed consent and is willing and able to comply with the study protocol.

Exclusion Criteria:

The subject is pregnant or nursing.
The subject is a hysterectomized female without a cervix.
The subject is a male with a current diagnosis of epididymitis or orchitis at the time of the Baseline Visit.
The subject has a body mass index >=40.0 kilograms (kg)/square meter (m^2).
The subject has a serious underlying disease that could be imminently life threatening, or the subject is unlikely to survive for the duration of the study period.
The subject has a medical condition or requires medication that may be aggravated by inhibition of acetylcholinesterase, such as: Poorly controlled asthma or chronic obstructive pulmonary disease at baseline and, in the opinion of the investigator, is not stable on current therapy; Acute severe pain, uncontrolled with conventional medical management; Active peptic ulcer disease; Parkinson's disease; Myasthenia gravis; A history of seizure disorder requiring medications for control. This does not include a history of childhood febrile seizures; Any evidence of mechanical obstruction of the urinary or digestive tracks.
The subject has had any past history or current diagnosis of Clostridium difficile infection at the time of the Baseline Visit.
The subject, in the judgment of the investigator, would not be able or willing to comply with the protocol or complete study follow-up.
The subject has a history of sensitivity to the study medication, or components thereof, or a history of a drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates their participation.
The subject has a PR interval <120 or >220 milliseconds (msec). Note: Subjects without an evaluable PR interval (e.g., stable atrial fibrillation) are not eligible for this study.
The subject has a corrected QT (QTc) >450 msec or a QTc >480 msec for subjects with bundle branch block. Note: The QTc is the QT interval corrected for heart rate according to either Bazett formula (QTcB), Fridericia formula (QTcF), machine, or manual overread.
The subject has QRS duration <70 or >120 msec.
The subject has pre-existing Grade II atrioventricular block or higher or a history of significant vasovagal and/or syncopal episodes or episodes of symptomatic bradycardia.
The subject has a current or chronic history of liver disease (with the exception of Gilbert's syndrome), including symptomatic viral hepatitis and moderate to severe liver insufficiency (Child Pugh class B or C).
The subject has been previously enrolled in this study or has previously been treated with GSK2140944.
The subject has participated in a clinical trial and has received an investigational product within 30 days or 5 half-lives, whichever is longer.
The subject has the following gonococcal infections: Suspected or confirmed pelvic inflammatory disease; Suspected or confirmed gonococcal arthritis; Other evidence of disseminated gonococcal infection.
The subject has received treatment with a systemic or intravaginal antibacterial within 14 days of study entry.
Subject is taking a medication that has a known risk of torsades de pointes.","Participants were randomized to receive oral dose of GSK2140944 1500 mg (3 immediate-release capsules of 500 mg each) with food and 240 milliliters (mL) of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.",ChEMBL:CHEMBL3317856 | DrugBank:DB12134 | PubChem:25101874,Gepotidacin,O=c1ccc2ncc(=O)n3c2n1C[C@H]3CN1CCC(NCc2cc3c(cn2)OCCC3)CC1,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02294682,NCT02294682_EG001,No,All,Adult | Older Adult,Phase 2,53,"Inclusion Criteria:

The subject is an adult male or female at least 18 years of age at the time of signing informed consent who meets one of the following criteria:

A non-pregnant, non-lactating female of childbearing potential who 1) is sexually inactive by abstinence, 2) has a sole male partner who has been sterilized, or 3) uses a contraceptive method with a failure rate of <1% through the Test-of-Cure Visit. Females of childbearing potential must not become pregnant during the study.
A female of non-childbearing potential, which includes the following: Females who are surgically sterile with a documented hysterectomy and/or bilateral oophorectomy; Females with documented tubal ligation. If the procedure was done hysteroscopically, the effectiveness of tubal occlusion must have been documented by hysterosalpingogram after the procedure (typically 3 months after the procedure); Females who are post-menopausal, defined as amenorrhoeic for greater than 1 year. For women whose menopausal status is in doubt, documented previous confirmatory blood samples with follicle-stimulating hormone >40 milli international units (mIU)/millilitre (mL) and estradiol <40 picograms (pg)/mL (<140 picomoles [pmol]/litre [L]) will need to be confirmed, or they will be required to use one of the acceptable contraception methods. Note: For the purposes of these criteria, ""documented"" includes information obtained via a verbal interview with the subject or from the subject's medical records.
There is clinical suspicion that the subject has a urogenital gonococcal infection (e.g., prior culture, nucleic acid amplification test [NAAT] or Gram stain presumptive or positive for the presence of N. gonorrhoeae, or sexual contact with a partner diagnosed with gonorrhea within the past 14 days, as reported by the subject). Note: All subjects will be tested for N. gonorrhoeae, but these results will not be used to determine subject eligibility for enrollment in the study.
The subject has provided written, dated, informed consent and is willing and able to comply with the study protocol.

Exclusion Criteria:

The subject is pregnant or nursing.
The subject is a hysterectomized female without a cervix.
The subject is a male with a current diagnosis of epididymitis or orchitis at the time of the Baseline Visit.
The subject has a body mass index >=40.0 kilograms (kg)/square meter (m^2).
The subject has a serious underlying disease that could be imminently life threatening, or the subject is unlikely to survive for the duration of the study period.
The subject has a medical condition or requires medication that may be aggravated by inhibition of acetylcholinesterase, such as: Poorly controlled asthma or chronic obstructive pulmonary disease at baseline and, in the opinion of the investigator, is not stable on current therapy; Acute severe pain, uncontrolled with conventional medical management; Active peptic ulcer disease; Parkinson's disease; Myasthenia gravis; A history of seizure disorder requiring medications for control. This does not include a history of childhood febrile seizures; Any evidence of mechanical obstruction of the urinary or digestive tracks.
The subject has had any past history or current diagnosis of Clostridium difficile infection at the time of the Baseline Visit.
The subject, in the judgment of the investigator, would not be able or willing to comply with the protocol or complete study follow-up.
The subject has a history of sensitivity to the study medication, or components thereof, or a history of a drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates their participation.
The subject has a PR interval <120 or >220 milliseconds (msec). Note: Subjects without an evaluable PR interval (e.g., stable atrial fibrillation) are not eligible for this study.
The subject has a corrected QT (QTc) >450 msec or a QTc >480 msec for subjects with bundle branch block. Note: The QTc is the QT interval corrected for heart rate according to either Bazett formula (QTcB), Fridericia formula (QTcF), machine, or manual overread.
The subject has QRS duration <70 or >120 msec.
The subject has pre-existing Grade II atrioventricular block or higher or a history of significant vasovagal and/or syncopal episodes or episodes of symptomatic bradycardia.
The subject has a current or chronic history of liver disease (with the exception of Gilbert's syndrome), including symptomatic viral hepatitis and moderate to severe liver insufficiency (Child Pugh class B or C).
The subject has been previously enrolled in this study or has previously been treated with GSK2140944.
The subject has participated in a clinical trial and has received an investigational product within 30 days or 5 half-lives, whichever is longer.
The subject has the following gonococcal infections: Suspected or confirmed pelvic inflammatory disease; Suspected or confirmed gonococcal arthritis; Other evidence of disseminated gonococcal infection.
The subject has received treatment with a systemic or intravaginal antibacterial within 14 days of study entry.
Subject is taking a medication that has a known risk of torsades de pointes.","Participants were randomized to receive oral dose of GSK2140944 3000 mg (6 immediate-release capsules of 500 mg each) with food and 240 mL of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.",ChEMBL:CHEMBL3317856 | DrugBank:DB12134 | PubChem:25101874,Gepotidacin,O=c1ccc2ncc(=O)n3c2n1C[C@H]3CN1CCC(NCc2cc3c(cn2)OCCC3)CC1,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT02296853,NCT02296853_EG000,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 1,10,"Key Inclusion Criteria:

Screening laboratory parameters within defined thresholds
Creatinine clearance must be ≥ 60 mL/min

Key Exclusion Criteria:

Females who are pregnant or nursing or males who have a pregnant partner
Infection with hepatitis B virus (HBV) or HIV
History of clinically significant illness (including psychiatric or cardiac) or any other medical disorder that may interfere with participant treatment and/or adherence to the protocol

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.",Participants with severe hepatic impairment received a single oral dose of TAF 25 mg on Day 1.,ChEMBL:CHEMBL1534 | DrugBank:DB00140 | PubChem:493570,Riboflavin,Cc1cc2nc3c(=O)[nH]c(=O)nc-3n(C[C@H](O)[C@H](O)[C@H](O)CO)c2cc1C,A11HA04 | S01XA26,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT02296853,NCT02296853_EG001,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 1,10,"Key Inclusion Criteria:

Screening laboratory parameters within defined thresholds
Creatinine clearance must be ≥ 60 mL/min

Key Exclusion Criteria:

Females who are pregnant or nursing or males who have a pregnant partner
Infection with hepatitis B virus (HBV) or HIV
History of clinically significant illness (including psychiatric or cardiac) or any other medical disorder that may interfere with participant treatment and/or adherence to the protocol

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.",Participants with normal hepatic function received a single oral dose of TAF 25 mg of on Day 1.,ChEMBL:CHEMBL1534 | DrugBank:DB00140 | PubChem:493570,Riboflavin,Cc1cc2nc3c(=O)[nH]c(=O)nc-3n(C[C@H](O)[C@H](O)[C@H](O)CO)c2cc1C,A11HA04 | S01XA26,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02300077,NCT02300077_EG001,No,All,Adult | Older Adult,Not Applicable,60,"Inclusion Criteria:

Age 18-65 years
Undergoing general anesthesia and moderately painful, ambulatory surgical procedures with anticipated overnight, postop hospital stay of < 24 hours
Signed, written, informed consent

Exclusion Criteria:

History of or known liver or kidney disease.
Females who are pregnant or nursing.
Opioid tolerant patients (e.g. preoperative methadone therapy or use of fentanyl transdermal patches)
History of allergy to methadone","methadone 0.1 mg/kg

methadone: Escalating dose of methadone up to .3mg/kg.",ChEMBL:CHEMBL350719 | ChEMBL:CHEMBL651 | DrugBank:DB00333 | DrugBank:DB15198 | PubChem:4095 | PubChem:643985,Methadone,CCC(=O)C(CC(C)N(C)C)(c1ccccc1)c1ccccc1,N02AC52 | N07BC02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02300077,NCT02300077_EG002,No,All,Adult | Older Adult,Not Applicable,60,"Inclusion Criteria:

Age 18-65 years
Undergoing general anesthesia and moderately painful, ambulatory surgical procedures with anticipated overnight, postop hospital stay of < 24 hours
Signed, written, informed consent

Exclusion Criteria:

History of or known liver or kidney disease.
Females who are pregnant or nursing.
Opioid tolerant patients (e.g. preoperative methadone therapy or use of fentanyl transdermal patches)
History of allergy to methadone",methadone: Escalating dose of methadone up to .3mg/kg.,ChEMBL:CHEMBL350719 | ChEMBL:CHEMBL651 | DrugBank:DB00333 | DrugBank:DB15198 | PubChem:4095 | PubChem:643985,Methadone,CCC(=O)C(CC(C)N(C)C)(c1ccccc1)c1ccccc1,N02AC52 | N07BC02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02300259,NCT02300259_EG000,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 1,16,"Inclusion Criteria:

Healthy participants as determined by medical history, physical examination, clinical laboratory tests, and electrocardiograms (ECGs).
Have a body mass index (BMI) between 18 and 32.0 kilograms per square meter (kg/m^2) inclusive, at screening
Female participants must be of non-childbearing potential

Exclusion Criteria:

In the opinion of the investigator or sponsor, are unsuitable for inclusion in the study",Period 1: Single oral dose of 6 mg LY2623091 on Day 1.,PubChem:42636651,"(E)-1-(5-((E)-(3-Fluorodibenzo(b,E)oxepin-11(6H)-ylidene)methyl)-1-((R)-1-morpholinopropan-2-yl)-1H-benzo(d)imidazol-2(3H)-ylidene)urea",CC(CN1CCOCC1)n1c(NC(N)=O)nc2cc(C=C3c4ccccc4COc4cc(F)ccc43)ccc21,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02301364,NCT02301364_EG000,No,All,Adult | Older Adult,Phase 2,4,"Inclusion Criteria:

Participants must be able to understand and be willing to sign a written informed consent document.
Subjects must be at least 18 years of age on the day of consenting to the study.
Histologically documented PCNSL or SCNSL. Patients with SCNSL need to have cytology or tissue biopsy documenting lymphomatous involvement of the CNS
Patients must have relapsed/refractory PCNSL or relapsed/refractory SCNSL
All patients need to have received at least one prior CNS directed therapy. There is no restriction on the number of recurrences.
Patients with parenchymal lesions must have unequivocal evidence of disease progression on imaging (MRI of the brain or head CT) 21 days prior to study registration. For patients with leptomeningeal disease only, CSF cytology must document lymphoma cells and/or imaging findings consistent with CSF disease 21 days prior to study registration.
Participants must have a Karnofsky performance status (KPS) of ≥ 50.
Participants must have adequate bone marrow and organ function shown by:

Absolute neutrophil count (ANC) ≥ 1.5x 109/L

Platelets ≥ 100 x 109/L and no platelet transfusion within the past 14 days prior to study registration
Hemoglobin (Hgb) ≥ 9 g/dL and no red blood cell (RBC) transfusion within the past 14 days prior to study registration
International Normalized Ratio (INR) ≤ 1.5
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 1.5 times the ULN.

Serum bilirubin ≤ upper limit of normal; or total bilirubin ≤ 2.0x the ULN with direct bilirubin within the normal range in patients with well documented Gilbert Syndrome.

Participants must be able to take oral medication.
Patients must be able to tolerate MRI scans.
Patients must be able to tolerate lumbar puncture and/or Ommaya taps.
Participants must have recovered to grade 1 toxicity from prior therapy.
Participates must be able to submit 20 unstained slides from the initial tissue diagnosis for confirmation of diagnosis and correlative studies
Life expectancy of > 3 months (in the opinion of the investigator) Note: Prior autologous stem cell transplant as well as radiation to the CNS is NOT an exclusion criterion. Prior allogenic stem cell transplant IS an exclusion criterion.

Exclusion Criteria:

Patients with SCNSL actively receiving treatment for extra-CNS disease are excluded. Patient should have complete resolution of their systemic disease not requiring additional systemic therapy (e.g. maintenance rituximab or decadron).
The patient has received prior treatment with a PI3K inhibitor, AKT inhibitor, or mTOR inhibitor (e.g. rapamycin, MK2206, perifosine, etc.).
Patient is concurrently using other approved or investigational antineoplastic agents
Patient has received chemotherapy or targeted anticancer therapy, monoclonal antibodies ≤ 4 weeks or 5 half-lives, whichever is shorter, or 6 weeks for nitrosourea or mitomycin-C prior to starting the study drug, or the patient has not recovered side the side effects of such therapy
Patient who has received wide field radiotherapy ≤ 4 weeks or limited field radiation for palliation ≤ 2 weeks prior to starting study drug or who have not recovered to grade 1 or better from related side effects of such therapy (except alopecia)
Patient requires more than 8 mg of dexamethasone daily or the equivalent
Patient is taking an enzyme inducing anti-epileptic drug (EIAED), including phenobarbital, phenytoin, fosphenytoin, primidone, carbamazepine, oxcarbazepine, eslicarbazepine, rufinamide, and felbamate. Participates must be off of any EIAED for a least two weeks prior to starting the study drug
Patient is taking a drug known to be a strong inhibitor or inducers of the isoenzyme CYP3A. Participants must be off a strong CYP3A inhibitors and inducers for at least two weeks prior to starting the study drug.
Patient is taking a drug with known risk to promote QT prolongation and Torsade de Pointes Patient is currently using herbal preparations or medications. Participants should stop using herbal medications 7 days prior to the first dose of the study drug.
Patient is using warfarin or any other Coumadin-derivative anticoagulant. Patients must be off Coumadin-derivative anticoagulants for at least seven days prior to starting the study drug. Low molecular weight heparin is allowed
Patient has a history of allergic reactions to compounds of similar chemical or biological composition to buparlisib
Patient has an uncontrolled intercurrent illness, including, but not limited to, ongoing or active infection, chronic liver disease, chronic renal disease, pancreatitis, chronic pulmonary disease, or psychiatric illness or social situations that would limit compliance with the study requirements
Patient has acute viral hepatitis or a history of chronic or active HBV or HCV infection
Patient has an active concurrent malignancy requiring active therapy.
Patient is known to have human immunodeficiency virus (HIV) infection
Patient has any severe psychiatric disease that would interfere with participation in the trial as determined by the study investigator
Patient has ≥ CTCAE grade 3 anxiety
Patient has ≥ CTCAE grade 2 diarrhea Patient has a score ≥12 on the PHQ-9 questionnaire
Patient selects a response of ""1, 2 or 3"" to question number 9 on the PHQ-9-questionaire regarding potential for suicidal thoughts or ideation (independent of the total score of the PHQ-9).
Patient has a GAD-7 mood scale score ≥15.
Patient has a medically documented history of or active major depressive episode, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia, a history of suicidal attempt or ideation, or homicidal ideation (e.g. risk of doing harm to self or others).
Patient has active cardiac disease or cardiac dysfunction including any of the following:
Left ventricular ejection fraction (LVEF) ,50% as determined by Multiple Gated Acquisition (MUGA) scan or echocardiogram (ECHO)
QTc>480msec on screening ECG (using the QTcF formula)
Angina pectoris that requires the use of anti-anginal medications
Ventricular arrhythmias except for benign premature ventricular contractions
Supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication
Conduction abnormality requiring a pacemaker
Valvular disease with documented compromise in cardiac function
Symptomatic pericarditis
Myocardial infarction within the last 6 months, documented by persistent elevated cardiac enzymes or persistent regional wall motion abnormalities on assessment of left ventricular ejection fraction function
History of documented congestive heart failure (New York Heart Association functional classification III-IV)
Documented cardiomyopathy
Congenital long QT syndrome
Patient is currently receiving treatment with QT prolonging medication known to have a risk to induce Torsades de Pointes, and the treatment cannot be discontinued or switched to a different medication prior to starting study drug.
Patient has impaired gastrointestinal function or gastrointestinal disease affecting absorption of buparlisib (e.g. ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or extensive small bowel resection).
Patient has poorly controlled diabetes mellitus with a glycosylated hemoglobin >8% or poorly controlled steroid-induced diabetes mellitus with a glycosylated hemoglobin of >8%.
Patient underwent major systemic surgery ≤ 2 weeks prior to starting the trial treatment or who has not recovered from the side effects of such surgery.
Women who are pregnant or nursing (lactating), where pregnancy is defined as a state of a female after conception until the termination of gestation, confirmed by a positive serum hCG laboratory test of > 5 mIU/mL.
Patients who have received allogenic stem cell transplants.","This is an open-label, phase II trial of the pan-PI3K inhibitor buparlisib (BKM120) for patients with recurrent or refractory primary central nervous lymphoma (PCNSL) and recurrent or refractory secondary central nervous lymphoma (SCNSL).",ChEMBL:CHEMBL2017974 | DrugBank:DB11666 | PubChem:16654980,Buparlisib,Nc1cc(C(F)(F)F)c(-c2cc(N3CCOCC3)nc(N3CCOCC3)n2)cn1,,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,1.0,1.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT02301390,NCT02301390_EG000,No,All,Adult | Older Adult,Not Applicable,27,"Inclusion Criteria:

≥ 18 and ≤ 85 years of age
History of a remote MI (≥1 month)
Survival of a ventricular arrhythmic event (VT/VF) that would mandate placement of an implantable cardioverter-defibrillator (ICD) (Patients who experience a ventricular arrhythmic event (VT/VF) while already being treated with Amiodarone (100-200 mg/day) are not excluded from the study. This is permitted provided that the patient had been treated with Amiodarone for at least 2 months prior to experiencing the index VT/VF event. These patients are randomized to either a higher dose of Amiodarone (e.g., 100mg/day -> 200mg/day or 200mg/day -> 400mg/day) or a higher dose of Amiodarone plus catheter ablation.)
Patient cannot afford an ICD and thus has been planned for treatment with Amiodarone (or an increased dose of Amiodarone)
Ability to understand the requirements of the study
Willingness to adhere to study restrictions and comply with all post- procedural follow-up requirements

Exclusion Criteria:

Patients with NYHA class IV congestive heart failure
Prior ablation for a ventricular arrhythmia
Presence of an LV thrombus
Contraindication to anticoagulation
Inability to access the endocardium because of mechanical mitral and aortic valve
Life expectance <1 year for any medical condition",Amiodarone is a Class III antiarrhythmic agent.,ChEMBL:CHEMBL633 | DrugBank:DB01118 | PubChem:2157,Amiodarone,CCCCc1oc2ccccc2c1C(=O)c1cc(I)c(OCCN(CC)CC)c(I)c1,C01BD01,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02304757,NCT02304757_EG000,No,Female,Adult | Older Adult,Not Applicable,70,"Inclusion Criteria:

(1) They were pathologically diagnosed with DTC including papillary or follicular carcinoma. (2) They received a near total thyroidectomy and radioiodine treatment. (3) TSH suppression should be at least one year before the study. (4) Bone mineral density (BMD) in lumbar spine and/or hip was tested by Dual-energy X-ray absorptiometry (DXA) at baseline, 6 month (m) and/or 12m follow up. 5) The diagnosis of osteoporosis was T-score ≤-2.5 SD at the lumbar spine, or hip.

Exclusion Criteria:

patients having medications for osteoporosis before TSH suppression treatment;
secondary osteoporosis ;
severe liver or kidney disease;
myelosuppression;
digestive disease;
long term use of immunosuppressive agent, estrogen or estrogen receptor modulators. This study was approved by the Institutional Review Board of Hospital Research Ethics. All the patients were fully acquainted with their treatment and consented to participate in the clinical trial.","15mg 99Tc-MDP were intravenously administered twice a week for 10 weeks, then once a week for 8 weeks, every two weeks for 22 weeks and monthly for another 3m.

99Tc-MDP: 99Tc-MDP, H20000218",PubChem:16040217,99mTc-Methylene diphosphonate,O.O.O=P(O)(O)CP(=O)(O)O.O=P(O)(O)CP(=O)(O)O.[Tc],,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02308020,NCT02308020_EG003,No,All,Adult | Older Adult,Phase 2,28,"Inclusion Criteria:

Have brain metastases secondary to hormone receptor positive breast cancer, NSCLC, or melanoma.
Have either human epidermal growth factor receptor 2 positive (HER2+) (Study Part A) or negative HER2- (Study Part B) breast cancer.
Participants in Study Part C must have HR+ breast cancer, NSCLC, or melanoma with brain lesions clinically indicated for surgical resection as well as consent to provide tissue for drug concentration determination after 5 to 14 days of study drug dosing.
Participants in Part D must have NSCLC of any subtype.
Participants in Part E must have melanoma of any subtype.
Participants in Part F must have HR+ breast cancer, NSCLC, or melanoma with leptomeningeal metastases.
For Parts A, B, D, and E: Must have at least 1 measurable brain lesion ≥10 millimeters (mm) in the longest diameter (LD).
For Part C (surgical): Have metastatic brain lesion(s) for which surgical resection is clinically indicated.
Have completed local therapy (surgical resection, whole-breast radiotherapy (WBRT), or SRS) ≥14 days prior to initiating abemaciclib and recovered from all acute effects.
If receiving concomitant corticosteroids, must be on a stable or decreasing dose for at least 7 days prior to the baseline Gd-MRI.
Have a Karnofsky performance status of ≥70.
Have a life expectancy ≥12 weeks.
For HR+ breast cancer participants in part A, B, C, and F: If currently receiving endocrine therapy, a participant may continue to receive the same endocrine therapy provided that extracranial disease is stable for at least 3 months and central nervous system (CNS) disease progression has occurred while on this endocrine therapy. If these conditions are not met, participants must discontinue endocrine therapy prior to initiation of abemaciclib.
For HER2+ breast cancer participants in parts A, C, and F: participants may receive concurrent treatment (ongoing or initiated simultaneously with abemaciclib) with IV trastuzumab.
For NSCLC participants in parts C, D, and F: if currently receiving gemcitabine or pemetrexed (single-agent or in combination with another therapy), a participant may continue to receive 1 of these 2 therapies provided that extracranial disease is stable for at least 6 weeks and CNS disease progression has occurred while on this therapy.
Have adequate organ function.

Exclusion Criteria:

Require immediate local therapy, including but not limited to WBRT, SRS, or surgical resection, for treatment of brain metastases.
Are taking concurrent enzyme-inducing antiepileptic drugs (EIAED).
Have evidence of significant (ie, symptomatic) intracranial hemorrhage.
For Parts A, B, C, D, E: Have evidence of leptomeningeal metastases. Note: discrete dural metastases are permitted.
Have experienced >2 seizures within 4 weeks prior to study entry.
For Parts A, B, D, E, and F: Have previously received treatment with any cyclin dependent kinase 6 (CDK6) inhibitor. For Part C participants may have received prior palbociclib or ribociclib, but not abemaciclib treatment.
Have known contraindication to Gd-MRI.
Have a preexisting chronic condition resulting in persistent diarrhea.","Abemaciclib 200 mg was administered orally once every 12 hours on days 1-21 of a 21-day cycle. Participants with NSCLC receiving concurrent gemcitabine or pemetrexed, 150 mg abemaciclib was given orally once every 12 hours on days 1-21 of a 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.",ChEMBL:CHEMBL3301610 | DrugBank:DB12001 | PubChem:46220502,Abemaciclib,CCN1CCN(Cc2ccc(Nc3ncc(F)c(-c4cc(F)c5nc(C)n(C(C)C)c5c4)n3)nc2)CC1,L01EF03,1.0,0.0,0.0,0.0,0.0,1.0,1.0,1.0,0.0,0.0,1.0,1.0,1.0,1.0,1.0,0.0,1.0,0.0,1.0,1.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT02308241,NCT02308241_EG000,No,All,Adult | Older Adult,Not Applicable,12,"Inclusion Criteria:

Recurrent and/or metastatic HPV-related carcinoma of the cervix, anus, vagina, vulva, penis, or oropharynx. The cancer diagnosis must be confirmed by slide review in the MSKCC Department of Pathology. HPV positive status must be demonstrated by HPV in situ-hybridization (ISH) and/or by p16 immunohistochemistry (IHC).

Note: For cervix squamous cancer, HPV ISH test or p16 IHC test is not required, because all cervix squamous cancers are presumed to be HPV-associated.

Adults (≥ 18 years of age)
ECOG performance status of 1 or better
Measurable disease according to RECIST 1.1 criteria
Availability of archived tumor tissue for correlative studies (5 unstained slides)
Adequate organ function, as follows:
Adequate bone marrow reserve: absolute neutrophil count (ANC) ≥ 1.5 X 109/L, platelets ≥ 160 X 109/L, hemoglobin ≥ 10 g/dL
Hepatic: total bilirubin within ULN (upper limit of normal); alkaline phosphatase (AP), aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.0 X ULN
Renal: Serum creatinine ≤ 1.3 mg/dL. Patients with serum creatinine > 1.3 mg/dL may be eligible if creatinine clearance (CrCl) ≥ 55 mL/min based on the standard Cockroft and Gault formula.
Ability to swallow oral medication.
Patients of childbearing potential must have a negative serum pregnancy test within 14 days of treatment. Patients must agree to use a reliable method of birth control during and for 6 months following the last dose of study drug.
At least one prior systemic therapy regimen for R/M HPV-related carcinoma

Exclusion Criteria:

History of hemolytic anemia or thalassemia
Current treatment or known prior treatment with ribavirin
Active infection or serious underlying medical condition that would impair the patient's ability to receive protocol treatment.
Current therapeutic anticoagulation with Coumadin (warfarin)
Known brain metastases","Study subjects will self-administer ribavirin 1400 mg PO BID (total dose, 2800 mg/day). All patients will complete pill diaries to document administration of study drug. Cycle length is 28 days with continuous dosing. Clinic visits for safety assessments and routine laboratory studies will occur weekly in Cycle 1, in weeks 1 and 3 of Cycle 2, and on Week 1 of subsequent cycles. Cross sectional imaging (CT or MRI) is obtained at baseline and q2 cycles and at End-of Treatment (EOT). Response assessments will follow RECIST 1.1 criteria.

Ribavirin: self-administer ribavirin 1400 mg PO BID (total dose, 2800 mg/day)",ChEMBL:CHEMBL1643 | DrugBank:DB00811 | PubChem:37542,Ribavirin,NC(=O)c1ncn([C@@H]2O[C@H](CO)[C@@H](O)[C@H]2O)n1,J05AP01,1.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,1.0,1.0,0.0,1.0,0.0,1.0,1.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0
NCT02313675,NCT02313675_EG000,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 4,44,"Inclusion Criteria:

carpal tunnel release surgery candidates,
distal radius fracture surgery candidates

Exclusion Criteria:

under 18 years of age,
pregnant women,
prisoners","One time intra-operative IV acetaminophen administration

Acetaminophen",ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02321527,NCT02321527_EG000,No,Female,Adult | Older Adult,Not Applicable,21,"Inclusion Criteria:

18 years or older.
Ipsilateral biopsy-proven invasive breast cancer <5 cm in maximal dimension by Ultrasound or Mammography.
No abnormal axillary nodes identified on grayscale AUS, or abnormal nodes with benign subsequent FNA biopsy.

Exclusion Criteria:

Pregnant or nursing women
Prior SLN dissection
Neoadjuvant chemotherapy.
Prior axillary lymph node surgery.
Prior history of ipsilateral breast cancer.
Known or suspected: Cardiac shunts
Known or suspected: hypersensitivity to perflutren, blood, blood products or albumin
Known or suspected: hypersensitivity to a prior OPTISON administration","Subdermal periareolar injection of 0.2 - 0.5 cc of microbubble contrast Perflutren Protein-Type A Microspheres Injectable Suspension before Contrast-Enhanced Ultrasound (CEUS), sentinel lymph node biopsy and radioactive seed placement.",ChEMBL:CHEMBL1663 | DrugBank:DB00556 | PubChem:6432,Perflutren,FC(F)(F)C(F)(F)C(F)(F)F,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT02322320,NCT02322320_EG000,No,All,Adult | Older Adult,Phase 3,98,"Inclusion Criteria:

Patients fulfilling the following criteria will be eligible to provide continued long-term follow-up data as part of this study:

Enrolled and randomized on the BMT CTN 0702 protocol.
Alive at the completion of BMT CTN 0702 protocol specified follow-up defined as 4 years post-randomization.
Patients without evidence of disease progression at the completion of BMT CTN 0702 protocol specified follow up.
Signed Informed Consent Form.
Patients with the ability to speak English or Spanish are eligible to participate in the HQL component of this trial.

Inclusion Criteria for Optional Long-term Lenalidomide Maintenance Therapy:

Patients fulfilling the following criteria will be eligible to provide continued long-term follow-up data AND receive long-term lenalidomide maintenance therapy as part of this study:

Enrolled and randomized to BMT CTN 0702.
Completion of 3 years of maintenance therapy on BMT CTN 0702.
Registered in the mandatory Revlimid REMS® program (formerly the RevAssist® for Study Participants (RASP) program), and be willing and able to comply with the requirements of the Revlimid REMS® program, including counseling, pregnancy testing, and phone surveys.
Signed informed consent form.
Patients with the ability to speak English or Spanish are eligible to participate in the HQL component of this trial.

Exclusion Criteria:

Patients who meet any of the following criteria will be ineligible to receive long-term lenalidomide maintenance therapy as part of this study:

Patients who have evidence of disease progression prior to enrollment.
Patients who were discontinued from BMT CTN 0702 lenalidomide maintenance therapy, for any reason, prior to the completion of the 3 years of 0702 maintenance.
Female patients who are pregnant (positive - Beta Human Chorionic Gonadotropin) or breastfeeding.
Females of childbearing potential (FCBP) or men who have sexual contact with FCBP unwilling to use contraceptive techniques during the length of lenalidomide maintenance therapy.
Patients who experienced thromboembolic events while on full anticoagulation during prior therapy with lenalidomide.
Patients unwilling to take Deep Vein Thrombosis (DVT) prophylaxis.
Patients who developed a second primary malignancy, excluding non-melanoma skin cancers after initiation of lenalidomide maintenance therapy on BMT CTN 0702.","Initial autologous transplant followed by a second autologous transplant and lenalidomide maintenance

Lenalidomide: In BMT CTN 0702, maintenance therapy with lenalidomide started at 10 mg daily for three months and increased to 15 mg daily. The duration of maintenance was three years in all treatment arms. Lenalidomide will be administered initially at the patient's last documented dose prior to discontinuation of BMT CTN 0702 lenalidomide maintenance therapy. Cycle duration is 28 days. Patients will continue lenalidomide until disease progression, or discontinuation due to toxicity, death, or withdrawal from the study.",ChEMBL:CHEMBL848 | DrugBank:DB00480 | PubChem:216326,Lenalidomide,Nc1cccc2c1CN(C1CCC(=O)NC1=O)C2=O,L04AX04,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02322320,NCT02322320_EG001,No,All,Adult | Older Adult,Phase 3,86,"Inclusion Criteria:

Patients fulfilling the following criteria will be eligible to provide continued long-term follow-up data as part of this study:

Enrolled and randomized on the BMT CTN 0702 protocol.
Alive at the completion of BMT CTN 0702 protocol specified follow-up defined as 4 years post-randomization.
Patients without evidence of disease progression at the completion of BMT CTN 0702 protocol specified follow up.
Signed Informed Consent Form.
Patients with the ability to speak English or Spanish are eligible to participate in the HQL component of this trial.

Inclusion Criteria for Optional Long-term Lenalidomide Maintenance Therapy:

Patients fulfilling the following criteria will be eligible to provide continued long-term follow-up data AND receive long-term lenalidomide maintenance therapy as part of this study:

Enrolled and randomized to BMT CTN 0702.
Completion of 3 years of maintenance therapy on BMT CTN 0702.
Registered in the mandatory Revlimid REMS® program (formerly the RevAssist® for Study Participants (RASP) program), and be willing and able to comply with the requirements of the Revlimid REMS® program, including counseling, pregnancy testing, and phone surveys.
Signed informed consent form.
Patients with the ability to speak English or Spanish are eligible to participate in the HQL component of this trial.

Exclusion Criteria:

Patients who meet any of the following criteria will be ineligible to receive long-term lenalidomide maintenance therapy as part of this study:

Patients who have evidence of disease progression prior to enrollment.
Patients who were discontinued from BMT CTN 0702 lenalidomide maintenance therapy, for any reason, prior to the completion of the 3 years of 0702 maintenance.
Female patients who are pregnant (positive - Beta Human Chorionic Gonadotropin) or breastfeeding.
Females of childbearing potential (FCBP) or men who have sexual contact with FCBP unwilling to use contraceptive techniques during the length of lenalidomide maintenance therapy.
Patients who experienced thromboembolic events while on full anticoagulation during prior therapy with lenalidomide.
Patients unwilling to take Deep Vein Thrombosis (DVT) prophylaxis.
Patients who developed a second primary malignancy, excluding non-melanoma skin cancers after initiation of lenalidomide maintenance therapy on BMT CTN 0702.","Initial autologous transplant followed by lenalidomide, bortezomib and dexamethasone (RVD) consolidation and lenalidomide maintenance

Lenalidomide: In BMT CTN 0702, maintenance therapy with lenalidomide started at 10 mg daily for three months and increased to 15 mg daily. The duration of maintenance was three years in all treatment arms. Lenalidomide will be administered initially at the patient's last documented dose prior to discontinuation of BMT CTN 0702 lenalidomide maintenance therapy. Cycle duration is 28 days. Patients will continue lenalidomide until disease progression, or discontinuation due to toxicity, death, or withdrawal from the study.",ChEMBL:CHEMBL848 | DrugBank:DB00480 | PubChem:216326,Lenalidomide,Nc1cccc2c1CN(C1CCC(=O)NC1=O)C2=O,L04AX04,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02322320,NCT02322320_EG002,No,All,Adult | Older Adult,Phase 3,89,"Inclusion Criteria:

Patients fulfilling the following criteria will be eligible to provide continued long-term follow-up data as part of this study:

Enrolled and randomized on the BMT CTN 0702 protocol.
Alive at the completion of BMT CTN 0702 protocol specified follow-up defined as 4 years post-randomization.
Patients without evidence of disease progression at the completion of BMT CTN 0702 protocol specified follow up.
Signed Informed Consent Form.
Patients with the ability to speak English or Spanish are eligible to participate in the HQL component of this trial.

Inclusion Criteria for Optional Long-term Lenalidomide Maintenance Therapy:

Patients fulfilling the following criteria will be eligible to provide continued long-term follow-up data AND receive long-term lenalidomide maintenance therapy as part of this study:

Enrolled and randomized to BMT CTN 0702.
Completion of 3 years of maintenance therapy on BMT CTN 0702.
Registered in the mandatory Revlimid REMS® program (formerly the RevAssist® for Study Participants (RASP) program), and be willing and able to comply with the requirements of the Revlimid REMS® program, including counseling, pregnancy testing, and phone surveys.
Signed informed consent form.
Patients with the ability to speak English or Spanish are eligible to participate in the HQL component of this trial.

Exclusion Criteria:

Patients who meet any of the following criteria will be ineligible to receive long-term lenalidomide maintenance therapy as part of this study:

Patients who have evidence of disease progression prior to enrollment.
Patients who were discontinued from BMT CTN 0702 lenalidomide maintenance therapy, for any reason, prior to the completion of the 3 years of 0702 maintenance.
Female patients who are pregnant (positive - Beta Human Chorionic Gonadotropin) or breastfeeding.
Females of childbearing potential (FCBP) or men who have sexual contact with FCBP unwilling to use contraceptive techniques during the length of lenalidomide maintenance therapy.
Patients who experienced thromboembolic events while on full anticoagulation during prior therapy with lenalidomide.
Patients unwilling to take Deep Vein Thrombosis (DVT) prophylaxis.
Patients who developed a second primary malignancy, excluding non-melanoma skin cancers after initiation of lenalidomide maintenance therapy on BMT CTN 0702.","Initial autologous transplant followed by lenalidomide maintenance

Lenalidomide: In BMT CTN 0702, maintenance therapy with lenalidomide started at 10 mg daily for three months and increased to 15 mg daily. The duration of maintenance was three years in all treatment arms. Lenalidomide will be administered initially at the patient's last documented dose prior to discontinuation of BMT CTN 0702 lenalidomide maintenance therapy. Cycle duration is 28 days. Patients will continue lenalidomide until disease progression, or discontinuation due to toxicity, death, or withdrawal from the study.",ChEMBL:CHEMBL848 | DrugBank:DB00480 | PubChem:216326,Lenalidomide,Nc1cccc2c1CN(C1CCC(=O)NC1=O)C2=O,L04AX04,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02327143,NCT02327143_EG000,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 1,11,"Inclusion Criteria:

Overtly healthy sterile males or surgically sterile females or postmenopausal females
Have a body mass index (BMI) of 18 to 32 kilogram per meter square (kg/m^2)
Have given written informed consent approved by Lilly and the ethical review board (ERB) governing the site.
Participants who are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures

Exclusion Criteria:

Have participated in a clinical trial involving investigational product within the last 90 days
Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study
Have an abnormal blood pressure
Show evidence of human immunodeficiency virus (HIV), hepatitis B or hepatitis C
Have donated blood of more than 500 milliliters (mL) within the last month
Have consumed any sensitive CYP2B6 substrate drugs, any CYP3A4 inhibitor or any CYP3A inducer, herbal supplements, grapefruits or grapefruit containing products, Seville oranges or Seville orange containing products, star fruits or star fruit containing products within 2 weeks prior to dosing or intend to consume during the study
Regularly use known drugs of abuse and/or show positive findings on urinary drug screening",200 mg LY2835219 administered orally on day 1.,ChEMBL:CHEMBL3301610 | DrugBank:DB12001 | PubChem:46220502,Abemaciclib,CCN1CCN(Cc2ccc(Nc3ncc(F)c(-c4cc(F)c5nc(C)n(C(C)C)c5c4)n3)nc2)CC1,L01EF03,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02334215,NCT02334215_EG001,No,All,Adult | Older Adult,Not Applicable,74,"Inclusion Criteria:

1) Meets Diagnostic and Statistical Manual -5 (DSM-5) criteria for opioid use disorder; (2) detained for at least 48 hours; (3) receiving opioid withdrawal treatment (as-usual) through the Detention Center's medical providers; (4) able and willing to provide informed consent in English; (5) detained for a charge that, if found guilty, will result in a sentence of less than 1 year; (6) plan to reside in Baltimore upon release; (7) 18 years of age and older.

Exclusion Criteria:

(1) enrolled in methadone or buprenorphine treatment in the community at the time of arrest; (2) having a medical (liver failure, congestive heart failure) or psychiatric condition (e.g., suicidal ideation, psychosis) that would make participation unsafe in the judgment of the medical staff or the PI; (3) pregnancy; (4) allergy to methadone; and, (5) requiring treatment for alcohol or sedative hypnotic withdrawal.","Participants will begin methadone during detention.

Methadone: Interim methadone treatment (methadone without routine counseling) will be provided in jail. Methadone treatment with counseling will be continued in the community.",ChEMBL:CHEMBL350719 | ChEMBL:CHEMBL651 | DrugBank:DB00333 | DrugBank:DB15198 | PubChem:4095 | PubChem:643985,Methadone,CCC(=O)C(CC(C)N(C)C)(c1ccccc1)c1ccccc1,N02AC52 | N07BC02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02342704,NCT02342704_EG001,Accepts Healthy Volunteers,All,Adult,Phase 4,54,"Key Inclusion Criteria for MS Patients:

Must have a documented diagnosis of relapsing MS (McDonald 2010 Criteria) at study screening with EDSS score from 0.0 to 5.5.
If the subject is on Betaseron, Rebif, Avonex, Copaxone, Extavia, Tecfidera, and Aubagio (BRACE-TA) at study screening:
He/she must have been on therapy for at least 6 months (unless experiencing highly active disease), have at least 9 T2-hyperintense lesions on a brain MRI scan, and have experienced ≥1 relapse within the last 6 months prior to study screening with ≥1 new T1-Gd+ lesion on a brain MRI scan performed ≤6 months prior to study screening or ≥2 new T2 lesions on a brain MRI scan performed ≤6 months prior to study screening, with comparison made to a T2 MRI scan performed up to 18 months before study screening
If the subject has highly active disease, regardless of whether they are disease-modifying therapy (DMT)-naïve or had previous exposure to Betaseron, Rebif, Avonex, Copaxone, Extavia, Tecfidera, and Aubagio (BRACE-TA), they must have had ≥2 disabling relapses in the 12 months prior to study screening and either ≥1 new T1-Gd+ lesion on a brain MRI scan performed ≤6 months prior to study screening or ≥2 new T2 lesions on a brain MRI scan performed ≤6 months prior to study screening, with comparison made to a T2 MRI scan performed up to 18 months before study screening

Key Exclusion Criteria for MS Patients:

Diagnosis of Primary Progressive Multiple Sclerosis and/or Secondary Progressive Multiple Sclerosis.
History or positive test result at study screening for human immunodeficiency virus (HIV), hepatitis C virus (HCV) antibody or current hepatitis B infection (defined as positive for hepatitis B surface antigen [HBsAg] and/or hepatitis B core antibody [HBcAb]).
Prior treatment with natalizumab or fingolimod.
History of or known active malignant disease, including solid tumors and hematologic malignancies (subjects with cutaneous basal and squamous cell carcinoma that has been completely excised and considered cured prior to study screening remain eligible).
History of opportunistic infections or any clinically significant major disease, as determined by the Investigator.
A clinically significant infectious illness (e.g., pneumonia, septicemia) within the 1 month prior to study screening.
History of drug or alcohol abuse (as defined by the Investigator) within 1 year prior to study screening.
Prior history of immunosuppressant use (e.g., mitoxantrone, azathioprine, methotrexate, cyclophosphamide, mycophenolate, cladribine, rituximab), or exposure to intravenous immunoglobulin (IGIV), monoclonal antibodies, cytokines, growth factors, soluble receptors, other recombinant products, or fusion proteins in the last 12 months prior to study screening.
History of myocardial infarction, unstable angina, stroke, transient ischemic attack, decompensated heart failure in last 6 months.
Treatment with Class Ia (e.g., procainamide, quinidine, ajmaline, disopyramide) or Class III (amiodarone, bretylium, dofelitide, sotalol, ibulitide, azilimide) anti-arrhythmic drugs.
Concurrent therapy with drugs that slow heart rate (e.g., beta-blockers, heart-rate lowering calcium channel blockers such as diltiazem or verapamil, or digoxin).
Hypertension not controlled with prescribed medications.
History of severe respiratory disease, pulmonary fibrosis or class III or IV chronic obstructive pulmonary disease.
The use of live or live attenuated vaccination within 8 weeks of study screening.

Key Inclusion Criteria for Healthy Volunteers:

Subjects who are generally healthy as demonstrated by physical examination and by medical history, with no history or evidence of major illnesses, diseases, or disorders.
Subjects of childbearing potential must practice effective contraception and be willing and able to continue contraception for duration of the study.
No history of drug or alcohol abuse (as defined by the Investigator) within 1 year prior to study screening.

Key Exclusion Criteria for Healthy Volunteers:

Claustrophobia sufficient to interfere with generating reliable MRI scans.
History of other major illness including neurological disorders as determined by the Investigator.
Presence of a metal device affected by MRI (e.g., any type of electronic, mechanical or magnetic implant, cardiac pacemaker, aneurysm clips, implanted cardiac defibrillator) or potential ferromagnetic foreign body (metal slivers, metal shavings, other metal objects), which would be a contraindication for MRI.
Women who are currently pregnant or breastfeeding, or who have a positive pregnancy test result at screening.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply",Open-label fingolimod 0.5 mg once daily orally,ChEMBL:CHEMBL314854 | DrugBank:DB08868 | PubChem:107970,Fingolimod,CCCCCCCCc1ccc(CCC(N)(CO)CO)cc1,L04AA27,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02347332,NCT02347332_EG001,No,All,Adult | Older Adult,Phase 3,227,"Inclusion Criteria:

Histologically or cytologically confirmed recurrent and/or metastatic squamous cell carcinoma
Documented progressive disease after chemotherapy for locoregionally advanced or recurrent/metastatic SCCHN which included a platinum derivative
Measurable or non measurable disease
adequate haematological, hepatic and renal functions
WHO performance status < 1

Exclusion Criteria:

Nasopharyngeal carcinoma
History of brain or leptomeningeal involvement
Albumin level < 35 g/L
Patients with weight loss ≥ 5% within the last 3 months
Grade > 2 peripheral neuropathy at study entry
""Third space"" fluids (pleural effusion, ascites, massive edema)
Prior treatment with vinca-alkaloids and methotrexate","Methotrexate IV 40 mg/m² days 1, 8 and 15 every 3 weeks

Methotrexate",ChEMBL:CHEMBL34259 | DrugBank:DB00563 | PubChem:126941,Methotrexate,CN(Cc1cnc2nc(N)nc(N)c2n1)c1ccc(C(=O)N[C@@H](CCC(=O)O)C(=O)O)cc1,L01BA01 | L04AX03,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,1.0,1.0,1.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT02353754,NCT02353754_EG000,No,Female,Adult | Older Adult,Phase 4,12,"Inclusion Criteria:

Females ≥18 years of age at screening.
Scheduled to undergo elective C-section (single or multiple births).
American Society of Anesthesiology (ASA) physical status 1, 2, or 3.
Able to provide informed consent, adhere to the study visit schedule, and complete all study assessments.

Exclusion Criteria:

History of hypersensitivity or idiosyncratic reaction to amide-type local anesthetics or opioids.
Contraindication to bupivacaine, morphine, ketorolac, ibuprofen, or acetaminophen.
Planned concurrent surgical procedure with the exception of salpingo-oophorectomy or tubal ligation.
Use of any of the following medications within the times specified before surgery: long-acting opioid medication, non-steroidal anti-inflammatory drugs (NSAIDs), or aspirin (except for low-dose aspirin used for cardioprotection) within 3 days, or any opioid medication or acetaminophen within 24 hours.
Initiation of treatment with any of the following medications within 1 month of study drug administration or if the medication(s) are being given to control pain: selective serotonin reuptake inhibitors (SSRIs), selective norepinephrine reuptake inhibitors (SNRIs), gabapentin, pregabalin (Lyrica®), or duloxetine (Cymbalta®). If a subject is taking one of these medications for a reason other than pain control, she must be on a stable dose for at least 1 month prior to study drug administration.
Clinically significant medical or psychiatric disease that, in the opinion of the Investigator, would constitute a contraindication to participation in the study or cause inability to comply with the study requirements.
History of, suspected, or known addiction to or abuse of illicit drug(s), prescription medication(s), or alcohol within the past 2 years.
Received an investigational drug within 30 days prior to study drug administration, and/or has planned administration of another investigational product or procedure while participating in this study.

Previous participating in an EXPAREL study.

The subject will be withdrawn from the study if she meets the following criteria:

Any clinically significant event or condition uncovered during the surgery (e.g., excessive bleeding, acute sepsis) that might render the subject medically unstable or complicate the subject's postsurgical course.
Her baby's 5-minute Apgar score is ≤7.","Subjects in Group 1 (Standard of Care) will receive intrathecal morphine injection (e.g., Duramorph®) 0.2 mg in conjunction with the single-shot spinal anesthesia. No TAP block will be administered.

Intrathecal morphine injection: 0.2 mg",PubChem:6321225,Morphine sulfate pentahydrate,CN1CCC23c4c5ccc(O)c4OC2C(O)C=CC3C1C5.CN1CCC23c4c5ccc(O)c4OC2C(O)C=CC3C1C5.O.O.O.O.O.O=S(=O)(O)O,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02353806,NCT02353806_EG000,No,Female,Adult,Phase 4,16,"Inclusion Criteria:

18 years or older;
Pregnant female
Already taking amlodipine 5 mg for treatment of chronic hypertension in pregnancy;
Hospitalized following routine term vaginal delivery or uncomplicated cesarean delivery
Breastfeeding or breast and bottle-feeding their infant

Exclusion Criteria:

Known kidney disease
Delivery complicated by chorioamnionitis, endometritis or postpartum hemorrhage
Administration of greater than 5 mg of amlodipine in 24 hour period","Women already taking amlodipine besylate 5 mg for treatment of chronic hypertension in pregnancy who plan to breastfeed postpartum will be assigned to the single experimental arm.

Amlodipine besylate: Pregnant and postpartum women will continue taking amlodipine besylate 5 mg for treatment of chronic hypertension as prescribed by their clinician.",PubChem:11365087 | PubChem:60496,Amlodipine Besylate,CCOC(=O)C1=C(COCCN)NC(C)=C(C(=O)OC)C1c1ccccc1Cl.O=S(=O)(O)c1ccccc1,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02354352,NCT02354352_EG001,No,Male,Child | Adult | Older Adult,Phase 3,26,"Inclusion Criteria:

Boys age ≥7 years with DMD confirmed clinically and by mutation analysis able to undergo cardiac magnetic resonance (CMR) without sedation
LV EF ≥45% (+/-5%) by clinically-acquired echocardiography, nuclear scan or cardiac MRI done within 2 weeks of enrollment

Exclusion Criteria:

Non-MR compatible implants
Severe claustrophobia
Gadolinium contrast allergy
Kidney disease
Prior use of or allergy to aldosterone antagonist
Use of other investigational therapy.","Spironolactone is an aldosterone antagonist used as an adjunct in the management of chronic heart failure. It is marketed under the trade name Aldactone. Spironolactone is a potassium-sparing diuretic.

Spironolactone: 26 Subjects will take Spironolactone, one 50mg capsule by mouth once daily for 12 months.",ChEMBL:CHEMBL1393 | DrugBank:DB00421 | PubChem:5833,Spironolactone,[H][C@]12CC[C@]3(C)[C@]4(CCC(=O)O4)CC[C@@]3([H])[C@]1([H])[C@]([H])(SC(C)=O)CC1=CC(=O)CC[C@@]12C,C03DA01,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02357849,NCT02357849_EG001,No,All,Child | Adult,Phase 4,9,"Inclusion Criteria:

consent obtained from patients and their parents (assent for patients under 18);
age 12-25 years (inclusive);
English-speaking;
at least one positive (Scale A) SOPS score of 3-5, i.e., moderate, moderately severe or severe.

Exclusion Criteria:

lifetime diagnosis of an Axis I psychotic disorder, including: schizophreniform disorder, schizophrenia, schizoaffective disorder, bipolar disorder, or major depression with psychotic features;
current psychosis (any positive symptom SOPS score of 6, i.e., extreme);
current diagnosis of Major Depressive Disorder, single episode or recurrent, severe without psychotic features;
current stimulant treatment;
history of neurological, neuroendocrine or other medical condition known to affect the brain;
any significant medical condition that contra-indicates treatment with either aripiprazole or fluoxetine;
past or current substance dependence; sunstance abuse within the last 4 weeks;
IQ < 70.",Active control arm,ChEMBL:CHEMBL41 | DrugBank:DB00472 | PubChem:3386,Fluoxetine,CNCCC(Oc1ccc(C(F)(F)F)cc1)c1ccccc1,N06AB03 | N06CA03,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02359006,NCT02359006_EG000,No,All,Adult,Not Applicable,27,"Inclusion Criteria:

Males and females, between the ages of 18 and 55
Diagnosed with opioid dependence and currently enrolled in methadone maintenance treatment
Compliant in methadone maintenance treatment and on a stable dose for two weeks or greater
No current dependence or abuse of any other drugs (other than tobacco or marijuana)
No current medical problems

For women:

not pregnant as determined by pregnancy screening;
not breast feeding; u
using acceptable birth control methods;
not experiencing moderate to severe premenstrual symptoms (may interfere with pain assessment);
regular menstrual cycles

Exclusion Criteria:

Current major psychiatric illnesses including mood, psychotic, or anxiety disorders
History of major medical illnesses, including liver diseases, heart disease, or other medical conditions that the physician investigator deems contraindicated for inclusion in the study
Current use of over-the-counter or prescription psychoactive drugs (including regular use of NSAIDS, antidepressant, anxiolytics, antipsychotics, mood stabilizers, psychostimulants) or drugs that would be expected to have major interactions with drugs to be tested, e.g., benzodiazepines, codeine, Percocet, and other opiate drugs
Liver function tests (ALT or AST) greater than 3x normal
Allergy to minocycline or other tetracyclines","200mg minocycline

Minocycline: Minocycline will be compared with placebo",ChEMBL:CHEMBL1440 | DrugBank:DB00759 | PubChem:54675776,Tetracycline,[H][C@]12C[C@@]3([H])[C@H](N(C)C)C(O)=C(C(N)=O)C(=O)[C@@]3(O)C(O)=C1C(=O)c1c(O)cccc1[C@@]2(C)O,A01AB13 | A02BD02 | A02BD08 | D06AA04 | J01AA07 | J01AA20 | J01RA08 | S01AA09 | S02AA08 | S03AA02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02360059,NCT02360059_EG000,No,All,Adult | Older Adult,Phase 2,1,"Inclusion Criteria:

Patients with histologically confirmed invasive breast cancer, stage I - IV, treated at Lyndon B. Johnson General Hospital in the Harris Health System.
Patients = or > 18 years old and < 75 years old.
Patients scheduled to undergo paclitaxel chemotherapy for breast cancer.
Patients with adequate renal function, as evidenced in laboratory values = or < 3 months old: epidermal growth factor receptor (eGFR) = or > 60 mL/min/1.73m2.
Patients with adequate hepatic function per institutional testing standards, as evidenced in laboratory values = or < 3 months old: (1) The screening results for total bilirubin must be < 1.5 times the upper limit of normal. (2) The screening results for aspartate aminotransferase (AST) and alanine aminotransferase (ALT) must be < 2 times the upper limit of normal.
Patients who speak English and/or Spanish.
Patients who are willing and able to review, understand, and provide written consent.
Patients with an Eastern Cooperative Oncology performance status of 0 or 1.

Exclusion Criteria:

Patients with a history of or known diagnosis of diabetes according to national guidelines (fasting plasma glucose > or = 126 mg/dL or random plasma glucose > or = 200 mg/dL), as evidenced in laboratory values < or = 3 months old).
Patients using carbonic anhydrase inhibitors (acetazolamide [Diamox®], brinzolamide [Azopt®], methazolamide [Neptazane®], dorzolamide [Trusopt®], pomegranate ellagitannins), cimetidine, or topiramate.
Patients who are enrolled in another symptom management trial.
Patients with nerve pathology or clinically identified neuropathy.
Patients with a history of clinically significant cutaneous drug reaction, hypersensitivity reaction, anaphylaxis, or any other serious adverse reaction to the medication used in the study.
Patients with any condition associated with increased risk of metformin-associated lactic acidosis (e.g., congestive heart failure defined as New York Heart Association Class III or IV functional status, history of acidosis of any type).
Patients with intestinal issues, including malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel.
Patients who are pregnant are excluded. Pre-menopausal women must have a negative pregnancy test. Patients that are post menopausal, or that have had a hysterectomy do not need to have a pregnancy test.
Patients with any condition that precludes use of the study medication as determined by the treating physician.
Patients with a diagnosis of hepatitis or HIV.
Patients currently receiving or scheduled to receive a chemotherapy infusion other than Adriamycin/Cyclophosphamide prior to initiation of the metformin adaptation phase are not eligible. Patients who are receiving Adriamycin/Cyclophosphamide must be scheduled to be at least 8 days post-chemotherapy infusion prior to initiation of the metformin adaptation phase in order to be eligible.
Patients who are currently using metformin (eg, Fortamet, Glucophage, Glucophage XR, Glumetza, Riomet).","Participants take 1,000 mg Metformin by mouth twice daily for 12 weeks during Paclitaxel treatment.",ChEMBL:CHEMBL1431 | DrugBank:DB00331 | PubChem:4091,Metformin,CN(C)C(=N)NC(=N)N,A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02360774,NCT02360774_EG001,No,All,Adult | Older Adult,Phase 4,13,"Inclusion Criteria:

Type 2 diabetes
BMI 25-45 kg/m2
Hemoglobin A1C > 6.5% but < 9%
Normal renal function (GFR > 60)
Age 18-75

Exclusion Criteria:

Type 1 diabetes
History of recurrent UTI or mycotic genital infections
Treatment with insulin or a GLP1 agent
Pregnant or breastfeeding","Subjects will be randomized (1:1) to treatment with canagliflozin 300mg or placebo once daily for 18 weeks.

Canagliflozin: Subjects will take one 300mg capsule of canagliflozin or identically dispensed placebo by mouth once daily, for 18 weeks.",DrugBank:DB08907 | PubChem:24812758,Canagliflozin,[H][C@@]1(c2ccc(C)c(Cc3ccc(-c4ccc(F)cc4)s3)c2)O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O,A10BD16 | A10BK02,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02360995,NCT02360995_EG000,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 4,129,"Inclusion Criteria:

Subjects, ages 18-70, inclusive.
Availability for the six-week duration of the clinical research study.
Good general health.
Minimum of 20 uncrowned permanent natural teeth (excluding third molars).
Initial gingivitis index of at least 1.0 as determined by the use of the Loe and Silness Gingival Index.
Initial plaque index of at least 1.5 as determined by the use of the Quigley and Hein Plaque Index (Turesky Modification).
Signed Informed Consent Form

Exclusion Criteria:

Presence of orthodontic bands.
Presence of partial removable dentures.
Tumor(s) of the soft or hard tissues of the oral cavity.
Advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone).
Five or more carious lesions requiring immediate restorative treatment.
Antibiotic use any time during the one month prior to entry into the study.
Participation in any other clinical study or test panel within the one month prior to entry into the study.
Dental prophylaxis during the past two weeks prior to baseline examinations.
History of allergies to oral care/personal care consumer products or their ingredients.
On any prescription medicines that might interfere with the study outcome.
An existing medical condition which prohibits eating or drinking for periods up to 4 hours.
History of alcohol or drug abuse.
Pregnant or lactating subjects.","Triclosan/fluoride toothpaste

Triclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (sold in the US), using a Total 360 toothbrush, 2 times/day for 6 weeks (study duration).",PubChem:24848164,Sodium fluoride and triclosan,Oc1cc(Cl)ccc1Oc1ccc(Cl)cc1Cl.[F-].[Na+],,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02363998,NCT02363998_EG000,No,All,Adult | Older Adult,Phase 3,286,"Inclusion Criteria:

Male or Female at least 18 years of age
Must be able to verbalize understanding of the consent form, able to provide written informed consent, and verbalize willingness to complete study procedures
Must have current dependence, according to the Mini International Neuropsychiatric Interview (M.I.N.I.), on any opioid (including methadone and buprenorphine maintenance treatment)
Must be seeking treatment for partial or total withdrawal from current opioid and expected, as determined by the Principal Investigator, to benefit from lofexidine treatment for at least 7 days at clinically relevant doses. This can include a variety of clinical situations where opioid withdrawal illness is likely to occur including abrupt and total withdrawal (including from methadone and buprenorphine), agonist-assisted total withdrawal, dose reduction of maintenance treatment (e.g., methadone, buprenorphine) and transition from an opioid agonist to naltrexone or buprenorphine maintenance
Must have Urine toxicology screen result of positive for opioid(s) relevant to the subject's withdrawal treatment goal
If female and of childbearing potential, subject must agree to use of one of the following methods of birth control including oral contraceptives, patch, barrier (diaphragm, sponge or condom) plus spermicidal preparations, intrauterine contraceptive system, levonorgestrel implant, medroxyprogesterone acetate contraceptive injection, complete abstinence from sexual intercourse, hormonal vaginal contraceptive ring or surgical sterilization or partner sterile (with documented proof)

Exclusion Criteria:

Female subject who is pregnant or lactating
History of very serious medical illness not under control including, but not limited to, active self-reported acquired immune deficiency syndrome (AIDS) or self-reported human immunodeficiency virus (HIV) positive status and taking retroviral medications currently or within the past 4 weeks and/or having an unstable psychiatric condition. These conditions will be determined at Screening by medical history, physical examination, 12 lead electrocardiogram (duplicate), clinical laboratory tests for infectious diseases, and a tuberculin test
Current dependence (based on the M.I.N.I.) on any psychoactive substance (excluding caffeine, nicotine, and the subject's current opioid-dependence agent, which can include methadone and buprenorphine, for example, in agonist-maintained subjects) that requires detoxification or dose reduction as part of the pre-defined individual subject withdrawal treatment goal
Have participated in an investigational drug study within the past 30 days
Have a history of lofexidine exposure in a prior clinical trial or otherwise
Have an abnormal cardiovascular exam at screening
Any subject that requires tricyclic antidepressants, which may reduce the efficacy of imidazoline derivatives and/or beta-receptor blockers, to avoid the risk of excessive bradycardia","Lofexidine: All enrolled subjects will take lofexidine orally, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.

Subjects are given the option to receive lofexidine tablets for a minimum of 7 days, and up to 14 days if requested.",ChEMBL:CHEMBL17860 | DrugBank:DB04948 | PubChem:30668,Lofexidine,CC(Oc1c(Cl)cccc1Cl)C1=NCCN1,N07BC04,0.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT02365207,NCT02365207_EG000,No,All,Adult | Older Adult,Not Applicable,5,"Inclusion Criteria:

Have suspected or known invasive (≥T1) bladder cancer
Be able to give informed consent
Be age 18 or older
Not be in an immunosuppressed state (e.g. HIV+, use of chronic steroids >1 month)

Exclusion Criteria:

Have non-invasive (<T1) bladder cancer
Unable to give informed consent
< 18 or older
Is in an immunosuppressed state (e.g. HIV+, use of chronic steroids >1 month)","Invasive bladder cancer treated with 3-6 weeks of intravesical BCG

BCG strain of Mycobacterium bovis: Invasive bladder cancer treated with 3-6 weeks of intravesical BCG",ChEMBL:CHEMBL3989866 | DrugBank:DB11799 | PubChem:90311989,Bictegravir,O=C(NCc1c(F)cc(F)cc1F)c1cn2c(c(O)c1=O)C(=O)N1[C@H]3CC[C@H](C3)O[C@@H]1C2,J05AR20,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0
NCT02366689,NCT02366689_EG000,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 4,179,"Inclusion Criteria:

Male and female subjects, ages 18-70, inclusive.
Availability for the six-month duration of the study.
Good general health.
Minimum of 20 uncrowned permanent natural teeth (excluding third molars).
Initial gingivitis index of at least 1.0 as determined by the use of the Loe and Silness Gingival Index.
Initial plaque index of at least 1.5 as determined by the use of the Quigley and Hein Plaque Index (Turesky Modification).
Signed Informed Consent Form.

Exclusion Criteria:

Presence of orthodontic bands.
Presence of partial removable dentures.
Tumor(s) of the soft or hard tissues of the oral cavity.
Advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone).
Five or more carious lesions requiring immediate restorative treatment.
Use of antibiotics any time during the one month prior to entry into the study.
Participation in any other clinical study or test panel within the one month prior to entry into the study.
Pregnant women or women who are breast feeding.
Dental prophylaxis received in the past two weeks prior to baseline examinations.
History of allergies to oral care/personal care consumer products or their ingredients.
On any prescription medicines that might interfere with the study outcome.
An existing medical condition which prohibits eating or drinking for periods up to 4 hours.
History of alcohol or drug abuse","Triclosan/fluoride toothpaste

Triclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (triclosan/fluoride) using Total 360 toothbrush for 1 minute, 2 times/day for 6 months (study duration).",PubChem:24848164,Sodium fluoride and triclosan,Oc1cc(Cl)ccc1Oc1ccc(Cl)cc1Cl.[F-].[Na+],,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02368691,NCT02368691_EG000,No,Female,Adult | Older Adult,Phase 2,32,"Inclusion Criteria:

Able and willing to give voluntary, written and signed, informed consent
Women ≥ 18 years of age
Women with TNBC who have received at least one but no more than two prior chemotherapy regimens for TNBC
Confirmation of AR+ (defined as ≥ 10% nuclear AR staining by immunohistochemistry [IHC]) TNBC in either the primary or metastatic lesion, assessed during the screening period by a local laboratory or by medical history
TNBC confirmed by medical history as: human epidermal growth factor receptor 2 [HER2]-negative (confirmed by IHC 0, 1+ regardless of fluorescence in situ hybridization [FISH] ratio; IHC 2+ with FISH ratio lower than 2.0 or HER2 gene copy less than 6.0; FISH ratio of 0, indicating gene deletion, when positive and negative in situ hybridization [ISH] controls are present); estrogen receptor (ER) negative (confirmed as ER expression less than or equal to 1% positive tumor nuclei); progesterone receptor negative (confirmed as progesterone receptor expression less than or equal to 1% positive tumor nuclei)
Availability of paraffin embedded or formalin fixed tumor tissue; OR, a minimum of 10 and up to 20 slides of archived tumor tissue for central laboratory confirmation of AR status and molecular subtyping. Metastatic tumor tissue is preferred when possible
Subjects must have either measurable disease or bone-only non-measurable disease, evaluable according to RECIST 1.1
Subjects with bone metastases should be treated with intravenous bisphosphonates or subcutaneous denosumab (or investigator preferred standard of care) prior to and during the trial, unless there is a contraindication or subject intolerance to these therapies
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 at the time of screening and enrollment
Negative pregnancy test in women of childbearing potential (premenopausal or less than 12 months of amenorrhea post-menopause, and who have not undergone surgical sterilization), no more than 7 days before the first dose of study treatment
For women of childbearing potential who are sexually active, agreement to use a highly effective, non-hormonal form of contraception during and for at least 6 months after completion of study treatment; OR, a fertile male partner willing and able to use effective non-hormonal of contraception (barrier method of contraception in conjunction with spermicidal jelly, or surgical sterilization) during and for at least 6 months after completion of study treatment

Adequate organ function as shown by:

Absolute neutrophil count ≥ 1,000 cells/mm3
Platelet count ≥ 100,000 cells/mm3
Hemoglobin ≥ 9 g/dL
Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 Upper Limit of the Normal range (ULN) (or ≤ 5 if hepatic metastases are present)
Total serum bilirubin ≤ 2.0 × ULN (unless the subject has documented Gilbert Syndrome)
Alkaline phosphatase levels ≤ 2.5 × ULN (≤ 5 × ULN in subjects with liver metastasis)
Serum creatinine < 2.0 mg/dL or 177 μmol/L
International normalized ratio (INR), activated partial thromboplastin time (aPTT), or partial thromboplastin time (PTT) < 1.5 × ULN (unless on anticoagulant treatment at screening)
Able to swallow capsules
Any toxicity from prior chemotherapy has resolved or Grade 1 (NCI-CTCAE, Version 4.0)

Exclusion Criteria:

Life expectancy < 4 months;
Subjects with radiographic evidence of central nervous system (CNS) metastases as assessed by computerized tomography (CT) or magnetic resonance imaging (MRI) that are not well controlled (symptomatic or requiring control with continuous corticosteroid therapy [e.g., dexamethasone]). Note: Subjects with CNS metastases are permitted to participate in the study if the CNS metastases are medically well controlled prior to screening (as assessed by the Investigator) after receiving local therapy (irradiation, surgery, etc.)
Radiotherapy within 14 days prior to first dose of study treatment
Have, in the judgment of the Investigator, a clinically significant concurrent illness or psychological, familial, sociological, geographical, or other concomitant condition that would not permit adequate follow-up and compliance with the study protocol
Positive hepatitis B virus (HBV) and/or hepatitis C virus (HCV) infection at screening
Positive human immunodeficiency virus (HIV) infection at screening
Prior treatment with any anti-androgens, including but not limited to, enzalutamide and bicalutamide
Major surgery within 28 days of the first dose of study treatment
Be currently taking or have previously taken testosterone, methyltestosterone, oxandrolone (Oxandrin®), oxymetholone, danazol, fluoxymesterone (Halotestin®), testosterone-like agents (such as dehydroepiandrosterone, androstenedione, and other androgenic compounds, including herbals), or anti-androgens

Treatment with any of the following hormone replacement therapies, unless discontinued at least 14 days prior to the first dose of study treatment:

Estrogens
Megesterol acetate
Treatment with any investigational agent within 28 days before the first dose of study treatment
Another active cancer (excluding adequately treated basal cell carcinoma or cervical intraepithelial neoplasia [CIN]/cervical carcinoma in situ or melanoma in situ). Prior history of other cancer is allowed as long as there is no active disease within the prior 5 years

Subject has a concomitant medical condition that precludes adequate study treatment compliance or assessment, or increases subject risk, in the opinion of the Investigator, such as but not limited to:

Myocardial infarction or arterial thromboembolic events within 6 months prior to baseline or severe or unstable angina, New York Heart Association (NYHA) Class III or IV disease, or a QTcB (corrected according to Bazett's formula) interval > 470 msec; serious uncontrolled cardiac arrhythmia grade II or higher according to NYHA; uncontrolled hypertension (systolic > 150 and/or diastolic > 100 mm Hg)
Acute and chronic active infectious disorders and non-malignant medical illnesses that are uncontrolled or whose control may be jeopardized by the complications of this study therapy
Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of study drugs (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome)
Current treatment with intravenous bisphosphonate or denosumab with elevated serum calcium corrected for albumin or ionized calcium levels outside institutional normal limits at screening
History of non-compliance to medical regimens
Subjects unwilling to or unable to comply with the protocol procedures as assessed by the Investigator
Concurrent participation in another therapeutic clinical trial","GTx-024 capsules, 18 mg PO once-daily for up to 12 months

GTx-024: GTx-024 softgel capsules will be administered once-daily to a total dose of 18 mg",ChEMBL:CHEMBL1738889 | DrugBank:DB12078 | PubChem:11326715,Enobosarm,C[C@](O)(COc1ccc(C#N)cc1)C(=O)Nc1ccc(C#N)c(C(F)(F)F)c1,,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT02369211,NCT02369211_EG000,Accepts Healthy Volunteers,Male,Adult | Older Adult,Phase 4,86,"Inclusion Criteria:

Patients undergoing robotic-assisted laparoscopic prostatectomy
≥18 years old males
American Society of Anesthesiologists class 1-4

Exclusion Criteria:

Chronic opiate use
Liver disease (known history of hepatitis B or C, cirrhosis, nonalcoholic steatohepatitis, history of alcoholism, liver function test results greater than 3 times upper limit of normal in the past 3 months)
Allergy/hypersensitivity to acetaminophen
Patients with baseline dementia
Chronic diathesis
Chronic kidney disease","Patient receives 1g intravenous acetaminophen after the incision

Acetaminophen (Ofirmev)",ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02370888,NCT02370888_EG000,No,Female,Adult | Older Adult,Phase 1,3,"Inclusion Criteria:

Subjects must be at least 18 years of age;
Subjects must be post-allogeneic transplant from any donor source;

Subjects must have either:

High risk CD34+ AML (de novo or secondary, and any WHO 2008 classification excluding acute promyelocytic leukemia). High risk AML is defined as (a) disease status beyond complete remission (CR) #1 at transplant or (b) treatment related AML or (c) presence of adverse cytogenetics including inv(3); t(3;3); t(6;9); t(v;11); -5 or del(5q); -7; abnl(17p) or complex karyotype; or
High risk CD34+ MDS (WHO 2008 classification). High risk is defined as (a) blast count ≥5% at the time of transplant or (b) treatment related MD or (c) presence of adverse cytogenetics including -7/del7q or complex karyotype;
For AML subjects, they must have a documented CR within 45 days prior to allo-HCT;
For MDS subjects, they must have < 20% myeloblasts in the bone marrow within 45 days prior to allo-HCT;
Subject Karnofsky performance status must be ≥ 70;
Subjects must be platelet transfusion independent (Platelet transfusion independence is defined as 7 days or greater without a platelet transfusion);
Neutrophil count ≥ 1.0 thou/mm3 and platelet count ≥ 30 thou/mm3;
Subjects must have total bilirubin ≤ 2 mg/dL;
Subjects must have serum AST and ALT levels ≤ 2.5 times upper limit of normal;
Subjects must have serum creatinine < 2.5 times upper limit of normal and a calculated creatinine clearance > 30 ml/min by Cockcroft-Gault formula (see Appendix I: Cockcroft-Gault Creatinine Clearance Calculation);
All study participants who will receive lenalidomide based on the CD34+ chimerism testing must be registered into the mandatory Revlimid REMS® program, and be willing and able to comply with the requirements of the REMS® program;

Females of child-bearing potential (i.e., women who are premenopausal or not surgically sterile) may participate, provided they meet the following conditions:

a) Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS® program; and

Written, voluntary informed consent, willingness, and ability to comply with all study procedures.

Exclusion Criteria:

CD34- AML or MDS;
Inability to give informed consent;
Uncontrolled active infection(s) requiring intravenous antibiotics;
Known or suspected hypersensitivity to lenalidomide;
Grade II-IV acute GVHD or extensive GVHD;
Not able to swallow the lenalidomide capsule as a whole;
Female subjects who are pregnant or nursing.",Subjects will be enrolled in cohorts of three (3). Lenalidomide will be administered for 21 consecutive days in a 28 day cycle X 2 cycles.,ChEMBL:CHEMBL848 | DrugBank:DB00480 | PubChem:216326,Lenalidomide,Nc1cccc2c1CN(C1CCC(=O)NC1=O)C2=O,L04AX04,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT02371980,NCT02371980_EG000,No,All,Adult | Older Adult,Phase 4,1106,"Inclusion Criteria:

In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
Suffers from recurrent major depressive disorder (MDD) as the primary diagnosis according to Diagnostic & Statistical Manual of Mental Disorders, 4th Edition - Text Revision (DSM-IV-TR) criteria (classification code 296.3x), and the current episode is confirmed by the Mini International Neuropsychiatric Interview (MINI).
Reported duration of the current episode is ≥8 weeks and ≤18months.
Had at least 2 other major depressive episodes (MDEs) before the current episode.
Has a Montgomery-Åsberg Depression Rating Scale (MADRS) total score ≥26 at the Screening and Baseline I visits.
Is a man or woman aged 18 to 75 years, inclusive.
A female participant of childbearing potential who is sexually active with a nonsterilized male partner agrees to routinely use adequate contraception from signing of the informed consent throughout the duration of the study and for 30 days after the last dose.

Exclusion Criteria:

Has received any investigational compound within 30 days prior to screening or 5 half-lives prior to screening, whichever is longer.
Has previously or is currently participating in this study.
Has participated in 2 or more clinical studies in the year prior to screening, or has participated in a clinical trial for a psychiatric condition that is exclusionary per this protocol.
Is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in conduct of this study (eg, spouse, parent, child, sibling) or may consent under duress.

Has one or more of the following:

Any current psychiatric disorder which is the primary focus of treatment other than MDD as defined in the DSM-IV-TR, and assessed by the MINI.
Current or history of: manic or hypomanic episode, schizophrenia or any other psychotic disorder, including schizoaffective disorder, major depression with psychotic features, bipolar depression with psychotic features, obsessive compulsive disorder (OCD), mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in the DSM-IV-TR.
Current diagnosis or history of alcohol or other substance abuse or dependence (excluding nicotine or caffeine) as defined in the DSM-IV-TR that has not been in full and sustained remission for at least 3 months from the day of screening (Participant must also have negative urine drug screen at Screening and Baseline I.)
Presence or history of a clinically significant neurological disorder (including epilepsy) as determined by the investigator.
Neurodegenerative disorder (Alzheimer disease, Parkinson disease, multiple sclerosis, Huntington disease, etc).
Any Axis II disorder as defined by DSM-IV-TR that might compromise the study.
The current depressive symptoms of the participant are considered by the investigator to have been resistant to 2 adequate antidepressant treatments of at least 6 weeks duration each.
Has a history of lack of response to previous adequate treatment with vortioxetine for any MDD episode with adequate treatment considered to be known dose of vortioxetine in the approved recommended dose range for at least 6 weeks duration.
Has received electroconvulsive therapy, vagal nerve stimulation, or repetitive transcranial magnetic stimulation within 6 months prior to Screening.
Has started receiving formal cognitive or behavioral therapy, systematic psychotherapy within 30 days from screening or plans to initiate such therapy during the study (supportive therapy, marital therapy and bereavement counseling are allowed).
Has a significant risk of suicide according to the investigator's clinical judgment or has a score ≥5 on item 10 (suicidal thoughts) of the MADRS or has made a suicide attempt in the previous 6 months.
Is required to take excluded medications or it is anticipated that the participant will require treatment with at least 1 of the disallowed concomitant medications during the study.

Has a clinically significant unstable illness, for example hepatic impairment or renal insufficiency, or a cardiovascular, pulmonary, gastrointestinal, endocrine, neurological, rheumatologic, immunologic, hematological, infectious, dermatological disorder or metabolic disturbance.

Note: For the purposes of this protocol fibromyalgia, obstructive sleep apnea, chronic pain diagnosis, and morbid obesity (BMI of > 40) are considered unstable due to the potential impact on assessment of the primary endpoint.

Has a known history of or currently has increased intraocular pressure or is at risk of acute narrow-angle glaucoma.

Has 1 or more laboratory value outside the normal range, based on the blood or urine samples taken at the Screening Visit, that are considered by the investigator to be clinically significant; or the participant has any of the following values at the Screening Visit:

A serum creatinine value >1.5 times the upper limits of normal (ULN).
A serum total bilirubin value >1.5 xULN.
A serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value >2 xULN.
Has glycosylated hemoglobin (HbA1C) ≥7% at screening and no prior diagnosis of diabetes and/or treatment for diabetes. NOTE: Participants with known stable diabetes are not excluded.
Has a thyroid stimulating hormone (TSH) value outside the normal range at the Screening Visit that is deemed clinically significant by the investigator. NOTE: Free T4 will be checked if TSH is out of range. If free T4 is abnormal the participant will be excluded.
Has clinically significant abnormal vital signs as determined by the investigator.
Has an abnormal electrocardiogram (ECG) as determined by the central reader and confirmed as clinically significant by the investigator.
Is positive for Hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibodies, or has a history of human immunodeficiency virus (HIV) infection.
Has a disease or takes medication that, in the opinion of the investigator, could interfere with the assessments of safety, tolerability or efficacy.
The participant, in the opinion of the investigator, is unlikely to comply with the clinical study protocol or is unsuitable for any reason.
Has a history of hypersensitivity or allergies to vortioxetine.
If female, the participant is pregnant or lactating or intending to become pregnant before, during, or within 1 month after participating in this study; or intending to donate ova during such time period.
The participant is considered to be treatment resistant, eg, the participant has not responded to adequate monotherapy treatments of at least 6 weeks' duration, or has only responded to combination or augmentation therapy.","Vortioxetine 10 mg, capsules, orally, once, daily (QD) up to 8 weeks. Participants who achieved response (defined as a ≥50% reduction in Montgomery Asberg Depression Rating Scale (MADRS) total score from Baseline) continued to receive vortioxetine 10 mg, capsules, orally, QD for up to Week 16 (stabilization period) in the Open-label Period.",ChEMBL:CHEMBL2104993 | DrugBank:DB09068 | PubChem:9966051,Vortioxetine,Cc1ccc(Sc2ccccc2N2CCNCC2)c(C)c1,N06AX26,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02371980,NCT02371980_EG002,No,All,Adult | Older Adult,Phase 4,140,"Inclusion Criteria:

In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
Suffers from recurrent major depressive disorder (MDD) as the primary diagnosis according to Diagnostic & Statistical Manual of Mental Disorders, 4th Edition - Text Revision (DSM-IV-TR) criteria (classification code 296.3x), and the current episode is confirmed by the Mini International Neuropsychiatric Interview (MINI).
Reported duration of the current episode is ≥8 weeks and ≤18months.
Had at least 2 other major depressive episodes (MDEs) before the current episode.
Has a Montgomery-Åsberg Depression Rating Scale (MADRS) total score ≥26 at the Screening and Baseline I visits.
Is a man or woman aged 18 to 75 years, inclusive.
A female participant of childbearing potential who is sexually active with a nonsterilized male partner agrees to routinely use adequate contraception from signing of the informed consent throughout the duration of the study and for 30 days after the last dose.

Exclusion Criteria:

Has received any investigational compound within 30 days prior to screening or 5 half-lives prior to screening, whichever is longer.
Has previously or is currently participating in this study.
Has participated in 2 or more clinical studies in the year prior to screening, or has participated in a clinical trial for a psychiatric condition that is exclusionary per this protocol.
Is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in conduct of this study (eg, spouse, parent, child, sibling) or may consent under duress.

Has one or more of the following:

Any current psychiatric disorder which is the primary focus of treatment other than MDD as defined in the DSM-IV-TR, and assessed by the MINI.
Current or history of: manic or hypomanic episode, schizophrenia or any other psychotic disorder, including schizoaffective disorder, major depression with psychotic features, bipolar depression with psychotic features, obsessive compulsive disorder (OCD), mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in the DSM-IV-TR.
Current diagnosis or history of alcohol or other substance abuse or dependence (excluding nicotine or caffeine) as defined in the DSM-IV-TR that has not been in full and sustained remission for at least 3 months from the day of screening (Participant must also have negative urine drug screen at Screening and Baseline I.)
Presence or history of a clinically significant neurological disorder (including epilepsy) as determined by the investigator.
Neurodegenerative disorder (Alzheimer disease, Parkinson disease, multiple sclerosis, Huntington disease, etc).
Any Axis II disorder as defined by DSM-IV-TR that might compromise the study.
The current depressive symptoms of the participant are considered by the investigator to have been resistant to 2 adequate antidepressant treatments of at least 6 weeks duration each.
Has a history of lack of response to previous adequate treatment with vortioxetine for any MDD episode with adequate treatment considered to be known dose of vortioxetine in the approved recommended dose range for at least 6 weeks duration.
Has received electroconvulsive therapy, vagal nerve stimulation, or repetitive transcranial magnetic stimulation within 6 months prior to Screening.
Has started receiving formal cognitive or behavioral therapy, systematic psychotherapy within 30 days from screening or plans to initiate such therapy during the study (supportive therapy, marital therapy and bereavement counseling are allowed).
Has a significant risk of suicide according to the investigator's clinical judgment or has a score ≥5 on item 10 (suicidal thoughts) of the MADRS or has made a suicide attempt in the previous 6 months.
Is required to take excluded medications or it is anticipated that the participant will require treatment with at least 1 of the disallowed concomitant medications during the study.

Has a clinically significant unstable illness, for example hepatic impairment or renal insufficiency, or a cardiovascular, pulmonary, gastrointestinal, endocrine, neurological, rheumatologic, immunologic, hematological, infectious, dermatological disorder or metabolic disturbance.

Note: For the purposes of this protocol fibromyalgia, obstructive sleep apnea, chronic pain diagnosis, and morbid obesity (BMI of > 40) are considered unstable due to the potential impact on assessment of the primary endpoint.

Has a known history of or currently has increased intraocular pressure or is at risk of acute narrow-angle glaucoma.

Has 1 or more laboratory value outside the normal range, based on the blood or urine samples taken at the Screening Visit, that are considered by the investigator to be clinically significant; or the participant has any of the following values at the Screening Visit:

A serum creatinine value >1.5 times the upper limits of normal (ULN).
A serum total bilirubin value >1.5 xULN.
A serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value >2 xULN.
Has glycosylated hemoglobin (HbA1C) ≥7% at screening and no prior diagnosis of diabetes and/or treatment for diabetes. NOTE: Participants with known stable diabetes are not excluded.
Has a thyroid stimulating hormone (TSH) value outside the normal range at the Screening Visit that is deemed clinically significant by the investigator. NOTE: Free T4 will be checked if TSH is out of range. If free T4 is abnormal the participant will be excluded.
Has clinically significant abnormal vital signs as determined by the investigator.
Has an abnormal electrocardiogram (ECG) as determined by the central reader and confirmed as clinically significant by the investigator.
Is positive for Hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibodies, or has a history of human immunodeficiency virus (HIV) infection.
Has a disease or takes medication that, in the opinion of the investigator, could interfere with the assessments of safety, tolerability or efficacy.
The participant, in the opinion of the investigator, is unlikely to comply with the clinical study protocol or is unsuitable for any reason.
Has a history of hypersensitivity or allergies to vortioxetine.
If female, the participant is pregnant or lactating or intending to become pregnant before, during, or within 1 month after participating in this study; or intending to donate ova during such time period.
The participant is considered to be treatment resistant, eg, the participant has not responded to adequate monotherapy treatments of at least 6 weeks' duration, or has only responded to combination or augmentation therapy.","Following Open-label Period, participants who achieved remission criteria (defined as MADRS total score ≤12 at Weeks 14 and 16) were randomized to receive vortioxetine 5 mg, capsules, orally, QD from Week 17 up to Week 44 in the Double-blind Period.",ChEMBL:CHEMBL2104993 | DrugBank:DB09068 | PubChem:9966051,Vortioxetine,Cc1ccc(Sc2ccccc2N2CCNCC2)c(C)c1,N06AX26,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02371980,NCT02371980_EG003,No,All,Adult | Older Adult,Phase 4,145,"Inclusion Criteria:

In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
Suffers from recurrent major depressive disorder (MDD) as the primary diagnosis according to Diagnostic & Statistical Manual of Mental Disorders, 4th Edition - Text Revision (DSM-IV-TR) criteria (classification code 296.3x), and the current episode is confirmed by the Mini International Neuropsychiatric Interview (MINI).
Reported duration of the current episode is ≥8 weeks and ≤18months.
Had at least 2 other major depressive episodes (MDEs) before the current episode.
Has a Montgomery-Åsberg Depression Rating Scale (MADRS) total score ≥26 at the Screening and Baseline I visits.
Is a man or woman aged 18 to 75 years, inclusive.
A female participant of childbearing potential who is sexually active with a nonsterilized male partner agrees to routinely use adequate contraception from signing of the informed consent throughout the duration of the study and for 30 days after the last dose.

Exclusion Criteria:

Has received any investigational compound within 30 days prior to screening or 5 half-lives prior to screening, whichever is longer.
Has previously or is currently participating in this study.
Has participated in 2 or more clinical studies in the year prior to screening, or has participated in a clinical trial for a psychiatric condition that is exclusionary per this protocol.
Is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in conduct of this study (eg, spouse, parent, child, sibling) or may consent under duress.

Has one or more of the following:

Any current psychiatric disorder which is the primary focus of treatment other than MDD as defined in the DSM-IV-TR, and assessed by the MINI.
Current or history of: manic or hypomanic episode, schizophrenia or any other psychotic disorder, including schizoaffective disorder, major depression with psychotic features, bipolar depression with psychotic features, obsessive compulsive disorder (OCD), mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in the DSM-IV-TR.
Current diagnosis or history of alcohol or other substance abuse or dependence (excluding nicotine or caffeine) as defined in the DSM-IV-TR that has not been in full and sustained remission for at least 3 months from the day of screening (Participant must also have negative urine drug screen at Screening and Baseline I.)
Presence or history of a clinically significant neurological disorder (including epilepsy) as determined by the investigator.
Neurodegenerative disorder (Alzheimer disease, Parkinson disease, multiple sclerosis, Huntington disease, etc).
Any Axis II disorder as defined by DSM-IV-TR that might compromise the study.
The current depressive symptoms of the participant are considered by the investigator to have been resistant to 2 adequate antidepressant treatments of at least 6 weeks duration each.
Has a history of lack of response to previous adequate treatment with vortioxetine for any MDD episode with adequate treatment considered to be known dose of vortioxetine in the approved recommended dose range for at least 6 weeks duration.
Has received electroconvulsive therapy, vagal nerve stimulation, or repetitive transcranial magnetic stimulation within 6 months prior to Screening.
Has started receiving formal cognitive or behavioral therapy, systematic psychotherapy within 30 days from screening or plans to initiate such therapy during the study (supportive therapy, marital therapy and bereavement counseling are allowed).
Has a significant risk of suicide according to the investigator's clinical judgment or has a score ≥5 on item 10 (suicidal thoughts) of the MADRS or has made a suicide attempt in the previous 6 months.
Is required to take excluded medications or it is anticipated that the participant will require treatment with at least 1 of the disallowed concomitant medications during the study.

Has a clinically significant unstable illness, for example hepatic impairment or renal insufficiency, or a cardiovascular, pulmonary, gastrointestinal, endocrine, neurological, rheumatologic, immunologic, hematological, infectious, dermatological disorder or metabolic disturbance.

Note: For the purposes of this protocol fibromyalgia, obstructive sleep apnea, chronic pain diagnosis, and morbid obesity (BMI of > 40) are considered unstable due to the potential impact on assessment of the primary endpoint.

Has a known history of or currently has increased intraocular pressure or is at risk of acute narrow-angle glaucoma.

Has 1 or more laboratory value outside the normal range, based on the blood or urine samples taken at the Screening Visit, that are considered by the investigator to be clinically significant; or the participant has any of the following values at the Screening Visit:

A serum creatinine value >1.5 times the upper limits of normal (ULN).
A serum total bilirubin value >1.5 xULN.
A serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value >2 xULN.
Has glycosylated hemoglobin (HbA1C) ≥7% at screening and no prior diagnosis of diabetes and/or treatment for diabetes. NOTE: Participants with known stable diabetes are not excluded.
Has a thyroid stimulating hormone (TSH) value outside the normal range at the Screening Visit that is deemed clinically significant by the investigator. NOTE: Free T4 will be checked if TSH is out of range. If free T4 is abnormal the participant will be excluded.
Has clinically significant abnormal vital signs as determined by the investigator.
Has an abnormal electrocardiogram (ECG) as determined by the central reader and confirmed as clinically significant by the investigator.
Is positive for Hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibodies, or has a history of human immunodeficiency virus (HIV) infection.
Has a disease or takes medication that, in the opinion of the investigator, could interfere with the assessments of safety, tolerability or efficacy.
The participant, in the opinion of the investigator, is unlikely to comply with the clinical study protocol or is unsuitable for any reason.
Has a history of hypersensitivity or allergies to vortioxetine.
If female, the participant is pregnant or lactating or intending to become pregnant before, during, or within 1 month after participating in this study; or intending to donate ova during such time period.
The participant is considered to be treatment resistant, eg, the participant has not responded to adequate monotherapy treatments of at least 6 weeks' duration, or has only responded to combination or augmentation therapy.","Following Open-label Period, participants who achieved remission criteria (defined as MADRS total score ≤12 at Weeks 14 and 16) were randomized to receive vortioxetine 10 mg, capsules, orally, QD from Week 17 up to Week 44 in the Double-blind Period.",ChEMBL:CHEMBL2104993 | DrugBank:DB09068 | PubChem:9966051,Vortioxetine,Cc1ccc(Sc2ccccc2N2CCNCC2)c(C)c1,N06AX26,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02371980,NCT02371980_EG004,No,All,Adult | Older Adult,Phase 4,144,"Inclusion Criteria:

In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
Suffers from recurrent major depressive disorder (MDD) as the primary diagnosis according to Diagnostic & Statistical Manual of Mental Disorders, 4th Edition - Text Revision (DSM-IV-TR) criteria (classification code 296.3x), and the current episode is confirmed by the Mini International Neuropsychiatric Interview (MINI).
Reported duration of the current episode is ≥8 weeks and ≤18months.
Had at least 2 other major depressive episodes (MDEs) before the current episode.
Has a Montgomery-Åsberg Depression Rating Scale (MADRS) total score ≥26 at the Screening and Baseline I visits.
Is a man or woman aged 18 to 75 years, inclusive.
A female participant of childbearing potential who is sexually active with a nonsterilized male partner agrees to routinely use adequate contraception from signing of the informed consent throughout the duration of the study and for 30 days after the last dose.

Exclusion Criteria:

Has received any investigational compound within 30 days prior to screening or 5 half-lives prior to screening, whichever is longer.
Has previously or is currently participating in this study.
Has participated in 2 or more clinical studies in the year prior to screening, or has participated in a clinical trial for a psychiatric condition that is exclusionary per this protocol.
Is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in conduct of this study (eg, spouse, parent, child, sibling) or may consent under duress.

Has one or more of the following:

Any current psychiatric disorder which is the primary focus of treatment other than MDD as defined in the DSM-IV-TR, and assessed by the MINI.
Current or history of: manic or hypomanic episode, schizophrenia or any other psychotic disorder, including schizoaffective disorder, major depression with psychotic features, bipolar depression with psychotic features, obsessive compulsive disorder (OCD), mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in the DSM-IV-TR.
Current diagnosis or history of alcohol or other substance abuse or dependence (excluding nicotine or caffeine) as defined in the DSM-IV-TR that has not been in full and sustained remission for at least 3 months from the day of screening (Participant must also have negative urine drug screen at Screening and Baseline I.)
Presence or history of a clinically significant neurological disorder (including epilepsy) as determined by the investigator.
Neurodegenerative disorder (Alzheimer disease, Parkinson disease, multiple sclerosis, Huntington disease, etc).
Any Axis II disorder as defined by DSM-IV-TR that might compromise the study.
The current depressive symptoms of the participant are considered by the investigator to have been resistant to 2 adequate antidepressant treatments of at least 6 weeks duration each.
Has a history of lack of response to previous adequate treatment with vortioxetine for any MDD episode with adequate treatment considered to be known dose of vortioxetine in the approved recommended dose range for at least 6 weeks duration.
Has received electroconvulsive therapy, vagal nerve stimulation, or repetitive transcranial magnetic stimulation within 6 months prior to Screening.
Has started receiving formal cognitive or behavioral therapy, systematic psychotherapy within 30 days from screening or plans to initiate such therapy during the study (supportive therapy, marital therapy and bereavement counseling are allowed).
Has a significant risk of suicide according to the investigator's clinical judgment or has a score ≥5 on item 10 (suicidal thoughts) of the MADRS or has made a suicide attempt in the previous 6 months.
Is required to take excluded medications or it is anticipated that the participant will require treatment with at least 1 of the disallowed concomitant medications during the study.

Has a clinically significant unstable illness, for example hepatic impairment or renal insufficiency, or a cardiovascular, pulmonary, gastrointestinal, endocrine, neurological, rheumatologic, immunologic, hematological, infectious, dermatological disorder or metabolic disturbance.

Note: For the purposes of this protocol fibromyalgia, obstructive sleep apnea, chronic pain diagnosis, and morbid obesity (BMI of > 40) are considered unstable due to the potential impact on assessment of the primary endpoint.

Has a known history of or currently has increased intraocular pressure or is at risk of acute narrow-angle glaucoma.

Has 1 or more laboratory value outside the normal range, based on the blood or urine samples taken at the Screening Visit, that are considered by the investigator to be clinically significant; or the participant has any of the following values at the Screening Visit:

A serum creatinine value >1.5 times the upper limits of normal (ULN).
A serum total bilirubin value >1.5 xULN.
A serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value >2 xULN.
Has glycosylated hemoglobin (HbA1C) ≥7% at screening and no prior diagnosis of diabetes and/or treatment for diabetes. NOTE: Participants with known stable diabetes are not excluded.
Has a thyroid stimulating hormone (TSH) value outside the normal range at the Screening Visit that is deemed clinically significant by the investigator. NOTE: Free T4 will be checked if TSH is out of range. If free T4 is abnormal the participant will be excluded.
Has clinically significant abnormal vital signs as determined by the investigator.
Has an abnormal electrocardiogram (ECG) as determined by the central reader and confirmed as clinically significant by the investigator.
Is positive for Hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibodies, or has a history of human immunodeficiency virus (HIV) infection.
Has a disease or takes medication that, in the opinion of the investigator, could interfere with the assessments of safety, tolerability or efficacy.
The participant, in the opinion of the investigator, is unlikely to comply with the clinical study protocol or is unsuitable for any reason.
Has a history of hypersensitivity or allergies to vortioxetine.
If female, the participant is pregnant or lactating or intending to become pregnant before, during, or within 1 month after participating in this study; or intending to donate ova during such time period.
The participant is considered to be treatment resistant, eg, the participant has not responded to adequate monotherapy treatments of at least 6 weeks' duration, or has only responded to combination or augmentation therapy.","Following Open-label Period, participants who achieved remission criteria (defined as MADRS total score ≤12 at Weeks 14 and 16) were randomized to receive vortioxetine 20 mg, capsules, orally, QD from Week 17 up to Week 44 in the Double-blind Period.",ChEMBL:CHEMBL2104993 | DrugBank:DB09068 | PubChem:9966051,Vortioxetine,Cc1ccc(Sc2ccccc2N2CCNCC2)c(C)c1,N06AX26,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02372799,NCT02372799_EG002,No,All,Child,Phase 3,97,"Inclusion Criteria:

Male or Female outpatients between 7-17 years of age
Primary diagnosis of Major Depressive Disorder (MDD)
Children's Depression Rating Scale-Revised (CDRS-R) score of 40 or greater
Clinical Global Impressions-Severity (CGI-S) score of 4 or greater

Exclusion Criteria:

Current (past 3 months) principal Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR) based diagnosis of an axis disorder other than major depressive disorder (MDD) that is the primary focus of treatment.
History of suicidal behavior, or requires precaution against suicide
Not generally healthy medical condition
Seizure disorder","Fluoxetine capsules 20 mg. Oral administration, once per day.",ChEMBL:CHEMBL41 | DrugBank:DB00472 | PubChem:3386,Fluoxetine,CNCCC(Oc1ccc(C(F)(F)F)cc1)c1ccccc1,N06AB03 | N06CA03,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02374957,NCT02374957_EG000,No,All,Adult | Older Adult,Phase 4,10,"Inclusion Criteria:

At least 35 years of age
Atherosclerotic peripheral arterial disease
Able to provide informed consent
Lower extremity open or endovascular revascularization.

Exclusion Criteria:

Known CHF (class III/IV)
Allergic reaction to phosphodiasterase inhibitors
Intracranial bleeding within 3 months or active bleeding peptic ulcer disease
Traumatic vascular injuries requiring revascularization
Pregnant or breast feeding women or women who plan to get pregnant over the study period
Planned ipsilateral major amputation within 30 days of index procedure
Moderate to severe hepatic impairment.","Administer Cilostazol100 mg twice daily for 90 days.

Cilostazol: 100 mg twice daily for 90 days",ChEMBL:CHEMBL799 | DrugBank:DB01166 | PubChem:2754,Cilostazol,O=C1CCc2cc(OCCCCc3nnnn3C3CCCCC3)ccc2N1,B01AC23,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0
NCT02375724,NCT02375724_EG000,No,All,Adult | Older Adult,Phase 4,135,"Inclusion Criteria:

Adult male or non-pregnant, non-lactating female aged ≥40. Women of childbearing potential will follow specific study requirements.
Current or ex-cigarette smoker, with a smoking history of at least 10 pack-years
Patients with a clinical diagnosis of moderate COPD, with a post bronchodilator test available within 6 months prior to Visit 1 (Screening), with FEV1 ≥50% and <80% and FEV1/FVC <70%.
Symptomatic patients with a CAT≥10 at Screening and Randomisation Visit (Visit 1 and 2)
Clinical Diagnosis of Chronic Bronchitis (defined as ""presence of cough and sputum production for at least 3 months in each of 2 consecutive years"")
Patient who is eligible and able to participate in the trial and who consent to do so in writing after the purpose and nature of the investigation have been explained

Exclusion Criteria:

History or current diagnosis of asthma.
Patients who suffered from a moderate or severe COPD exacerbation in the last year prior to Visit 1 (Screening) or during the run-in period.
Patients who develop a respiratory tract infection within 6 weeks before Visit 1 (Screening) or during the run-in period.
Clinically significant respiratory and cardiovascular conditions thought to be contributing to cough or likely to interfere in the conduct of the study.
Patient who in the investigator's opinion may need to start a pulmonay rehabilitation program during the study and/or patients who started/finished it within 3 months prior to Screening Visit.
Use of long-term oxygen therapy.
Patients in non-stable treatment with angiotensin-converting enzyme inhibitors or opiates.
Patients in treatment with mucolytics, antihistamines, expectorants or antitussive drugs including over-the-counter medication.
Patient who does not maintain regular day/night, waking/sleeping cycles including night shift workers.
Patient with clinically relevant abnormalities in the results of the physical examination at Visit 1 (Screening)
Patient with a history of hypersensitivity reaction to inhaled anticholinergics,sympathomimetic amines, or inhaled medication or any component thereof (including report of paradoxical bronchospasm).
Patient with known narrow-angle glaucoma, symptomatic bladder neck obstruction, acute urinary retention, or patients with symptomatic non-stable prostatic hypertrophy.
Patient with known non-controlled history of infection with human immunodeficiency virus (HIV) and/or active hepatitis
Current diagnosis of cancer other than basal or squamous cell skin cancer
Patient with any other serious or uncontrolled physical or mental dysfunction
Patient with a history (within 2 years prior to Screening Visit) of drug and/or alcohol abuse that may prevent study compliance based on investigator judgment.
Patient unlikely to be cooperative or that can not comply with the study procedures
Patient treated with any investigational drug within 30 days (or 6 half-lives, whichever is longer) prior to Visit 1 (Screening).
Patient who intend to use any concomitant medication not permitted by this protocol or who have not undergone the required stabilization periods for prohibited medication.
Any other conditions that, in the investigator's opinion, might indicate the patient to be unsuitable for the study.",Aclidinium bromide 400 μg BID administered by Genuair® multidose dry powder inhaler,PubChem:11519741,Aclidinium Bromide,O=C(OC1C[N+]2(CCCOc3ccccc3)CCC1CC2)C(O)(c1cccs1)c1cccs1.[Br-],R03AL05,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02387814,NCT02387814_EG000,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 1,10,"Inclusion Criteria:

Female participants must be of non-child-bearing potential
Have a body mass index of 18 to 40 kilograms per square meter (kg/m²)

Exclusion Criteria:

No history of cardiovascular, renal, respiratory, gastrointestinal, endocrine or hematological disorders
Have known allergies to abemaciclib, related compounds, or any components of the formulation
No human immunodeficiency virus (HIV) infection or antibodies","200 mg abemaciclib administered once, orally, to participants with normal hepatic function.",ChEMBL:CHEMBL3301610 | DrugBank:DB12001 | PubChem:46220502,Abemaciclib,CCN1CCN(Cc2ccc(Nc3ncc(F)c(-c4cc(F)c5nc(C)n(C(C)C)c5c4)n3)nc2)CC1,L01EF03,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02387814,NCT02387814_EG002,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 1,10,"Inclusion Criteria:

Female participants must be of non-child-bearing potential
Have a body mass index of 18 to 40 kilograms per square meter (kg/m²)

Exclusion Criteria:

No history of cardiovascular, renal, respiratory, gastrointestinal, endocrine or hematological disorders
Have known allergies to abemaciclib, related compounds, or any components of the formulation
No human immunodeficiency virus (HIV) infection or antibodies","200 mg abemaciclib administered once, orally, to participants with moderate hepatic impairment.",ChEMBL:CHEMBL3301610 | DrugBank:DB12001 | PubChem:46220502,Abemaciclib,CCN1CCN(Cc2ccc(Nc3ncc(F)c(-c4cc(F)c5nc(C)n(C(C)C)c5c4)n3)nc2)CC1,L01EF03,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,1.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT02388321,NCT02388321_EG001,No,All,Child,Phase 4,11,"Inclusion Criteria:

Children aged 3-17,
weighing less than 50kg
present to the pediatric ED with moderate-severe acute pain (defined as pain greater than or equal to 6/10).
Treating physician determines the patient to require opioid analgesia.

Exclusion Criteria:

Children with facial trauma or any abnormal nasal anatomy;
developmentally delayed children;
children with head trauma/increased intracranial pressure (ICP);
children with known allergy to fentanyl or ketamine;
children who are unable to provide pain scale assessment;
children with chronic pain of greater than 4 weeks;
Pregnant females;
and children with a Glasgow Coma Scale (GCS)<15.","intranasal fentanyl for the treatment of moderate to severe pain in pediatric patients in the emergency department.

Fentanyl: intranasal fentanyl for the treatment of moderate to severe pain in pediatric patients in the emergency department.",ChEMBL:CHEMBL596 | DrugBank:DB00813 | PubChem:3345,Fentanyl,CCC(=O)N(c1ccccc1)C1CCN(CCc2ccccc2)CC1,N01AH01 | N01AH51 | N02AB03,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02389712,NCT02389712_EG001,No,All,Adult | Older Adult,Phase 4,2,"Inclusion Criteria:

Adult participants, age 18-65.
Outpatients or inpatients with a diagnosis of bipolar I, II or schizoaffective bipolar disorder, depressed phase, non-psychotic, (DSM-5 criteria, Structured Clinical Interview for the Diagnostic and Statistical Manual for Mental Disorders Module D confirmed)
At least mild symptom severity of depression as defined by the Clinical Global Impression for Bipolar Disorder (CGI-BP, Spearing et al. 1997) >2.
Bipolar I participants must be on conventional mood stabilizing treatment [lithium, divalproex or valproate, or an atypical antipsychotic]. Participants with a bipolar II disorder may pursue the FLAME Study as monotherapy.
Negative urine pregnancy test.
Participants not planning pregnancy in the near future (6 months).
Negative urine toxicology screen (except cannabis).
No evidence of clinically significant laboratory screening tests (complete blood count (CBC); electrolytes; thyroid stimulating hormone (TSH); creatinine/blood urea nitrogen, Aspartate Aminotransferase (AST)/ALT). Clinical laboratory evaluation within the last three months is acceptable.

Exclusion Criteria:

Inability or unwilling to provide informed consent.
Inability to understand English.
Actively suicidal participants at screening or enrollment visit as defined by a response of 3 or 4 on question 4 of the Bipolar Inventory of Symptoms Scale (BISS).
Active delusions or hallucinations defined as a score of 3 or 4 on the BISS question 40 (persecutory ideas) or 41 (delusions or hallucinations).
Impaired insight as defined as a score of 3 or 4 on BISS question 42 (insight).
Hypomania defined by a BISS manic subscore of ≥15.
Axis I or II comorbidity that by referring mental health professional and/or study psychiatrist is primary need of treatment. (This will be assessed by the site principal investigator, who has >10 years clinical experience with this population. Hospital discharge summaries and outpatient medical records may be reviewed (i.e., adequate trials of mood stabilizing treatments with minimal to no response, prominent self-injurious behavior in the absence of significant mood symptomatology, or atypical cycle patterns) to make this decision.
Pregnant participants
Unwilling or unable to taper any current antidepressant therapy
Participants currently breastfeeding
Female not practicing a reliable form of birth control (condom, intrauterine device (IUD), Depo-Provera injection)
Due to lamotrigine pharmacokinetics, female subjects wishing to commence oral contraceptive therapy (OCT) within 3 months of enrollment date or anticipate discontinuing OCT during study (stable oral contraceptive therapy exception).
History of active substance abuse disorder within the last 3 months (other than caffeine or cannabis)
Participants with medical contraindications that preclude lamotrigine or fluoxetine treatment
History of severe adverse reaction to lamotrigine and/or fluoxetine
Current carbamazepine or oxcarbazepine treatment
Unstable active medical illness","Subjects on this arm will be randomized to Fluoxetine.

Fluoxetine: Fluoxetine dosing: 20mg for month 1, 40mg for month 2, and if still depressed (CGI ≥ 3) 60mg for month 3 and 4. Lower doses of fluoxetine will be prescribed for those with side effects. For known Cytochrome P450 2D6 poor metabolizers, fluoxetine will not be dosed > 40mg.",ChEMBL:CHEMBL41 | DrugBank:DB00472 | PubChem:3386,Fluoxetine,CNCCC(Oc1ccc(C(F)(F)F)cc1)c1ccccc1,N06AB03 | N06CA03,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02389816,NCT02389816_EG001,No,All,Adult | Older Adult,Phase 3,165,"Inclusion Criteria:

In the opinion of the investigator or sub-investigator, the participant is capable of understanding and complying with protocol requirements.
The participant signs and dates a written, informed consent form prior to the initiation of any study procedures.
The participant suffers from recurrent MDD as the primary diagnosis according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria (classification code 296.3x).
The participant is a man or a woman aged 20 to 75 years (both inclusive) at the time of informed consent.
The reported duration of the current major depressive episode is 3 to 12 months (both inclusive) at the start of screening period.
The participant has a MADRS total score ≥26, Hamilton Depression Rating Scale (HAM-D17) total score ≥18, and Clinical global impression scale-Severity (CGI-S) score ≥4 at the start of screening period, at the start of placebo lead-in period and at the start of double-blind treatment period.
A female participant of childbearing potential who is sexually active with a nonsterilized male partner agrees to use routinely adequate contraception from signing of informed consent to the end of the follow-up period.

Exclusion Criteria:

The participant has any following current or past history of psychiatric disorder and/or neurological disorder:

Any current psychiatric disorder other than MDD as defined by DSM-IV-TR (To be assessed by Mini International Neuropsychiatric Interview: MINI). A participant who exhibits symptoms of anxiety is eligible unless the participant fulfills the diagnostic criteria for a current anxiety disorder per DSM-IV-TR.
Current diagnosis or history of manic, mixed or hypomanic episode, MDD with psychotic features, schizophrenia or any other psychotic disorder (including substance-related mental disorders, or mental disorders due to a general medical condition) as defined by DSM-IV-TR.
Current diagnosis or history of any substance-related disorder (except nicotine and caffeine-related disorders) as defined by DSM-IV-TR.
The participant with a positive urine drug screening result at the start of screening period or the start of placebo lead-in period. In case that a participant showed positive test result at the start of screening period because the test was conducted before washout of pretreatment drug, the participant is eligible as long as he/she shows negative result at the start of placebo lead-in period.
Presence or history of any clinically significant neurological disorder (including epilepsy).
Any neurodegenerative disorder (e.g. Alzheimer's disease, Parkinson's disease, multiple sclerosis, Huntington's disease).
Any DSM-IV-TR axis II disorder.
The participant has the current or previous major depressive episode which was considered by the investigator or sub-investigator to have been resistant to 2 or more adequate antidepressants treatments of at least 6 weeks duration each at sufficient doses.
The participant has received any augmentation therapy (e.g. lithium, T3/T4, lamotrigine, sodium valproate, carbamazepine, additional atypical antipsychotic, or concomitant use of other antidepressant, etc.) for the current major depressive episode.
In the opinion of the investigator or sub-investigator, the participant has experienced significant number of major depressive episodes in the past, and is suspected of disease other than MDD.
In the opinion of the investigator or sub-investigator, the participant has experienced the first major depressive episode at his/her young age, and is suspected of disease other than MDD.
The participant has a MADRS total score at the start of double-blind treatment period that has improved or aggravated by 25% or more from the score at the start of placebo lead-in period.
The participant is significantly non-compliant with the study drug in the placebo lead-in period; e.g., not taking the study drug for 6 or more consecutive days.
The participant has received electroconvulsive therapy, vagus nerve stimulation, or repetitive transcranial magnetic stimulation therapy within 6 months prior to the screening period, or plans to initiate such therapy during the study.
The participant is receiving cognitive-behavioral therapy or psychotherapy at the time of informed consent, or plans to initiate such therapy during the study.
The participant is at significant risk of suicide or has a score ≥5 on Item 10 (suicidal thoughts) of the MADRS at the start of screening period, at the start of placebo lead-in period or at the start of double-blind treatment period, or has attempted suicide within 6 months prior to the start of screening period.
The participant has experienced any environmental change (e.g. temporary retirement, returnment, change of residence) considered by the investigator or sub-investigator to have the potential to impact on the efficacy evaluation, or plans such environmental changes during the study.
The participant is currently receiving drug therapy for thyroid dysfunction.
The participant is currently receiving hormonal therapy for gynecological disease.
The participant has taken excluded medications during the protocol-specified period, or will require to take excluded medications during the study.
The participant has previously received vortioxetine.
The participant has received study drug in a previous clinical study of Lu AA21004 (including this study).
The participant has a clinically significant chronic liver disease.
The participant has a history of severe allergy or hypersensitivity to drugs.
The participant has a clinically significant unstable illness, for example, liver disorder or renal insufficiency, or a cardiovascular, pulmonary, gastrointestinal, endocrine, neurological, rheumatologic, immunologic, infectious, neoplastic, skin and subcutaneous tissue disorders, eye disorders, or metabolic disturbance.
The participant has clinically significant abnormal vital signs as determined by the investigator or sub-investigator at the start of screening period, placebo lead-in period, or double-blind treatment period.
The participant has clinically significant abnormal electrocardiogram (ECG) as determined by the investigator or sub-investigator, at the start of the screening period, at the start of placebo lead-in period, or at the start of double-blind treatment period.
The participant has clinically significant abnormal findings of clinical laboratory tests as determined by the investigator or sub-investigator, or has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2 × ULN at the start of screening period or at the start of placebo lead-in period.
If female, the participant is pregnant or lactating.
The participant has a disease or takes medications that could, in the opinion of the investigator or sub-investigator, interfere with the evaluation of the safety, tolerability, or efficacy.
The participant is, in the opinion of the investigator or sub-investigator, unsuitable for this study for any other reason.","Vortioxetine 10 mg tablets, orally, once daily for up to Week 8",ChEMBL:CHEMBL2104993 | DrugBank:DB09068 | PubChem:9966051,Vortioxetine,Cc1ccc(Sc2ccccc2N2CCNCC2)c(C)c1,N06AX26,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02389816,NCT02389816_EG002,No,All,Adult | Older Adult,Phase 3,163,"Inclusion Criteria:

In the opinion of the investigator or sub-investigator, the participant is capable of understanding and complying with protocol requirements.
The participant signs and dates a written, informed consent form prior to the initiation of any study procedures.
The participant suffers from recurrent MDD as the primary diagnosis according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria (classification code 296.3x).
The participant is a man or a woman aged 20 to 75 years (both inclusive) at the time of informed consent.
The reported duration of the current major depressive episode is 3 to 12 months (both inclusive) at the start of screening period.
The participant has a MADRS total score ≥26, Hamilton Depression Rating Scale (HAM-D17) total score ≥18, and Clinical global impression scale-Severity (CGI-S) score ≥4 at the start of screening period, at the start of placebo lead-in period and at the start of double-blind treatment period.
A female participant of childbearing potential who is sexually active with a nonsterilized male partner agrees to use routinely adequate contraception from signing of informed consent to the end of the follow-up period.

Exclusion Criteria:

The participant has any following current or past history of psychiatric disorder and/or neurological disorder:

Any current psychiatric disorder other than MDD as defined by DSM-IV-TR (To be assessed by Mini International Neuropsychiatric Interview: MINI). A participant who exhibits symptoms of anxiety is eligible unless the participant fulfills the diagnostic criteria for a current anxiety disorder per DSM-IV-TR.
Current diagnosis or history of manic, mixed or hypomanic episode, MDD with psychotic features, schizophrenia or any other psychotic disorder (including substance-related mental disorders, or mental disorders due to a general medical condition) as defined by DSM-IV-TR.
Current diagnosis or history of any substance-related disorder (except nicotine and caffeine-related disorders) as defined by DSM-IV-TR.
The participant with a positive urine drug screening result at the start of screening period or the start of placebo lead-in period. In case that a participant showed positive test result at the start of screening period because the test was conducted before washout of pretreatment drug, the participant is eligible as long as he/she shows negative result at the start of placebo lead-in period.
Presence or history of any clinically significant neurological disorder (including epilepsy).
Any neurodegenerative disorder (e.g. Alzheimer's disease, Parkinson's disease, multiple sclerosis, Huntington's disease).
Any DSM-IV-TR axis II disorder.
The participant has the current or previous major depressive episode which was considered by the investigator or sub-investigator to have been resistant to 2 or more adequate antidepressants treatments of at least 6 weeks duration each at sufficient doses.
The participant has received any augmentation therapy (e.g. lithium, T3/T4, lamotrigine, sodium valproate, carbamazepine, additional atypical antipsychotic, or concomitant use of other antidepressant, etc.) for the current major depressive episode.
In the opinion of the investigator or sub-investigator, the participant has experienced significant number of major depressive episodes in the past, and is suspected of disease other than MDD.
In the opinion of the investigator or sub-investigator, the participant has experienced the first major depressive episode at his/her young age, and is suspected of disease other than MDD.
The participant has a MADRS total score at the start of double-blind treatment period that has improved or aggravated by 25% or more from the score at the start of placebo lead-in period.
The participant is significantly non-compliant with the study drug in the placebo lead-in period; e.g., not taking the study drug for 6 or more consecutive days.
The participant has received electroconvulsive therapy, vagus nerve stimulation, or repetitive transcranial magnetic stimulation therapy within 6 months prior to the screening period, or plans to initiate such therapy during the study.
The participant is receiving cognitive-behavioral therapy or psychotherapy at the time of informed consent, or plans to initiate such therapy during the study.
The participant is at significant risk of suicide or has a score ≥5 on Item 10 (suicidal thoughts) of the MADRS at the start of screening period, at the start of placebo lead-in period or at the start of double-blind treatment period, or has attempted suicide within 6 months prior to the start of screening period.
The participant has experienced any environmental change (e.g. temporary retirement, returnment, change of residence) considered by the investigator or sub-investigator to have the potential to impact on the efficacy evaluation, or plans such environmental changes during the study.
The participant is currently receiving drug therapy for thyroid dysfunction.
The participant is currently receiving hormonal therapy for gynecological disease.
The participant has taken excluded medications during the protocol-specified period, or will require to take excluded medications during the study.
The participant has previously received vortioxetine.
The participant has received study drug in a previous clinical study of Lu AA21004 (including this study).
The participant has a clinically significant chronic liver disease.
The participant has a history of severe allergy or hypersensitivity to drugs.
The participant has a clinically significant unstable illness, for example, liver disorder or renal insufficiency, or a cardiovascular, pulmonary, gastrointestinal, endocrine, neurological, rheumatologic, immunologic, infectious, neoplastic, skin and subcutaneous tissue disorders, eye disorders, or metabolic disturbance.
The participant has clinically significant abnormal vital signs as determined by the investigator or sub-investigator at the start of screening period, placebo lead-in period, or double-blind treatment period.
The participant has clinically significant abnormal electrocardiogram (ECG) as determined by the investigator or sub-investigator, at the start of the screening period, at the start of placebo lead-in period, or at the start of double-blind treatment period.
The participant has clinically significant abnormal findings of clinical laboratory tests as determined by the investigator or sub-investigator, or has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2 × ULN at the start of screening period or at the start of placebo lead-in period.
If female, the participant is pregnant or lactating.
The participant has a disease or takes medications that could, in the opinion of the investigator or sub-investigator, interfere with the evaluation of the safety, tolerability, or efficacy.
The participant is, in the opinion of the investigator or sub-investigator, unsuitable for this study for any other reason.","Vortioxetine 10 mg tablets, orally, once daily for up to Week 1, followed by vortioxetine 20 mg tablets, orally, once daily for up to Week 8",ChEMBL:CHEMBL2104993 | DrugBank:DB09068 | PubChem:9966051,Vortioxetine,Cc1ccc(Sc2ccccc2N2CCNCC2)c(C)c1,N06AX26,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02390362,NCT02390362_EG001,No,All,Child | Adult,Phase 3,3,"Inclusion Criteria:

SDNS or FRNS
Complete remission, defined by absence of edema and 3 consecutive daily urine dipstick readings of trace or negative for protein
Must be taking MMF and have had at least one relapse while taking MMF in the prior 6 months that responded to corticosteroid treatment by re-entering complete remission at least 2 weeks prior to study entry.
BMI prior to onset of NS <99th percentile
Age 1-18 years
Estimated GFR >40 ml/min/1.73m² (by Modified Schwartz formula)
Negative serum pregnancy test (for females who are tanner stage 4 or 5)
Males and females of reproductive potential (sexually active in boys or post-menarche in girls) must agree to use an acceptable method of birth control during treatment and for twelve months (1 year) after completion of treatment

Exclusion Criteria:

• Prior therapy with rituximab, tacrolimus or cyclosporine

Prior therapy with cytotoxic agents in the past 90 days
History of genetic defects known to directly cause nephrotic syndrome (i.e. NPHS2 (podocin), NPHS1 (nephrin), PLCE1, WT1)
History of or concomitant severe, active infection (e.g. HIV, hepatitis B, hepatitis C)
History of diabetes mellitus
History of organ or bone marrow transplant
Secondary nephrotic syndrome (i.e. reflux nephropathy, IgA nephropathy, lupus nephritis, etc)
Live viral vaccines administered in the past 6 weeks (42 days)
Participation in another therapeutic trial within 30 days of enrollment
Allergy to study medications
ANC < 1.5 x 103
Hemoglobin: < 8.0 gm/dL
Platelets: < 100,000/mm
AST or ALT >2.5 x Upper Limit of Normal at the local institutions laboratory
Positive Hepatitis B or C serology (Hep B Surface antigen, Hep B Core antibody, and Hep C antibody)
History of HIV infection
Treatment with any investigational agent within 4 weeks of screening or 5 half-lives of the investigational drug (whichever is longer)
Receipt of a live vaccine within 4 weeks prior to randomization
Previous treatment with Natalizumab (Tysabri®)
Previous Treatment with Rituximab (Rituxan®)
Known hypersensitivity to Rituximab, to any of its excipients, or to murine proteins
History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
History of recurrent significant infection or history of recurrent bacterial infections
Known active bacterial, viral, fungal, mycobacterial, or other infection (including tuberculosis or atypical mycobacterial disease, but excluding fungal infections of nail beds) or any major episode of infection requiring hospitalization or treatment with i.v. antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks prior to screening
Lack of peripheral venous access
History of drug, alcohol, or chemical abuse within 6 months prior to screening
Pregnant, lactating, or refusal of birth control in an adolescent of child-bearing potential
Concomitant malignancies or previous malignancies
History of psychiatric disorder that would interfere with normal participation in this protocol
Significant cardiac or pulmonary disease (including obstructive pulmonary disease)
Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications
Inability to comply with study and follow-up procedures

Patients who fail screening due to an abnormal laboratory parameter may be rescreened within the next 6 months if the local PI believes that the abnormality was transient and not related to a chronic underlying disease. Rescreening may only occur once and may not occur within 2 weeks of the initial screen failure.

If a patient has a clinically significant laboratory abnormality, the PI will be asked to define a follow-up plan (timing of repeating the laboratory test and/or additional work-up).","Mycophenolate Mofetil will be continued in the patients in the MMF arm at a standard oral dose of 600 mg/m2 PO, BID starting on Study week 1 and continuing for 12 months

MMF: Subjects randomized to MMF, will continue MMF as scheduled by the investigator",ChEMBL:CHEMBL589586 | DrugBank:DB14219 | PubChem:5369209,MONOMETHYL FUMARATE,COC(=O)/C=C/C(=O)O,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02393339,NCT02393339_EG000,Accepts Healthy Volunteers,All,Child,Early Phase 1,114,"Inclusion Criteria:

healthy
in need of dental treatment with local anesthesia

Exclusion Criteria:

preoperative pain,
patients taking analgesics within 5 h prior to the dental treatment
allergic reaction or adverse effect to paracetamol
not available (by phone) at least 2 hours after treatment
patient refuse to drink the syrup
dental treatment without local anesthesia","Study group will receive syrup paracetamol (15 mg/kg) 15 min before the dental treatment

paracetamol: Pre-operative administration of Paracetamol syrup",ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02400307,NCT02400307_EG000,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 1,10,"Key Inclusion Criteria:

All Individuals:

Must have a calculated BMI from 18 to 40 kg/m^2, inclusive, at screening

Individuals with impaired renal function

Chronic stable renal impairment without recent clinical change

Mild: Creatinine clearance (CrCl) = 60 - 89 mL/min
Moderate: CrCl = 30 - 59 mL/min
Severe: CrCl = 15 - 29 mL/min

Healthy individuals

CrCl ≥ 90 mL/min

Key Exclusion Criteria:

All Individuals:

Pregnant or lactating females
HIV positive or chronic hepatitis B infected

Individuals with impaired renal function

Chronic liver disease
Dialysis or anticipated use of dialysis
Renal transplant

Note: Other protocol defined Inclusion/Exclusion criteria may apply.",Participants with severe renal impairment (CrCl = 15 - 29 mL/min) received a single dose of bictegravir 75 mg tablet orally on Day 1 under fed conditions,ChEMBL:CHEMBL3989866 | DrugBank:DB11799 | PubChem:90311989,Bictegravir,O=C(NCc1c(F)cc(F)cc1F)c1cn2c(c(O)c1=O)C(=O)N1[C@H]3CC[C@H](C3)O[C@@H]1C2,J05AR20,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT02400580,NCT02400580_EG000,Accepts Healthy Volunteers,Female,Adult | Older Adult,Phase 4,91,"Inclusion Criteria:

Women aged 18-75
Ability to read and write in English (our post-operative pain log is only available in English)
Planning a laparoscopic hysterectomy (includes total laparoscopic hysterectomy, laparoscopic supracervical hysterectomy, laparoscopically assisted vaginal hysterectomy, with or without salpingooophorectomy)

Exclusion Criteria:

Answering yes to any of the following questions: ""Do you have a history of liver disease, kidney disease, hepatitis C, history of liver failure, greater than 3 drinks per day or being have you ever been told by your doctor that they should not take acetaminophen""
History of cardiac arrhythmia
History of jaundice
Acute abdominal inflammatory or infectious process at time of surgery
Known malignancy at time of surgery
Known pregnancy at time of surgery
Plan to perform additional significant surgical procedure at the time of hysterectomy such as extensive excision of endometriosis on bowel or bladder or pelvic reconstructive procedure
>6cm abdominal incision in order to remove the uterus at time of study-related hysterectomy
Regular use of narcotic pain medication (defined as use on most days of the week at any point in the past 3 months)
Allergy to acetaminophen
Women who weigh less than 50 kilograms on the day of surgery.","The patients in the treatment arm will receive 1000mg of IV acetaminophen.

IV acetaminophen",ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02409732,NCT02409732_EG000,No,All,Adult | Older Adult,Phase 4,20,"Inclusion Criteria:

Must be able to understand and voluntarily sign an informed consent form
Must be male or female ≥ 18 years of age at the time of consent
Must be able to adhere to the study visit schedule and other protocol requirements
Must have a diagnosis of actinic cheilitis by histopathological evaluation of biopsy specimen or clinical presentation

Exclusion Criteria:

Inability to provide voluntarily consent or mentally incompetent
Active herpes labialis lesions
Subjects with any condition which places the subject at unacceptable risk if he/she were to participate in the study, or confounds the ability to interpret data from the study
Subjects with any other skin condition that might affect the evaluation of the study disease
Pregnant or breastfeeding female subjects
Subjects who have used any investigational medication within one month prior to study entry
Subjects who have been previously exposed to PDT and/or topical Levulan therapy for the treatment of actinic cheilitis
Subjects who have used local therapy (e.g. cryotherapy) or topical treatment (e.g. 5% fluorouracil) within three months of study entry
Subjects who have used an oral photosensitizing drug (e.g. Declomycin) within six months of study entry
Subjects who are currently using photosensitizing agents (e.g. thiazides, tetracyclines, fluoroquinolones, phenothiazines, and sulfonamides) because of the risk of augmented photosensitivity
Subjects who are frequently exposed to ultraviolet radiation (e.g. lifeguards, construction workers, frequent sunbed users, etc.)
Subjects with a history of cutaneous photosensitization, porphyria, hypersensitivity to porphyrins, or photodermatosis
Subjects with a known hypersensitivity to Levulan
Subjects who are immunocompromised",Photodynamic therapy (PDT) with aminolevulinic acid hydrochloride (HCl) and blue light to the affected area of the lips every six weeks up to three treatments,PubChem:123608,Aminolevulinic Acid Hydrochloride,Cl.NCC(=O)CCC(=O)O,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT02411643,NCT02411643_EG000,No,All,Adult | Older Adult,Early Phase 1,2,"Inclusion Criteria:

Subjects with clinically-diagnosed or biopsy proven plaque-type, guttate, linear, segmental, and generalized morphea that are receiving calcipotriene 0.005% ointment as part of their standard of care treatment will be included.
Subjects are allowed to have previously been on any therapy as long as they have been off systemic treatment, topical therapy or phototherapy for 4 weeks prior to baseline.
Age ≥ 18 years.
Ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria:

Subjects with the diagnosis of morphea profundus, eosinophilic fasciitis, and atrophoderma will be excluded.
Subjects who are receiving oral or topical immunosuppression therapy or phototherapy within 4 weeks prior to entering the study.
Subjects may not be receiving any investigational agents.
Subjects must not be pregnant or nursing.
Patients allergic to lidocaine or epinephrine or who have a history of impaired wound healing or for any reason are unable to undergo a skin biopsy.","Calcipotriene 0.005% applied to affected areas twice daily to all enrolled subjects

topical calcipotriene 0.005% ointment: Affected area will be treated twice daily for 3 months",ChEMBL:CHEMBL1200666 | PubChem:5288783,CALCIPOTRIENE,C=C1/C(=C\C=C2/CCC[C@]3(C)[C@@H]([C@H](C)/C=C/[C@@H](O)C4CC4)CC[C@@H]23)C[C@@H](O)C[C@@H]1O,D05AX02 | D05AX52,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02412111,NCT02412111_EG000,No,All,Child | Adult | Older Adult,Phase 3,156,"Inclusion Criteria:

Heterozygous for F508del-CFTR mutation and a second CFTR allele with a gating defect that is clinically demonstrated to be ivacaftor responsive
FEV1 ≥40% and ≤90% of predicted normal for age, sex, and height during screening
Stable CF disease as judged by the investigator.

Exclusion Criteria:

History of any comorbidity that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject.
Pregnant and nursing females (females of childbearing potential must have a negative pregnancy test at Screening and Week -4 Visits).
Sexually active subjects of reproductive potential who are not willing to follow the contraception requirements",Ivacaftor 150 milligram (mg) tablet orally every 12 hours for 4 weeks.,ChEMBL:CHEMBL2010601 | DrugBank:DB08820 | DrugBank:DB15141 | PubChem:16220172 | PubChem:71470491,Ivacaftor,CC(C)(C)c1cc(C(C)(C)C)c(NC(=O)c2c[nH]c3ccccc3c2=O)cc1O,R07AX02 | R07AX30 | R07AX31 | R07AX32,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT02412111,NCT02412111_EG002,No,All,Child | Adult | Older Adult,Phase 3,75,"Inclusion Criteria:

Heterozygous for F508del-CFTR mutation and a second CFTR allele with a gating defect that is clinically demonstrated to be ivacaftor responsive
FEV1 ≥40% and ≤90% of predicted normal for age, sex, and height during screening
Stable CF disease as judged by the investigator.

Exclusion Criteria:

History of any comorbidity that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject.
Pregnant and nursing females (females of childbearing potential must have a negative pregnancy test at Screening and Week -4 Visits).
Sexually active subjects of reproductive potential who are not willing to follow the contraception requirements",Ivacaftor 150 mg tablet orally every 12 hours as monotherapy for 8 weeks.,ChEMBL:CHEMBL2010601 | DrugBank:DB08820 | DrugBank:DB15141 | PubChem:16220172 | PubChem:71470491,Ivacaftor,CC(C)(C)c1cc(C(C)(C)C)c(NC(=O)c2c[nH]c3ccccc3c2=O)cc1O,R07AX02 | R07AX30 | R07AX31 | R07AX32,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT02418182,NCT02418182_EG001,Accepts Healthy Volunteers,Female,Adult,Phase 4,33,"Inclusion Criteria:

English Speaking
Undergoing Transvaginal Oocyte Retrieval Procedure

Exclusion Criteria:

Acetaminophen allergy
Opioid dependency","Experimental group participants will receive 2 acetaminophen 500mg tablets approximately 1 hour prior to transvaginal oocyte retrieval procedure.

Acetaminophen: Acetaminophen total dose of 1000mg",ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02424955,NCT02424955_EG000,No,All,Adult | Older Adult,Not Applicable,11,"Inclusion Criteria:

Ability to understand and willingness to sign the written informed consent document
Patient with primary liver tumor or metastasis scheduled for Stereotactic Ablative Radiotherapy (SABR)
Patient is at least 18 years of age. No gender/race-ethnic restrictions.
Performance status (ECOG) between 0-3
History and Physical done within 4 weeks of enrollment.

Exclusion Criteria:

Patient has previously been enrolled in and completed this study.
Known right to left cardiac shunt, bidirectional or transient.
Patient has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or post-dose follow-up examinations.
History of hypersensitivity to the contrast agent perflutren
History of pulmonary hypertension
Patients who are pregnant or are trying to become pregnant",Patients undergo 3D ultrasound perfusion imaging with perflutren lipid microspheres,ChEMBL:CHEMBL1663 | DrugBank:DB00556 | PubChem:6432,Perflutren,FC(F)(F)C(F)(F)C(F)(F)F,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02428296,NCT02428296_EG000,No,All,Child | Adult | Older Adult,Phase 2,39,"INCLUSION CRITERIA:
Age: greater than or equal to 3 years to less than or equal to 65 years
Male or Female
Confirmed PIK3CA somatic mutation
Measurably progressive overgrowth, in current progression or with clinical history of overgrowth progression

Adequate Bone Marrow Function Defined as:

Peripheral absolute neutrophil count (ANC) greater than or equal to 1500/microliter, except for those participants with an absolute neutrophil count (ANC) of 1000-1500, caused by a benign condition associated with moderately decreased neutrophils known as Benign Ethnic Neutropenia (BEN), d those who have an ANC of 1000-1500 caused by a confirmed infection, which resolves with treatment of infection to greater than or equal to 1500.
Platelet count less than or equal to 100,000/microliter
Hemoglobin less than or equal to 10.0 gm/dL
Adequate Renal Function Defined as:

A serum creatinine based on age as follows:

Age (years) [Maximum Serum Creatinine (mg/dl)]
Less than or equal to 5 [0.8 mg/dl]
5 less than age less than or equal to10 [1.0 mg/dl]
10 less than age less than or equal to 15 [1.2 mg/dl]
Less than 15 [1.5 mg/dl]

OR a creatinine clearance or radioisotope GFR greater than or equal to 70ml/min/1.73 m2

Adequate Liver Function Defined As:

Bilirubin (sum of conjugated + unconjugated) less than or equal to 1.5 x upper limit of normal (ULN) for age, and
SGPT (ALT) less than or equal to 5 x upper limit of normal (ULN) for age, and
Serum albumin greater than or equal to 2 g/dL.

Fasting LDL Cholesterol:

Patients must have a fasting LDL cholesterol of less than or equal to 160 mg/d
All women of childbearing potential and all sexually active male patients must agree to use effective contraception
Adolescent (15-17 year old) participants who are fluent in English and can thereby complete the pediatric self-report questionnaires and communicate well with the study team but whose parent(s) and/or legal guardian are primarily Spanish-speaking.

EXCLUSION CRITERIA:

The participant may not enter the study if ANY of the following apply:

Age less than 3 years or greater than 65 years
Pregnant or breastfeeding
Women and men of reproductive age without an effective method of contraception (during treatment and up to 12 weeks after sirolimus discontinuation)
Hypersensitivity to sirolimus or any of the excipients
Any current medical disorder or medication likely to impair ability to follow the study protocol safely and effectively
Incapacity to give informed consent
Sirolimus treatment in the prior 4 weeks
If less than 3 months post-surgery
Prior malignancy or ongoing investigations for malignancy
Active skin infections requiring antibiotics or anti-viral medication
HCV/HBV/HIV seropositivity
Previous/ active MTB infection
Pneumonitis
Research radiation exposure within previous 12 months
Adult participants or participants under the age of 15 years with insufficient English language proficiency to complete informed consent and quality of life measures

We propose to restrict participation in this study to those with sufficient English language skills to complete the quality of life measures we will employ among all three study sites, as many of the specific quality of life measures we are employing at the NIH only are not available in other languages.","Participants were assessed for sirolimus efficacy at week 0 (before the run-in phase), week 26 (after the run-in phase and before treatment), and at week 52 (after 26 weeks of treatment).

Pharmacokinetic data for sirolimus for children and adults with renal transplants informed dosing algorithms. A target sirolimus plasma concentration of 2-6ng/ml was selected based on in vitro preclinical studies off-label clinical experience, and with the aim of minimizing AEs.",ChEMBL:CHEMBL413 | DrugBank:DB00877 | PubChem:134760597 | PubChem:138404388 | PubChem:21944094 | PubChem:5284616,Sirolimus,COC1CC2CCC(C)C(O)(O2)C(=O)C(=O)N2CCCCC2C(=O)OC(C(C)CC2CCC(O)C(OC)C2)CC(=O)C(C)C=C(C)C(O)C(OC)C(=O)C(C)CC(C)C=CC=CC=C1C,L01EG04 | L04AA10 | S01XA23,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0
NCT02428855,NCT02428855_EG000,No,All,Adult | Older Adult,Phase 2,8,"Inclusion Criteria:

Participants must meet the following criteria on screening examination to be eligible to participate in the study:
Participants must have unresectable or metastatic histologically confirmed intrahepatic cholangiocarcinoma
Patients must have either IDH1 or IDH2 mutations (any known mutations) based on the SNaPshot platform or other molecular testing platform from either archived tissue or fresh biopsy (tested in CLIA-certified lab)
Patients with other biliary tract cancers (extrahepatic or gallbladder cancers) with IDH1 or IDH2 mutations are allowed
Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 20 mm with conventional techniques or as ≥10 mm with spiral CT scan. See section 10 for the evaluation of measureable disease.
Participants must have received at least one prior platinum-based regimen for advanced cholangiocarcinoma and had progressive disease or become intolerable to the regimen
Age ≥18 years.
Life expectancy of ≥3 months.
ECOG performance status 0 or 1 (see Appendix A).

Participants must have adequate organ and marrow function as defined below:

Absolute neutrophil count ≥ 1,200/mcL
Platelets ≥75,000/mcL
Hemoglobin ≥9 g/dL
Total bilirubin ≤ 2.5 x the upper limit of normal
AST (SGOT)/ALT (SGPT) ≤ 5 X institutional upper limit of normal
PT/PTT ≤ 1.5 x ULN
Creatinine ≤ 1.5 or GFR ≥ 60 mL/min/1.73m2
Serum Albumin ≥2.8 g/dl
Prior chemoembolization, radiofrequency ablation, or radiation to the liver is allowed as long as the patient has measurable disease outside of the treated area or measurable progression at the site of the treated area
Ability to understand and the willingness to sign a written informed consent document.
Sexually active subjects (men and women) must agree to use medically accepted barrier methods of contraception (eg, male or female condom) during the course of the study and for 4 months after the last dose of study drug(s), even if oral contraceptives are also used. All subjects of reproductive potential must agree to use both a barrier method and a second method of birth control during the course of the study and for 4 months after the last dose of study drug(s).
Women of childbearing potential must have a negative pregnancy test at screening. Women of childbearing potential include women who have experienced menarche and who have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or are not postmenopausal. Postmenopause is defined as amenorrhea ≥ 12 consecutive months. Note: women who have been amenorrheic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, antiestrogens, ovarian suppression or any other reversible reason.

Exclusion Criteria:

Participants who exhibit any of the following conditions at screening will not be eligible for admission into the study.
Prior treatment with dasatinib
Periampullary tumors
Chemotherapy, within 4 weeks prior to entering the study (6 weeks for nitrosoureas or mitomycin) or those who have not recovered to less than or equal to grade 1 from adverse events due to agents administered more than 4 weeks earlier.

The subject has received radiation therapy:

to bone or brain metastasis within 14 days of the first dose of study treatment
to any other site(s) within 28 days of the first dose of study treatment
The subject has active brain metastases or epidural disease (Note: Subjects with brain metastases previously treated with whole brain radiation or radiosurgery or subjects with epidural disease previously treated with radiation or surgery who are asymptomatic and do not require steroid treatment for at least 2 weeks before starting study treatment are eligible. Neurosurgical resection of brain metastases or brain biopsy is permitted if completed at least 3 months before starting study treatment. (Baseline brain imaging with contrast-enhanced CT or MRI scans for subjects with known brain metastases is required to confirm eligibility.)

The subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:

Cardiovascular disorders including

Congestive heart failure (CHF): New York Heart Association (NYHA) Class III (moderate) or Class IV (severe) at the time of screening
Concurrent uncontrolled hypertension defined as sustained BP > 140 mm Hg systolic, or > 90 mm Hg diastolic despite optimal antihypertensive treatment within 7 days of the first dose of study treatment
Diagnosed or suspected congenital long QT syndrome

Any of the following within 6 months before the first dose of study treatment:

Unstable angina pectoris
Clinically-significant cardiac arrhythmias
Stroke (including TIA, or other ischemic event)
Myocardial infarction
Thromboembolic event requiring therapeutic anticoagulation (Note: subjects with a venous filter (e.g. vena cava filter) are not eligible for this study)
Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de pointes)
Prolonged QTc interval on pre-entry electrocardiogram (> 450 msec), may use either the Fridericia and Bazett's correction
Hypokalemia or hypomagnesemia that is not corrected prior to dasatinib administration
Patients should not be taking drugs that are generally accepted to have a risk of causing Torsades de Pointes. The following must be discontinued at least 7 days prior to starting dasatinib to be eligible:quinidine, procainamide, disopyramide, amiodarone, sotalol, ibutilide,dofetilide, erythromycins, clarithromycin, chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide, cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone, halofantrine,levomethadyl, pentamidine, sparfloxacin, lidoflazine

Other clinically significant disorders such as:

active infection requiring systemic treatment within 28 days before the first dose of study treatment
serious non-healing wound/ulcer/bone fracture within 28 days before the first dose of study treatment
Patients with known moderate/severe pleural effusions that are unrelated to malignancy or established diagnosis of pulmonary arterial hypertension
Concurrent malignancy (other than adequately treated non-melanoma skin cancer, superficial transitional cell carcinoma of the bladder, and cervical carcinoma in situ) diagnosed within the past 3 years or any currently active malignancy
Psychiatric illness/social situations that would limit compliance with study requirements.
The subject has received any other type of investigational agent within 28 days before the first dose of study treatment.
The subject is unable to swallow tablets
Individuals who are known to be HIV-positive are excluded from this study.
Pregnant women are excluded from this study due to the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk of adverse events in nursing infants secondary to treatment of the mother with dasatinib, breastfeeding should be discontinued if the mother is treated with dasatinib. These potential risks may also apply to other agents used in this study.
Subjects may not be receiving any other study agents concurrently while on this study","Patients with advanced intrahepatic cholangiocarcinoma who have either IDH1 or IDH2 mutations and have received at least one prior platinum containing regimen

Dasatinib, oral, daily, predetermined dosage per cycle
Radiologic Response Assessment every 2 cycles",ChEMBL:CHEMBL1421 | DrugBank:DB01254 | PubChem:3062316,Dasatinib,Cc1nc(Nc2ncc(C(=O)Nc3c(C)cccc3Cl)s2)cc(N2CCN(CCO)CC2)n1,L01EA02 | L01XE06,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02431806,NCT02431806_EG003,No,All,Child,Phase 3,134,"Key Inclusion Criteria:

Male or female outpatients;12-17 years of age
Meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for MDD, confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children--Present and Lifetime (K-SADS-PL)
Score ≥ 40 on the Children's Depression Rating Scale-Revised (CDRS-R) at Visits 1 and 2
Clinical Global Impressions-Severity (CGI-S) score ≥ 4 at Visits 1 and 2
Reliable caregiver
Physical examination, vital signs, clinical laboratory tests, and electrocardiogram (ECG) normal or not clinically significant

Key Psychiatric Exclusion Criteria:

DSM-IV-TR-based diagnosis of an axis I disorder other than MDD that is the primary focus of treatment
Mental retardation or amnestic or other cognitive disorders
Significant suicide risk:
Suicide attempt within the past year OR
Investigator judgment (based on psychiatric interview and Columbia-Suicide Severity Rating Scale (C-SSRS))

Key Treatment-Related Exclusion Criteria:

Allergy, intolerance, or hypersensitivity to levomilnacipran, milnacipran, fluoxetine, or any other selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitors (SNRI)
Use of prohibited concomitant medication that cannot be discontinued

Other Key Medical Exclusion Criteria:

Any current medical condition that might interfere with the conduct of the study, confound the interpretation of study results, or affect participants safety
Liver enzyme tests aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 2X the upper limit of normal (ULN)
Clinically significant cardiovascular disorders
Seizure disorder or risk of seizure
Drug or alcohol abuse or dependence (within the past year)
Positive urine drug screen or blood alcohol","Participants received over-encapsulated fluoxetine 20 mg/day tablets orally starting at a dose of 10 mg/day in Week 1 and 20 mg/day in Week 2 through Week 8 during the Double-blind Treatment Period, followed by a 1-week Double-blind Taper-down Period if applicable as determined by the investigator. Participants received 1 dose matched placebo capsule each day to maintain the blind.",ChEMBL:CHEMBL41 | DrugBank:DB00472 | PubChem:3386,Fluoxetine,CNCCC(Oc1ccc(C(F)(F)F)cc1)c1ccccc1,N06AB03 | N06CA03,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02432287,NCT02432287_EG000,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 4,15,"Inclusion Criteria:

Men and women;
age >60 years with IGT based on 75g OGTT (fasting plasma glucose < 126 mg/dl, 2-hr glucose between 140 - 199 mg/dl);
this definition of IGT will include individuals with combined impaired fasting glucose (IFG) and IGT.

The investigators chose these inclusion criteria in order to study subjects who have evidence of impaired glucose regulation, but are not yet diabetic.

Exclusion Criteria:

Serious chronic or acute illness: cancer, clinically significant congestive heart failure, COPD, inflammatory conditions, serum creatinine > 1.4 mg/dl (female) or > 1.5 mg/dl (male), active liver disease, history of metabolic acidosis, poorly controlled hypertension, epilepsy, recent (within 3 months) CVD event (MI, PTCA, CABG, stroke); history of bariatric or other gastric surgery, cigarette smoking, binge alcohol use (>7 drinks in 24 hrs).
Treatment with drugs known to influence glucose metabolism (other diabetes medications, systemic glucocorticoids, pharmacologic doses of niacin)
Hypersensitivity to metformin or any component of the formulation","Metformin, an FDA approved first-line drug for the treatment of type 2 diabetes, has known beneficial effects on glucose metabolism.

Participants took metformin capsules 2 times daily for 6 weeks.",ChEMBL:CHEMBL1431 | DrugBank:DB00331 | PubChem:4091,Metformin,CN(C)C(=N)NC(=N)N,A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02438540,NCT02438540_EG001,No,All,Adult | Older Adult,Not Applicable,43,"Inclusion Criteria:

Who had been diagnosed with type 2 diabetes mellitus and has using Metformin monotherapy as well to control their diabetes during the period of this study as previously (500 mg one/two/three times per day)
All patients were overweight according to BMI ≥25

Exclusion Criteria:

Individuals with nephritic syndrome (urine protein over 3.5 g/day), edema or renal failure (serum creatinine over 115 µmol/L)
Individuals who had been diagnosed with heart failure (NYHA Fc III-IV) or who had been a pacemaker implanted
Individuals with abnormal liver dysfunction (GOT and glutamate-pyruvate transaminase (GPT) levels twofold above the normal range) or a diagnosis of liver cirrhosis
Individuals with a high HbA1C level (HbA1C above 9 %)
Pregnant women
Individuals who were receiving insulin therapy already
Individuals who receive other therapy or had any change at dosage during the period of therapy
Individuals who were suffering from endocrine abnormalities such as Thyroid disease, polycystic ovary syndrome (PCOS), etc
Individuals who were receiving weight loss medicine, anti depressant agents' or hormonal medicines during the last 3 months and the period of study
Individuals who were suffering from a homeostasis disorder or other systemic disease
Individuals who did not comply(signed informed consent) with the treatment during the study period","Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and placebo acupuncture treatment, needling not in right acupoints and EA machine was switched off during 30 minutes of therapeutic time. For ear acupuncture was just used sticky layers without seeds. All placebo treatment used for 30 minutes, 10 times, every other day, for 3 weeks.

metformin

Placebo acupuncture including placebo EA and auricular acupuncture",ChEMBL:CHEMBL1431 | DrugBank:DB00331 | PubChem:4091,Metformin,CN(C)C(=N)NC(=N)N,A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02439879,NCT02439879_EG000,No,All,Child | Adult | Older Adult,Phase 4,45,"Inclusion Criteria:

Type 2 diabetic patients (according to American Diabetes Association (ADA) criteria)
Symptomatic diabetic polyneuropathy
Total Symptom Score (TSS) >7 points,
HbA1c<10%,
Serum creatinine <2 mg/dl.

Exclusion Criteria:

Active cardiovascular disease
Malignancy
Any other conditions causing neuropathic pain
Use of analgesic, antidepressant, or antiepileptic drugs, or any other medication aimed to relief neuropathic pain.
Child-bearing female patients not using any effective birth control method and under surveillance of a board-certified gynecologist",After a decrease in the total symptoms score >3 points with 600 mg orally tid of alpha lipoic acid for 4 weeks patients were randomized to recieve for 16 weeks 600 mg orally once a day of alpha lipoic acid,ChEMBL:CHEMBL33864 | DrugBank:DB00166 | PubChem:6112 | PubChem:864,Lipoic acid,O=C(O)CCCCC1CCSS1,A16AX01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02439957,NCT02439957_EG000,No,All,Adult | Older Adult,Phase 3,3,"Inclusion Criteria

Subjects must have met all of the following criteria, as applicable, to be eligible to participate in this study:

Were male or female kidney transplant recipients who were ≥18 years of age (subject to local law/practice for clinical trial participation) and ≤14 days following their first or second renal allograft.
Were at high risk of cytomegalovirus (CMV) infection, which for the purposes of this study, was defined as CMV-seropositive recipients who received lymphocyte depleting induction treatment with antithymocyte globulin (Thymoglobulin® or Atgam®) prior to or during the qualifying transplant.
Had an estimated glomerular filtration rate of >10 mL/min (Cockcroft-Gault equation) at screening based on local laboratory results.
Were CMV viremia negative (i.e., ""not detected"") as measured by the designated central virology laboratory using the Roche COBAS® AmpliPrep/COBAS® TaqMan® CMV Test no more than 5 days prior to subject randomization, and at all prior assessments performed since transplant under local standard of care.
Were able to ingest, absorb, and tolerate tablets.
If male, was willing to use an acceptable contraceptive method(s) throughout the duration of his participation in the study, i.e., through Week 24.
If female of childbearing potential, i.e., not postmenopausal or surgically sterile, was willing to use 2 acceptable contraceptive methods, 1 of which must have been a barrier method, throughout the duration of her participation in the study, i.e., through Week 24.
Were willing and able to provide informed consent.
Were willing and able to participate in all required study activities for the entire duration of the study (i.e., through Week 24).

Exclusion Criteria

Subjects who met any of the following criteria were not eligible to participate in this study:

Weighed ≤50 kg (110 lbs) or ≥120 kg (265 lbs).
Were pregnant or breastfeeding or intended to conceive during the study period (i.e., through Week 24).
Received a stem cell transplant or solid organ transplant other than a kidney transplant.
Had suspected CMV disease (either syndrome or tissue-invasive disease) or detectable CMV viremia by the central virology laboratory prior to the first dose of study drug.
Had a history of CMV disease (either syndrome or tissue-invasive disease) within 6 months prior to the first dose of study drug.
Had an absolute neutrophil count of < 500 cells/μL, platelet count of < 25,000 platelets/μL, or hemoglobin of < 8 g/dL at screening.
Had hypersensitivity (not including renal dysfunction or an eye disorder) to valganciclovir (vGCV), ganciclovir (GCV), cidofovir (CDV), or brincidofovir (BCV) or their excipients.

Had received (or who are anticipated to need treatment with) any of the following:

GCV, vGCV, foscarnet, intravenous CDV, or any other anti-CMV therapy (including CMV immune globulin, cell-based therapies, and investigational anti-CMV drugs, e.g., leflunomide, letermovir [previously AIC246], or maribavir) at any time posttransplant;
Any anti-CMV vaccine at any time;
Any other investigational drug within 14 days prior to the first dose of study drug (unless prior approval had been received from the Chimerix Medical Monitor or designee); or
Prior treatment with BCV at any time. [Note: An ""investigational drug"" was defined as any drug that was not approved for any indication by the FDA (or appropriate regulatory authority).]
Received acyclovir (ACV) orally at >2000 mg total daily dose (TDD) or intravenously at >15 mg/kg TDD, valacyclovir (vACV) at > 3000 mg TDD on the first dose of study drug or were anticipated to receive any of these drugs at the doses described after the first dose of study drug.
Were infected with HIV, hepatitis B virus (HBV), and/or hepatitis C virus (HCV), had evidence of active viral replication within 6 months prior to screening, as demonstrated by detectable HIV or HCV RNA, or detectable HBV DNA in blood, plasma or serum.
Had severe vomiting, diarrhea or malabsorption syndrome on or prior to the first dose of study drug.
Had gastrointestinal (GI) disease that would have, in the judgment of the investigator, precluded the subject from taking or absorbing oral medication (e.g., gastroparesis, diabetic autonomic neuropathy affecting the GI tract, clinically active Crohn's disease, ischemic colitis, moderate or severe ulcerative colitis, small bowel resection, ileus, or any condition expected to require abdominal surgery during the course of study participation).
Had serum alanine aminotransferase or aspartate aminotransferase concentrations >5 x the upper limit of normal (ULN).
Had total serum bilirubin >2 x the ULN and direct bilirubin >1.5 x the ULN.
Had moderate (Class B) to severe (Class C) hepatic dysfunction according to the Child-Pugh Turcotte scoring system.
Received or would require digoxin or ketoconazole therapy (other than topical formulations) during the treatment phase of the study.
Had active malignancies (with the exception of basal cell carcinoma).
Had a serious psychiatric, medical disorder, including abnormal laboratory values, that would have, in the judgment of the investigator, put the subject at increased risk by participating in the study, or would have interfered with the conduct of study.",100 mg brincidofovir (BCV; one 100 mg tablet) twice weekly plus valganciclovir (vGCV) placebo (2 tablets) once daily.,ChEMBL:CHEMBL203321 | DrugBank:DB12151 | PubChem:483477,Brincidofovir,CCCCCCCCCCCCCCCCOCCCOP(=O)(O)CO[C@H](CO)Cn1ccc(N)nc1=O,J05AB17,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT02439970,NCT02439970_EG000,No,All,Adult | Older Adult,Phase 3,2,"Inclusion Criteria

Subjects must have met all of the following criteria, as applicable, to be eligible to participate in this study:

Were male or female kidney transplant recipients who were ≥18 years of age (subject to local law/practice for clinical trial participation) and ≤14 days following their first or second renal allograft.
Were at high risk of cytomegalovirus (CMV) infection defined as CMV-seronegative recipients who have received an allograft from a CMV-seropositive donor.
Had an estimated glomerular filtration rate of >10 mL/min (Cockcraft-Gault equation) at screening based on local laboratory results.
Were CMV viremia negative (i.e., ""not detected"") as measured by the desginated central virology laboratory using the Roche COBAS® AmpliPrep/COBAS® TaqMan® CMV Test no more than 5 days prior to subject randomization, and at all prior assessments performed since transplant under local standard of care.
Were able to ingest, absorb, and tolerate tablets.
If male, was willing to use an acceptable contraceptive method(s) throughout the duration of his participation in the study, i.e., through Week 52.
If female of childbearing potential, i.e., not post menopausal or surgically sterile, was willing to use 2 acceptable contraceptive methods, 1 of which must have been a barrier method, throughout the duration of her participation in the study, i.e., through Week 52.
Were willing and able to provide informed consent.
Were willing and able to participate in all required study activities for the entire duration of the study (i.e., through Week 52).

Exclusion Criteria

Subjects who met any of the following criteria were not eligible to participate in this study:

Weighed ≤50 kg (110 lbs) or ≥120 kg (265 lbs).
Were pregnant or breastfeeding or intended to conceive during the study period (i.e., through Week 52).
Received a stem cell transplant or a solid organ transplant other than a kidney transplant.
Had suspected CMV disease (either syndrome or tissue-invasive disease) or detectable CMV viremia by the central virology laboratory prior to the first dose of study drug.
Had a history of CMV disease (either syndrome or tissue-invasive disease) within 6 months prior to the first dose of study drug.
Had an absolute neutrophil count of <500 cells/μL, platelet count of <25,000/μL, or hemoglobin of <8 g/dL at screening.
Had hypersensitivity (not including renal dysfunction or an eye disorder) to valganciclovir (vGCV), ganciclovir (GCV), cidofovir (CDV) or to brincidofovir (BCV) or their excipients.

Received (or were anticipated to need treatment with) any of the following:

GCV, vGCV, foscarnet, intravenous CDV, or any other anti-CMV therapy (including CMV immune globulin, cell-based therapies, and investigational anti-CMV drugs, e.g., leflunomide, letermovir [previously AIC246], or maribavir) at any time posttransplant;
Any anti-CMV vaccine at any time;
Any other investigational drug within 14 days prior to the first dose of study drug (unless prior approval had been received from the Chimerix Medical Monitor or designee); or
Prior treatment with BCV at any time. [Note: An ""investigational drug"" was defined as any drug that is not approved for any indication by the FDA (or appropriate regulatory authority).]
Received acyclovir orally at >2000 mg total daily dose (TDD) or intravenously at >15 mg/kg TDD, valacyclovir at >3000 mg TDD on the first dose of study drug or were anticipated to receive any of these drugs at the doses described after the the first dose of study drug.
Were infected with HIV, hepatitis B virus (HBV), and/or hepatitis C virus (HCV), had evidence of active viral replication within 6 months prior to screening, as demonstrated by detectable HIV or HCV RNA, or detectable HBV DNA in blood, plasma or serum.
Had severe vomiting, diarrhea, or malabsorption syndrome on or prior to the first dose of study drug.
Had gastrointestinal (GI) disease that would have, in the judgement of the investigator, precluded the subject form taking or absorbing oral medication (e.g., gastroparesis, diabetic autonomic neuropathy affecting the GI tract, clinically active Crohn's disease, ischemic colitis, moderate or severe ulcerative colitis, small bowel resection, ileus, or any condition that was expected to require abdominal surgery during the course of study participation).
Had serum alanine aminotransferase or aspartate aminotransferase concentrations >5 x the upper limit of normal (ULN).
Had total serum bilirubin >2 x the ULN and direct bilirubin >1.5x the ULN.
Had moderate (Class B) to severe (Class C) hepatic dysfunction according to the Child-Pugh Turcotte scoring system.
Were receiving or would require digoxin or ketoconazole therapy (other than topical formulations) during the treatment phase of the study.
Had active malignancies (with the exception of basal cell carcinoma).
Had a serious psychiatric, medical disorder, including abnormal laboratory values, that would have, in the judgement of the investigator, put the subject at increased risk by participating in the study, or would have interfered with the conduct of the study.","100 mg brincidofovir (BCV; 1 tablet) administered orally twice weekly, plus valganciclovir (vGCV) placebo (2 tablets) administered orally once daily.",ChEMBL:CHEMBL203321 | DrugBank:DB12151 | PubChem:483477,Brincidofovir,CCCCCCCCCCCCCCCCOCCCOP(=O)(O)CO[C@H](CO)Cn1ccc(N)nc1=O,J05AB17,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02440334,NCT02440334_EG000,No,All,Adult | Older Adult,Phase 2,53,"Inclusion Criteria:

Previously received cryotherapy of RCC.
Be scheduled for contrast-enhanced MRI/CT to monitoring of RCC recurrence as part of their 8, 12, 18, 24, or 36 month CT/MRI follow up.
Be at least 18 years of age.
Be medically stable.
If a female of child-bearing age, must have a negative pregnancy test.
Have signed Informed Consent to participate in the study.

Exclusion Criteria:

Females who are pregnant or nursing.
Patients who are medically unstable, patients who are seriously or terminally ill, and patients whose clinical course is unpredictable. For example:
Patients on life support or in a critical care unit.
Patients with unstable occlusive disease (eg, crescendo angina)
Patients with clinically unstable cardiac arrhythmias, such as recurrent ventricular tachycardia.
Patients with uncontrolled congestive heart failure (NYHA Class IV)
Patients with recent cerebral hemorrhage.
Patients with known sensitivities to albumin, blood, or blood products
Patients who have undergone surgery within 24 hours prior to the study sonographic examination.
Patients with known hypersensitivity to perflutren
Patients with cardiac shunts.
Patients with congenital heart defects.
Patients with severe emphysema, pulmonary vasculitis, or a history of pulmonary emboli.
Patients with respiratory distress syndrome.","Patients scheduled for MRI/CT follow up of a renal cancer previously treated by cryoablation therapy who will also undergo a contrast-enhanced ultrasound exam. This is a one-time imaging study and contrast ultrasound exams will be compared to the clinically scheduled MRI/CT.

Optison: Optison is an ultrasound contrast agent. The agent is a blood pooling agent administered via catheter and provides improved ultrasound visualization of the vasculature.",ChEMBL:CHEMBL1663 | DrugBank:DB00556 | PubChem:6432,Perflutren,FC(F)(F)C(F)(F)C(F)(F)F,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02455518,NCT02455518_EG000,No,All,Adult | Older Adult,Phase 4,416,"Inclusion Criteria:

Complaint of acute pain of < 7 days duration
Location of pain in one or more extremities defined as distal to and including the shoulder joint in the upper extremities and distal to and including the hip joint in the lower extremities;
Radiologic evaluation is planned

Exclusion Criteria:

Inability to confirm reliable means of phone followup.
Past use of methadone
Chronic condition requiring frequent pain management such as sickle cell disease, fibromyalgia, or any neuropathy
History of an adverse reaction to any of the study medications
Opioids taken in the past 24 hours
Ibuprofen or acetaminophen taken in past 8 hours
Pregnancy by either urine or serum HCG testing
Breastfeeding per patient report
History of peptic ulcer disease
Report of any prior use of recreational narcotics
Medical condition that might affect metabolism of opioid analgesics, acetaminophen, or ibuprofen such as hepatitis, renal insufficiency, hypo- or hyperthyroidism, Addison's or Cushing's disease
Taking any medicine that might interact with one of the study medications, such as antidepressant SSRI's or Tricyclics, antipsychotics, anti-malaria medications quinidine or halofantrine, Amiodarone or Dronedarone, diphenhydramine, celecoxib, ranitidine, cimetidine, ritanovir, terbinafine, or St John's Wort.","Oxycodone/acetaminophen (5 mg/325 mg)

Oxycodone/acetaminophen",ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02457520,NCT02457520_EG000,No,All,Child | Adult,Phase 4,201,"General Inclusion Criteria Subjects must meet the following mandatory inclusion criteria at the time of screening to be eligible to enter the study and must agree to conform to the requirements of the study and the iPLEDGE program.

Written informed consent, including mandatory photographic consent, on a gender-specific informed consent form (ICF) & Health Insurance Portability and Accountability Act (HIPAA) authorization prior to the performance of any study-related procedures.
Pregnant females and females who are not to become pregnant during the ATP phase of the trial and for 30 days after receiving their last dose of study drug.
Female subjects of childbearing potential ready to use 2 forms of effective contraception simultaneously for 1 month before starting Absorica® (isotretinoin), while taking Absorica® & for 1 month after Absorica® has been stopped.
Male and female subjects of non-childbearing potential

Specific Inclusion Criteria:

Severe recalcitrant nodular acne.
Five or more nodule lesions on the face.
Treatment-naïve subjects.
Age between 12 and 45 years.
Weight between 40 and 110 kg.
Female subjects of childbearing potential only: Negative results from serum pregnancy tests with a sensitivity of at least 25 milli-international unit/mL.
Good general health as determined by the investigator based on the subject's medical history, physical examination, vital signs measurements, and laboratory test results.
Subjects who present with stable & controlled diabetes mellitus (Types I and II).
Subjects with previously diagnosed polycystic ovarian syndrome (PCOS) can be included in the study if in the opinion of the investigator they do not have any other clinically significant abnormality (eg, metabolic syndrome or elevated lipids

Exclusion Criteria:

General Exclusion Criteria

Presence of any clinically significant physical examination finding, vital signs measurement, or abnormal laboratory value;
Presence of a beard or other facial hair that could interfere with the study assessments;
Participated in another clinical trial or received an investigational product within 3 months prior to screening;
History of excessive or suspected abuse of alcohol (based on the clinical judgment of the investigator), recreational drugs, and/or drugs of abuse, e.g., club drugs, cocaine, ecstasy/ methylenedioxymethamphetamine, heroin, inhalants, marijuana, methamphetamine, phencyclidine, prescription medications, anabolic steroids, etc.
Use of prohibited or restricted prior or concomitant medications. Female Specific Exclusion Criteria
Are pregnant;
Are at a high risk for becoming pregnant or likely to become pregnant during treatment;
Are breast-feeding or considering breast-feeding during the course of the study;
Have a known history of PCOS with another clinically significant abnormality (eg, metabolic syndrome or elevated lipids);
Are unable or unwilling to maintain compliance with birth control measures","Absorica capsules 0.5 mg/kg/day for 4 weeks, followed by 1.0 mg/kg/day for 16 weeks.

Study ABS1517LT was a Phase 4, open-label, single-arm study in subjects with severe recalcitrant nodular acne, consisting of 2 phases: a 20-week (5-month) Active Treatment Phase and a 104-week (2-year) Post Treatment Period.",ChEMBL:CHEMBL38 | ChEMBL:CHEMBL547 | ChEMBL:CHEMBL705 | DrugBank:DB00523 | DrugBank:DB00755 | DrugBank:DB00982 | PubChem:444795 | PubChem:449171 | PubChem:5282379,Tretinoin,CC(C=CC1=C(C)CCCC1(C)C)=CC=CC(C)=CC(=O)O,D10AD01 | D10AD04 | D10AD51 | D10AD54 | D10BA01 | D11AH04 | L01XF01 | L01XF02,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT02457559,NCT02457559_EG002,No,All,Adult | Older Adult,Phase 1,3,"Key Inclusion Criteria:

Currently enrolled in a prior tirabrutinib study
Did not discontinue treatment with tirabrutinib for any reason other than to enroll in this study
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 at enrollment in this study
Any Grade 3 or 4 non-hematologic toxicity that the investigator considers related to previous tirabrutinib use must have resolved, reverted to Grade 1, or reverted to the baseline of the prior study prior to Day 1 of this study
Negative serum and urine pregnancy test is required for female individuals (unless surgically sterile or greater than 2 years post menopausal)
Male and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception as described in the protocol
Lactating females must agree to discontinue nursing before the study drug is administered
Ability and agreement to attend protocol-specified visits at the study site
Able to comprehend and willing to sign the informed consent form

Key Exclusion Criteria:

Known hypersensitivity to tirabrutinib, its metabolites, or formulation excipients

Note: Other protocol defined Inclusion/Exclusion criteria may apply.",Participants with relapsed/refractory CLL received tirabrutinib 160 mg once daily for up to 96 months from first dose in the parent study.,ChEMBL:CHEMBL4071161 | DrugBank:DB15227 | PubChem:54755438,Tirabrutinib,CC#CC(=O)N1CC[C@@H](n2c(=O)n(-c3ccc(Oc4ccccc4)cc3)c3c(N)ncnc32)C1,,1.0,1.0,0.0,1.0,0.0,1.0,1.0,1.0,0.0,1.0,1.0,1.0,1.0,0.0,1.0,1.0,1.0,0.0,1.0,0.0,1.0,1.0,1.0,0.0,1.0,0.0,0.0
NCT02457559,NCT02457559_EG005,No,All,Adult | Older Adult,Phase 1,1,"Key Inclusion Criteria:

Currently enrolled in a prior tirabrutinib study
Did not discontinue treatment with tirabrutinib for any reason other than to enroll in this study
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 at enrollment in this study
Any Grade 3 or 4 non-hematologic toxicity that the investigator considers related to previous tirabrutinib use must have resolved, reverted to Grade 1, or reverted to the baseline of the prior study prior to Day 1 of this study
Negative serum and urine pregnancy test is required for female individuals (unless surgically sterile or greater than 2 years post menopausal)
Male and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception as described in the protocol
Lactating females must agree to discontinue nursing before the study drug is administered
Ability and agreement to attend protocol-specified visits at the study site
Able to comprehend and willing to sign the informed consent form

Key Exclusion Criteria:

Known hypersensitivity to tirabrutinib, its metabolites, or formulation excipients

Note: Other protocol defined Inclusion/Exclusion criteria may apply.",Participants with relapsed/refractory CLL received tirabrutinib 500 mg once daily for up to 96 months from first dose in the parent study.,ChEMBL:CHEMBL4071161 | DrugBank:DB15227 | PubChem:54755438,Tirabrutinib,CC#CC(=O)N1CC[C@@H](n2c(=O)n(-c3ccc(Oc4ccccc4)cc3)c3c(N)ncnc32)C1,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0
NCT02457559,NCT02457559_EG006,No,All,Adult | Older Adult,Phase 1,1,"Key Inclusion Criteria:

Currently enrolled in a prior tirabrutinib study
Did not discontinue treatment with tirabrutinib for any reason other than to enroll in this study
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 at enrollment in this study
Any Grade 3 or 4 non-hematologic toxicity that the investigator considers related to previous tirabrutinib use must have resolved, reverted to Grade 1, or reverted to the baseline of the prior study prior to Day 1 of this study
Negative serum and urine pregnancy test is required for female individuals (unless surgically sterile or greater than 2 years post menopausal)
Male and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception as described in the protocol
Lactating females must agree to discontinue nursing before the study drug is administered
Ability and agreement to attend protocol-specified visits at the study site
Able to comprehend and willing to sign the informed consent form

Key Exclusion Criteria:

Known hypersensitivity to tirabrutinib, its metabolites, or formulation excipients

Note: Other protocol defined Inclusion/Exclusion criteria may apply.",Participants with relapsed/refractory CLL received tirabrutinib 600 mg once daily for up to 96 months from first dose in the parent study.,ChEMBL:CHEMBL4071161 | DrugBank:DB15227 | PubChem:54755438,Tirabrutinib,CC#CC(=O)N1CC[C@@H](n2c(=O)n(-c3ccc(Oc4ccccc4)cc3)c3c(N)ncnc32)C1,,1.0,0.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,1.0,0.0,1.0,1.0,1.0,1.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT02457559,NCT02457559_EG008,No,All,Adult | Older Adult,Phase 1,1,"Key Inclusion Criteria:

Currently enrolled in a prior tirabrutinib study
Did not discontinue treatment with tirabrutinib for any reason other than to enroll in this study
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 at enrollment in this study
Any Grade 3 or 4 non-hematologic toxicity that the investigator considers related to previous tirabrutinib use must have resolved, reverted to Grade 1, or reverted to the baseline of the prior study prior to Day 1 of this study
Negative serum and urine pregnancy test is required for female individuals (unless surgically sterile or greater than 2 years post menopausal)
Male and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception as described in the protocol
Lactating females must agree to discontinue nursing before the study drug is administered
Ability and agreement to attend protocol-specified visits at the study site
Able to comprehend and willing to sign the informed consent form

Key Exclusion Criteria:

Known hypersensitivity to tirabrutinib, its metabolites, or formulation excipients

Note: Other protocol defined Inclusion/Exclusion criteria may apply.",Participants with relapsed/refractory non-Hodgkin's lymphoma (NHL) received tirabrutinib 160 mg once daily for up to 96 months from first dose in the parent study.,ChEMBL:CHEMBL4071161 | DrugBank:DB15227 | PubChem:54755438,Tirabrutinib,CC#CC(=O)N1CC[C@@H](n2c(=O)n(-c3ccc(Oc4ccccc4)cc3)c3c(N)ncnc32)C1,,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,1.0,0.0,1.0,0.0,1.0,1.0,1.0,0.0,0.0,1.0,0.0
NCT02457559,NCT02457559_EG009,No,All,Adult | Older Adult,Phase 1,3,"Key Inclusion Criteria:

Currently enrolled in a prior tirabrutinib study
Did not discontinue treatment with tirabrutinib for any reason other than to enroll in this study
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 at enrollment in this study
Any Grade 3 or 4 non-hematologic toxicity that the investigator considers related to previous tirabrutinib use must have resolved, reverted to Grade 1, or reverted to the baseline of the prior study prior to Day 1 of this study
Negative serum and urine pregnancy test is required for female individuals (unless surgically sterile or greater than 2 years post menopausal)
Male and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception as described in the protocol
Lactating females must agree to discontinue nursing before the study drug is administered
Ability and agreement to attend protocol-specified visits at the study site
Able to comprehend and willing to sign the informed consent form

Key Exclusion Criteria:

Known hypersensitivity to tirabrutinib, its metabolites, or formulation excipients

Note: Other protocol defined Inclusion/Exclusion criteria may apply.",Participants with relapsed/refractory NHL received tirabrutinib 320 mg once daily for up to 96 months from first dose in the parent study.,ChEMBL:CHEMBL4071161 | DrugBank:DB15227 | PubChem:54755438,Tirabrutinib,CC#CC(=O)N1CC[C@@H](n2c(=O)n(-c3ccc(Oc4ccccc4)cc3)c3c(N)ncnc32)C1,,1.0,1.0,0.0,1.0,0.0,0.0,1.0,1.0,1.0,0.0,1.0,1.0,1.0,1.0,1.0,1.0,1.0,0.0,1.0,0.0,1.0,1.0,1.0,0.0,0.0,1.0,0.0
NCT02463357,NCT02463357_EG002,Accepts Healthy Volunteers,Male,Adult,Phase 4,20,"Inclusion Criteria:

healthy,
young (18-30 years old) men who can meet APFT requirements for special operation forces (SOF) training as outlined by the US Army (42 push ups, 53 sit-ups, 6 pull-ups, 2 mile run in < 15 min 54 s)

Exclusion Criteria:

women;
smokers;
participants with diseases or disorders known to be affected by hypoxia or the drugs used in this study, such as hypotension, anemia, sickle cell trait or disease, and diabetes;
participants with a history of significant head injury, migraines or seizures;
participants taking any medication (over-the-counter or prescription) or herbal supplements;
participants with known flavonoid allergies;
participants with known allergies to metformin;
participants with known hypersensitivity reaction to nifedipine;
participants with known allergies to sulfonamide-based drugs;
participants with inability to be headache-free when consuming the amount of caffeine in two six ounce cups of coffee or less per day;
exposure to high altitude above 1000m in the previous three months; or
participants who have been on an airline flight over six hours (the lowered cabin pressure for an extended period of time approximates exposure to high altitude);
participants who are unable to achieve the minimum physical criteria required for SOF training","Metformin: 500mg pill, once daily for 2 days, then 500mg twice daily at altitude (3 days)

Metformin",ChEMBL:CHEMBL1431 | DrugBank:DB00331 | PubChem:4091,Metformin,CN(C)C(=N)NC(=N)N,A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02466399,NCT02466399_EG001,No,All,Adult | Older Adult,Phase 2,27,"Inclusion Criteria:

18 year of age or greater.
Diagnosis of primary open angle glaucoma (OAG) or ocular hypertension (OHT).
Unmedicated (post-washout) intraocular pressure (IOP) ≥ 24 mm Hg at 2 eligibility visits (0800 hr), 2-7 days apart. If both eyes meet the IOP criteria, the eye with the higher IOP at Visit 1 will be designated as the study eye. If IOP in both eyes is the same, the right eye will be designated as the study eye. Note that both eyes will be treated.
Corrected visual acuity at Visit -1 in each eye +1.0 logarithm of minimum angle of resolution (logMAR) or better by Early Treatment of Diabetic Retinopathy Study (ETDRS) in each eye (equivalent to 20/200).
Able and willing to give signed informed consent and follow study instructions.
Subjects must have a documented history of ≥ 20% IOP reduction O.U. using any topical ocular prostaglandin/prostamide ocular hypotensive medication.

Exclusion Criteria:

Ophthalmic

Glaucoma: pseudoexfoliation or pigment dispersion component, history of angle closure or narrow angles judged to be occludable by the investigator. Note: Previous laser peripheral iridotomy is NOT acceptable.
IOP > 36 mm Hg in either eye at any pre-randomization study visit.
Known corticosteroid-responder as judged by investigator.
Known hypersensitivity to any component of the Investigational Product formulation (benzalkonium chloride, etc.), fluoroquinolone ophthalmic solution, or topical anesthetics, Povidone Iodine antiseptic, or diagnostic eye drops.
Previous glaucoma intraocular surgery or glaucoma laser procedures in either eye.
Refractive surgery in either eye .
Ocular trauma, extraocular or intraocular surgery or laser treatment within the past six months in either eye.
Evidence of ocular infection, inflammation, clinically significant blepharitis or conjunctivitis at baseline (Visit 1), or a history of herpes simplex keratitis in either eye. Note: mild blepharitis, allergy and dry eye is acceptable.
Ocular medication of any kind within 30 days of Visit 1 in either eye, with the exception of a) ocular hypotensive therapy (which must be washed out according to the provided schedule), b) lid scrubs (which may be used prior to, but not after Visit 1) or c) lubricating drops for dry eye (which may be used throughout the study).
Clinically significant ocular disease (e.g. uveitis, severe keratoconjunctivitis sicca) in either eye which might interfere with the study, including glaucomatous damage so severe that washout of ocular hypotensive medications for one month is not judged safe by the investigator (i.e., cup-disc ratio > 0.8).
Central corneal thickness greater than 600 µm in either eye.
Any ocular abnormality preventing reliable applanation tonometry of either eye.
Significant media opacity in either eye that would exclude adequate posterior segment examination
Contraindications to pupil dilation in either eye.
Unwillingness to accept known adverse events of latanoprost such as eyelid and/or iris pigmentation, eyelash growth, etc.
History of macular edema, including cystoid macular edema, or current or recent (6 months) uveitis.

Planned intraocular surgery in either eye during study participation

Systemic:

Clinically significant abnormalities (as determined by the treating physician) in laboratory tests at screening.
Known hypersensitivity or systemic contraindication to latanoprost or components of study medication.
Clinically significant systemic disease (e.g., myasthenia gravis, hepatic, renal, endocrine or cardiovascular disorders), which might interfere with the study.
Participation in any investigational study within 30 days prior to baseline.
Changes of systemic medication that could have a substantial effect on IOP within 30 days prior to screening, or anticipated during the study.
Any individual the investigator believes might suffer physical or mental harm by participating in this trial. Due to the current status of the preclinical safety program, women of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control. An adult woman is considered to be of childbearing potential unless she is one year post-menopausal or three months post-surgical sterilization. All females of childbearing potential must have a negative urine pregnancy test result at the Visit 1 examination and must agree to use an acceptable method of contraception during the study.","latanoprost ophthalmic solution 0.005%

Latanoprost ophthalmic solution: Latanoprost ophthalmic solution q.d., evening",ChEMBL:CHEMBL1051 | DrugBank:DB00654 | PubChem:5311221,Latanoprost,CC(C)OC(=O)CCC/C=C\C[C@@H]1[C@@H](CC[C@@H](O)CCc2ccccc2)[C@H](O)C[C@@H]1O,S01EE01 | S01EE51,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02470390,NCT02470390_EG002,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 4,12,"Inclusion Criteria:

Normal healthy male or female between the ages of 18 to 65 years. Never smokers or Non-smokers (cessation of smoking ≥ 6 months ago). Body Mass Index (BMI = weight/height2) greater than or equal to 18.5 kg/m2 and less than or equal to 32.0 kg/m2.

No clinically meaningful findings in the physical examination, oral and nasal examination and 12-lead electrocardiogram.

Negative for drugs of abuse, alcohol, and nicotine. Negative for hepatitis A, B, and C and Human Immunodeficiency Virus (HIV). No clinical laboratory values outside of the acceptable range, unless, in the opinion of the Principal Investigator, they are deemed not clinically significant.

Exclusion Criteria:

Subject has a known history of allergic reaction, hypersensitivity, or clinically significant intolerance to opioids, fentanyl or components of the study drugs.

2. Subjects with a high potential for opioid addiction (personal or family history).

3. Subject is lactating or considered at risk of pregnancy. 4. Subject has impaired liver function (e.g., alanine aminotransferase [ALT] ≥ 3 times the upper limit of normal [ULN] or bilirubin ≥ 3 times ULN), known active hepatic disease (e.g., hepatitis), or evidence of clinically significant liver disease or other condition affecting the liver that may suggest the potential for an increased susceptibility to hepatic toxicity with oral diclofenac exposure.

5. Subject has any history of renal disease that, in the opinion of the investigator, would contraindicate study participation; or subject has significantly impaired renal function as evidenced by an estimated GFR of ≤60 ml/min/1.73m2.

6. Subject has a history or evidence of significant nasal pathology, including polyps or nasal obstructions.","IV Fentanyl, 100 μg in 2 mL administered as an intravenous injection over 1-3 minutes on Study Day 5 per protocol.",ChEMBL:CHEMBL596 | DrugBank:DB00813 | PubChem:3345,Fentanyl,CCC(=O)N(c1ccccc1)C1CCN(CCc2ccccc2)CC1,N01AH01 | N01AH51 | N02AB03,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02471313,NCT02471313_EG000,No,All,Adult | Older Adult,Phase 2,3,"INCLUSION CRITERIA:
Patients must have confirmed inoperable primary hepatic malignancy or hepatic dominant metastatic - neoplastic disease evidenced by histology or cytology, or characteristic enhancement pattern on CT or MRI together with an abnormal serum alpha-fetoprotein >200mg/dl in the case of hepatocellular carcinoma.
Patients with hepatocellular carcinoma should conform to intermediate stage disease according to the BCLC(16) staging system (Stage A4 or B) and be otherwise eligible to receive TACE treatment.
Patients must have had no chemotherapy or radiotherapy to the liver therapy for, their malignancy for at least 2 weeks (or until response can be adequately assessed) prior to treatment and must have recovered from all clinically significant side effects of therapeutic and diagnostic interventions.
Serum creatinine less than or equal to 2.0 mg/dl unless the measured creatinine clearance is greater than 60ml/min
Age greater than or equal to18 years
Ability of subject to understand and willingness to sign a written informed consent document
Patient must be able to lie still for the procedure
ECOG status less than or equal to 2

In addition, for patients receiving TACE outside NIH:

Patient must have physician willing to collaborate with NIH PI by providing required medical record and digital MR/ CT scan documentation pre and post TACE procedure.
Patient must be willing to sign an Authorization for the Release of Medical Information form

EXCLUSION CRITERIA:

Patients who have received prior TACE treatment
History of allergic reactions attributed to compounds of similar chemical or biologic composition to misonidazole or other agents used in study.
Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Patients of childbearing age must not be pregnant. The effects of [(18)F]FMISO on the developing human fetus are unknown. Pregnancy is a contraindication for TACE.",Patients with primary hepatic malignancy are undergo [18F] FMISO PET Scan following transarterial chemoembolization (TACE) procedure.,DrugBank:DB14830 | PubChem:450173 | PubChem:92242,Fluoromisonidazole F-18,O=[N+]([O-])c1nccn1CC(O)CF,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02482935,NCT02482935_EG000,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 1,30,"Inclusion Criteria:

Are overtly healthy sterile males or surgically sterile or postmenopausal females
Have a body mass index (BMI) of 18 to 32 kilogram per meter square (kg/m^2), inclusive

Exclusion Criteria:

Participated in a clinical trial involving investigational product within 30 days
Have known allergies to abemaciclib, related compounds or any components of the formulation, or history of significant atopy
Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study
Have an abnormal blood pressure
Show evidence of human immunodeficiency virus (HIV), hepatitis B or hepatitis C
Have donated blood of more than 500 milliliter (mL) within the last month
Have an average weekly alcohol intake that exceeds 21 units per week (males up to age 65) and 14 units per week (males over 65 and females), or are unwilling to stop alcohol consumption 48 hours prior to each admission until collection of the last PK sample in each period
Are unwilling to refrain from consuming xanthine-containing food and drink from 48 hours prior to admission until collection of the last pharmacokinetic (PK) sample in each period
Are currently or have been smokers or users of tobacco or nicotine replacement products within the 6 months prior to admission or have a positive urine cotinine test
Are unwilling to comply with the dietary requirements/restrictions during the study: Consume only the meals provided during the inpatient stays and refrain from eating any food or drinking any beverages containing grapefruit, grapefruit juice, grapefruit-containing products, Seville oranges, star fruit or star fruit juice, pomelo, or commercial apple juice or orange juice for at least 2 weeks prior to the first dose until the final PK sample is collected","200 mg abemaciclib administered once, orally, in a fasted state.",ChEMBL:CHEMBL3301610 | DrugBank:DB12001 | PubChem:46220502,Abemaciclib,CCN1CCN(Cc2ccc(Nc3ncc(F)c(-c4cc(F)c5nc(C)n(C(C)C)c5c4)n3)nc2)CC1,L01EF03,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02487303,NCT02487303_EG000,Accepts Healthy Volunteers,Female,Adult | Older Adult,Not Applicable,148,"Inclusion Criteria:

Parturients 18 years
Elective Cesarean delivery
Spinal anesthesia
Able to consent to the study and participate in the follow-up.

Exclusion Criteria:

Weight under 50 kgs
Allergy to acetaminophen
General anesthesia
Urgent or emergent cases
Bleeding diathesis or other coagulopathy
G6PD deficiency
Liver disease
Substance abuse or dependence
HELLP syndrome
Thrombocytopenia or platelet dysfunction
History or active gastrointestinal bleeding
Acute kidney injury or chronic renal insufficiency
Contraindication/refusal to spinal anesthesia
Chronic pain
Chronic narcotic use
Illicit drug use
Allergy to any study related medications.","(group 1) 1 gram IV acetaminophen every 8 hours for three doses

Acetaminophen Intravenous: IV 1 gram f3 doses over 24 hours",ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02487303,NCT02487303_EG001,Accepts Healthy Volunteers,Female,Adult | Older Adult,Not Applicable,148,"Inclusion Criteria:

Parturients 18 years
Elective Cesarean delivery
Spinal anesthesia
Able to consent to the study and participate in the follow-up.

Exclusion Criteria:

Weight under 50 kgs
Allergy to acetaminophen
General anesthesia
Urgent or emergent cases
Bleeding diathesis or other coagulopathy
G6PD deficiency
Liver disease
Substance abuse or dependence
HELLP syndrome
Thrombocytopenia or platelet dysfunction
History or active gastrointestinal bleeding
Acute kidney injury or chronic renal insufficiency
Contraindication/refusal to spinal anesthesia
Chronic pain
Chronic narcotic use
Illicit drug use
Allergy to any study related medications.","(group 2) 1 gram oral acetaminophen every 8 hours for three doses

Acetaminophen Oral: Oral 1 gram 3 doses over 24 hours",ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02488980,NCT02488980_EG001,Accepts Healthy Volunteers,All,Adult,Phase 2,104,"Inclusion Criteria:

Healthy male or female volunteers who provided informed consent (a healthy volunteer was defined as one who was free of ailments that might cause difficulty in evaluating drug efficacy or adverse experiences).
Subjects aged 18-55 years.
Subjects planning to reside in the study area for the entire study duration of approximately 70 weeks

Exclusion Criteria:

Subjects with positive parasitaemia following halofantrine treatment for radical cure.
Subjects with any medical condition which, in the opinion of the investigator, made the subject unsuitable to enter the study.
Subjects with personal or family history of seizures.
Female subjects with a positive serum beta-HCG5 (tested during screening and within 48 hours of first drug administration and approximately monthly thereafter).
Women who were pregnant or lactating or who in the opinion of the investigator were at risk of becoming pregnant.
Subjects with clinically significant abnormalities (to include but not limited to abnormal hepatic or renal function) as determined by history, physical and routine blood chemistries and haematology values. Subjects who had demonstrated hypersensitivity to any of the study drugs especially to any other 8-aminoquinolines.
Subjects unwilling to report for drug administration or blood drawing during the 70 week duration of the study.
Subjects with G6PD deficiency.
Subjects with laboratory guideline values for exclusion: haemoglobin <10 gm/dL, platelets <80,000/mm3, WBC <3000ul3, creatinine or ALT more than twice the upper limit of normal for age.
Subjects with an abnormal ECG, particularly an extended QTc interval > 0.42 seconds.
Subjects taking any other anti-malarial product, or who had taken an antimalarial drug other than halofantrine within the previous two weeks.
Subjects who had received an investigational drug (a new chemical entity not registered for use) within 30 days or 5 half-lives whichever was the longer.
Subjects with a history of psychiatric disorder.","Tafenoquine 200 mg for three days followed by Tafenoquine 200 once a week for 24 weeks.

Tafenoquine: Tafenoquine 200 mg for three days followed by Tafenoquine 200 mg once a week for 24 weeks.",ChEMBL:CHEMBL298470 | DrugBank:DB06608 | PubChem:115358,Tafenoquine,COc1cc(C)c2c(Oc3cccc(C(F)(F)F)c3)c(OC)cc(NC(C)CCCN)c2n1,P01BA07,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT02489045,NCT02489045_EG000,No,All,Adult | Older Adult,Phase 4,178,"Inclusion Criteria:

Be scheduled for trans-jugular liver biopsy the day of the ultrasound procedure.
Be at least 21 years of age.
Be medically stable.
If a female of child-bearing potential, must have a negative pregnancy test.
Be conscious and able to comply with study procedures.
Have read and signed the IRB-approved Informed Consent form for participating in the study.

Exclusion Criteria:

Females who are pregnant or nursing.
Patients not scheduled for trans-jugular liver biopsy
Patients who have received an investigational drug in the 30 days before study drug administration, or will receive one within 72 h afterwards,.
Patients with known or suspected right-to-left, bi-directional, or transient right-to-left cardiac shunts
Patients with pulmonary hypertension or unstable cardiopulmonary conditions
Patients currently on chemotherapy or with other primary cancers requiring systemic or hepatic loco-regional treatment.
Patients who are medically unstable, patients who are seriously or terminally ill, and patients whose clinical course is unpredictable. For example:
Patients on life support or in a critical care unit.
Patients with unstable occlusive disease (e.g., crescendo angina)
Patients with clinically unstable cardiac arrhythmias, such as recurrent ventricular tachycardia.
Patients with uncontrolled congestive heart failure (NYHA Class IV)
Patients with recent cerebral hemorrhage.
Patients who have undergone surgery within 24 hours prior to the study sonographic examination.
Patients with a history of anaphylactic allergy to eggs or egg products, manifested by one or more of the following symptoms: generalized urticaria, difficulty in breathing, swelling of the mouth and throat, hypotension, or shock. (Subjects with nonanaphylactic allergies to eggs or egg products may be enrolled in the study, but must be watched carefully for 1 h following the administration of SONAZOID).
Patients with congenital heart defects.
Patients with severe emphysema, pulmonary vasculitis, or a history of pulmonary emboli.
Patients with respiratory distress syndrome
Patients with thrombosis within the hepatic, portal, or mesenteric veins.","48 µl of Sonazoid microbubbles (GE Healthcare, Oslo, Norway) will be co-infused at a rate of 0.024 µl/kg body weight/minute together with a 0.9% NaCl solution infused at a rate of at least 2 ml/min.

SHAPE measurement (Sonazoid ultrasoud contrast agent): Three vials with 48 µl of Sonazoid (GE Healthcare, Oslo, Norway) microbubbles (6 ml) will be prepared and drawn into a 10 ml syringe, placed in a syringe pump. Sonazoid will be co-infused at a rate of 0.024 µl/kg body weight/minute (suspension infusion rate of 0.18 ml/kg/hour) together with a 0.9% NaCl solution infused at a rate of at least 2 ml/min.",ChEMBL:CHEMBL2104979 | DrugBank:DB12821 | PubChem:9638,Perflubutane,FC(F)(F)C(F)(F)C(F)(F)C(F)(F)F,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02490293,NCT02490293_EG000,No,All,Adult | Older Adult,Not Applicable,93,"Inclusion Criteria:

grade I Tokyo guideline for acute cholecystitis
grade II Tokyo guideline for acute cholecystitis without the evidence of gallbladder perforation

Exclusion Criteria:

chronic cholecystitis
gallbladder polyp or gallbladder cancer
the patient who underwent reduced port surgery
the patient who underwent common bile duct exploration during the operation
the patient who underwent concurrent operation
the patient who had past history of upper abdominal surgery
the patient who had a immunodeficiency state
the case which had a suspicion of delayed bile leakage
the case which had a incomplete cystic duct ligation
the patient who underwent open conversion surgery during the operation
the patient who had a high risk of bleeding","During the period of hospitalization, intake of active drug ('pacetin', 2nd generation cephalosporin). 3 g per day divided into 3 times via intravenous route until the day of discharge.

After discharge, oral intakes of 500mg each (1 pill of cefaclor, the 2nd generation cephalosporin every 12 hrs) for three days.

Cephalosporin: During the hospitalization, intake of pacetin, 2nd generation cephalosporin. 3 g per day divided into 3 times via intravenous route until the day of discharge.

After discharge, oral intakes of 500mg each (1 pill of cefaclor, the 2nd generation cephalosporin every 12 hrs) for three days.",PubChem:25058126,Cephalosporin,C=C1CSC(C(NC(=O)CCCCC(N)C(=O)O)C(=O)O)N=C1C(=O)O,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02498444,NCT02498444_EG001,No,All,Child | Adult,Not Applicable,18,"Inclusion Criteria:

Pediatric patient undergoing Fontan operation and/or pre-Fontan cardiac catheterization at Lucile Packard Children's Hospital (LPCH)

Exclusion Criteria:

Platelet count < 50K (treprostinil can act as a platelet inhibitor and this may place patient at additional risk of bleeding if already thrombocytopenic)
Dermatologic condition that renders the patient unable to tolerate a subcutaneous infusion (can still take part in inhaled vasodilator testing during cardiac catheterization)
Currently receiving any vasodilator therapy specifically for the purpose of pulmonary vasodilation (phosphodiesterase type 5 inhibitor, endothelia receptor antagonist and/or prostacyclin).",Saline administration via subcutaneous infusion.,ChEMBL:CHEMBL1237119 | DrugBank:DB00374 | PubChem:6918140,Treprostinil,[H][C@@]12Cc3c(cccc3OCC(=O)O)C[C@]1([H])[C@@H](CC[C@@H](O)CCCCC)[C@H](O)C2,B01AC21,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02498483,NCT02498483_EG000,Accepts Healthy Volunteers,Male,Child,Phase 4,11,"Inclusion Criteria:

Healthy newborns between 36-42 weeks gestational age Admitted to the well baby nursery who's parents are requesting circumcision. Eligibility includes

Apgar score at 5 minutes >7
birthweight greater than 2.4 kg
Age of at least 10 hours
At least one void.

Exclusion Criteria:

Newborns of substance abusing mothers.
Newborns with any contraindications to routine circumcision, anatomical or hematologic.",Acetaminophen 15 mg/kg PO solution administered via syringe one time immediately post circumcision.,ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02498522,NCT02498522_EG000,Accepts Healthy Volunteers,Female,Adult,Early Phase 1,83,"Inclusion Criteria:

Age : 25 - 35.

Pregnant patients in their 1st trimester with history of infertility due to PCOS confirmed by at least 2 of the following criteria ( Rotterdam Criteria )

At least twelve small follicles 2-9 mm in at least one ovary; diagnosed by ultra sound examination.
Symptoms or biochemical evidence of hyperandrogenism; diagnosed by examination and laboratory investigations.
Anovulation or oligo-ovulation with fewer than nine menstrual periods every 12 months : diagnosed by thorough history taking.
Non diabetic patients who received metformin along with other ovulation-inducing drugs prior to pregnancy.

Exclusion Criteria:

patients with other causes of infertility other than PCOS
contraindications to metformin : liver impairment , renal failure.
Patients with PCOS who didn't receive Metformin with drugs of induction of ovulation before pregnancy.","83 patients will continue metformin until end of 1st trimester (14 weeks gestation)

Metformin: 83 patients will continue metformin until end of 1st trimester",ChEMBL:CHEMBL1431 | DrugBank:DB00331 | PubChem:4091,Metformin,CN(C)C(=N)NC(=N)N,A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02498522,NCT02498522_EG001,Accepts Healthy Volunteers,Female,Adult,Early Phase 1,83,"Inclusion Criteria:

Age : 25 - 35.

Pregnant patients in their 1st trimester with history of infertility due to PCOS confirmed by at least 2 of the following criteria ( Rotterdam Criteria )

At least twelve small follicles 2-9 mm in at least one ovary; diagnosed by ultra sound examination.
Symptoms or biochemical evidence of hyperandrogenism; diagnosed by examination and laboratory investigations.
Anovulation or oligo-ovulation with fewer than nine menstrual periods every 12 months : diagnosed by thorough history taking.
Non diabetic patients who received metformin along with other ovulation-inducing drugs prior to pregnancy.

Exclusion Criteria:

patients with other causes of infertility other than PCOS
contraindications to metformin : liver impairment , renal failure.
Patients with PCOS who didn't receive Metformin with drugs of induction of ovulation before pregnancy.","83 patients will stop metformin at diagnosis of pregnancy ( 5-6 weeks gestation)

Metformin: 83 patients will continue metformin until end of 1st trimester",ChEMBL:CHEMBL1431 | DrugBank:DB00331 | PubChem:4091,Metformin,CN(C)C(=N)NC(=N)N,A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02500628,NCT02500628_EG000,No,All,Adult | Older Adult,Phase 2,38,"Inclusion Criteria:

EITHER chronic neurogenic pain meeting American College of Rheumatology criteria for fibromyalgia or previous/current exposure to antipsychotic medications

Exclusion Criteria:

recent infection,
renal failure,
pre-existing cardiac disease,
chronic obstructive pulmonary disease
inability to participate in informed consent,
lack of transport to return home from study site,
severe fasting intolerance or hypoglycemia,
history of stroke-alike episode,
uncontrolled migraine or cyclic vomiting,
diabetes on insulin or sulfonylurea,
non-English speaker,
medications with strong effects on baseline heart rate variability","Fibromyalgia (subgroups: opioid responsive, opioid resistant, opioid intolerant) Metformin 500 mg po in AM

Metformin: 500 mg po after baseline testing of heart rate",ChEMBL:CHEMBL1431 | DrugBank:DB00331 | PubChem:4091,Metformin,CN(C)C(=N)NC(=N)N,A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02500628,NCT02500628_EG001,No,All,Adult | Older Adult,Phase 2,23,"Inclusion Criteria:

EITHER chronic neurogenic pain meeting American College of Rheumatology criteria for fibromyalgia or previous/current exposure to antipsychotic medications

Exclusion Criteria:

recent infection,
renal failure,
pre-existing cardiac disease,
chronic obstructive pulmonary disease
inability to participate in informed consent,
lack of transport to return home from study site,
severe fasting intolerance or hypoglycemia,
history of stroke-alike episode,
uncontrolled migraine or cyclic vomiting,
diabetes on insulin or sulfonylurea,
non-English speaker,
medications with strong effects on baseline heart rate variability","Antipsychotic use (subgroups: no side effects, dyskinesia, weight gain) Metformin 500 mg po in AM

Metformin: 500 mg po after baseline testing of heart rate",ChEMBL:CHEMBL1431 | DrugBank:DB00331 | PubChem:4091,Metformin,CN(C)C(=N)NC(=N)N,A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02501473,NCT02501473_EG004,No,All,Adult | Older Adult,Phase 1 | Phase 2,4,"Inclusion Criteria:

Follicular low-grade NHL:

In Part 1-3: either treatment naïve (except for France) OR relapsed or refractory following at least one prior treatment.
In Part 4, enrollment is limited to relapsed OR refractory follicular NHL participants.
In Part 5, enrollment will include relapsed and refractory CD20+ follicular NHL following at least one but not more than 2 prior treatments.

Tumor mass(es) accessible for intratumoral injection

For Part 1-3, are being considered for local radiation therapy and at least one additional site of disease outside the radiation field for assessment of distal (abscopal) response.
For Part 4 and 5, radiation therapy is omitted. Measurable tumor mass(es) accessible for intratumoral injection must be present for treatment and assessment of response.
≥ 18 years of age
Life expectancy of ≥ 6 months per the investigator
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Electrocardiogram (ECG) without evidence of clinically significant arrhythmia or ischemia
If female of childbearing potential (FCBP), willing to undergo pregnancy testing and agrees to use two methods of birth control or is considered highly unlikely to conceive during the dosing period and for three months after last study treatment, or if receiving pembrolizumab, four months after last treatment
If male and sexually active with a FCBP, must agree to use highly effective contraception such as latex condom or is sterile (e.g. following a surgical procedure) during the dosing period and for three months after last study treatment, or if receiving pembrolizumab, four months after last treatment

Exclusion Criteria:

Cancer therapies, including chemotherapy, radiation (non-study regimen related), biologics or kinase inhibitors, granulocyte-colony stimulating factor (G-CSF) or granulocyte/monocyte-colony stimulating factor (GM-CSF) within 4 weeks prior to the first scheduled G100 dose
Investigational therapy within 4 weeks prior to G100 dosing
Prior administration of other intratumoral immunotherapeutics

Inadequate organ function including:

Marrow: Peripheral blood leukocyte count (WBC) < 3000/mm^3, absolute neutrophil count ≤ 1500/mm^3, platelets < 75000/mm^3, or hemoglobin < 10 gm/dL
Hepatic: alanine aminotransferase (ALT), and aspartate aminotransferase (AST) > 2.5 x Upper Limit of Normal (ULN), total serum bilirubin > 1.5 x ULN (participants with Gilbert's Disease may be included if their total bilirubin is ≤3.0 mg/dL)
Renal: Creatinine > 1.5x ULN
Other: INR (international normalized ratio) or partial thromboplastin time (PTT) >1.5 x ULN

Significant immunosuppression from:

Concurrent, recent (≤ 4 weeks ago) or anticipated treatment with systemic corticosteroids at any dose, or
Other immunosuppressive medications such as methotrexate, cyclosporine, azathioprine or conditions such as common variable hypogammaglobulinemia
Pregnant or nursing
Myocardial infarction within 6 months of study initiation, active cardiac ischemia or New York Heart Association (NYHA) Grade III or IV heart failure
History of other cancer within 2 years (except non-melanoma cutaneous malignancies and cervical carcinoma in situ)
Recent (<1 week ago) clinically significant infection, active tuberculosis or evidence of active hepatitis B, hepatitis C or HIV infection
Central nervous system involvement with lymphoma, including parenchymal and leptomeningeal disease.
Significant autoimmune disease, including active non-infectious pneumonitis, with the exception of alopecia, vitiligo, hypothyroidism or other conditions that have never been clinically active or were transient and have completely resolved and require no ongoing therapy
Psychiatric, other medical illness or other condition that in the opinion of the principal investigator (PI) prevents compliance with study procedures or ability to provide valid informed consent
History of significant adverse or allergic reaction to any component of G100 and, if enrolled in Part 2 or Part 4, pembrolizumab and/or any of its excipients, and if enrolled in Part 5, anti-CD20 antibodies including rituximab and/or any of its excipients

Use of anti-coagulant agents or history a significant bleeding diathesis. (If a superficial lymph node or subcutaneous mass is to be injected, participants on agents such as non-steroidal anti-inflammatory drugs (NSAIDs), aspirin, or clopidogrel are eligible and these agents do not have to be withheld. For procedures with moderate or significant risk of bleeding, long-acting agents such as aspirin or clopidogrel should be discussed with the Medical Monitor and may need to be discontinued before G100 therapy.

For participants enrolled in Part 2 or Part 4 with the potential to receive pembrolizumab:

History of (non-infectious) pneumonitis that required steroids or has current pneumonitis or interstitial lung disease
Received a live virus vaccine within 30 days of planned study start
Has undergone prior allogeneic hematopoietic stem cell transplantation within the last 5 years. (Participants who have had a transplant greater than 5 years ago are eligible as long as there are no symptoms of graft vs. host disease [GVHD]).
Has had an allogeneic tissue/solid organ transplant
Has received prior therapy with an anti-PD-1, anti-programmed death ligand (PD-L)1, or anti-PD-L2 agent or if the participant has previously participated in Merck MK-3475 clinical trials or was previously treated with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137) and was discontinued from that treatment due to a Grade 3 or higher immune-related adverse event.",Part 2: Local radiation and G100 at 20 μg/tumor administered IT into accessible large tumors (injectable lymphoma mass(es) ≥ 4 cm in total size) for up to 8 weeks.,PubChem:56998,"Caffeine, 8-((3-methoxypropyl)amino)-",COCCCNc1nc2c(c(=O)n(C)c(=O)n2C)n1C,,1.0,0.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,1.0,1.0,1.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0
NCT02504723,NCT02504723_EG001,No,All,Adult | Older Adult,Phase 4,61,"Inclusion Criteria:

Age of 20 to 80 years
Cirrhotic patients with acute gastric variceal bleeding proven by an endoscopy within 24 h of bleeding
Stable hemodynamic condition for at least 3 days after cyanoacrylate injection

Exclusion Criteria:

Previous treatment of gastric varices, including endoscopic therapy, transjugular intrahepatic porto-systemic shunt, or surgery
Contraindications to non-selective beta-blockers or cyanoacrylate injection
Serum total bilirubin >10 mg/dL
Grade III/IV hepatic encephalopathy
Hepato-renal syndrome
Severe heart failure (NYHA Fc III/IV)
Chronic kidney disease under renal replacement therapy
Refractory ascites
Malignancy other than hepatocellular carcinoma
Pregnancy
Pacemaker use
Refusal to participate","The patients undergo repeated endoscopic cyanoacrylate injection every 3-4 weeks until obturation of gastric varices.

cyanoacrylate: The patients undergo repeated endoscopic cyanoacrylate injection every 3-4 weeks until obturation of gastric varices.",ChEMBL:CHEMBL2106424 | PubChem:8711,MECRYLATE,C=C(C#N)C(=O)OC,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02504827,NCT02504827_EG000,No,All,Adult | Older Adult,Phase 4,12,"Inclusion Criteria:

Diagnosis of CF based on positive sweat chloride or know CF mutation
Age > 17 years
Able to spontaneously expectorate sputum

Exclusion Criteria:

Any clinically significant laboratory abnormality
Presence of an ongoing acute pulmonary exacerbation
Pregnancy
Serious past allergy to a beta-lactam antibiotic","Ceftazidime/avibactam 2.5gm IV q8h for 3 doses

Ceftazidime/avibactam: Ceftazidime/avibactam 2.5gm iv q8h for 3 doses",PubChem:77050660 | PubChem:90643431,Avycaz,CC(C)(ON=C(C(=O)NC1C(=O)N2C(C(=O)[O-])=C(C[n+]3ccccc3)CSC12)c1csc(N)n1)C(=O)O.NC(=O)C1CCC2CN1C(=O)N2OS(=O)(=O)O,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02514252,NCT02514252_EG000,No,All,Adult | Older Adult,Phase 2,6,"Inclusion Criteria:

Patients with advanced cancer (locally advanced, metastatic, recurrent and/or incurable cancer).
Opioid tolerant, taking daily doses of strong opioid pain medication in the past 1 week.
On strong opioid intravenous continuous infusion MEDD >=70 mg/day at the time of enrollment.
Inpatient at MD Anderson seen by palliative care team.
Background cancer pain that is <=3/10 in the last 24 hours.
Breakthrough cancer pain that is >=4/10 in the last 24 hours.
Stable pain control defined as rescue doses <=6 in last 24 hours.
Age >=18
Ability to communicate in English

Exclusion Criteria:

Memorial Delirium Assessment Scale >13/30
History of opioid abuse
CAGE positivity (>=2/4)
Allergy to fentanyl
Grade 2 or higher oral mucositis
Unable/unwilling to sign consent",Fentanyl sublingual spray was administered with a starting dose of 100 mcg up to 1600 mcg maximum for each breakthrough pain.,ChEMBL:CHEMBL596 | DrugBank:DB00813 | PubChem:3345,Fentanyl,CCC(=O)N(c1ccccc1)C1CCN(CCc2ccccc2)CC1,N01AH01 | N01AH51 | N02AB03,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT02516332,NCT02516332_EG001,No,All,Adult | Older Adult,Not Applicable,128,"Inclusion Criteria:

Men and women with documented CHD (i.e., a prior MI, coronary revascularization procedure, or >70% stenosis in at least one coronary artery)
Age > 39 years
Patients also will have an anxiety symptom severity score of at least 8 on the Hospital Anxiety and Depression-Anxiety scale (HADS-A) or a DSM-5 diagnosis of an Anxiety Disorder, such as General Anxiety, Social Anxiety, or Panic Disorder.

The study team plans to actively recruit women and minorities, with at least 50% women and 25% minorities.

Exclusion Criteria:

An MI or coronary revascularization procedure (i.e., CABG or percutaneous coronary intervention) within the last 3 months
Unstable angina
Severe left ventricular dysfunction (ejection fraction <30%) or decompensated heart failure
Unrevascularized left main coronary artery stenosis >50%
Complete Pacemaker dependence
Resting BP >200/120 mm Hg
Conditions that would preclude randomization to either the drug (e.g., prolonged QT interval, known allergy to or intolerance of escitalopram) or exercise (e.g., musculoskeletal problems or abnormal cardiac response to exercise)

Patients with a primary psychiatric diagnosis other than Anxiety Disorder will be excluded, including patients with PTSD, OCD, or any of the following DSM-5 diagnoses:

Dementia, delirium;
Schizophrenia, Schizoaffective, or other psychotic disorder;
Psychotic features including any delusions or hallucinations; or
Current alcohol or other substance abuse disorder.
Similarly, patients who pose an acute suicide or homicide risk or who, during the course of the study, would likely require treatment with additional psychopharmacologic agents will not be enrolled.
Patients will also be excluded if they are taking other medications that would preclude assignment to either drug or exercise conditions (e.g., clonidine, dicumarol, anticonvulsants, and MAO inhibitors) or are taking herbal supplements with purported mood effects (e.g., St. John's Wort, valerian, ginkgo).
Patients already engaged in regular exercise (at least 30 minutes >1x/week) will not be enrolled.
Finally, pregnant women will be excluded from participation.","Treatment in the medication will be supervised by a study psychiatrist. Drug dispensing will be done by licensed pharmacists at the Duke Investigational Pharmacy Service. The investigators will use the SSRI escitalopram (Lexapro), which has received FDA approval for the treatment of anxiety, in 5 mg capsules. Medication will be dispensed as capsules of escitalopram in individually coded bottles. Medication adherence will be assessed using pill count at each study visit. Patients will visit face-to-face with a study psychiatrist at week 0 (baseline), week 1, week 2, week 4, week 8, and week 12 with phone encounters at weeks 3 and 6. The psychiatrist will make all medication adjustments based primarily upon Spielberger Anxiety Scores. Depending on symptoms, daily escitalopram doses will be titrated to 10 mg after week 2 and to 15 mg or placebo equivalent at week 3 if patients show no change or only minimal improvement.

Lexapro",PubChem:146571,Escitalopram Oxalate,CN(C)CCCC1(c2ccc(F)cc2)OCc2cc(C#N)ccc21.O=C(O)C(=O)O,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02519439,NCT02519439_EG000,No,All,Adult | Older Adult,Phase 3,26,"Inclusion Criteria:

Subjects who have completed all scheduled clinical study visits in the previous protocol 1042-0603 and have shown a minimum 35% improvement in mean 28-day seizure frequency over the last three 28-day periods in study 1042-603 as compared to the baseline of study 1042-603.
Subjects whose daily study drug compliance in Study 1042-0603 was 90% or greater, and for whom the investigator feels that the subject was compliant with the full dose as prescribed.
Able to give informed consent in writing, or have a legally authorized representative able to do so, after being properly informed of the nature and risks of the study and prior to engaging in any study-related procedures.
Currently being treated and maintained with a stable regimen of 1, 2, or 3 anti-epileptic drugs (AED) at a consistent dose for one month prior to study entry.
Implanted Vagus Nerve Stimulator (VNS) is permitted and will not count towards the number of concomitant AEDs.
Able and willing to maintain an accurate and complete daily written seizure calendar or has a caregiver who is able and willing to maintain an accurate and complete daily written seizure calendar.
Able and willing to take drug with food twice daily. Ganaxolone must be administered with food.
Sexually active women of childbearing potential (WCBP) must be using a medically acceptable method of birth control and have a negative pregnancy test at Visit 1 and at subsequent visits.

Exclusion Criteria:

Have any medical condition that, in the investigator's judgment, is considered to be clinically significant and could potentially affect subject safety or study outcome
Experienced a Serious Adverse Event or a moderate or severe medically important adverse event judged probably or definitely related to open-label ganaxolone in the previous study, 1042-0603
Have Alanine transferase (ALT; SGPT) or Aspartate transferase (AST; SGOT) levels > 3 times upper limits of normal (ULN), or total bilirubin >1.5 time ULN during Study 1042-0603.
Have a history of malignancy within the past 2 years, with the exception of basal cell carcinoma.
Seizures secondary to illicit drug or alcohol use, infection, neoplasm, demyelinating disease, degenerative neurological disease, or central nervous system (CNS) disease deemed progressive, metabolic illness, or progressive degenerative disease.
Have active suicidal plan/intent, or have had active suicidal thoughts in the past 6 months. Have a history of an actual suicide attempt in the last 5 years or more than 1 lifetime actual suicide attempt as classified by the Columbia-Suicide Severity Rating Scale (C-SSRS).
Have a history of drug or alcohol abuse within the past 5 years. As with other AEDs, the use of alcohol is not advised.
Are currently following or planning to follow a ketogenic diet.
Current use of vigabatrin or ezogabine (retigabine; Potiga; Trobalt) is not permitted.
Females who are pregnant, currently breastfeeding or planning to become pregnant during the study.
Inability/unwillingness to withhold grapefruit and grapefruit juice from diet during the entire clinical trial.",Participants entered the study at their current dose of ganaxolone (450 milligrams [mg] to 900 mg twice daily; up to a maximum dose of 1800 mg per day) from Study 1042-0603 (NCT01963208). The dose of ganaxolone has been adjusted for tolerability and response.,ChEMBL:CHEMBL1568698 | DrugBank:DB05087 | PubChem:6918305,Ganaxolone,[H][C@@]12CC[C@]3([H])[C@]([H])(CC[C@]4(C)[C@@H](C(C)=O)CC[C@@]34[H])[C@@]1(C)CC[C@@](C)(O)C2,N03AX27,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02528409,NCT02528409_EG001,No,All,Adult | Older Adult,Phase 2,40,"Inclusion Criteria:

Men and women age 18-65;
Primary diagnosis of Binge eating disorder;
At least 3 binge eating days per week for the 2 weeks before the baseline visit;
Ability to understand and sign the consent form.

Exclusion Criteria:

Unstable medical illness based on history or clinically significant abnormalities on baseline physical examination (history of medical illness which is currently stable is allowed such as diabetes well controlled, treated hypothyroidism, hypertension, etc)
Current pregnancy or lactation, or inadequate contraception in women of childbearing potential
Subjects considered an immediate suicide risk based on the Columbia Suicide Severity rating Scale (C-SSRS) (www.cssrs.columbia.edu/docs)
Past 12-month DSM-5 major psychiatric disorder (psychotic disorder, bipolar disorder, major depressive disorder)
Past 6-month alcohol or substance use disorders
Illegal substance use based on urine toxicology screening
Initiation of psychological or weight-loss interventions within 3 months of screening
Use of any other prescription psychotropic medication (except an as needed hypnotic or as needed benzodiazepine)
Previous treatment with Vortioxetine
Currently taking over the counter weight loss medications. If willing to stop these medications, the participant will not be excluded based on this criterion.

10) Cognitive impairment that interferes with the capacity to understand and self-administer medication or provide written informed consent","10 milligrams per day day for the first week and 10 milligrams per day for the final taper week 20 milligrams per day for 10 weeks between taper periods.

Vortioxetine: Medication currently approved for major depression.",ChEMBL:CHEMBL2104993 | DrugBank:DB09068 | PubChem:9966051,Vortioxetine,Cc1ccc(Sc2ccccc2N2CCNCC2)c(C)c1,N06AX26,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT02536833,NCT02536833_EG000,No,All,Adult | Older Adult,Phase 2,111,"Inclusion Criteria:

Males and females between 40 and 80 years of age, inclusive, in general good health
Ambulatory (single assistive devices such as canes allowed if needed less than 50% of the time, subjects requiring a walker are excluded)
Established diagnosis of primary femorotibial OA in the target knee by standard American College of Rheumatology (ACR) criteria for at least 6 months (clinical AND radiographic criteria); if bilateral knee OA is present, the target knee is defined as the knee with greater pain at screening based on the subject's evaluation and the Investigator's clinical judgment
Radiographic disease Stage 2 or 3 in the target knee according to the Kellgren-Lawrence grading of knee OA as assessed by independent central readers
Screening pain visual analog scale (VAS) score of 30-80 mm (on a scale of 0-100 mm) for the target knee while on symptomatic oral treatment at screening (if the subject requires oral treatment)
Total WOMAC score of 72-192 (out of 240) for the target knee while on symptomatic oral treatment at screening (if the subject requires oral treatment)

Willingness to omit the following for 24 hours prior to all Study Visits, excluding the Screening Visit:

Pain medications
Medications or supplements for the treatment of OA
Participation in a formalized in-office and/or supervised OA disease program (e.g., a prescribed patient education program, physiotherapy, etc.)
Full understanding of the requirements of the study and willingness to comply with all study visits and assessments
Subjects must have read and understood the informed consent form, and must have signed it prior to any study-related procedure being performed
Subject's Day 1 visit must occur while enrollment into the study is open

Exclusion Criteria:

Women who are pregnant or lactating
Women of childbearing potential (i.e., who are not surgically sterile or postmenopausal as defined by no menstrual periods for 12 consecutive months and no other biological or physiological cause for amenorrhea can be identified); males who are sexually active and have a partner who is capable of becoming pregnant, neither of which have had surgery to become sterilized, who are not using an effective method of birth control (e.g., surgically-implanted hormonal therapy, intrauterine devices or oral birth control with barrier method)
Body mass index (BMI) >40
Partial or complete joint replacement in the target knee
Previous exposure to SM04690
Major surgery (e.g., interventional arthroscopy) in the target knee within 52 weeks prior to any study injection
Any planned or elective surgery during the study period
Significant and clinically evident misalignment of the target knee that would impact subject function, as determined by the Investigator
History of malignancy within the last 5 years; however, subjects with prior history of in situ cancer or basal or squamous cell skin cancer are eligible. Subjects with other malignancies are eligible if they have been continuously disease free for at least 5 years prior to any study injection
Clinically significant abnormal Screening Visit hematology values, blood chemistry values, HbA1c, or urinalysis values as determined by the investigator
Any condition, including laboratory findings (not included in the Screening Visit laboratory tests) and findings in the medical history or in the pre-study assessments, that, in the opinion of the Investigator, constitutes a risk or contraindication for participation in the study or that could interfere with the study objectives, conduct, or evaluation
Comorbid conditions that could affect pain assessment of the target knee, including, but not limited to, inflammatory rheumatic conditions such as rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus, diabetic neuropathy, pseudogout, gout, and fibromyalgia
Other conditions that, in the opinion of the Investigator, could affect pain assessment of the target knee, including, but not limited to, symptomatic hip osteoarthritis and symptomatic degenerative disc disease
Any diagnosed psychiatric condition that includes, but is not limited to, a history of mania, bipolar disorder, psychotic disorder, schizophrenia, major depressive disorder, or generalized anxiety disorder
Participation in a clinical research trial that included the receipt of an investigational product or any experimental therapeutic procedure within 12 weeks prior to any study injection; the last date of participation in the trial, not the last date of receipt of investigational product, must be at least 12 weeks prior to Study Visit Day 1
Treatment of the target knee with systemic or intra-articular corticosteroids (e.g., methylprednisolone) within 8 weeks prior to Study Visit Day 1
Viscosupplementation (e.g., hyaluronic acid) in the target knee within 24 weeks prior to Study Visit Day 1
Effusion of the target knee clinically requiring aspiration within 12 weeks prior to Study Visit Day 1
Use of electrotherapy, acupuncture, and/or chiropractic treatments for knee OA within 4 weeks prior to Study Visit Day 1
Any known active infections, including suspicion of intra-articular infection, hepatitis B or hepatitis C infection, and/or infections that may compromise the immune system such as human immunodeficiency virus (HIV)
Subjects taking prescription medications for OA who have not maintained a stable therapeutic regimen for a minimum of 12 weeks prior to Study Visit Day 1

Subjects requiring the chronic use (i.e., regular and consistent use for ≥ 12 weeks) of the medications listed below within 12 weeks prior to Study Visit Day 1:

Opioids, both oral (e.g., tramadol) or transdermal (e.g., fentanyl patches) formulations
Centrally acting analgesics (e.g., duloxetine)
Glucocorticoids (e.g., methylprednisolone) administered by any route, with exception of inhaled, intranasal, and ophthalmic solutions

Any chronic condition that has not been well controlled or subjects with a chronic condition who have not maintained a stable therapeutic regimen of a prescription therapy for a minimum of 12 weeks prior to Study Visit Day 1. In addition, the following subjects will be excluded:

Subjects with a baseline HbA1c >9
Subjects with uncontrolled hypertension in the opinion of the investigator
Subjects with symptomatic coronary artery disease in the opinion of the investigator
Subjects who have a current or pending disability claim, workers' compensation, or litigation(s) that may compromise response to treatment
Subjects who are immediate family members (spouse, parent, child, or sibling; biological or legally adopted) of personnel directly affiliated with the study at the investigative site, or are directly affiliated with the study at the investigative site
Subjects employed by Samumed, LLC, or any of its affiliates or development partners (that is, an employee, temporary contract worker, or designee) responsible for the conduct of the study",Single intra-articular injection of SM04690 0.03 mg in 2 mL injectable suspension,ChEMBL:CHEMBL4297639 | DrugBank:DB14883 | PubChem:135565709,Adavivint,CC(C)CC(=O)Nc1cncc(-c2ccc3[nH]nc(-c4nc5c(-c6cccc(F)c6)cncc5[nH]4)c3c2)c1,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02536833,NCT02536833_EG001,No,All,Adult | Older Adult,Phase 2,114,"Inclusion Criteria:

Males and females between 40 and 80 years of age, inclusive, in general good health
Ambulatory (single assistive devices such as canes allowed if needed less than 50% of the time, subjects requiring a walker are excluded)
Established diagnosis of primary femorotibial OA in the target knee by standard American College of Rheumatology (ACR) criteria for at least 6 months (clinical AND radiographic criteria); if bilateral knee OA is present, the target knee is defined as the knee with greater pain at screening based on the subject's evaluation and the Investigator's clinical judgment
Radiographic disease Stage 2 or 3 in the target knee according to the Kellgren-Lawrence grading of knee OA as assessed by independent central readers
Screening pain visual analog scale (VAS) score of 30-80 mm (on a scale of 0-100 mm) for the target knee while on symptomatic oral treatment at screening (if the subject requires oral treatment)
Total WOMAC score of 72-192 (out of 240) for the target knee while on symptomatic oral treatment at screening (if the subject requires oral treatment)

Willingness to omit the following for 24 hours prior to all Study Visits, excluding the Screening Visit:

Pain medications
Medications or supplements for the treatment of OA
Participation in a formalized in-office and/or supervised OA disease program (e.g., a prescribed patient education program, physiotherapy, etc.)
Full understanding of the requirements of the study and willingness to comply with all study visits and assessments
Subjects must have read and understood the informed consent form, and must have signed it prior to any study-related procedure being performed
Subject's Day 1 visit must occur while enrollment into the study is open

Exclusion Criteria:

Women who are pregnant or lactating
Women of childbearing potential (i.e., who are not surgically sterile or postmenopausal as defined by no menstrual periods for 12 consecutive months and no other biological or physiological cause for amenorrhea can be identified); males who are sexually active and have a partner who is capable of becoming pregnant, neither of which have had surgery to become sterilized, who are not using an effective method of birth control (e.g., surgically-implanted hormonal therapy, intrauterine devices or oral birth control with barrier method)
Body mass index (BMI) >40
Partial or complete joint replacement in the target knee
Previous exposure to SM04690
Major surgery (e.g., interventional arthroscopy) in the target knee within 52 weeks prior to any study injection
Any planned or elective surgery during the study period
Significant and clinically evident misalignment of the target knee that would impact subject function, as determined by the Investigator
History of malignancy within the last 5 years; however, subjects with prior history of in situ cancer or basal or squamous cell skin cancer are eligible. Subjects with other malignancies are eligible if they have been continuously disease free for at least 5 years prior to any study injection
Clinically significant abnormal Screening Visit hematology values, blood chemistry values, HbA1c, or urinalysis values as determined by the investigator
Any condition, including laboratory findings (not included in the Screening Visit laboratory tests) and findings in the medical history or in the pre-study assessments, that, in the opinion of the Investigator, constitutes a risk or contraindication for participation in the study or that could interfere with the study objectives, conduct, or evaluation
Comorbid conditions that could affect pain assessment of the target knee, including, but not limited to, inflammatory rheumatic conditions such as rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus, diabetic neuropathy, pseudogout, gout, and fibromyalgia
Other conditions that, in the opinion of the Investigator, could affect pain assessment of the target knee, including, but not limited to, symptomatic hip osteoarthritis and symptomatic degenerative disc disease
Any diagnosed psychiatric condition that includes, but is not limited to, a history of mania, bipolar disorder, psychotic disorder, schizophrenia, major depressive disorder, or generalized anxiety disorder
Participation in a clinical research trial that included the receipt of an investigational product or any experimental therapeutic procedure within 12 weeks prior to any study injection; the last date of participation in the trial, not the last date of receipt of investigational product, must be at least 12 weeks prior to Study Visit Day 1
Treatment of the target knee with systemic or intra-articular corticosteroids (e.g., methylprednisolone) within 8 weeks prior to Study Visit Day 1
Viscosupplementation (e.g., hyaluronic acid) in the target knee within 24 weeks prior to Study Visit Day 1
Effusion of the target knee clinically requiring aspiration within 12 weeks prior to Study Visit Day 1
Use of electrotherapy, acupuncture, and/or chiropractic treatments for knee OA within 4 weeks prior to Study Visit Day 1
Any known active infections, including suspicion of intra-articular infection, hepatitis B or hepatitis C infection, and/or infections that may compromise the immune system such as human immunodeficiency virus (HIV)
Subjects taking prescription medications for OA who have not maintained a stable therapeutic regimen for a minimum of 12 weeks prior to Study Visit Day 1

Subjects requiring the chronic use (i.e., regular and consistent use for ≥ 12 weeks) of the medications listed below within 12 weeks prior to Study Visit Day 1:

Opioids, both oral (e.g., tramadol) or transdermal (e.g., fentanyl patches) formulations
Centrally acting analgesics (e.g., duloxetine)
Glucocorticoids (e.g., methylprednisolone) administered by any route, with exception of inhaled, intranasal, and ophthalmic solutions

Any chronic condition that has not been well controlled or subjects with a chronic condition who have not maintained a stable therapeutic regimen of a prescription therapy for a minimum of 12 weeks prior to Study Visit Day 1. In addition, the following subjects will be excluded:

Subjects with a baseline HbA1c >9
Subjects with uncontrolled hypertension in the opinion of the investigator
Subjects with symptomatic coronary artery disease in the opinion of the investigator
Subjects who have a current or pending disability claim, workers' compensation, or litigation(s) that may compromise response to treatment
Subjects who are immediate family members (spouse, parent, child, or sibling; biological or legally adopted) of personnel directly affiliated with the study at the investigative site, or are directly affiliated with the study at the investigative site
Subjects employed by Samumed, LLC, or any of its affiliates or development partners (that is, an employee, temporary contract worker, or designee) responsible for the conduct of the study",Single intra-articular injection of SM04690 0.07 mg in 2 mL injectable suspension,ChEMBL:CHEMBL4297639 | DrugBank:DB14883 | PubChem:135565709,Adavivint,CC(C)CC(=O)Nc1cncc(-c2ccc3[nH]nc(-c4nc5c(-c6cccc(F)c6)cncc5[nH]4)c3c2)c1,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02536833,NCT02536833_EG002,No,All,Adult | Older Adult,Phase 2,104,"Inclusion Criteria:

Males and females between 40 and 80 years of age, inclusive, in general good health
Ambulatory (single assistive devices such as canes allowed if needed less than 50% of the time, subjects requiring a walker are excluded)
Established diagnosis of primary femorotibial OA in the target knee by standard American College of Rheumatology (ACR) criteria for at least 6 months (clinical AND radiographic criteria); if bilateral knee OA is present, the target knee is defined as the knee with greater pain at screening based on the subject's evaluation and the Investigator's clinical judgment
Radiographic disease Stage 2 or 3 in the target knee according to the Kellgren-Lawrence grading of knee OA as assessed by independent central readers
Screening pain visual analog scale (VAS) score of 30-80 mm (on a scale of 0-100 mm) for the target knee while on symptomatic oral treatment at screening (if the subject requires oral treatment)
Total WOMAC score of 72-192 (out of 240) for the target knee while on symptomatic oral treatment at screening (if the subject requires oral treatment)

Willingness to omit the following for 24 hours prior to all Study Visits, excluding the Screening Visit:

Pain medications
Medications or supplements for the treatment of OA
Participation in a formalized in-office and/or supervised OA disease program (e.g., a prescribed patient education program, physiotherapy, etc.)
Full understanding of the requirements of the study and willingness to comply with all study visits and assessments
Subjects must have read and understood the informed consent form, and must have signed it prior to any study-related procedure being performed
Subject's Day 1 visit must occur while enrollment into the study is open

Exclusion Criteria:

Women who are pregnant or lactating
Women of childbearing potential (i.e., who are not surgically sterile or postmenopausal as defined by no menstrual periods for 12 consecutive months and no other biological or physiological cause for amenorrhea can be identified); males who are sexually active and have a partner who is capable of becoming pregnant, neither of which have had surgery to become sterilized, who are not using an effective method of birth control (e.g., surgically-implanted hormonal therapy, intrauterine devices or oral birth control with barrier method)
Body mass index (BMI) >40
Partial or complete joint replacement in the target knee
Previous exposure to SM04690
Major surgery (e.g., interventional arthroscopy) in the target knee within 52 weeks prior to any study injection
Any planned or elective surgery during the study period
Significant and clinically evident misalignment of the target knee that would impact subject function, as determined by the Investigator
History of malignancy within the last 5 years; however, subjects with prior history of in situ cancer or basal or squamous cell skin cancer are eligible. Subjects with other malignancies are eligible if they have been continuously disease free for at least 5 years prior to any study injection
Clinically significant abnormal Screening Visit hematology values, blood chemistry values, HbA1c, or urinalysis values as determined by the investigator
Any condition, including laboratory findings (not included in the Screening Visit laboratory tests) and findings in the medical history or in the pre-study assessments, that, in the opinion of the Investigator, constitutes a risk or contraindication for participation in the study or that could interfere with the study objectives, conduct, or evaluation
Comorbid conditions that could affect pain assessment of the target knee, including, but not limited to, inflammatory rheumatic conditions such as rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus, diabetic neuropathy, pseudogout, gout, and fibromyalgia
Other conditions that, in the opinion of the Investigator, could affect pain assessment of the target knee, including, but not limited to, symptomatic hip osteoarthritis and symptomatic degenerative disc disease
Any diagnosed psychiatric condition that includes, but is not limited to, a history of mania, bipolar disorder, psychotic disorder, schizophrenia, major depressive disorder, or generalized anxiety disorder
Participation in a clinical research trial that included the receipt of an investigational product or any experimental therapeutic procedure within 12 weeks prior to any study injection; the last date of participation in the trial, not the last date of receipt of investigational product, must be at least 12 weeks prior to Study Visit Day 1
Treatment of the target knee with systemic or intra-articular corticosteroids (e.g., methylprednisolone) within 8 weeks prior to Study Visit Day 1
Viscosupplementation (e.g., hyaluronic acid) in the target knee within 24 weeks prior to Study Visit Day 1
Effusion of the target knee clinically requiring aspiration within 12 weeks prior to Study Visit Day 1
Use of electrotherapy, acupuncture, and/or chiropractic treatments for knee OA within 4 weeks prior to Study Visit Day 1
Any known active infections, including suspicion of intra-articular infection, hepatitis B or hepatitis C infection, and/or infections that may compromise the immune system such as human immunodeficiency virus (HIV)
Subjects taking prescription medications for OA who have not maintained a stable therapeutic regimen for a minimum of 12 weeks prior to Study Visit Day 1

Subjects requiring the chronic use (i.e., regular and consistent use for ≥ 12 weeks) of the medications listed below within 12 weeks prior to Study Visit Day 1:

Opioids, both oral (e.g., tramadol) or transdermal (e.g., fentanyl patches) formulations
Centrally acting analgesics (e.g., duloxetine)
Glucocorticoids (e.g., methylprednisolone) administered by any route, with exception of inhaled, intranasal, and ophthalmic solutions

Any chronic condition that has not been well controlled or subjects with a chronic condition who have not maintained a stable therapeutic regimen of a prescription therapy for a minimum of 12 weeks prior to Study Visit Day 1. In addition, the following subjects will be excluded:

Subjects with a baseline HbA1c >9
Subjects with uncontrolled hypertension in the opinion of the investigator
Subjects with symptomatic coronary artery disease in the opinion of the investigator
Subjects who have a current or pending disability claim, workers' compensation, or litigation(s) that may compromise response to treatment
Subjects who are immediate family members (spouse, parent, child, or sibling; biological or legally adopted) of personnel directly affiliated with the study at the investigative site, or are directly affiliated with the study at the investigative site
Subjects employed by Samumed, LLC, or any of its affiliates or development partners (that is, an employee, temporary contract worker, or designee) responsible for the conduct of the study",Single intra-articular injection of SM04690 0.23 mg in 2 mL injectable suspension,ChEMBL:CHEMBL4297639 | DrugBank:DB14883 | PubChem:135565709,Adavivint,CC(C)CC(=O)Nc1cncc(-c2ccc3[nH]nc(-c4nc5c(-c6cccc(F)c6)cncc5[nH]4)c3c2)c1,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02553629,NCT02553629_EG000,No,All,Adult | Older Adult,Phase 4,109,"Inclusion Criteria:

ASA I-III
BMI > 34 kg/m2
Elective bariatric surgery.

Exclusion Criteria:

Known or suspected neuromuscular disorders impairing neuromuscular function
Allergies to muscle relaxants, anesthetics or narcotics
A(family) history of malignant hyperthermia
Women who are or may be pregnant or are currently breast feeding
Renal insufficiency, as defined by serum creatinine x 2 of normal, or urine output < 0.5 ml/kg/h for at least 6 h.","rocuronium 0.1-0.6 mg/kg aimed at a train of four of 1 - 2 twitches

Rocuronium",ChEMBL:CHEMBL1201244 | DrugBank:DB00728 | PubChem:441290,Rocuronium,[H][C@@]12CC[C@]3([H])[C@]([H])(CC[C@]4(C)[C@@H](OC(C)=O)[C@@H]([N+]5(CC=C)CCCC5)C[C@@]34[H])[C@@]1(C)C[C@H](N1CCOCC1)[C@@H](O)C2,M03AC09,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02553629,NCT02553629_EG001,No,All,Adult | Older Adult,Phase 4,109,"Inclusion Criteria:

ASA I-III
BMI > 34 kg/m2
Elective bariatric surgery.

Exclusion Criteria:

Known or suspected neuromuscular disorders impairing neuromuscular function
Allergies to muscle relaxants, anesthetics or narcotics
A(family) history of malignant hyperthermia
Women who are or may be pregnant or are currently breast feeding
Renal insufficiency, as defined by serum creatinine x 2 of normal, or urine output < 0.5 ml/kg/h for at least 6 h.","rocuronium 0.1-0.6 mg/kg aimed at a post tetanic count of 1 - 2 twitches

Rocuronium",ChEMBL:CHEMBL1201244 | DrugBank:DB00728 | PubChem:441290,Rocuronium,[H][C@@]12CC[C@]3([H])[C@]([H])(CC[C@]4(C)[C@@H](OC(C)=O)[C@@H]([N+]5(CC=C)CCCC5)C[C@@]34[H])[C@@]1(C)C[C@H](N1CCOCC1)[C@@H](O)C2,M03AC09,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02553772,NCT02553772_EG001,No,All,Adult | Older Adult,Phase 3,122,"Inclusion Criteria:

Used artificial tears for dry eye
Visual acuity of at least 20/32 (while wearing glasses, if necessary).

Exclusion Criteria:

Use of contact lenses in the last 3 months, or anticipated use of contact lenses during the study
Herpes keratitis in the last 6 months
Cataract surgery, laser-assisted in situ keratomileusis [LASIK], or photorefractive keratectomy, within the last 6 months","Carboxymethylcellulose sodium 0.5% (REFRESH OPTIVE® ADVANCED) administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days.",PubChem:6328154,Carmellose sodium,CC(=O)O.O=CC(O)C(O)C(O)C(O)CO.[Na],,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02564055,NCT02564055_EG000,No,All,Child | Adult | Older Adult,Phase 2,40,"Inclusion Criteria:

Male or female between 12 and 65 years of age inclusive, at the time of signing the informed consent
Diagnosis of atopic dermatitis according to Hanifin and Rajka criteria and having active inflammation.
Body surface area involvement >=5% and <=35%, excluding scalp, at Screening and Baseline.
An IGA of atopic dermatitis score of >=3 at Baseline.
At least one target lesion that measure at least 3 centimetre (cm) х 3 cm in size at Screening and Baseline and must be representative of the subject's disease state, but not located on the hands, feet, or genitalia.
A female subject is eligible to participate if she is not pregnant (as confirmed by a negative urine human chorionic gonadotrophin test), not lactating, and at least one of the following conditions applies: Non-reproductive potential defined as: 1) Pre-menopausal females with one of the following procedures documented: tubal ligation; hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion; hysterectomy; bilateral oophorectomy. 2) Post-menopausal defined as 12 months of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous follicle stimulating hormone and estradiol levels consistent with menopause and falling into the central laboratory's postmenopausal reference range is confirmatory). Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt are required to use one of the highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrolment; Reproductive potential and agrees to follow one of the options listed in the modified list of highly effective methods for avoiding pregnancy in females of reproductive potential from 30 days prior to the first dose of study medication and until after the last dose of study medication and completion of the follow-up visit.

Exclusion Criteria:

Unstable course of atopic dermatitis (spontaneously improving or rapidly deteriorating) as determined by the investigator over the previous 4 weeks prior to Baseline.
Concurrent conditions and history of other diseases: 1) Immunocompromized (eg, lymphoma, acquired immunodeficiency syndrome, Wiskott-Aldrich Syndrome) or have a history of malignant disease within 5 years before the baseline visit; 2) Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 4 weeks before the baseline visit; 3) Active acute bacterial, fungal, or viral (eg, herpes simplex, herpes zoster, chicken pox) skin infection within 1 week before the baseline visit; 4) Any other concomitant skin disorder (eg, generalized erythroderma such as Netherton's Syndrome, or psoriasis); pigmentation, or extensive scarring that in the opinion of the investigator may interfere with the evaluation of AD lesions or compromise subject safety; 5) Presence of AD lesions only on the hands or feet without prior history of involvement of other classical areas of involvement such as the face or the folds; 6) Other types of eczema.
A history or ongoing serious illness or medical, physical, or psychiatric condition(s) that, in the investigator's opinion, may interfere with the subject's completion of the study.
Known hypersensitivity to study treatment excipients.
Current or chronic history of liver disease, known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones), presence of hepatitis B surface antigen (HBsAg), or positive hepatitis C antibody test result within 3 months of screening.
Liver function tests: alanine aminotransferase (ALT) >=2x upper limit of normal (ULN); alkaline phosphatase and bilirubin >1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
QTc >=450 milliseconds (msec) or QTc >=480 msec for subjects with bundle branch block.

NOTES: The QTc is the QT interval corrected for heart rate according to Fridericia's formula (QTcF), with machine over-read. The QTc should be based on a single ECG obtained over a brief recording period. If QTc is outside of the threshold value, triplicate ECGs may be performed with the QTc values averaged.

Ultraviolet (UV) light therapy or prolonged exposure to natural or artificial sources of UV radiation (eg, sunlight or tanning booth) within 4 weeks prior to the baseline visit and/or intention to have such exposure during the study, which is thought by the investigator to potentially impact the subject's atopic dermatitis.
Used any of the following treatments within the indicated washout period before the baseline visit: 12 weeks or 5 half-lives (whichever is longer) - biologic agents (eg, 18 weeks for omalizumab); 8 weeks - cyclosporin, methotrexate, azathioprine, or other systemic immunosuppressive or immunomodulating agents (eg, mycophenolate or tacrolimus); 4 weeks - systemic corticosteroids or adrenocorticotropic hormone analogs; 2 weeks - topical treatments: corticosteroids, calcineurin inhibitors, or coal tar (on the body); 2 weeks - immunizations; sedating antihistamines (non sedating antihistamines are permitted); 1 week - topical antibiotics, antibacterial cleansing body wash/soap or diluted sodium hypochlorite ""bleach"" baths.
Participated in a clinical study and received an investigational product within the following time period prior to the baseline visit: 4 weeks, 5 half-lives, or twice the duration of the biological effect of the investigational product (whichever is longer).
History of alcohol or other substance abuse within the last 2 years.
Participated in a previous study using GSK2894512 (or WBI-1001).","Subjects will apply a thin layer of GSK2894512 1% (10 milligram per gram [mg/g]) topical cream twice daily (morning and evening) for 12 weeks, to all atopic dermatitis lesions (except on the scalp).",ChEMBL:CHEMBL259571 | DrugBank:DB06083 | PubChem:6439522,Tapinarof,CC(C)c1c(O)cc(/C=C/c2ccccc2)cc1O,D05AX07,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT02564055,NCT02564055_EG001,No,All,Child | Adult | Older Adult,Phase 2,41,"Inclusion Criteria:

Male or female between 12 and 65 years of age inclusive, at the time of signing the informed consent
Diagnosis of atopic dermatitis according to Hanifin and Rajka criteria and having active inflammation.
Body surface area involvement >=5% and <=35%, excluding scalp, at Screening and Baseline.
An IGA of atopic dermatitis score of >=3 at Baseline.
At least one target lesion that measure at least 3 centimetre (cm) х 3 cm in size at Screening and Baseline and must be representative of the subject's disease state, but not located on the hands, feet, or genitalia.
A female subject is eligible to participate if she is not pregnant (as confirmed by a negative urine human chorionic gonadotrophin test), not lactating, and at least one of the following conditions applies: Non-reproductive potential defined as: 1) Pre-menopausal females with one of the following procedures documented: tubal ligation; hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion; hysterectomy; bilateral oophorectomy. 2) Post-menopausal defined as 12 months of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous follicle stimulating hormone and estradiol levels consistent with menopause and falling into the central laboratory's postmenopausal reference range is confirmatory). Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt are required to use one of the highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrolment; Reproductive potential and agrees to follow one of the options listed in the modified list of highly effective methods for avoiding pregnancy in females of reproductive potential from 30 days prior to the first dose of study medication and until after the last dose of study medication and completion of the follow-up visit.

Exclusion Criteria:

Unstable course of atopic dermatitis (spontaneously improving or rapidly deteriorating) as determined by the investigator over the previous 4 weeks prior to Baseline.
Concurrent conditions and history of other diseases: 1) Immunocompromized (eg, lymphoma, acquired immunodeficiency syndrome, Wiskott-Aldrich Syndrome) or have a history of malignant disease within 5 years before the baseline visit; 2) Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 4 weeks before the baseline visit; 3) Active acute bacterial, fungal, or viral (eg, herpes simplex, herpes zoster, chicken pox) skin infection within 1 week before the baseline visit; 4) Any other concomitant skin disorder (eg, generalized erythroderma such as Netherton's Syndrome, or psoriasis); pigmentation, or extensive scarring that in the opinion of the investigator may interfere with the evaluation of AD lesions or compromise subject safety; 5) Presence of AD lesions only on the hands or feet without prior history of involvement of other classical areas of involvement such as the face or the folds; 6) Other types of eczema.
A history or ongoing serious illness or medical, physical, or psychiatric condition(s) that, in the investigator's opinion, may interfere with the subject's completion of the study.
Known hypersensitivity to study treatment excipients.
Current or chronic history of liver disease, known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones), presence of hepatitis B surface antigen (HBsAg), or positive hepatitis C antibody test result within 3 months of screening.
Liver function tests: alanine aminotransferase (ALT) >=2x upper limit of normal (ULN); alkaline phosphatase and bilirubin >1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
QTc >=450 milliseconds (msec) or QTc >=480 msec for subjects with bundle branch block.

NOTES: The QTc is the QT interval corrected for heart rate according to Fridericia's formula (QTcF), with machine over-read. The QTc should be based on a single ECG obtained over a brief recording period. If QTc is outside of the threshold value, triplicate ECGs may be performed with the QTc values averaged.

Ultraviolet (UV) light therapy or prolonged exposure to natural or artificial sources of UV radiation (eg, sunlight or tanning booth) within 4 weeks prior to the baseline visit and/or intention to have such exposure during the study, which is thought by the investigator to potentially impact the subject's atopic dermatitis.
Used any of the following treatments within the indicated washout period before the baseline visit: 12 weeks or 5 half-lives (whichever is longer) - biologic agents (eg, 18 weeks for omalizumab); 8 weeks - cyclosporin, methotrexate, azathioprine, or other systemic immunosuppressive or immunomodulating agents (eg, mycophenolate or tacrolimus); 4 weeks - systemic corticosteroids or adrenocorticotropic hormone analogs; 2 weeks - topical treatments: corticosteroids, calcineurin inhibitors, or coal tar (on the body); 2 weeks - immunizations; sedating antihistamines (non sedating antihistamines are permitted); 1 week - topical antibiotics, antibacterial cleansing body wash/soap or diluted sodium hypochlorite ""bleach"" baths.
Participated in a clinical study and received an investigational product within the following time period prior to the baseline visit: 4 weeks, 5 half-lives, or twice the duration of the biological effect of the investigational product (whichever is longer).
History of alcohol or other substance abuse within the last 2 years.
Participated in a previous study using GSK2894512 (or WBI-1001).","Subjects will apply a thin layer of GSK2894512 1% (10 mg/g) topical cream once daily (evening) for 12 weeks, to all atopic dermatitis lesions (except on the scalp).",ChEMBL:CHEMBL259571 | DrugBank:DB06083 | PubChem:6439522,Tapinarof,CC(C)c1c(O)cc(/C=C/c2ccccc2)cc1O,D05AX07,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02564055,NCT02564055_EG002,No,All,Child | Adult | Older Adult,Phase 2,43,"Inclusion Criteria:

Male or female between 12 and 65 years of age inclusive, at the time of signing the informed consent
Diagnosis of atopic dermatitis according to Hanifin and Rajka criteria and having active inflammation.
Body surface area involvement >=5% and <=35%, excluding scalp, at Screening and Baseline.
An IGA of atopic dermatitis score of >=3 at Baseline.
At least one target lesion that measure at least 3 centimetre (cm) х 3 cm in size at Screening and Baseline and must be representative of the subject's disease state, but not located on the hands, feet, or genitalia.
A female subject is eligible to participate if she is not pregnant (as confirmed by a negative urine human chorionic gonadotrophin test), not lactating, and at least one of the following conditions applies: Non-reproductive potential defined as: 1) Pre-menopausal females with one of the following procedures documented: tubal ligation; hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion; hysterectomy; bilateral oophorectomy. 2) Post-menopausal defined as 12 months of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous follicle stimulating hormone and estradiol levels consistent with menopause and falling into the central laboratory's postmenopausal reference range is confirmatory). Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt are required to use one of the highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrolment; Reproductive potential and agrees to follow one of the options listed in the modified list of highly effective methods for avoiding pregnancy in females of reproductive potential from 30 days prior to the first dose of study medication and until after the last dose of study medication and completion of the follow-up visit.

Exclusion Criteria:

Unstable course of atopic dermatitis (spontaneously improving or rapidly deteriorating) as determined by the investigator over the previous 4 weeks prior to Baseline.
Concurrent conditions and history of other diseases: 1) Immunocompromized (eg, lymphoma, acquired immunodeficiency syndrome, Wiskott-Aldrich Syndrome) or have a history of malignant disease within 5 years before the baseline visit; 2) Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 4 weeks before the baseline visit; 3) Active acute bacterial, fungal, or viral (eg, herpes simplex, herpes zoster, chicken pox) skin infection within 1 week before the baseline visit; 4) Any other concomitant skin disorder (eg, generalized erythroderma such as Netherton's Syndrome, or psoriasis); pigmentation, or extensive scarring that in the opinion of the investigator may interfere with the evaluation of AD lesions or compromise subject safety; 5) Presence of AD lesions only on the hands or feet without prior history of involvement of other classical areas of involvement such as the face or the folds; 6) Other types of eczema.
A history or ongoing serious illness or medical, physical, or psychiatric condition(s) that, in the investigator's opinion, may interfere with the subject's completion of the study.
Known hypersensitivity to study treatment excipients.
Current or chronic history of liver disease, known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones), presence of hepatitis B surface antigen (HBsAg), or positive hepatitis C antibody test result within 3 months of screening.
Liver function tests: alanine aminotransferase (ALT) >=2x upper limit of normal (ULN); alkaline phosphatase and bilirubin >1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
QTc >=450 milliseconds (msec) or QTc >=480 msec for subjects with bundle branch block.

NOTES: The QTc is the QT interval corrected for heart rate according to Fridericia's formula (QTcF), with machine over-read. The QTc should be based on a single ECG obtained over a brief recording period. If QTc is outside of the threshold value, triplicate ECGs may be performed with the QTc values averaged.

Ultraviolet (UV) light therapy or prolonged exposure to natural or artificial sources of UV radiation (eg, sunlight or tanning booth) within 4 weeks prior to the baseline visit and/or intention to have such exposure during the study, which is thought by the investigator to potentially impact the subject's atopic dermatitis.
Used any of the following treatments within the indicated washout period before the baseline visit: 12 weeks or 5 half-lives (whichever is longer) - biologic agents (eg, 18 weeks for omalizumab); 8 weeks - cyclosporin, methotrexate, azathioprine, or other systemic immunosuppressive or immunomodulating agents (eg, mycophenolate or tacrolimus); 4 weeks - systemic corticosteroids or adrenocorticotropic hormone analogs; 2 weeks - topical treatments: corticosteroids, calcineurin inhibitors, or coal tar (on the body); 2 weeks - immunizations; sedating antihistamines (non sedating antihistamines are permitted); 1 week - topical antibiotics, antibacterial cleansing body wash/soap or diluted sodium hypochlorite ""bleach"" baths.
Participated in a clinical study and received an investigational product within the following time period prior to the baseline visit: 4 weeks, 5 half-lives, or twice the duration of the biological effect of the investigational product (whichever is longer).
History of alcohol or other substance abuse within the last 2 years.
Participated in a previous study using GSK2894512 (or WBI-1001).","Subjects will apply a thin layer of GSK2894512 0.5% (5 mg/g) topical cream twice daily (morning and evening) for 12 weeks, to all atopic dermatitis lesions (except on the scalp).",ChEMBL:CHEMBL259571 | DrugBank:DB06083 | PubChem:6439522,Tapinarof,CC(C)c1c(O)cc(/C=C/c2ccccc2)cc1O,D05AX07,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT02564055,NCT02564055_EG003,No,All,Child | Adult | Older Adult,Phase 2,41,"Inclusion Criteria:

Male or female between 12 and 65 years of age inclusive, at the time of signing the informed consent
Diagnosis of atopic dermatitis according to Hanifin and Rajka criteria and having active inflammation.
Body surface area involvement >=5% and <=35%, excluding scalp, at Screening and Baseline.
An IGA of atopic dermatitis score of >=3 at Baseline.
At least one target lesion that measure at least 3 centimetre (cm) х 3 cm in size at Screening and Baseline and must be representative of the subject's disease state, but not located on the hands, feet, or genitalia.
A female subject is eligible to participate if she is not pregnant (as confirmed by a negative urine human chorionic gonadotrophin test), not lactating, and at least one of the following conditions applies: Non-reproductive potential defined as: 1) Pre-menopausal females with one of the following procedures documented: tubal ligation; hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion; hysterectomy; bilateral oophorectomy. 2) Post-menopausal defined as 12 months of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous follicle stimulating hormone and estradiol levels consistent with menopause and falling into the central laboratory's postmenopausal reference range is confirmatory). Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt are required to use one of the highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrolment; Reproductive potential and agrees to follow one of the options listed in the modified list of highly effective methods for avoiding pregnancy in females of reproductive potential from 30 days prior to the first dose of study medication and until after the last dose of study medication and completion of the follow-up visit.

Exclusion Criteria:

Unstable course of atopic dermatitis (spontaneously improving or rapidly deteriorating) as determined by the investigator over the previous 4 weeks prior to Baseline.
Concurrent conditions and history of other diseases: 1) Immunocompromized (eg, lymphoma, acquired immunodeficiency syndrome, Wiskott-Aldrich Syndrome) or have a history of malignant disease within 5 years before the baseline visit; 2) Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 4 weeks before the baseline visit; 3) Active acute bacterial, fungal, or viral (eg, herpes simplex, herpes zoster, chicken pox) skin infection within 1 week before the baseline visit; 4) Any other concomitant skin disorder (eg, generalized erythroderma such as Netherton's Syndrome, or psoriasis); pigmentation, or extensive scarring that in the opinion of the investigator may interfere with the evaluation of AD lesions or compromise subject safety; 5) Presence of AD lesions only on the hands or feet without prior history of involvement of other classical areas of involvement such as the face or the folds; 6) Other types of eczema.
A history or ongoing serious illness or medical, physical, or psychiatric condition(s) that, in the investigator's opinion, may interfere with the subject's completion of the study.
Known hypersensitivity to study treatment excipients.
Current or chronic history of liver disease, known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones), presence of hepatitis B surface antigen (HBsAg), or positive hepatitis C antibody test result within 3 months of screening.
Liver function tests: alanine aminotransferase (ALT) >=2x upper limit of normal (ULN); alkaline phosphatase and bilirubin >1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
QTc >=450 milliseconds (msec) or QTc >=480 msec for subjects with bundle branch block.

NOTES: The QTc is the QT interval corrected for heart rate according to Fridericia's formula (QTcF), with machine over-read. The QTc should be based on a single ECG obtained over a brief recording period. If QTc is outside of the threshold value, triplicate ECGs may be performed with the QTc values averaged.

Ultraviolet (UV) light therapy or prolonged exposure to natural or artificial sources of UV radiation (eg, sunlight or tanning booth) within 4 weeks prior to the baseline visit and/or intention to have such exposure during the study, which is thought by the investigator to potentially impact the subject's atopic dermatitis.
Used any of the following treatments within the indicated washout period before the baseline visit: 12 weeks or 5 half-lives (whichever is longer) - biologic agents (eg, 18 weeks for omalizumab); 8 weeks - cyclosporin, methotrexate, azathioprine, or other systemic immunosuppressive or immunomodulating agents (eg, mycophenolate or tacrolimus); 4 weeks - systemic corticosteroids or adrenocorticotropic hormone analogs; 2 weeks - topical treatments: corticosteroids, calcineurin inhibitors, or coal tar (on the body); 2 weeks - immunizations; sedating antihistamines (non sedating antihistamines are permitted); 1 week - topical antibiotics, antibacterial cleansing body wash/soap or diluted sodium hypochlorite ""bleach"" baths.
Participated in a clinical study and received an investigational product within the following time period prior to the baseline visit: 4 weeks, 5 half-lives, or twice the duration of the biological effect of the investigational product (whichever is longer).
History of alcohol or other substance abuse within the last 2 years.
Participated in a previous study using GSK2894512 (or WBI-1001).","Subjects will apply a thin layer of GSK2894512 0.5% (5 mg/g) topical cream once daily (evening) for 12 weeks, to all atopic dermatitis lesions (except on the scalp).",ChEMBL:CHEMBL259571 | DrugBank:DB06083 | PubChem:6439522,Tapinarof,CC(C)c1c(O)cc(/C=C/c2ccccc2)cc1O,D05AX07,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT02580240,NCT02580240_EG001,No,All,Adult | Older Adult,Not Applicable,58,"Inclusion Criteria:

age 18 years old or older;
onset of septic shock within 6 h

Exclusion Criteria:

Systemic corticosteroid therapy within the last 3 months before septic shock;
high-dose steroid therapy;
immunosuppression;
refusal of the attending staff or patient family.","Hydrocortisone was administered 200 mg/d as a continuous infusion for 6d, then tapered off. Once all vasopressors were discontinued, the taper protocol was initiated (half dose for three days, then quarter dose for three days and then stopped).",ChEMBL:CHEMBL389621 | DrugBank:DB00741 | PubChem:5754,Hydrocortisone,[H][C@@]12CC[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)CC[C@@]21C,A01AC03 | A07EA02 | C05AA01 | D07AA02 | D07BA04 | D07CA01 | D07XA01 | H02AB09 | R01AD60 | S01BA02 | S01BB01 | S01CA03 | S01CB03 | S02BA01 | S02CA03 | S03CA04,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02581111,NCT02581111_EG000,No,All,Child | Adult | Older Adult,Phase 2 | Phase 3,199,"Inclusion Criteria:

Brain-dead organ donor being managed by OPO (organ procurement organization)
Lungs being considered for recovery and transplant
Baseline ABG (after authorization) with P/F ratio < 300

Exclusion Criteria:

No authorization for research
Lungs already excluded for transplant (e.g. known chronic obstructive pulmonary disease [COPD], human immunodeficiency virus [HIV] infection)","Naloxone 8-mg IV given once after baseline ABG

Naloxone: Naloxone 8-mg IV bolus",ChEMBL:CHEMBL80 | DrugBank:DB01183 | PubChem:5284596,Naloxone,C=CCN1CC[C@]23c4c5ccc(O)c4O[C@H]2C(=O)CC[C@@]3(O)[C@H]1C5,A06AH04 | N02AA53 | N02AA55 | N02AX51 | V03AB15,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02584140,NCT02584140_EG000,No,Female,Adult | Older Adult,Phase 4,136,"Inclusion Criteria:

Female at birth and identifies as female gender
Age 18 years or older
Able to understand and provide consent in English or Spanish
HIV negative by 4th generation test (Ag/Ab test) or combination of enzymeimmunoassay (EIA) and HIV RNA
Creatinine clearance ≥ 60 ml/min (via Cockcroft-Gault formula)

At-Risk Criteria (at least one):

Condomless sex in the last 3 months with one or more male partners of unknown HIV status known to be at substantial risk of HIV infection (IDU, bisexual, sex for goods, recently incarcerated, from a country with HIV prevalence >1%, interpersonal Partner Violence);
STI (rectal or vaginal gonorrhea or syphilis) diagnosis during the last 6 months.
Previous post-exposure prophylaxis (PEP) use during the last 12 months.
Has at least one HIV-infected sexual partner for ≥4 weeks.
Sex for exchange of money, goods or services

Exclusion Criteria:

Pregnancy at enrollment.
Any condition, which in the opinion of the provider, will seriously compromise the participant's ability to comply with the protocol, including adherence to PrEP medication dosing, such as active, untreated or unstable major mental illness (i.e. untreated psychotic disorder).
Use of prohibited medications, in particular, agents known to be nephrotoxic or drugs slow in renal excretion.
Previous participation in an HIV vaccine trial. Participants that were documented to have received only placebo are not excluded.
Signs or symptoms suspicious for Primary HIV Infection (PHI).","All participants will be assigned to this arm of the study.

Text Messaging: All participants assigned to the iTAB intervention will receive daily dosing reminders that will be sent for the first 6 weeks and then continue with reminders for the duration of the study.

Adherence Counseling: All participants assigned to the counseling intervention will receive sexual health and medication adherence counseling at each study visit. Participants with suboptimal adherence (TFV-DP levels of <1050 fmol/punch (representing fewer than mean 6-7 daily doses per week)) will trigger a targeted iNSC session. Participants with two TFV-DP levels of <1050 fmol/punch will trigger PrEP Steps, a higher intensity adherence counseling intervention consisting of four 50-minute counseling sessions and 2 booster counseling sessions.

Daily Oral PrEP: All participants will be offered daily oral emtricitabine/tenofovir disoproxil fumarate for Pre-exposure Prophylaxis.",PubChem:27982,Ethephon,O=P(O)(O)CCCl,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02585843,NCT02585843_EG000,No,All,Adult | Older Adult,Phase 2 | Phase 3,10,"Inclusion Criteria:

History of heart failure with either reduced or preserved ejection fraction for 3 months
Patients with New York Heart Association (NYHA) class II- IV heart failure symptoms, with at least one worsening symptom (Dyspnea on exertion, shortness of breath, orthopnea, early satiety) and one sign of congestion (pulmonary rales, elevated jugular venous pressure10cmHg, peripheral edema and ascites)
Decision by primary cardiologist or heart failure (HF) specialist to increase the home diuretic dose
Stable treatment with beta-blockers for 1 month unless contraindicated (i.e. intolerance, bradycardia) as specified by primary cardiologist/HF provider
Stable treatment with angiotensin converting enzyme-1 (ACE-1) or angiotensin receptor blocker (ARB) for 1 month
Spironolactone dose 25mg or eplerenone 50mg per day
Daily furosemide or furosemide equivalent dose of 80mg or greater
Serum potassium concentration 4.5 mmol/L or 5.0 mmol/L if on potassium supplements
Estimated Glomerular Filtration Rate (eGFR) by Modification of Diet in Renal Disease (MDRD) equation 40 ml/min/1.73

Exclusion Criteria:

Inability to complete informed consent form
Allergy or intolerance to spironolactone
Systolic blood pressure <100 mmHg
Patient in need of hospitalization per cardiologist decision
Current inotrope dependency
Current mechanical circulatory support
Acute coronary syndromes or unstable angina within the past 4 weeks
History of cardiac transplant
Obstructive cardiac valvular disease
Primary hypertrophic cardiomyopathy, infiltrative cardiomyopathy
Significant ventricular arrhythmia necessitating defibrillator therapy within the past 14 days
Atrioventricular conduction abnormality greater than first-degree block
Primary liver disease resulted in cirrhosis or abnormal liver function tests (transaminases and alkaline phosphatase levels 3 times the upper limit of normal
Acute malignancy
Active infection requiring antimicrobial treatment (Suppression antimicrobial for chronic infections are exempt)","Spironolactone 100mg: 100mg/day of spironolactone (2 capsules), PO (oral) for 7 days

Spironolactone 100mg: 2 capsules of study medication consist of 100mg, PO (oral) for 7 days",ChEMBL:CHEMBL1393 | DrugBank:DB00421 | PubChem:5833,Spironolactone,[H][C@]12CC[C@]3(C)[C@]4(CCC(=O)O4)CC[C@@]3([H])[C@]1([H])[C@]([H])(SC(C)=O)CC1=CC(=O)CC[C@@]12C,C03DA01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02585843,NCT02585843_EG001,No,All,Adult | Older Adult,Phase 2 | Phase 3,10,"Inclusion Criteria:

History of heart failure with either reduced or preserved ejection fraction for 3 months
Patients with New York Heart Association (NYHA) class II- IV heart failure symptoms, with at least one worsening symptom (Dyspnea on exertion, shortness of breath, orthopnea, early satiety) and one sign of congestion (pulmonary rales, elevated jugular venous pressure10cmHg, peripheral edema and ascites)
Decision by primary cardiologist or heart failure (HF) specialist to increase the home diuretic dose
Stable treatment with beta-blockers for 1 month unless contraindicated (i.e. intolerance, bradycardia) as specified by primary cardiologist/HF provider
Stable treatment with angiotensin converting enzyme-1 (ACE-1) or angiotensin receptor blocker (ARB) for 1 month
Spironolactone dose 25mg or eplerenone 50mg per day
Daily furosemide or furosemide equivalent dose of 80mg or greater
Serum potassium concentration 4.5 mmol/L or 5.0 mmol/L if on potassium supplements
Estimated Glomerular Filtration Rate (eGFR) by Modification of Diet in Renal Disease (MDRD) equation 40 ml/min/1.73

Exclusion Criteria:

Inability to complete informed consent form
Allergy or intolerance to spironolactone
Systolic blood pressure <100 mmHg
Patient in need of hospitalization per cardiologist decision
Current inotrope dependency
Current mechanical circulatory support
Acute coronary syndromes or unstable angina within the past 4 weeks
History of cardiac transplant
Obstructive cardiac valvular disease
Primary hypertrophic cardiomyopathy, infiltrative cardiomyopathy
Significant ventricular arrhythmia necessitating defibrillator therapy within the past 14 days
Atrioventricular conduction abnormality greater than first-degree block
Primary liver disease resulted in cirrhosis or abnormal liver function tests (transaminases and alkaline phosphatase levels 3 times the upper limit of normal
Acute malignancy
Active infection requiring antimicrobial treatment (Suppression antimicrobial for chronic infections are exempt)","Spironolactone 25mg: 25mg/day of spironolactone, PO (oral)

Spironolactone 25mg: 25mg/day of spironolactone",ChEMBL:CHEMBL1393 | DrugBank:DB00421 | PubChem:5833,Spironolactone,[H][C@]12CC[C@]3(C)[C@]4(CCC(=O)O4)CC[C@@]3([H])[C@]1([H])[C@]([H])(SC(C)=O)CC1=CC(=O)CC[C@@]12C,C03DA01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02587117,NCT02587117_EG000,No,All,Adult | Older Adult,Phase 4,13,"Inclusion Criteria:

Subject had symptomatic i.e. burning sensation and/or pain secondary to oral lichen planus.
Subject had clinically & histo-pathologically diagnosed as oral lichen planus.
Subject had not on any treatment for the same or treatment likely to modify their oral lichen planus (e.g. systemic steroids, antifungals, immunosuppressant's, anti-oxidant).

Exclusion Criteria:

Suffering from any systemic disease/s such as diabetes, hypertension, cardiovascular, respiratory system disease, renal dysfunction, liver disorders, malignancy, active peptic ulcer diseases, acute gastrointestinal diseases, anemia and glaucoma, etc.
Suffering from serious or recurrent infection, immunodeficiency or HIV.
Pregnant or breast feeding (including women who wish to be pregnant during the study period).
Any other mucosal diseases or any other skin diseases which might be associated with oral lesions.
On any drug therapy which might be causes lichen planus like lesions.
Known allergy or contraindication to study medications.",Lycopene- 4 mg capsule by mouth single dose per day for 2 months,DrugBank:DB11231 | PubChem:168312947 | PubChem:446925,Lycopene,CC(C)=CCCC(C)=CC=CC(C)=CC=CC(C)=CC=CC=C(C)C=CC=C(C)C=CC=C(C)CCC=C(C)C,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02593097,NCT02593097_EG000,No,All,Adult | Older Adult,Phase 3,30,"Inclusion Criteria:

age 18-65 years
a diagnosis of migraine with or without aura for >1 year according to the International Classification of Headache Disorders-IIIb

Exclusion Criteria:

a diagnosis of diabetes mellitus or polycystic ovarian syndrome
overuse of acute migraine treatments
failure to respond to 3 or more classes of preventive drug treatments
change in dose of migraine-preventive medication within 2 months of beginning the baseline diary phase
significant somatic or psychiatric disease
known alcohol or other substance abuse
pregnant or breastfeeding.",Subjects who received Metformin in either the first or last 12 weeks of the study,ChEMBL:CHEMBL1431 | DrugBank:DB00331 | PubChem:4091,Metformin,CN(C)C(=N)NC(=N)N,A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT02595684,NCT02595684_EG000,No,Male,Adult,Phase 4,9,"Inclusion Criteria:

Men
Age: 30-50 years
BMI: 30 to 39.9 kg/m²
No Pharmacotherapy during the last 3 months
Signature Consent under Information

Exclusion Criteria:

Cholesterol: ≥ 240 mg / dl
Triglycerides: ≥ 400 mg / dl
Fasting glucose: ≥ 126 mg / dl
Diabetes mellitus.
Hypertension
Patients with renal, liver and / or thyroid disease
Consumption of drugs with known effects on glucose or insulin metabolism.
Use of cigar and / or drugs
Hypersensitivity to tadalafil","Tadalafil capsules

Tadalafil: Tadalafil capsules: 5 mg, one per day, at night, during 28 days.",ChEMBL:CHEMBL779 | DrugBank:DB00820 | PubChem:110635,Tadalafil,[H][C@]12Cc3c([nH]c4ccccc34)[C@@H](c3ccc4c(c3)OCO4)N1C(=O)CN(C)C2=O,C02KX52 | C02KX54 | G04BE08 | G04CA54 | G04CB51,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02598934,NCT02598934_EG000,No,Female,Child | Adult | Older Adult,Phase 4,308,"Inclusion Criteria:

Women newly diagnosed with postmenopausal osteoporosis
Naive to prior bisphosphonate therapy

Exclusion Criteria:

Inability to stand or sit upright for at least 60 minutes
Inability to swallow a tablet whole
Hypersensitivity to any component of ibandronate
Hormone (estrogen) replacement therapy within last 3 months, or will start on therapy within next 6 months
Other osteoporosis drug within last 3 months
Malignant disease diagnosed within previous 10 years, except resected basal cell cancer","Participants received ibandronate 150-mg tablet once a month and a combination of calcium plus vitamin D supplement twice daily for 6 months. Depending on the physician consultation on BTM response, participants were randomized into consult group and non-consult group.",ChEMBL:CHEMBL997 | DrugBank:DB00710 | PubChem:60852,Ibandronate,CCCCCN(C)CCC(O)(P(=O)(O)O)P(=O)(O)O,M05BA06 | M05BB09,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02600611,NCT02600611_EG000,No,All,Adult | Older Adult,Phase 3,298,"Inclusion Criteria:

written informed consent;
≥18 years of age;
a bacterial infection of the skin with a lesion size area of at least 75 cm2;
a major cutaneous abscess, cellulitis/erysipelas, and/or wound infections;
the presence of purulent or seropurulent drainage or at least three signs and symptoms of infection (discharge, erythema, swelling, warmth, or pain).

Exclusion Criteria:

severely impaired arterial blood supply such that amputation of the infected anatomical site is likely;
infected diabetic foot ulcers;
infected decubitus ulcers;
necrotizing fasciitis or gangrene;
uncomplicated skin or skin structure infection;
infections associated with a prosthetic device;
suspected or confirmed osteomyelitis;
conditions requiring systemic anti-microbial treatment, prophylaxis, or suppression therapy.","iclaprim 80 mg intravenous every 12 hours

iclaprim: Experimental treatment",ChEMBL:CHEMBL134561 | DrugBank:DB06358 | PubChem:213043,Iclaprim,COc1cc(Cc2cnc(N)nc2N)c2c(c1OC)OC(C1CC1)C=C2,J01EA03,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0
NCT02607618,NCT02607618_EG000,No,All,Adult | Older Adult,Phase 3,299,"Inclusion Criteria:

written informed consent;
≥18 years of age;
a bacterial infection of the skin with a lesion size area of at least 75 cm2;
a major cutaneous abscess, cellulitis/erysipelas, and/or wound infections;
the presence of purulent or seropurulent drainage or at least three signs and symptoms of infection (discharge, erythema, swelling, warmth, or pain).

Exclusion Criteria:

severely impaired arterial blood supply such that amputation of the infected anatomical site is likely;
infected diabetic foot ulcers;
infected decubitus ulcers;
necrotizing fasciitis or gangrene;
uncomplicated skin or skin structure infection;
infections associated with a prosthetic device;
suspected or confirmed osteomyelitis;
conditions requiring systemic anti-microbial treatment, prophylaxis, or suppression therapy.","iclaprim 80 mg intravenous every 12 hours

Iclaprim: Experimental treatment",ChEMBL:CHEMBL134561 | DrugBank:DB06358 | PubChem:213043,Iclaprim,COc1cc(Cc2cnc(N)nc2N)c2c(c1OC)OC(C1CC1)C=C2,J01EA03,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02621606,NCT02621606_EG000,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 1,3,"Inclusion Criteria:

Part 1, 2 and 3:

Male, or non-pregnant and non-breast feeding female of 18 to 55 years of age (Part 1) or 55 to 85 years of age (Parts 2 and 3); in addition:

Male participant who is sexually active with females of childbearing potential must be willing to use a condom from the first dose of study drug until 3 months post the last dose of study drug
Female participant with reproductive potential must have serum β-human chorionic gonadotropin (β-hCG) test result consistent with non-pregnant state at screening and agree to use two acceptable methods of birth control beginning at screening visit, during study and until 2 weeks after the last dose of study drug
Female participant of non-childbearing potential must be post-menopausal female (participant has been without menses for at least 1 year and has a follicle stimulating hormone [FSH] level in the postmenopausal range at screening), or surgically sterile female (status post hysterectomy, oophorectomy, or tubal ligation)
Body Mass Index (BMI) ≤35 kg/m^2, with height ≤195 cm and weight ≤136 kg
In good health (Part 1) or generally healthy (Parts 2 and 3) based on medical history, physical examination, vital sign measurements and electrocardiogram (ECG)
Nonsmoker and/or has not used nicotine or nicotine-containing products for at least approximately 3 months

Part 2 Only:

Willing to allow placement of an arterial catheter in the radial artery
Mini Mental Status Examination (MMSE) score ≥27
No history of subjective memory or other cognitive complaints
No objective evidence of memory or cognitive impairment

Part 3 Only:

Moderate to severe AD as defined by:

MMSE score ≤20
Meets National Institute of Neurological and Communicative Diseases and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria for probable AD
Meets Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-V) criteria for AD
Rosen-Modified Hachinski score ≤4
Screening magnetic resonance imaging (MRI) scan consistent with a diagnosis of AD
Clear history of cognitive and functional decline over ≥1 year
On a stable dose of one of protocol-defined acetylcholinesterase inhibitors (AChEIs) (i.e., donepezil and rivastigmine) for symptomatic treatment of AD. Dose must be stable for at least the last 4 weeks before screening
Has a reliable trial partner/caregiver who is able to accompany the participant to all clinic visits, if needed, and able to provide information to study investigator/staff via telephone contact

Exclusion Criteria:

Part 1, 2, and 3:

Mentally or legally incapacitated, has significant emotional problems at the time of screening visit or expected during the conduct of the trial or has a history of clinically significant psychiatric disorder of the last 5 years, except (for Part 3 only) for psychiatric disorders associated with AD
History of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary or major neurological abnormalities or diseases, unless (for Part 2 and 3 only) adequately controlled through a stable medication regimen
History of cancer
History of significant multiple and/or severe allergies or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food. For Part 2, this includes any known allergy to lidocaine which may be used as an anesthetic for the placement of the arterial catheter
Has positive test result for hepatitis B surface antigen, hepatitis C antibodies or human immunodeficiency virus (HIV)
Has had major surgery or donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to screening
Has participated in another investigational trial within 4 weeks of screening
Corrected QT (QTc) interval ≥470 msec (for males) or ≥480 msec (for females)
Is unable to refrain from or anticipates the use of any medication, including prescription and non-prescription drugs or herbal remedies, beginning approximately 2 weeks prior to administration of the initial dose of study drug and throughout the study.
Consumes >3 servings of alcohol a day
Consumes >6 caffeine servings a day
Is currently a regular or recreational user of cannabis, any illicit drugs or has a history of drug (including alcohol) abuse within approximately 3 months
Has participated in a PET research study or other study involving administration of a radioactive substance or ionizing radiation within 12 months prior to screening or has undergone an extensive radiological examination within this period
Suffers from claustrophobia or an inability to tolerate confinement in small places and would be unable to undergo MRI or PET scanning

Part 2 Only:

- Has been administered an AChEI within the prior 3 months or will require administration of an AChEI during study

Part 3 Only:

Has been administered galantamine within the prior 7 days or will require administration of galantamine during study
History within 2 years prior to screening, or current evidence of any neurological or neurodegenerative disorder other than AD that is associated with transient or sustained alterations in cognition
History within 2 years prior to screening, or current evidence of a psychotic disorder or a major depressive disorder

Part 2 and 3 Only:

- Has or is suspected to have implanted or embedded metal objects, or fragments in the head or body that would present a risk during the MRI scanning procedure",Healthy participants receive a single IV dose of ~370 MBq [11C]MK-6884 in Part 1 of the study.,PubChem:162641051,N88C2T6Ybp,CN1Cc2ccc(-c3nc(C#N)ccc3-c3cnn(CC4(C)CCCC4)c3)cc2C1=O,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02621606,NCT02621606_EG002,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 1,10,"Inclusion Criteria:

Part 1, 2 and 3:

Male, or non-pregnant and non-breast feeding female of 18 to 55 years of age (Part 1) or 55 to 85 years of age (Parts 2 and 3); in addition:

Male participant who is sexually active with females of childbearing potential must be willing to use a condom from the first dose of study drug until 3 months post the last dose of study drug
Female participant with reproductive potential must have serum β-human chorionic gonadotropin (β-hCG) test result consistent with non-pregnant state at screening and agree to use two acceptable methods of birth control beginning at screening visit, during study and until 2 weeks after the last dose of study drug
Female participant of non-childbearing potential must be post-menopausal female (participant has been without menses for at least 1 year and has a follicle stimulating hormone [FSH] level in the postmenopausal range at screening), or surgically sterile female (status post hysterectomy, oophorectomy, or tubal ligation)
Body Mass Index (BMI) ≤35 kg/m^2, with height ≤195 cm and weight ≤136 kg
In good health (Part 1) or generally healthy (Parts 2 and 3) based on medical history, physical examination, vital sign measurements and electrocardiogram (ECG)
Nonsmoker and/or has not used nicotine or nicotine-containing products for at least approximately 3 months

Part 2 Only:

Willing to allow placement of an arterial catheter in the radial artery
Mini Mental Status Examination (MMSE) score ≥27
No history of subjective memory or other cognitive complaints
No objective evidence of memory or cognitive impairment

Part 3 Only:

Moderate to severe AD as defined by:

MMSE score ≤20
Meets National Institute of Neurological and Communicative Diseases and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria for probable AD
Meets Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-V) criteria for AD
Rosen-Modified Hachinski score ≤4
Screening magnetic resonance imaging (MRI) scan consistent with a diagnosis of AD
Clear history of cognitive and functional decline over ≥1 year
On a stable dose of one of protocol-defined acetylcholinesterase inhibitors (AChEIs) (i.e., donepezil and rivastigmine) for symptomatic treatment of AD. Dose must be stable for at least the last 4 weeks before screening
Has a reliable trial partner/caregiver who is able to accompany the participant to all clinic visits, if needed, and able to provide information to study investigator/staff via telephone contact

Exclusion Criteria:

Part 1, 2, and 3:

Mentally or legally incapacitated, has significant emotional problems at the time of screening visit or expected during the conduct of the trial or has a history of clinically significant psychiatric disorder of the last 5 years, except (for Part 3 only) for psychiatric disorders associated with AD
History of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary or major neurological abnormalities or diseases, unless (for Part 2 and 3 only) adequately controlled through a stable medication regimen
History of cancer
History of significant multiple and/or severe allergies or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food. For Part 2, this includes any known allergy to lidocaine which may be used as an anesthetic for the placement of the arterial catheter
Has positive test result for hepatitis B surface antigen, hepatitis C antibodies or human immunodeficiency virus (HIV)
Has had major surgery or donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to screening
Has participated in another investigational trial within 4 weeks of screening
Corrected QT (QTc) interval ≥470 msec (for males) or ≥480 msec (for females)
Is unable to refrain from or anticipates the use of any medication, including prescription and non-prescription drugs or herbal remedies, beginning approximately 2 weeks prior to administration of the initial dose of study drug and throughout the study.
Consumes >3 servings of alcohol a day
Consumes >6 caffeine servings a day
Is currently a regular or recreational user of cannabis, any illicit drugs or has a history of drug (including alcohol) abuse within approximately 3 months
Has participated in a PET research study or other study involving administration of a radioactive substance or ionizing radiation within 12 months prior to screening or has undergone an extensive radiological examination within this period
Suffers from claustrophobia or an inability to tolerate confinement in small places and would be unable to undergo MRI or PET scanning

Part 2 Only:

- Has been administered an AChEI within the prior 3 months or will require administration of an AChEI during study

Part 3 Only:

Has been administered galantamine within the prior 7 days or will require administration of galantamine during study
History within 2 years prior to screening, or current evidence of any neurological or neurodegenerative disorder other than AD that is associated with transient or sustained alterations in cognition
History within 2 years prior to screening, or current evidence of a psychotic disorder or a major depressive disorder

Part 2 and 3 Only:

- Has or is suspected to have implanted or embedded metal objects, or fragments in the head or body that would present a risk during the MRI scanning procedure",Participants with AD receive a single IV dose of ~370 MBq [11C]MK-6884 in Part 3 of the study.,PubChem:162641051,N88C2T6Ybp,CN1Cc2ccc(-c3nc(C#N)ccc3-c3cnn(CC4(C)CCCC4)c3)cc2C1=O,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02621619,NCT02621619_EG000,No,All,Older Adult,Phase 4,46,"Inclusion Criteria:

Acute (less than 1 week in duration) severe pain necessitating use of intravenous (IV) opioids in the judgement of the treating attending physician

Exclusion Criteria:

Use of other opioids or tramadol within past 24 hours: to avoid introducing assembly bias related to recent opioid use, since this may affect baseline levels of pain and need for analgesics.
Prior adverse reaction to hydromorphone, morphine, or acetaminophen.
Chronic pain syndrome: frequently recurrent or daily pain for at least 3 months results in modulation of pain perception which is thought to be due to down-regulation of pain receptors. Examples of chronic pain syndromes include sickle cell anemia, osteoarthritis, fibromyalgia, and peripheral neuropathies.
Alcohol intoxication: the presence of alcohol intoxication as judged by the treating physician may alter pain perception.
Systolic Blood Pressure (SBP) <100 mm Hg: Opioids can produce peripheral vasodilation that may result in orthostatic hypotension.
Heart Rate (HR) < 60/min: Opioids can cause bradycardia.
Oxygen saturation < 95% on room air: For this study, oxygen saturation must be 95% or above on room air in order to be enrolled.
Use of monoamine oxidase (MAO) inhibitors in past 30 days: MAO inhibitors have been reported to intensify the effects of at least one opioid drug causing anxiety, confusion and significant respiratory depression or coma.
Patients using transdermal pain patches","1 gram IV acetaminophen in addition to 0.5 mg IV hydromorphone

IV acetaminophen + 0.5 mg IV hydromorphone: 1 gram (100 ml) IV acetaminophen in addition to 0.5 mg IV hydromorphone

0.5 mg IV hydromorphone: Both groups (intervention and placebo) will receive 0.5 mg IV hydromorphone",ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT02626026,NCT02626026_EG000,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 1,8,"Inclusion Criteria

Part A

Be a nonsmoker
Have a calculated body mass index (BMI) from 19 to 30 kg/m^2, inclusive, at screening
Have a creatinine clearance (CrCl) ≥ 90 mL/min (using the Cockcroft-Gault method based on serum creatinine and actual body weight as measured at screening
Females of childbearing potential must have a negative serum pregnancy test at screening and clinic admission.
Male and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
Must, in the opinion of the investigator, be in good health based upon medical history and physical examination, including vital signs
Screening laboratory evaluations (hematology including reticulocytes, fasting lipids, chemistry, and urinalysis) must fall within the normal range of the local laboratory's reference ranges unless the results have been determined by the investigator to have no clinical significance
Have either a normal 12-lead ECG or one with abnormalities that are considered clinically insignificant by the investigator in consultation with the Sponsor

Part B

Diagnosis of RA (according to the 1987 American College of Rheumatology (ACR) classification criteria OR a score of ≥ 6 as defined by the ACR/European League Against Rheumatism Classification and Diagnostic Criteria for RA)
Individuals must have taken methotrexate (MTX) 7.5 to 25 mg/week continuously for at least 12 weeks, with at least 6 weeks of stable dose prior to first study drug dose and throughout study duration.
Individuals must be receiving folic or folinic acid supplementation at a stable dose for at least 6 weeks prior to Day 1 dosing and throughout study duration
Individuals are allowed to remain on anti-malarial therapy, with at least 8 weeks of stable dose prior to first study drug dose
Use of oral corticosteroids of no more than 10 mg prednisone or its equivalent per day is allowed if dose is stable for at least 28 days prior to first study drug dose
Nonsteroidal anti-inflammatory drugs (NSAIDs) or other analgesics (including aspirin ≤ 100 mg daily) are allowed if doses are stable for at least 14 days prior to the first dose of study drug
Estimated creatinine clearance (CLCr) ≥ 60 mL/min (using the Cockcroft-Gault method) based on serum creatinine and actual body weight as measured at the screening evaluation
White blood cells (WBC), neutrophil count, lymphocyte count, and platelet count ≥ 0.75 x lower limit of normal (LLN)
A negative serum pregnancy test at screening and a negative pregnancy test on the Day 1 visit prior to the first dose of study drug for female individual of child bearing potential.
Male and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception

Exclusion Criteria

Part A

Pregnant or lactating individuals
Have any serious or active medical or psychiatric illness (including depression) which, in the opinion of the Investigator, would interfere with individual's treatment, assessment, or compliance with the protocol. This would include renal, cardiac, hematological, hepatic, pulmonary (including chronic asthma), endocrine (including diabetes), central nervous, gastrointestinal (including an ulcer), vascular, metabolic (thyroid disorders, adrenal disease), immunodeficiency disorders, active infection, or malignancy that are clinically significant or requiring treatment
Positive test for drugs of abuse, including alcohol at screening or on Day -1/check-in
A positive test result for human immunodeficiency virus (HIV-1) antibody, hepatitis B (HBV) surface antigen or hepatitis C (HCV) antibody
Have poor venous access that limits phlebotomy
Have taken any prescription medications or over-the-counter medications, including herbal products, within 28 days prior to start of study drug dosing, with the exception of vitamins and/or acetaminophen and/or hormonal contraceptive medications
Have been treated with systemic steroids, immunosuppressant therapies, or chemotherapeutic agents within 3 months prior to Screening or expected to receive these agents during the study (eg, corticosteroids, immunoglobulins, and other immune- or cytokine-based therapies)
Significant drug sensitivity or drug allergy (such as anaphylaxis or hepatoxicity)
Medical or surgical treatment that permanently alters gastric absorption (eg, gastric or intestinal surgery); a history of cholecystectomy is not exclusionary

Part B

Known hypersensitivity to formulation excipient.
Pregnant or lactating females
Previous treatment with B-cell depleting agents (eg, rituximab) within 12 months of treatment
Prior treatment with any commercially available or investigational Bruton's tyrosine kinase (BTK) inhibitor
Diagnosis of diabetes, history of impaired glucose tolerance test, history of abnormal glycated haemoglobin (HbA1c), or history of impaired fasting glucose
Current treatment with any other disease modifying anti-rheumatic drug (DMARD) other than MTX and hydroxychloroquine, unless appropriate wash out
Current treatment with any biologic agent, unless appropriate wash out
Any laboratory abnormality or condition that, in the investigator's opinion, could adversely affect the safety of the individual or impair the assessment of study results
History of or current inflammatory joint disease, other than RA
Active significant systemic involvement secondary to RA such as vasculitis, pulmonary fibrosis or Felty's syndrome
History of or current autoimmune or rheumatic disorders, other than RA
RA functional class 4 or other uncontrolled medical conditions
History of ongoing, chronic or recurrent infections or recent serious or life-threatening infection
Presence of any condition that could, in the opinion of the investigator, compromise the individual's ability to participate in the study, such as history of substance abuse, alcoholism, or a psychiatric condition",Tirabrutinib 20 mg capsules orally once daily (QD) in the morning for 1 week.,ChEMBL:CHEMBL4071161 | DrugBank:DB15227 | PubChem:54755438,Tirabrutinib,CC#CC(=O)N1CC[C@@H](n2c(=O)n(-c3ccc(Oc4ccccc4)cc3)c3c(N)ncnc32)C1,,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02626026,NCT02626026_EG001,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 1,8,"Inclusion Criteria

Part A

Be a nonsmoker
Have a calculated body mass index (BMI) from 19 to 30 kg/m^2, inclusive, at screening
Have a creatinine clearance (CrCl) ≥ 90 mL/min (using the Cockcroft-Gault method based on serum creatinine and actual body weight as measured at screening
Females of childbearing potential must have a negative serum pregnancy test at screening and clinic admission.
Male and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
Must, in the opinion of the investigator, be in good health based upon medical history and physical examination, including vital signs
Screening laboratory evaluations (hematology including reticulocytes, fasting lipids, chemistry, and urinalysis) must fall within the normal range of the local laboratory's reference ranges unless the results have been determined by the investigator to have no clinical significance
Have either a normal 12-lead ECG or one with abnormalities that are considered clinically insignificant by the investigator in consultation with the Sponsor

Part B

Diagnosis of RA (according to the 1987 American College of Rheumatology (ACR) classification criteria OR a score of ≥ 6 as defined by the ACR/European League Against Rheumatism Classification and Diagnostic Criteria for RA)
Individuals must have taken methotrexate (MTX) 7.5 to 25 mg/week continuously for at least 12 weeks, with at least 6 weeks of stable dose prior to first study drug dose and throughout study duration.
Individuals must be receiving folic or folinic acid supplementation at a stable dose for at least 6 weeks prior to Day 1 dosing and throughout study duration
Individuals are allowed to remain on anti-malarial therapy, with at least 8 weeks of stable dose prior to first study drug dose
Use of oral corticosteroids of no more than 10 mg prednisone or its equivalent per day is allowed if dose is stable for at least 28 days prior to first study drug dose
Nonsteroidal anti-inflammatory drugs (NSAIDs) or other analgesics (including aspirin ≤ 100 mg daily) are allowed if doses are stable for at least 14 days prior to the first dose of study drug
Estimated creatinine clearance (CLCr) ≥ 60 mL/min (using the Cockcroft-Gault method) based on serum creatinine and actual body weight as measured at the screening evaluation
White blood cells (WBC), neutrophil count, lymphocyte count, and platelet count ≥ 0.75 x lower limit of normal (LLN)
A negative serum pregnancy test at screening and a negative pregnancy test on the Day 1 visit prior to the first dose of study drug for female individual of child bearing potential.
Male and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception

Exclusion Criteria

Part A

Pregnant or lactating individuals
Have any serious or active medical or psychiatric illness (including depression) which, in the opinion of the Investigator, would interfere with individual's treatment, assessment, or compliance with the protocol. This would include renal, cardiac, hematological, hepatic, pulmonary (including chronic asthma), endocrine (including diabetes), central nervous, gastrointestinal (including an ulcer), vascular, metabolic (thyroid disorders, adrenal disease), immunodeficiency disorders, active infection, or malignancy that are clinically significant or requiring treatment
Positive test for drugs of abuse, including alcohol at screening or on Day -1/check-in
A positive test result for human immunodeficiency virus (HIV-1) antibody, hepatitis B (HBV) surface antigen or hepatitis C (HCV) antibody
Have poor venous access that limits phlebotomy
Have taken any prescription medications or over-the-counter medications, including herbal products, within 28 days prior to start of study drug dosing, with the exception of vitamins and/or acetaminophen and/or hormonal contraceptive medications
Have been treated with systemic steroids, immunosuppressant therapies, or chemotherapeutic agents within 3 months prior to Screening or expected to receive these agents during the study (eg, corticosteroids, immunoglobulins, and other immune- or cytokine-based therapies)
Significant drug sensitivity or drug allergy (such as anaphylaxis or hepatoxicity)
Medical or surgical treatment that permanently alters gastric absorption (eg, gastric or intestinal surgery); a history of cholecystectomy is not exclusionary

Part B

Known hypersensitivity to formulation excipient.
Pregnant or lactating females
Previous treatment with B-cell depleting agents (eg, rituximab) within 12 months of treatment
Prior treatment with any commercially available or investigational Bruton's tyrosine kinase (BTK) inhibitor
Diagnosis of diabetes, history of impaired glucose tolerance test, history of abnormal glycated haemoglobin (HbA1c), or history of impaired fasting glucose
Current treatment with any other disease modifying anti-rheumatic drug (DMARD) other than MTX and hydroxychloroquine, unless appropriate wash out
Current treatment with any biologic agent, unless appropriate wash out
Any laboratory abnormality or condition that, in the investigator's opinion, could adversely affect the safety of the individual or impair the assessment of study results
History of or current inflammatory joint disease, other than RA
Active significant systemic involvement secondary to RA such as vasculitis, pulmonary fibrosis or Felty's syndrome
History of or current autoimmune or rheumatic disorders, other than RA
RA functional class 4 or other uncontrolled medical conditions
History of ongoing, chronic or recurrent infections or recent serious or life-threatening infection
Presence of any condition that could, in the opinion of the investigator, compromise the individual's ability to participate in the study, such as history of substance abuse, alcoholism, or a psychiatric condition","Tirabrutinib 10 mg capsules orally twice daily (BID) (morning and approximately 12 hours later) for 7 days. On Day 7, only morning dose was administered.",ChEMBL:CHEMBL4071161 | DrugBank:DB15227 | PubChem:54755438,Tirabrutinib,CC#CC(=O)N1CC[C@@H](n2c(=O)n(-c3ccc(Oc4ccccc4)cc3)c3c(N)ncnc32)C1,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02626026,NCT02626026_EG002,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 1,16,"Inclusion Criteria

Part A

Be a nonsmoker
Have a calculated body mass index (BMI) from 19 to 30 kg/m^2, inclusive, at screening
Have a creatinine clearance (CrCl) ≥ 90 mL/min (using the Cockcroft-Gault method based on serum creatinine and actual body weight as measured at screening
Females of childbearing potential must have a negative serum pregnancy test at screening and clinic admission.
Male and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
Must, in the opinion of the investigator, be in good health based upon medical history and physical examination, including vital signs
Screening laboratory evaluations (hematology including reticulocytes, fasting lipids, chemistry, and urinalysis) must fall within the normal range of the local laboratory's reference ranges unless the results have been determined by the investigator to have no clinical significance
Have either a normal 12-lead ECG or one with abnormalities that are considered clinically insignificant by the investigator in consultation with the Sponsor

Part B

Diagnosis of RA (according to the 1987 American College of Rheumatology (ACR) classification criteria OR a score of ≥ 6 as defined by the ACR/European League Against Rheumatism Classification and Diagnostic Criteria for RA)
Individuals must have taken methotrexate (MTX) 7.5 to 25 mg/week continuously for at least 12 weeks, with at least 6 weeks of stable dose prior to first study drug dose and throughout study duration.
Individuals must be receiving folic or folinic acid supplementation at a stable dose for at least 6 weeks prior to Day 1 dosing and throughout study duration
Individuals are allowed to remain on anti-malarial therapy, with at least 8 weeks of stable dose prior to first study drug dose
Use of oral corticosteroids of no more than 10 mg prednisone or its equivalent per day is allowed if dose is stable for at least 28 days prior to first study drug dose
Nonsteroidal anti-inflammatory drugs (NSAIDs) or other analgesics (including aspirin ≤ 100 mg daily) are allowed if doses are stable for at least 14 days prior to the first dose of study drug
Estimated creatinine clearance (CLCr) ≥ 60 mL/min (using the Cockcroft-Gault method) based on serum creatinine and actual body weight as measured at the screening evaluation
White blood cells (WBC), neutrophil count, lymphocyte count, and platelet count ≥ 0.75 x lower limit of normal (LLN)
A negative serum pregnancy test at screening and a negative pregnancy test on the Day 1 visit prior to the first dose of study drug for female individual of child bearing potential.
Male and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception

Exclusion Criteria

Part A

Pregnant or lactating individuals
Have any serious or active medical or psychiatric illness (including depression) which, in the opinion of the Investigator, would interfere with individual's treatment, assessment, or compliance with the protocol. This would include renal, cardiac, hematological, hepatic, pulmonary (including chronic asthma), endocrine (including diabetes), central nervous, gastrointestinal (including an ulcer), vascular, metabolic (thyroid disorders, adrenal disease), immunodeficiency disorders, active infection, or malignancy that are clinically significant or requiring treatment
Positive test for drugs of abuse, including alcohol at screening or on Day -1/check-in
A positive test result for human immunodeficiency virus (HIV-1) antibody, hepatitis B (HBV) surface antigen or hepatitis C (HCV) antibody
Have poor venous access that limits phlebotomy
Have taken any prescription medications or over-the-counter medications, including herbal products, within 28 days prior to start of study drug dosing, with the exception of vitamins and/or acetaminophen and/or hormonal contraceptive medications
Have been treated with systemic steroids, immunosuppressant therapies, or chemotherapeutic agents within 3 months prior to Screening or expected to receive these agents during the study (eg, corticosteroids, immunoglobulins, and other immune- or cytokine-based therapies)
Significant drug sensitivity or drug allergy (such as anaphylaxis or hepatoxicity)
Medical or surgical treatment that permanently alters gastric absorption (eg, gastric or intestinal surgery); a history of cholecystectomy is not exclusionary

Part B

Known hypersensitivity to formulation excipient.
Pregnant or lactating females
Previous treatment with B-cell depleting agents (eg, rituximab) within 12 months of treatment
Prior treatment with any commercially available or investigational Bruton's tyrosine kinase (BTK) inhibitor
Diagnosis of diabetes, history of impaired glucose tolerance test, history of abnormal glycated haemoglobin (HbA1c), or history of impaired fasting glucose
Current treatment with any other disease modifying anti-rheumatic drug (DMARD) other than MTX and hydroxychloroquine, unless appropriate wash out
Current treatment with any biologic agent, unless appropriate wash out
Any laboratory abnormality or condition that, in the investigator's opinion, could adversely affect the safety of the individual or impair the assessment of study results
History of or current inflammatory joint disease, other than RA
Active significant systemic involvement secondary to RA such as vasculitis, pulmonary fibrosis or Felty's syndrome
History of or current autoimmune or rheumatic disorders, other than RA
RA functional class 4 or other uncontrolled medical conditions
History of ongoing, chronic or recurrent infections or recent serious or life-threatening infection
Presence of any condition that could, in the opinion of the investigator, compromise the individual's ability to participate in the study, such as history of substance abuse, alcoholism, or a psychiatric condition",Tirabrutinib 20 mg capsules orally QD for 4 weeks.,ChEMBL:CHEMBL4071161 | DrugBank:DB15227 | PubChem:54755438,Tirabrutinib,CC#CC(=O)N1CC[C@@H](n2c(=O)n(-c3ccc(Oc4ccccc4)cc3)c3c(N)ncnc32)C1,,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT02628236,NCT02628236_EG000,No,All,Adult | Older Adult,Phase 2,14,"Inclusion Criteria:

At least 6 Grade 1/2 AKs on one upper extremity AND
At least 12 Grade 1/2 AKs on the OTHER upper extremity

Exclusion Criteria:

Pregnancy
history of cutaneous photosensitization, porphyria, hypersensitivity to porphyrins or photodermatosis
lesions suspicious for skin cancer (skin cancer not ruled out by biopsy) or untreated skin cancers within the Treatment Area
Body Mass Index (BMI) > 32.0 kg/m2
skin pathology or condition which could interfere with the evaluation of the test product or requires the use of interfering topical or systemic therapy
significant blood loss within 60 days or donated blood/plasma within 72 hours prior to Visit 2 (Baseline)
tested positive at screening for human immunodeficiency virus (HIV) or was known to be seropositive for HIV
a history of lead poisoning or a history of a significant exposure to lead
tested positive at screening for hepatitis B surface antigen, hepatitis C antibody or had a history of a positive result
positive drug screen at Screening
Screening safety labs are clinically significant in the opinion of the investigator
major surgery within 30 days prior to Visit 2 (Baseline) or plans to have surgery during the study
Subject is immunosuppressed
currently enrolled in an investigational drug or device study
has received an investigational drug or been treated with an investigational device within 30 days prior to Visit 2 (Baseline)
known sensitivity to one or more of the vehicle components (ethyl alcohol, isopropyl alcohol, laureth 4, polyethylene glycol)

use of the following topical preparations on the extremities to be treated:

Keratolytics including urea (greater than 5%), alpha hydroxyacids [e.g.glycolic acid, lactic acid, etc. greater than 5%], salicylic acid (greater than 2%) within 2 days of initiation of treatment
Cryotherapy within 2 weeks of initiation of treatment
Retinoids, including tazarotene, adapalene, tretinoin, retinol, within 4 weeks of initiation of treatment
Microdermabrasion, laser ablative treatments, ALA-PDT, chemical peels, 5-FU, diclofenac, imiquimod or other topical treatments for AK within 8 weeks of initiation of treatment
use of systemic retinoid therapy within 6 months of initiation of treatment","20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment

Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light

BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2",PubChem:123608,Aminolevulinic Acid Hydrochloride,Cl.NCC(=O)CCC(=O)O,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT02628743,NCT02628743_EG000,No,All,Child | Adult | Older Adult,Phase 2,131,"Inclusion Criteria:

Participation in the previous studies (TRO19622 CL E Q 1115-1 or TRO19622 CL E Q 1275-1)
For women of childbearing potential: agreement to use an acceptable birth control method during the treatment period and for at least 28 days after the last dose of olesoxime

Exclusion Criteria:

Female participants who are pregnant or lactating, or intending to become pregnant during the study
Participants who, in the opinion of the investigator, are not suitable to participate in this open-label study
Participants who have developed study drug hypersensitivity to olesoxime or one of the formulation excipients, including sesame oil
Concomitant or previous participation in any investigational drug or device study within 90 days prior to screening
Concomitant or previous participation in a survival motor neuron 2 (SMN2) targeting antisense oligonucleotide study within 6 months prior to screening
History of human immunodeficiency virus infection, history of Hepatitis B infection within the past year, history of Hepatitis C infection which has not been adequately treated
History of illicit drug or alcohol abuse within 12 months prior to screening, in the investigator's judgment
Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the participant's safe participation in and completion of the study
History or presence of an abnormal electrocardiogram (ECG) that is clinically significant in the investigator's opinion",Participants received a dose of 10 mg/kg suspension once a day (QD) orally or via a naso-gastric or gastronomy tube. Participants who consented to dose increase received 10 milligrams per kilogram (mg/kg) suspension twice a day (BID) either orally or via a naso-gastric or gastrostomy tube.,ChEMBL:CHEMBL3545254 | DrugBank:DB05185 | PubChem:146158151 | PubChem:21763506 | PubChem:228400 | PubChem:5354851 | PubChem:56603725 | PubChem:76971721 | PubChem:9930827,Olesoxime,CC(C)CCCC(C)C1CCC2C3CCC4=CC(=NO)CCC4(C)C3CCC12C,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT02633488,NCT02633488_EG001,No,All,Adult,Not Applicable,19,"Inclusion Criteria:

Age 18-60

No smoking the past 6 months
Normal screening labs or no clinically significant values-except those listed below

Must have 3 of the following 4 characteristics established by NCEP-AHA-NHLBI

Males waist circumference greater than 40 inches, females greater than 35 inches
Blood pressure greater than 130/85 or on treatment with one or more antihypertensive agent
Fasting plasma triglycerides >150 or HDL <40 (males) <50 (females)
Fasting blood sugar >100 but <126

Subject may participate if on the following drugs, provided the drugs can remain at stable doses throughout the 12 week treatment interval.

Ace inhibitor
ARB
HMG CoA reductase inhibitor
Beta blocker
Calcium channel blockers
Alpha-adrenergic antagonist

Exclusion Criteria:

Smoking presently or in the past 6 months
HbA1c ≥ 6.5
Glucocorticoids-eg: prednisone, dexamethasone
Any known sensitivity or intolerance to Metformin
Any chronic GI disorders such as Irritable Bowel Syndrome or Crohns disease
History of congestive heart failure, ischemic heart disease, severe pulmonary disease, liver or kidney disease.
History of malignant or metabolic disorders including diabetes
Presence of an intracardiac or intrapulmonary shunt (we will screen for this by auscultation during the physical exam by PI)
Hypersensitivity to perflutren (contained in Definity)
Pregnant or breastfeeding","12 weeks of Metformin tablet 850 mg 3 x daily

metformin: A 12 week single blind metformin",ChEMBL:CHEMBL1431 | DrugBank:DB00331 | PubChem:4091,Metformin,CN(C)C(=N)NC(=N)N,A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02637895,NCT02637895_EG001,No,All,Adult | Older Adult,Phase 4,20,"Inclusion

Males and Females between the ages of 18 and 65
Fulfills Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for primary diagnosis of PTSD.
Able to give consent
Willingness to sign the treatment contract
A negative urine toxicology
For females of reproductive age, use of an effective birth control method* for the duration of the study or abstinence.
Duration of illness of PTSD for at least 3 months
An initial score at Screening, and Visit 3 (randomization) of ≥ 50 on the Clinician Administered PTSD Scale (CAPS) for PTSD Studies

Exclusion

Lifetime or current diagnosis of schizophrenia or other psychotic disorder, dementia, bipolar disorder.
Subject is currently participating in another clinical trial in which s/he is or will be exposed to an investigational or non-investigational drug or device, or has done so within the preceding month.
Current evidence or history of significant unstable medical illness or organic brain impairment, including stroke, Central Nervous System (CNS) tumor, demyelinating disease, cardiac, pulmonary, gastrointestinal, renal or hepatic impairment that would likely interfere with the action, absorption, distribution, metabolism, or excretion of Vortioxetine. History of moderate or more severe Traumatic Brain Injury (TBI) will also be exclusionary.
Patients who in the investigator's judgment pose a current suicidal or homicidal risk
DSM-5 substance abuse or dependence within the past 90 days. Subject has a positive urine toxicology test for illegal substances.
Diagnosis of anorexia nervosa, bulimia, or Obsessive Compulsive Disorder (OCD) in the past year.
Subject has a documented history of hepato-biliary disease including a history of, or positive laboratory results for hepatitis (hepatitis B surface antigen and/or hepatitis C antibody), and clinically significant hepatic enzyme elevation, including any one of the following enzymes greater than 3 times the upper limit of normal (ULN) value (Alanine transaminase (ALT), aspartate aminotransferase (AST), alkaline phosphatase( ALP)), or total or direct bilirubin > 1.5 x ULN, unless consistent with presumed or diagnosed Gilbert's disease
Subject has taken systemic corticosteroids within 2 weeks of the Randomization Visit
Treatment with any other psychoactive medication within 2 weeks of Visit 1, including all antidepressants, psychoactive herbal or nutritional treatment (St Johns Wort,S-Adenosyl methionine(SAM-e)), lithium, other mood stabilizers, oral antipsychotics, depot antipsychotics within 12 weeks, beta blockers, thioridazine, pimozide, opiates, anxiolytics, and sedatives (with the exception of zolpidem, eszopiclone, and zaleplon). Also any treatment with any medication that the PI judges not acceptable for this study.
Pregnancy or lactation*
Subjects who, in the opinion of the investigator, would be noncompliant with the visit schedule or study procedures (e.g. illiteracy, planned vacations, or planned hospitalizations during the study).
Any laboratory abnormality that in the investigator's judgment is considered to be clinically significant
Patients who are receiving exposure-based psychotherapy that targets PTSD symptoms
Current or planned litigation or other actions related to secondary gain regarding the traumatic event

Subject has clinical evidence of, or ElectroCardiogram (ECG) results indicating any of the following at either screen or Randomization Visit unless repeat ECG shows that the parameter had returned to within normal range by the Randomization Visit:

Q to T interval change (QTc)> 450 msec for men, or > 475 msec for women;
any cardiac condition or ECG evidence that the investigator feels may pose a potential safety concern.","Vortioxetine pill 10mg once daily up to 4 weeks followed by 20mg once daily if tolerated for the rest of the study. Patients unable to tolerate the 20 mg/day dose may be reduced to 10 mg/day between weeks 4 and 8. The dose of study medication should remain stable for weeks 8-12.

Vortioxetine: Vortioxetine pill 10mg once daily up to 4 weeks followed by 20mg once daily if tolerated for the rest of the study. Patients unable to tolerate the 20 mg/day dose may be reduced to 10 mg/day between weeks 4 and 8. The dose of study medication should remain stable for weeks 8-12.",ChEMBL:CHEMBL2104993 | DrugBank:DB09068 | PubChem:9966051,Vortioxetine,Cc1ccc(Sc2ccccc2N2CCNCC2)c(C)c1,N06AX26,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02641067,NCT02641067_EG000,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 1,8,"Inclusion Criteria:

is a non-smoker or moderate smoker
has a body mass index (BMI) ≥ 18.5 and ≤ 40.0 kg/m^2
other than renal impairment, participant is judged to be in good health based on medical history, physical examination, vital signs, and laboratory safety tests
female informed of the risks of pregnancy, agree not to become pregnant while participating in this study. Female of childbearing potential must either be sexually inactive for 14 days prior to dosing and throughout the study, or uses one acceptable birth control method
female of non-childbearing potential must have undergone sterilization procedures at least 6 months prior to dosing.
Participants with severe renal impairment only: has baseline estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m^2

Exclusion Criteria:

is mentally or legally incapacitated or has significant emotional problems
has a history or presence of clinically significant medical or psychiatric condition or disease
has history or presence of alcoholism or drug abuse within the past 2 years
has history or presence of hypersensitivity or idiosyncratic reaction to the study drug, any inactive ingredients, or related compounds
has history or presence of renal artery stenosis
has had a renal transplant or nephrectomy
has rapidly fluctuating renal function as determined by historical measurements
female is pregnant or lactating
has positive results for the urine or saliva drug and urine or breath alcohol screen at screening or check-in
has positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV)
is unable to refrain from or anticipates the use of any drug, including prescription and non-prescription medications, herbal remedies, or vitamin supplements beginning 14 days prior to dosing and throughout the study. Certain medications including those to treat kidney disease will be permitted. Other medications may be permitted following consultation with the Sponsor Clinical Monitor.
is unable to refrain from or anticipates the use of inducers of cytochrome P450 3A (CYP3A) or permeability glycoprotein (P-gp) transporters for at least 28 days prior to dosing and throughout the study.
has been on a diet incompatible with the on-study diet, within 28 days prior to dosing, and throughout the study
has donated blood or had significant blood loss within 56 days prior to dosing
has donated plasma within 7 days prior to dosing
has participated in another clinical trial within 28 days prior to dosing",Participants with severe renal impairment received a single oral dose of 100 mg doravirine,ChEMBL:CHEMBL2364608 | DrugBank:DB12301 | PubChem:58460047,Doravirine,Cn1c(Cn2ccc(C(F)(F)F)c(Oc3cc(Cl)cc(C#N)c3)c2=O)n[nH]c1=O,J05AG06 | J05AR24,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02641067,NCT02641067_EG001,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 1,8,"Inclusion Criteria:

is a non-smoker or moderate smoker
has a body mass index (BMI) ≥ 18.5 and ≤ 40.0 kg/m^2
other than renal impairment, participant is judged to be in good health based on medical history, physical examination, vital signs, and laboratory safety tests
female informed of the risks of pregnancy, agree not to become pregnant while participating in this study. Female of childbearing potential must either be sexually inactive for 14 days prior to dosing and throughout the study, or uses one acceptable birth control method
female of non-childbearing potential must have undergone sterilization procedures at least 6 months prior to dosing.
Participants with severe renal impairment only: has baseline estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m^2

Exclusion Criteria:

is mentally or legally incapacitated or has significant emotional problems
has a history or presence of clinically significant medical or psychiatric condition or disease
has history or presence of alcoholism or drug abuse within the past 2 years
has history or presence of hypersensitivity or idiosyncratic reaction to the study drug, any inactive ingredients, or related compounds
has history or presence of renal artery stenosis
has had a renal transplant or nephrectomy
has rapidly fluctuating renal function as determined by historical measurements
female is pregnant or lactating
has positive results for the urine or saliva drug and urine or breath alcohol screen at screening or check-in
has positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV)
is unable to refrain from or anticipates the use of any drug, including prescription and non-prescription medications, herbal remedies, or vitamin supplements beginning 14 days prior to dosing and throughout the study. Certain medications including those to treat kidney disease will be permitted. Other medications may be permitted following consultation with the Sponsor Clinical Monitor.
is unable to refrain from or anticipates the use of inducers of cytochrome P450 3A (CYP3A) or permeability glycoprotein (P-gp) transporters for at least 28 days prior to dosing and throughout the study.
has been on a diet incompatible with the on-study diet, within 28 days prior to dosing, and throughout the study
has donated blood or had significant blood loss within 56 days prior to dosing
has donated plasma within 7 days prior to dosing
has participated in another clinical trial within 28 days prior to dosing",Healthy participants matched for age and weight received a single oral dose of 100 mg doravirine,ChEMBL:CHEMBL2364608 | DrugBank:DB12301 | PubChem:58460047,Doravirine,Cn1c(Cn2ccc(C(F)(F)F)c(Oc3cc(Cl)cc(C#N)c3)c2=O)n[nH]c1=O,J05AG06 | J05AR24,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT02642094,NCT02642094_EG000,No,Female,Adult | Older Adult,Phase 2,40,"Inclusion Criteria:

Women with confirmed menopausal status. All patients who have NOT had a prior bilateral oophorectomy and/or are younger than age 60, will require menopausal status verified by FSH and estradiol local labs.
Women diagnosed with DCIS/LCIS, Atypical lobular hyperplasia (ALH) or ADH lesions detected by pathology
Women scheduled for mastectomy or lumpectomy after DCIS/LCIS, ALH or ADH diagnosis
Women consented to the UT Health Cancer Center MD Anderson Cancer Center tissue biorepository (HSC20070684H)
Women of child-bearing potential willing to practice 2 forms of contraception, one of which must be a barrier method until at least 30 days after the last dose of rapamycin.
Women of child-bearing potential must have a negative serum pregnancy test at time of enrollment.
Patients must be able to swallow and retain oral medication.
All patients must have given signed informed consent prior to registration on study.

Patients must have normal organ and marrow function as defined below:

Leukocytes ≥ 3,000/uL
Absolute neutrophil count ≥ 1,500/uL
Platelets ≥ 100,000/uL
AST ≤ 2.5 X ULN
ALT ≤ 2.5 X ULN
Total bili ≤ 1.5 X ULN or Direct bili ≤ 1 X ULN

Exclusion Criteria:

Women who are pregnant.
Women who are receiving any other concomitant treatment for their DCIS/LCIS, ALH or ADH
Women who are taking rapamycin for another diagnosis.
Women with an allergy to rapamycin or its derivatives.
Active infection requiring systemic therapy.
Patients who are taking any pills containing herbal (alternative) medicines are NOT eligible for participation. Patients must be off any such medications by the time of registration.
Immunocompromised subjects, including patients with human immunodeficiency virus
Women currently taking strong CYP3A4 inducers or inhibitors. Drugs that cannot be coadministered with rapamycin include but are not limited to: Calcium channel blockers: nicardipine, Antifungal agents: clotrimazole, fluconazole, Antibiotics: troleandomycin, Gastrointestinal prokinetic agents: cisapride, metoclopramide, Other drugs: bromocriptine, cimetidine, danazol, HIV-protease inhibitors (e.g., ritonavir, indinavir), Anticonvulsants: carbamazepine, phenobarbital, phenytoin, Antibiotics: rifapentine. The research team can provide a full list of these medications.

Patients with any of the following conditions or complications are NOT eligible for participation:

GI tract disease resulting in an inability to take oral medication
Malabsorption syndrome
Require IV alimentation
History of prior surgical procedures affecting absorption
Uncontrolled inflammatory GI disease (e.g., Crohn's, ulcerative colitis)",Adverse events are only reported for the treatment group who received the intervention.,ChEMBL:CHEMBL413 | DrugBank:DB00877 | PubChem:134760597 | PubChem:138404388 | PubChem:21944094 | PubChem:5284616,Sirolimus,COC1CC2CCC(C)C(O)(O2)C(=O)C(=O)N2CCCCC2C(=O)OC(C(C)CC2CCC(O)C(OC)C2)CC(=O)C(C)C=C(C)C(O)C(OC)C(=O)C(C)CC(C)C=CC=CC=C1C,L01EG04 | L04AA10 | S01XA23,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT02643394,NCT02643394_EG000,No,All,Adult | Older Adult,Phase 4,51,"Inclusion Criteria:

Adult patients aged 18 years or older
Undergoing elective sinus surgery at Zale Lipshy Hospital

Exclusion Criteria:

Inability of the patient to follow directions or comprehend either English or Spanish language.

Disorders of the liver which would make acetaminophen contraindicated (such as hepatitis, liver failure, prior liver transplant, etc).
Patients with chronic pain manifest by a baseline pain score > 4/10
Chronic opioid use (>2 weeks continuously), or illicit drug abuse
Body weight < 50 kg.
Patients with contraindications to any of the study drugs (such as Malignant Hyperthermia susceptible, celecoxib or sulfa allergy, etc.).
Patients who have taken analgesic medications on the morning of surgery (prior to arrival).
Allergy to acetaminophen","Oral Acetaminophen 1-hour before surgery

Oral Acetaminophen: 1000mg oral acetaminophen + 400mg oral celecoxib given within one hour of incision",ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02643394,NCT02643394_EG001,No,All,Adult | Older Adult,Phase 4,50,"Inclusion Criteria:

Adult patients aged 18 years or older
Undergoing elective sinus surgery at Zale Lipshy Hospital

Exclusion Criteria:

Inability of the patient to follow directions or comprehend either English or Spanish language.

Disorders of the liver which would make acetaminophen contraindicated (such as hepatitis, liver failure, prior liver transplant, etc).
Patients with chronic pain manifest by a baseline pain score > 4/10
Chronic opioid use (>2 weeks continuously), or illicit drug abuse
Body weight < 50 kg.
Patients with contraindications to any of the study drugs (such as Malignant Hyperthermia susceptible, celecoxib or sulfa allergy, etc.).
Patients who have taken analgesic medications on the morning of surgery (prior to arrival).
Allergy to acetaminophen","Intravenous Acetaminophen within 1-hour prior to anesthetic emergence

Intravenous acetaminophen: 400mg oral celecoxib given within one hour of incision + 1000mg IV acetaminophen within one hour prior to anesthetic emergence.",ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02656017,NCT02656017_EG000,No,All,Adult,Phase 2,49,"Inclusion Criteria:

Subject has Autosomal Dominant Polycystic Kidney Disease; Subject is fluent in English

Exclusion Criteria:

Subject is not on active military duty; Subject is not currently participating in another clinical trial; Subject's current GFR is not <50 cc/min/1.73m2; Subject does not have diabetes; Subject does not have a systemic disease other than hypertension and PKD; Subject does not have a solitary kidney; Subject does not have an allergy or intolerance to metformin; Subject is not pregnant or lactating or intending to become pregnant within the next three years; Subject does not have an unstable or unclipped cerebral aneurysm; Subject does not have active coronary artery disease; Subject does not have an MRI incompatible device/implant; Subject does not have severe claustrophobia; Subject has not had any solid organ transplant; Subject does not have a Vitamin B12 deficiency; Subject does not currently take any medications that interact with metformin, such as nifedipine, furosemide, cationic drugs (amiloride, ranitidine, triamterene digoxin, procainamide, quinidine, vancomycin, trimethoprim); Subject does not currently take nor has taken (within 2 weeks) the drug tolvaptan (Jynarque or Samsca)","Participants will be started on 500 mg of metformin once daily, with the following scheduled dose titrations:

Increase to 500mg twice daily at week 2
Increase to 1000mg qAM, 500mg qPM at week 4

Increase to 1000mg twice daily at week 6 for the duration of their participation (26 months).

Increased titrations based on tolerability

Metformin: Monitoring of tolerability and symptoms.",ChEMBL:CHEMBL1431 | DrugBank:DB00331 | PubChem:4091,Metformin,CN(C)C(=N)NC(=N)N,A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,1.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT02660229,NCT02660229_EG000,No,All,Adult | Older Adult,Phase 4,34,"Inclusion Criteria:

Adult men and women aged 19 years or more
Patients with cancerous pain who are hospitalized or scheduled for hospitalization at Screening and not planned to be discharged during the study
Patients with mean moderate to severe pain over the past 7 days at Screening as verbally confirmed (NRS 4 or higher)
Subjects who voluntarily signed the Informed Consent Form for the study
Subjects who are capable of understanding details of the study and verbal communication on pain intensity

Exclusion Criteria:

Patients who reached the narcotic analgesic dose corresponding to the followings for cancerous pain treatment immediately prior to Screening (oral morphine dose 195mg/day, oral oxycodone dose 130mg/day, patch fentanyl dose 75μg/hour)
Patients with a medical history of hypersensitivity to an ingredient of oxycodone hydrochloride or morphine sulfate or other narcotic analgesics
Patients who have contraindications and cautions when study drugs administered.","Brand Name: OxyNorm® Generic name: Oxycodone hydrochloride

Oxycodone Hydrochloride: Oxycodone injection",PubChem:5462350,Oxycodone Hydrochloride,COc1ccc2c3c1OC1C(=O)CCC4(O)C(C2)N(C)CCC314.Cl,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02668432,NCT02668432_EG000,No,All,Adult | Older Adult,Phase 4,9,"Inclusion Criteria:

New onset atrial fibrillation
Severe sepsis or septic shock (defined by ≥2 systemic inflammatory response syndrome criteria + infection)

Exclusion Criteria:

Age < 18 years
History of atrial flutter
History of atrial fibrillation
QTc >500 msec at baseline
2nd or 3rd degree AV block
Currently receiving anti-arrhythmic therapy
Untreated thyroid dysfunction
Acute or chronic hepatic failure
Other indication for antiarrhythmic therapy
Recent cardiac surgery in last 30 days
Pregnancy",< 10g oral loading dose of amiodarone,ChEMBL:CHEMBL633 | DrugBank:DB01118 | PubChem:2157,Amiodarone,CCCCc1oc2ccccc2c1C(=O)c1cc(I)c(OCCN(CC)CC)c(I)c1,C01BD01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02668432,NCT02668432_EG001,No,All,Adult | Older Adult,Phase 4,9,"Inclusion Criteria:

New onset atrial fibrillation
Severe sepsis or septic shock (defined by ≥2 systemic inflammatory response syndrome criteria + infection)

Exclusion Criteria:

Age < 18 years
History of atrial flutter
History of atrial fibrillation
QTc >500 msec at baseline
2nd or 3rd degree AV block
Currently receiving anti-arrhythmic therapy
Untreated thyroid dysfunction
Acute or chronic hepatic failure
Other indication for antiarrhythmic therapy
Recent cardiac surgery in last 30 days
Pregnancy",10 g (+/- 20%) oral loading dose of amiodarone,ChEMBL:CHEMBL633 | DrugBank:DB01118 | PubChem:2157,Amiodarone,CCCCc1oc2ccccc2c1C(=O)c1cc(I)c(OCCN(CC)CC)c(I)c1,C01BD01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02671760,NCT02671760_EG000,No,All,Adult,Phase 2,39,"Inclusion Criteria:

Body mass index (BMI) between 19 and 32 kg/m2, inclusive;
Report occasional difficulty falling asleep or staying asleep;
Report a regular, habitual bedtime between 21:00 and 24:00, routinely spend at least 7.5 and no more than 9.0 hours in bed each night and observe a bedtime that does not vary by more than 2 hours over the course of the week. Subjects will be required to complete at least 5 days of sleep information in a diary provided at the screening visit and returned to study personnel no later than 24 hours prior to check-in for the first overnight visit.
Be in good general health as determined by a thorough medical history and physical examination including vital signs and clinical laboratory tests;
Females of childbearing potential must be using an acceptable method of contraception, have a negative serum pregnancy test at screening and have a negative urine pregnancy test before randomization and prior to each Treatment Period. Acceptable methods of contraception include oral, intrauterine and injectable contraceptives or double barrier methods. After screening, subjects using oral contraceptives must agree to add a double barrier method until 30 days following the last dose of study medication. Female subjects relying on oral contraceptives must have been using them for at least one month prior to screening;
Female subjects who have been surgically sterilized are eligible if they have a negative serum pregnancy test at screening and negative urine pregnancy test at check-in for Visits 2 and 3, or are post-menopausal as defined by the cessation of menses for a period of at least 2 years prior to screening or have had a complete hysterectomy;

Male subjects must use an acceptable method of contraception during the course of the study and for the 30 days following the last dose of study medication. Acceptable methods of contraception include:

Abstinence
A condom and one of the following:

i. Vasectomy for more than 6 months. ii. Female partner who meets one of the following conditions:

Uses a spermicidal gel or foam; or
Has had a tubal ligation, hysterectomy or bilateral oophorectomy; or
Is post-menopausal (menopause is defined as over the age of 60 years, or between 45 and 60 years being amenorrheic for at least 2 years with plasma follicle stimulating hormone (FSH) level > 30 UI/L); or
Be able to read, understand, and provide written/dated informed consent before enrolling in the study and must be willing to comply with all study procedures;
Be willing and able to be confined to the clinical research site for one night in each of 3 treatment periods as required by the protocol.
Refrain from alcohol on PSG days;
On the days of check-in for each of the study's two treatment periods, refrain from the use of alcohol and from napping, defined as any sleep episode occurring outside of the subject's main sleep episode of the day;
Report a recent history of napping of no more than once per week.
An Epworth Sleepiness Scale score ≤8 at screening.

Exclusion Criteria:

Clinically significant, acute illness within 14 days prior to screening (Visit 1).
Clinically significant, unstable medical illness;
Evidence or history of clinically significant allergic (except for untreated, asymptomatic, seasonal allergies at time of dosing), hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic or neurological disease;
History of cancer or diabetes;
A supine blood pressure > 140/90 millimeters mercury (mm/Hg) at screening;
Heart rate > 100 beats per minute (BPM) at screening;
Clinically significant psychiatric illness, including chronic psychiatric illness or the history or presence of any Axis I condition;
History or presence of chronic pain;
Lifetime history of seizure disorder or serious head injury;
Clinically significant sleep disorder, including insomnia, sleep apnea, narcolepsy, parasomnia, restless leg syndrome or circadian rhythm disorder;
Any condition that may affect drug absorption;
Travel across more than three time zones, an expected change in sleep schedule or involvement in night shift work within one month prior to screening or during the study period;
Any clinically significant abnormal finding on physical examination, vital signs or clinical laboratory tests, as determined by the Investigator;
History of allergies, or known sensitivity, hypersensitivity, or adverse reaction to any drug similar to diphenhydramine, zolpidem or lorazepam;
Pregnant or lactating females;
Positive serum pregnancy test at Visit 1 or positive urine pregnancy test at check-in for Visit 2 or 3;
Positive urine drug screen at the Visit 1;
Recent history (≤ one year) of alcohol or drug abuse, or current evidence of substance dependence or abuse as defined by DSM-V criteria;
Regular consumption of ""large amounts"" of xanthine-containing substances (i.e., more than 500 mg of caffeine per day or equivalent amounts of xanthine-containing substances);
Self-report of a usual consumption of more than 14 units of alcohol per week. One unit of alcohol is equivalent to 12 ounces of beer, 4 ounces of wine or 1 ounce of liquor;
Use of more than 10 products containing nicotine per day or routinely smokes during sleep period
Discontinuation of smoking or participation in a smoking cessation program within 90 days of screening;
Any use with the six months prior to screening of restricted concomitant medications including prescription hypnotics, antidepressants, anxiolytics, anticonvulsants or narcotics;
Use of any prescription drug, OTC medication, grapefruit juice, herbal preparation or food supplement, excluding vitamins, acetaminophen or hormonal contraceptives within two weeks of randomization;
Use of any investigational drug within 30 days prior to screening or any prior exposure to the study drugs diphenhydramine, zolpidem or lorazepam or other drugs of the same pharmaceutical classes;
Positive alcohol breathalyzer test at the time of screening or prior to dosing at Visit 2, 3 or 4.","SM-1

SM-1: 3-drug combination product containing 50 mg diphenhydramine, 5 mg zolpidem and 0.5 mg lorazepam",PubChem:57339223,Fumigaclavine C,C=CC(C)(C)c1[nH]c2cccc3c2c1CC1C3C(OC(C)=O)C(C)CN1C,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02673138,NCT02673138_EG001,No,All,Adult,Not Applicable,10,"Inclusion Criteria:

Age 18-45 years
Clinical diagnosis of T1D (type 1 diabetes) (formal antibody and/or genetic testing will not be required)
Duration of T1D ≥ 1 year
HbA1c ≤ 9 %
Treated with continuous subcutaneous insulin infusion (with or without adjunctive treatment with a SGLT2 inhibitor) for at least 3 months
Body weight > 40 kg
Be in good general health without other acute or chronic illness that in the judgment of the investigator could interfere with the study or jeopardize subject safety
Normal hematocrit
Able to give consent
Female subjects of reproductive potential must be abstinent or consistently using appropriate family planning methods.

Exclusion Criteria:

Insulin resistant (defined as requiring > 1.5 units/kg/day at time of study enrollment)

Renal impairment, determined as eGFR < 60 ml/minute/1.73m2

History of unstable or rapidly progressing renal disease
Conditions of congenital renal glucosuria
Renal allograft
Recurrent UTI (urinary tract infection)
History of Vesico-ureteral-reflux disease
Presence of any medical or psychiatric disorder that may interfere with subject safety or study conduct
Use of metformin, thiazolidinedione or GLP1 agonist within 1 month prior to screening visit. For those subjects on canagliflozin or other SGLT2 inhibitors, an alternate study procedure may be utilized as described above
Use of any medications (besides insulin or SGLT2 inhibitor) known to effect blood glucose levels, including oral or other systemic glucocorticoid therapy. Inhaled, intranasal, or rectal corticosteroid use is allowed as long as not given within 2 weeks of the closed loop admissions. Use of topical glucocorticoids is allowable as long as affected skin area does not overlap with study device sites
History of hypoglycemic seizure within last 3 months
History of diabetic ketoacidosis (DKA) requiring medical intervention (ie. emergency room visit and/or hospitalization) within 1 month prior to the screening visit
Allergies or contraindication to the contents of canagliflozin tablets or insulin
Volume depleted subjects. Subjects at risk for volume depletion due to co-existing conditions or concomitant medications, such as loop diuretics who cannot carefully monitor their volume status should be excluded from the study
Female subjects who are pregnant, lactating, or unwilling to be tested for pregnancy
Recurrent GU (genitourinary) infections
Uncircumcised males secondary to increased risk of development of GU infections
History of hypotension, defined as blood pressure (BP) <10th% for age and sex","Subjects will undergo basal interruption with canagliflozin during an overnight stay on the research unit

canagliflozin: basal interruption with canagliflozin",DrugBank:DB08907 | PubChem:24812758,Canagliflozin,[H][C@@]1(c2ccc(C)c(Cc3ccc(-c4ccc(F)cc4)s3)c2)O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O,A10BD16 | A10BK02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02677623,NCT02677623_EG000,No,Female,Adult | Older Adult,Phase 4,33,"Inclusion Criteria:

- Planned cystoscopy

Exclusion Criteria:

Women who are pregnant

Women with contraindications to pyridium, sodium fluorescein or mannitol:

Intra-operative administration of nitric oxide, prilocaine and sodium nitrite
Anuria
Women with creatinine greater than 1 or Cr Cl < 50ml/minute
Known allergy to pyridium, sodium fluorescein or mannitol.
Women with a known urologic anatomical anomaly","Method of administration: oral
Dose: 200 mg PO with small sip of water
Known adverse events: yellow discoloration of skin or sclera, 1-10% central nervous system effects including headache and dizziness, GI effect of cramping, < 1% acute renal failure, methemoglobinemia, hemolytic anemia, hepatitis, rash, skin pigmentation, vertigo, stomach cramps
Contraindications: to be used in caution in patients with renal impairment Cr Cl < 50ml/minute and in patients who are receiving nitric oxide, prilocaine and sodium nitrite as it can cause methemoglobinemia

Pyridium",PubChem:8691,Phenazopyridine hydrochloride,Cl.Nc1ccc(N=Nc2ccccc2)c(N)n1,,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02677623,NCT02677623_EG001,No,Female,Adult | Older Adult,Phase 4,32,"Inclusion Criteria:

- Planned cystoscopy

Exclusion Criteria:

Women who are pregnant

Women with contraindications to pyridium, sodium fluorescein or mannitol:

Intra-operative administration of nitric oxide, prilocaine and sodium nitrite
Anuria
Women with creatinine greater than 1 or Cr Cl < 50ml/minute
Known allergy to pyridium, sodium fluorescein or mannitol.
Women with a known urologic anatomical anomaly","Method of administration: intravenous
Dose: 25 mg
Known adverse events: nausea, vomiting, flushing or rash, hypersensitivity and anaphylactic reactions can occur following injection and immediate treatment with epinephrine should be available, skin and urine discoloration (urine may appear bright yellow for 24-36 hours), extravasation may cause skin sloughing, toxic neuritis and phlebitis, nausea, rare cardiac arrest and seizure,
Contraindications: use with caution in patients with history of hypersensitivity, allergies or asthma

Sodium Fluorescein",PubChem:10608,Fluorescein Sodium,O=C([O-])c1ccccc1-c1c2ccc(=O)cc-2oc2cc([O-])ccc12.[Na+].[Na+],,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02677623,NCT02677623_EG002,No,Female,Adult | Older Adult,Phase 4,32,"Inclusion Criteria:

- Planned cystoscopy

Exclusion Criteria:

Women who are pregnant

Women with contraindications to pyridium, sodium fluorescein or mannitol:

Intra-operative administration of nitric oxide, prilocaine and sodium nitrite
Anuria
Women with creatinine greater than 1 or Cr Cl < 50ml/minute
Known allergy to pyridium, sodium fluorescein or mannitol.
Women with a known urologic anatomical anomaly","Method of administration: irrigant during cystoscopy
Dose: 300cc during cystoscopy to visualize the ureters
Known adverse events: dysuria, polyuria, hyponatremia with excess absorption, potential increased risk of urinary tract infection
Contraindications when used as a genitourinary irrigation solution: anuria

Mannitol",ChEMBL:CHEMBL1682 | ChEMBL:CHEMBL689 | DrugBank:DB00742 | DrugBank:DB01638 | PubChem:5780 | PubChem:6251 | PubChem:90540,Mannitol,OCC(O)C(O)C(O)C(O)CO,A06AD16 | A06AD18 | A06AG07 | B05BC01 | B05CX02 | B05CX04 | R05CB16 | V04CC01 | V04CX04,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02679508,NCT02679508_EG000,No,All,Adult | Older Adult,Phase 4,139,"Inclusion Criteria

Healing Phase:

Participants endoscopically diagnosed with EE of grades A to D by the LA Classification Grading System at the start of treatment (Week 0 of the healing phase)
Participants with H. pylori negative
Participants who, in the opinion of the principal investigator or investigator, are capable of understanding the content of the clinical research and complying with the research protocol requirements.
Participants who can sign and date an informed consent form and information sheet prior to the conduction of the clinical research procedures.
Male or female participants aged 20 years or older at the time of informed consent

Therapeutic category: Ambulatory

Maintenance Phase:

Participants who have endoscopically confirmed EE healing* (mucous membrane disorder is not observed) at completion of the healing phase (Week 4 or 8 of the healing phase)

* Participants who are classified as grade 0 according to severity classification of EE (See Table 9.b)

Participants who have been determined to be appropriate as subjects for maintenance treatment of EE by the principal investigator or investigator

Exclusion Criteria:

Healing Phase:

Participants with concurrent peptic ulcer (except scarred stage) or Zollinger-Ellison syndrome
Participants who received treatment with PPIs (including vonoprazan) within 4 weeks (Week -4 to Week 0) prior to the start of healing phase (Week 0 of the healing phase)
Participants with a history of H. pylori eradication.
Participants who have received surgery or treatment affecting gastroesophageal reflux (fundoplication or dilation for esophageal stenosis [excluding Schatzki's ring], etc.)
Participants with an esophagus-related complication (eosinophilic esophagitis, esophageal varices, scleroderma, viral or fungal infection, esophageal stenosis, etc.), a history of radiotherapy or cryotherapy of the esophagus, a caustic or physiochemical trauma (esophageal sclerotherapy, etc.). However, participants with Schatzki's ring (mucosal tissue ring around inferior esophageal sphincter) or Barrett's esophagus are allowed to be included.
Participants with clinically apparent hepatic impairment (e.g., AST or ALT levels at the time of informed consent: >1.5 times the upper limit of normal (ULN).
Participants with renal impairment or renal failure [creatinine clearance (CCr) ˂30 mL/min, etc.]
Participants with a history of hypersensitivity or allergy for PPIs.
Participants with a history of gastrectomy, gastrointestinal resection, or vagotomy
Participants with a malignant tumor
Participants who are pregnant, breast-feeding, possibly pregnant, or planning to become pregnant
Participants with one of the diseases listed under administration contraindication in the vonoprazan or lansoprazole package insert
Participants planning to take prohibited concomitant medications during the research period
Participants participating in other clinical studies

Participants who have been determined to be inappropriate as subjects in the study by the principal investigator or investigator

Maintenance Phase:

Participants who have taken PPIs other than the study drug or the control drug during the healing phase
Participants who have been determined to be inappropriate as subjects in the study by the principal investigator or investigator","Vonoprazan 20 mg administered orally once daily in the healing phase, after that Vonoprazan 10 mg (as the initial dose and adjusted to Vonoprazan 10 mg or 20 mg) administered orally once daily in the maintenance phase.",ChEMBL:CHEMBL2079130 | DrugBank:DB11739 | PubChem:15981397,Vonoprazan,CNCc1cc(-c2ccccc2F)n(S(=O)(=O)c2cccnc2)c1,A02BC08 | A02BD14 | A02BD15,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0
NCT02679573,NCT02679573_EG000,No,All,Adult | Older Adult,Phase 3,429,"Inclusion Criteria:

Male or female 18 years of age or older

Evidence of acute onset of CABP with 2 or more of the following symptoms (new or worsening)

Cough
Production of purulent sputum consistent with bacterial infection
Difficulty breathing
Chest pain due to pneumonia

AND have at least 2 of the following findings:

Fever (oral temperature >38.0°C)
Hypothermia (oral temperature <35.0°C)
Tachycardia (heart rate >100 beats/min)
Tachypnea (respiratory rate >18 breaths/min)

AND have at least 1 of the following findings:

Hypoxemia (oxygen saturation <90% or PaO2 < 60 mmHg) on room air or with subject's baseline (pre-CABP under study) supplemental oxygen
Clinical evidence of pulmonary consolidation and/or presence of pulmonary rales
An elevated white blood cell count (WBC) >10,000/mm3 or 15% immature neutrophils (bands), regardless of total peripheral WBC count or leukopenia with WBC <4500/mm^3
Presence of lobar, multilobar, or patchy parenchymal infiltrate(s) consistent with acute bacterial pneumonia on a pulmonary imaging study within 48 hours before the first dose of study drug
PORT risk class of II to V (PSI score >50)
Must be a suitable candidate for possible IV to oral switch antibiotic therapy and must also be able to swallow large tablets/capsules intact without crushing

Exclusion Criteria:

A medical history of significant hypersensitivity or allergic reaction to antibiotics of the quinolone or oxazolidinone class or study drug excipients according to the investigator
Any infection expected to require other systemic antibiotics in addition to study drug

Receipt of systemic antibiotic therapy in the 7 days before enrollment unless 1 of the following is documented:

Received at least 48 hours of antibiotic therapy for CABP and clinic notes document treatment failure (i.e., not by patient history or pulmonary imaging alone) with new or worsening symptoms while on pre-study therapy
Received 1 dose of a single, potentially effective, short-acting antibacterial drug or drug regimen for CABP within 24 hours before enrollment (limited to 25% of enrolled patients)
Respiratory infection confirmed or suspected to be secondary to hospital-acquired or ventilator-associated pneumonia OR requires treatment in an intensive care setting, OR requires mechanical ventilation
Current or suspected diagnosis of viral, fungal, or aspiration pneumonia, noninfectious causes of pulmonary infiltrates, lung cancer, cystic fibrosis, tuberculosis, empyema (not including sterile parapneumonic effusions)
Known anatomical or pathological bronchial obstruction OR history of bronchiectasis OR GOLD Stage 4 COPD OR history of post obstructive pneumonia
Severely compromised immune system
Known history of Child-Pugh Class B or C liver disease
History of post-antibiotic colitis within last 3 months
Other exclusions include those described in the safety label for drugs in the quinolone and/or oxazolidinone classes such as QT prolongation, proarrhythmic conditions, concomitant use of drugs known to cause QT prolongation, peripheral neuropathy, tendon disorders, history of myasthenia gravis, liver disease, severe renal disease, seizures and concomitant use of MAO A or B inhibitor agents and adrenergic serotonergic agents","Delafloxacin: 300 mg IV, Q12H for at least 6 doses with potential to switch to 450 mg oral tablet, Q12H for up to 20 doses total",ChEMBL:CHEMBL2105637 | DrugBank:DB11943 | PubChem:487101,Delafloxacin,Nc1nc(-n2cc(C(=O)O)c(=O)c3cc(F)c(N4CC(O)C4)c(Cl)c32)c(F)cc1F,J01MA23,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02684435,NCT02684435_EG000,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 2,63,"Inclusion Criteria:

To be eligible for the present study, patients must meet the following criteria:

Able to provide written informed consent
Willing to comply with protocol requirements
At least 18 years of age
Have kidney disease, defined as either CKD II-VI, determined by estimated glomerular filtration rate (GFR) of <90 and derived from serum creatinine measurements, or albuminuria/proteinuria, determined by albumin to creatinine ratio or protein to creatinine ratio of >30mg/gm, or having received a kidney transplant
Have at least one kidney lesion identified but incompletely characterized on a non-contrasted US, CT, or MR exam for which the patient's provider recommends follow-up studies or further evaluation with an additional imaging tests.

Exclusion Criteria:

Patients who meet any of the following criteria will be excluded for enrollment:

Critically ill or medically unstable and whose critical course during the observation period would be unpredictable (e.g., chronic obstructive pulmonary disease (COPD) requiring oxygen)
Known hypersensitivity to sulfur hexafluoride or to any component of perflutren lipid (Definity®)
Right to left shunt, severe pulmonary hypertension (Pulmonary artery pressure >90mmHg), or adult respiratory distress syndrome

Active cardiac disease including any of the following:

Severe congestive heart failure (class IV in accordance with the classification of the New York Heart Association)
Unstable angina.
Severe arrhythmia (i.e. ventricular tachycardia, flutter fibrillation; ventricular premature complexes occurring close to the preceding T- wave, multifocal complexes).
Myocardial infarction within 14 days prior to the date of proposed Definity® administration.
Uncontrolled systemic hypertension (systolic blood pressure (BP) >180 mm Hg and/or diastolic BP >100 mm Hg despite optimal medical management
Is in an intensive care setting
Has an unstable neurological disease (e.g cerebrovascular accident (including transient ischemic attacks (TIAs) within the 3 months before signing of informed consent
Has undergone an invasive procedure on kidney lesion (e.g. tissue biopsy, surgery, nonsurgical cytoreductive procedure) since identification of lesion via US without contrast

Has any other medical condition or other circumstances that would significantly decrease the chances of obtaining reliable data or of achieving the study objectives such as:

Mental illness
Drug abuse
Female patient who is pregnant or lactating (the possibility of pregnancy has to be excluded by negative serum or urine beta human chorionic gonadotropin results, obtained within 24 hours before the perflutren lipid administration, or on the basis of patient history, e.g.: tubal ligation, hysterectomy or a minimum of 1 year without menses)

Obesity that limits obtainment of acceptable images

-","Activate by shaking for 45 seconds using VIALMIX. Use activated product within 5 minutes. Infusion: The recommended infusion dose for activated perflutren is via an IV infusion of 1.3 mL added to 50 mL of preservative-free saline. The rate of infusion should be initiated at 4.0 mL/minute, but titrated as necessary to achieve optimal image enhancement, not to exceed 10 mL/minute per P.I. approval

Perflutren lipid microsphere: Dosing per approved package label",ChEMBL:CHEMBL1663 | DrugBank:DB00556 | PubChem:6432,Perflutren,FC(F)(F)C(F)(F)C(F)(F)F,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02689063,NCT02689063_EG001,No,All,Adult | Older Adult,Phase 3,75,"Inclusion Criteria:

Is male or female ≥ 18 and ≤ 65 years of age.
Is classified by the anesthesiologist as P1 to P2 in the American Society of Anesthesiologists (ASA) Physical Status Classification System.
Has undergone primary, unilateral, distal, first metatarsal bunionectomy (osteotomy and internal fixation) with no additional collateral procedures.
Experiences a pain intensity rating of ≥ 40 mm on a 100-mm Visual Analogue Scale (VAS) during the 9-hour period after discontinuation of the anesthetic block.
Has a body weight ≥ 45 kg and a body mass index (BMI) ≤ 40 kg/m2.
If female and of childbearing potential, is nonlactating and nonpregnant (has negative pregnancy test results at Screening [urine] and on the day of surgery prior to surgery [urine]).

If female, is either not of childbearing potential (defined as postmenopausal for at least 1 year or surgically sterile [bilateral tubal ligation, bilateral oophorectomy, or hysterectomy]) or practicing 1 of the following medically acceptable methods of birth control:

Hormonal methods such as oral, implantable, injectable, or transdermal contraceptives for a minimum of 1 full cycle (based on the subject's usual menstrual cycle period) before study drug administration.

Total abstinence from sexual intercourse since the last menses before study drug administration through completion of final study visit.

Intrauterine device (IUD). Double-barrier method (condoms, sponge, diaphragm, or vaginal ring with spermicidal jellies or cream).

Is able to provide written informed consent to participate in the study and able to understand the procedures and study requirements.
Must voluntarily sign and date an informed consent form (ICF) that is approved by an Institutional Review Board (IRB) before the conduct of any study procedure.
Is willing and able to comply with study requirements (including diet, alcohol, and smoking restrictions), complete the pain evaluations, remain at the study site for approximately 72 hours, and return for follow-up 7 ± 2 days after surgery.

Exclusion Criteria:

Has a known history of allergic reaction or clinically significant intolerance to acetaminophen, aspirin, opioids, or any nonsteroidal anti-inflammatory drugs (NSAIDs, including ibuprofen); history of NSAID-induced bronchospasm (subjects with the triad of asthma, nasal polyps, and chronic rhinitis are at greater risk for bronchospasm and should be considered carefully); or hypersensitivity, allergy, or significant reaction to sulfa (including sulfonamide) medicines, ingredients of the study drug, or any other drugs used in the study including anesthetics and antibiotics that may be required on the day of surgery.
Has experienced any surgical complications or other issues that, in the opinion of the investigator, could compromise the safety of the subject if he or she continues into randomized treatment period or could confound the results of the study.
Has known or suspected history of alcoholism or drug abuse or misuse within 2 years of screening or evidence of tolerance or physical dependence before dosing with study drug.
Has any clinically significant unstable cardiac, respiratory, neurological, immunological, hematological, or renal disease or any other condition that, in the opinion of the investigator, could compromise the subject's welfare, ability to communicate with the study staff, or otherwise contraindicate study participation.
Has any ongoing condition, other than a condition associated with the current primary, unilateral, first metatarsal bunionectomy that could generate levels of pain sufficient to confound the results of the study (eg, gout, severe osteoarthritis of the target joint or extremity).
Has a history or current diagnosis of a significant psychiatric disorder that, in the opinion of the investigator, would affect the subject's ability to comply with the study requirements.
Has tested positive either on the urine drug screen or on the alcohol breathalyzer test. Subjects who test positive at Screening only and can produce a prescription for the medication from their physician may be considered for study enrolment at the discretion of the investigator.
Has a history of a clinically significant (investigator opinion) gastrointestinal (GI) event within 6 months before Screening or has any history of peptic or gastric ulcers or GI bleeding.
Has a surgical or medical condition of the GI or renal system that might significantly alter the absorption, distribution, or excretion of any drug substance.
Is considered by the investigator, for any reason (including, but not limited to, the risks described as precautions, warnings, and contraindications in the current version of the Investigator's Brochure for IV Maxigesic®), to be an unsuitable candidate to receive the study drug.
Is receiving systemic chemotherapy, has an active malignancy of any type, or has been diagnosed with cancer within 5 years before Screening (excluding treated squamous or basal cell carcinoma of the skin).
Is currently receiving anticoagulants (eg, heparin or warfarin).
Has received a course of systemic corticosteroids (either oral or parenteral) within 3 months before Screening (inhaled nasal steroids and regional/limited area application of topical corticosteroids (investigator discretion) are allowed).
Has received or will require any analgesic medication within 5 half-lives (or, if half-life is unknown, within 48 hours) before surgery.
Has a history of chronic use (defined as daily use for > 2 weeks) of NSAIDs, opiates, or glucocorticoids (except inhaled nasal steroids and regional/limited topical corticosteroids), for any condition within 6 months before study drug administration. Aspirin at a daily dose of ≤ 325 mg is allowed for cardiovascular prophylaxis if the subject has been on a stable dose regimen for ≥ 30 days before Screening and has not experienced any relevant medical problem.
Has been treated with agents that could affect the analgesic response (such as central alpha agents [clonidine and tizanidine], neuroleptic agents, and other antipsychotic agents) within 2 weeks before dosing with study drug.
Has a significant renal or hepatic disease, as indicated by clinical laboratory assessment (results ≥ 3 times the upper limit of normal [ULN] for any liver function test, including aspartate aminotransferase [AST], alanine aminotransferase [ALT], and lactate dehydrogenase, or creatinine ≥ 1.5 times the ULN).
Has any clinically significant laboratory finding at Screening that, in the opinion of the investigator, contraindicates study participation.
Has significant difficulties swallowing capsules or is unable to tolerate oral medication.
Previously participated in another clinical study of Maxigesic® IV or received any investigational drug or device or investigational therapy within 30 days before Screening.","IV Acetaminophen 1000 mg/100 mL solution for infusion, 100mL. every 6 hours for 48 hours

IV Acetaminophen: IV Acetaminophen 1000 mg/100 mL solution for infusion, 100mL, every 6 hours for 48 hours",ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT02695420,NCT02695420_EG000,No,All,Adult | Older Adult,Phase 2,21,"Inclusion Criteria:

Japanese male or female ≥ 20 years and ≤ 85 years of age
History of chronic stable heart failure (HF) with reduced ejection fraction, defined as requiring treatment for HF for a minimum of 4 weeks prior to screening
Treated for HF with optimal pharmacological therapy
Left ventricular ejection fraction ≤ 40% at screening

Exclusion Criteria:

Severe uncorrected valvular heart disease
Hypertrophic obstructive cardiomyopathy, active myocarditis, constrictive pericarditis, or clinically significant congenital heart disease
Acute myocardial infarction, unstable angina, or persistent angina at rest within 30 days prior to randomization
Systolic blood pressure (BP) > 160 mmHg or < 90 mmHg, or diastolic BP > 90 mmHg, or heart rate (HR) > 110 beats per minute (bpm) or HR < 50 bpm
Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m^2
Total bilirubin (TBL) ≥ 2x upper limit of normal (ULN), or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 3x ULN Other Exclusion Criteria may apply.",Placebo for omecamtiv mecarbil BID,ChEMBL:CHEMBL1800955 | DrugBank:DB11816 | PubChem:11689883,OMECAMTIV MECARBIL,COC(=O)N1CCN(Cc2cccc(NC(=O)Nc3ccc(C)nc3)c2F)CC1,C01CX10,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02700048,NCT02700048_EG001,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 1 | Phase 2,11,"Inclusion Criteria:

Subjects are capable of giving informed consent.
Female subjects must be post-menopausal for at least 1 year, or surgically incapable of bearing children, or practicing at least one or more of the following methods of contraception for three months prior to, and during the study: hormonal, intrauterine device (IUD), or barrier method in combination with a spermicide.
Subject should be medication free, other than hormonal birth control, for 48 hours before through 24 hours after study drug administration. If the need for medication is identified during this time period, it will be discussed with and approved by the PI.

Exclusion Criteria:

Women who are pregnant.
Women who are breastfeeding.
Subject has a known hypersensitivity to naloxone.
Subject with hypertension
Subject has a significant history of cardiac, neurologic, psychiatric, oncologic, endocrine, metabolic, renal or hepatic disease
Subject has taken or used any investigational drug or device in the 30 days prior to screening.
Subject has taken either prescribed or over the counter medication for 48 hours prior to study drug administration on either of the study days, other than hormonal birth control.
History of narcotic or heroin abuse.","3 doses of intra-nasal naloxone (4 mg each) will be given during controlled hypoglycemic insulin clamps

intra-nasal naloxone: 3 doses of intra-nasal naloxone (4 mg each) will be given during controlled hypoglycemic insulin clamps",ChEMBL:CHEMBL80 | DrugBank:DB01183 | PubChem:5284596,Naloxone,C=CCN1CC[C@]23c4c5ccc(O)c4O[C@H]2C(=O)CC[C@@]3(O)[C@H]1C5,A06AH04 | N02AA53 | N02AA55 | N02AX51 | V03AB15,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02701985,NCT02701985_EG001,No,All,Adult | Older Adult,Phase 2,38,"Inclusion Criteria:

A diagnosis of primary Sjogren's syndrome according to the revised American-European Consensus Group (AECG) criteria
ESSDAI score greater than or equal to (>/=) 5
ESSPRI score >/=5
Elevated serum titers of anti-Sjogren's-syndrome-related antigen A (anti-SSA) and/or anti-Sjogren's-syndrome-related antigen B (anti-SSB) antibodies at screening
Negative pregnancy test at screening and baseline (for women only)
Willing to comply with the study procedures and restrictions, including measures to prevent pregnancy and restrictions on sperm donation

Exclusion Criteria:

A diagnosis of secondary Sjogren's syndrome according to the revised AECG criteria
Severe complications of Sjogren's syndrome
Systemic immunosuppressant therapy, cyclophosphamide, or B-cell depleting therapy within 6 months prior to the screening visit
Corticosteroid therapy exceeding 7.5 mg prednisone equivalents per day
A positive test result for hepatitis B (HBV), hepatitis C (HCV), or human immunodeficiency virus (HIV), or tuberculosis, or any other active viral, fungal, yeast or bacterial infection at screening
A history suggesting reduced immune function or any other conditions predisposing participants to serious infection
A history of lymphoma, myeloma or monoclonal gammopathy of unknown significance (MGUS), or any other malignancies within the past 5 years
A diagnosis of fibromyalgia or significant depression
Having any concomitant disease or condition that could interfere with the conduct of the study, or that would pose an unacceptable risk to the individual
Participation in an investigational drug or device study within 3 months prior to screening
Inability to comply with the study protocol for any other reason
Women who are lactating, breastfeeding or planning to nurse
Using other prohibited medication (moderate or potent inhibitors of CYP3A4; strong inducers of CYP3A4; strong inhibitors of the transporter P-glycoprotein [P-gp]; sensitive substrates of CYP3A4 with a narrow therapeutic index)","RO5459072 at a dose of 100 milligrams (as capsules) was administered orally, 2 times a day, for up to 12 weeks.",ChEMBL:CHEMBL4297638 | DrugBank:DB15297 | PubChem:59543597,Petesicatib,Cn1cc(-c2ccc(S(=O)(=O)[C@@H]3C[C@@H](C(=O)NC4(C#N)CC4)N(C(=O)C4(C(F)(F)F)CC4)C3)c(C(F)(F)F)c2)cn1,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT02704403,NCT02704403_EG000,No,All,Adult | Older Adult,Phase 3,1433,"Inclusion Criteria:

Males or females aged from 18 to 75 years inclusive at first screening visit.
Must provide signed written informed consent and agree to comply with the study protocol.

Females participating in this study must be of nonchildbearing potential or using highly efficient contraception for the full duration of the study and for 1 month after the end of treatment, as described below:

Cessation of menses for at least 12 months due to ovarian failure,
Surgical sterilization such as bilateral oopherectomy, hysterectomy, or medically documented ovarian failure
If requested by local IRB regulations and/or National laws, sexual abstinence may be considered adequate (the reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient)
Using a highly effective nonhormonal method of contraception (bilateral tubal occlusion, vasectomized partner, or intra-uterine device)
Double contraception with barrier AND highly effective hormonal method of contraception (oral, intravaginal, or transdermal combined estrogen and progestogen hormonal contraception associated with inhibition of ovulation; oral, injectable, or implantable progestogen-only hormonal contraception associated with inhibition of ovulation; or intrauterine hormone-releasing system). The hormonal contraception must be started at least 1 month prior to Randomization.
Histological confirmation of steatohepatitis on a diagnostic liver biopsy by central reading of the slides (biopsy obtained within 6 months prior to randomization or during the screening period) with at least 1 in each component of the NAS score (steatosis scored 0-3, ballooning degeneration scored 0-2, and lobular inflammation scored 0-3).
NAS score ≥4.
Fibrosis stage of 1 or greater and below 4, according to the NASH CRN fibrosis staging system.
Stable dose of vitamin E, polyunsaturated fatty acids, or ursodeoxycholic acid from at least 6 months prior to diagnostic liver biopsy

For participants with type 2 diabetes, glycemia must be controlled. If glycemia is controlled by antidiabetic drugs, change in anti-diabetic therapy must follow these requirements:

No qualitative change 6 months prior to diagnostic liver biopsy up to Randomization (i.e., implementation of a new anti-diabetic therapy) for participants treated with metformin, gliptins, sulfonylureas, sodium/glucose cotransporter (SGLT) 2 inhibitors, glucagon-like peptide (GLP)-1 agonists, or insulin. Dose changes of these medications are allowed in the 6 months prior to diagnostic liver biopsy, except for GLP-1 agonists, which must remain on stable dose in the 6 months prior to diagnostic liver biopsy.
No implementation of GLP-1 agonists and SGLT2 inhibitors up to 72 weeks of treatment (Visit 7).

Initiation of any other antidiabetic drugs is allowed after Randomization based on treating physicians' judgment, except for glitazones which are prohibited 6 months prior to diagnostic liver biopsy until the end of treatment.

Exclusion Criteria:

Known heart failure (Grade I to IV of New York Heart Association classification).
History of efficient bariatric surgery within 5 years prior to screening.
Uncontrolled hypertension during the Screening Period despite optimal antihypertensive therapy
Type 1 diabetes participants .
Participants with decompensated diabetes (HbA1c>9%).
Participants with a history of clinically significant acute cardiac event within 6 months prior to screening
Weight loss of more than 5% within 6 months prior to randomization
Compensated and decompensated cirrhosis
Current or recent history (<5 years) of significant alcohol consumption
Pregnant or lactating females or females planning to become pregnant during the study period.
Other well documented causes of chronic liver disease according to standard diagnostic procedures
Participants with previous exposure to Elafibranor
Prohibited concomitant medication
Any medical conditions that may diminish life expectancy to less than 2 years including known cancers.
Evidence of any other unstable or untreated clinically significant immunological, endocrine, hematological, gastrointestinal, neurological, neoplastic or psychiatric disease.
Mental instability or incompetence, such that the validity of informed consent or ability to be compliant with the study is uncertain.
Participants with biological criteria exclusion as per effective protocol",Coated 120 mg elafibranor tablets; oral administration; one tablet per day before breakfast with a glass of water,ChEMBL:CHEMBL3707395 | DrugBank:DB05187 | PubChem:9864881,Elafibranor,CSc1ccc(C(=O)/C=C/c2cc(C)c(OC(C)(C)C(=O)O)c(C)c2)cc1,A05AX06,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0
NCT02710214,NCT02710214_EG000,No,Female,Adult,Phase 2,24,"Inclusion Criteria:

Women aged 40-62 years.
Perimenopausal: 6 months of amenorrhea; women who had a bi-lateral oophorectomy; women without a uterus and who still have one or both ovaries, with FSH level > 20 mIU/mL and estradiol ≤ 50 pg/mL; women with a uterus who have skipped 2 or more menstrual cycles with an amenorrhea interval; women who are using the Mirena IUD or who have had an endometrial ablation and who still have one or both ovaries, with FSH level > 20 mIU/mL and estradiol ≤ 50 pg/mL
Bothersome MS symptoms: Mean of two or more hot flashes/night sweats per 24 hrs; Hot flashes/night sweats rated as bothersome ('moderately' to 'a lot') and/or severe ('moderate' to 'severe') on 4 or more 12 hour (day/night) blocks of times
In general good health (determined by medical history, blood pressure, and heart rate)
No history of endometrial, ovarian, or breast cancer; No abnormal mammogram in the last 2 years; Absence of any current severe or unstable medical illness

MS considerations:

If using psychotropic medications: no change in the past 3 months
If on DMT, no change in past 6 months Normal vitamin D levels (20-50 ng/mL)

Exclusion Criteria:

BMI >35 kg/m2 as higher BMI may affect PK/PD
Use of hormone therapy or hormonal contraceptives 2 months prior to enrollment
Use of any prescribed therapy that is taken specifically for hot flashes in the past 1 month.
Use of any over-the-counter or herbal therapies that are taken specifically for hot flashes in the past 2 weeks.
Use of selective estrogen receptor modulators (SERMs) or aromatase inhibitors during the 2 months before enrollment.
Known hypersensitivity or contraindications to estrogen.
Drug or alcohol abuse in the past 1 year
Depression: moderate or severe (HAD score > 8) Other psychiatric disease meeting DSM-IV criteria
Lifetime diagnosis of psychosis or bipolar disorder.
Pregnancy, intending pregnancy, or breast feeding

History of any of the following, as determined by clinician review of the potential participant's medical history:

Pre-breast cancer or high-risk breast cancer condition;
Abnormal bleeding suggestive of endometrial pre-cancer;
Endometrial hyperplasia;
Asthma, diabetes mellitus, epilepsy, and migraine disorders that are not stable or under medical management;
Active or past history of venous or arterial thromboembolism
History of gallstones IF gallbladder intact
Known or suspected estrogen-dependent neoplasia
History of coronary artery disease
Hypersensitivity (angioedema, anaphylaxis) to estrogens, bazedoxifene, or any ingredients
Known hepatic impairment or disease
Thyroid dysfunction on thyroid medications
Known hypoparathyroidism
Blood test results indicating:
Liver function tests: AST >2.5 times upper limit of normal; ALT >2.5 times upper limit of normal; total bilirubin 1.5 times upper limit of normal;
Kidney test: creatinine >1.5 mg/dL;
Blood count: hematocrit <30%;
Hemoglobin <8 g/dL.
Current participation in another drug trial or intervention study.
Inability or unwillingness to complete the study procedures.

MS considerations:

Clinical relapse within the last three months (to ensure disease stability)
Steroid treatment in prior 1 month
Evidence of other structural brain disease (e.g. prior stroke)

MRI considerations:

Metal implants
Prior head trauma
Claustrophobia requiring anxiolytic or sedation, or other contraindication to MRI.","1 Tablet of 0.45mg conjugated estrogens/20 mg bazedoxifene daily for 8 weeks

Tissue Selective Estrogen Complex: Once-daily dosing of Duavee for 8 weeks.",PubChem:85364158,Duavee,CC12CCC3C(=CCc4cc(OS(=O)(=O)O)ccc43)C1CCC2=O.CC12CCC3c4ccc(OS(=O)(=O)O)cc4CCC3C1CCC2=O.CC12CCc3c(ccc4cc(OS(=O)(=O)O)ccc34)C1CCC2=O.Cc1c(-c2ccc(O)cc2)n(Cc2ccc(OCCN3CCCCCC3)cc2)c2ccc(O)cc12,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02712554,NCT02712554_EG007,Accepts Healthy Volunteers,All,Adult,Phase 1,38,"Inclusion Criteria:

BMI within 18.0 to 33.0 kg/m2, inclusive (minimum weight of 50.0 kg at Screening)
Healthy, as determined by no clinically significant medical history, physical examination findings, 12-lead ECG findings, vital signs measurements, and laboratory results at screening, as judged by the investigator
Current opioid users who had used oral opioids for recreational (non-therapeutic) purposes, at least 10 times in the past year

Exclusion Criteria:

Drug or alcohol dependence within the last 12 months (except nicotine)
Subjects who had ever been in treatment for substance use disorders (except smoking cessation
History of presence of any clinically significant cardiac, neurologic, pulmonary, psychiatric, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, dermatologic, renal, or other major disease at screening, which in the opinion of the investigator, would have jeopardized the safety of the subject or the validity of the study results
History or presence of hypotension, judged to be clinically significant based on investigator judgement",M366 22.5 mg/975 mg tablet by mouth,ChEMBL:CHEMBL413 | DrugBank:DB00877 | PubChem:134760597 | PubChem:138404388 | PubChem:21944094 | PubChem:5284616,Sirolimus,COC1CC2CCC(C)C(O)(O2)C(=O)C(=O)N2CCCCC2C(=O)OC(C(C)CC2CCC(O)C(OC)C2)CC(=O)C(C)C=C(C)C(O)C(OC)C(=O)C(C)CC(C)C=CC=CC=C1C,L01EG04 | L04AA10 | S01XA23,0.0,0.0,0.0,0.0,0.0,1.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT02712554,NCT02712554_EG008,Accepts Healthy Volunteers,All,Adult,Phase 1,39,"Inclusion Criteria:

BMI within 18.0 to 33.0 kg/m2, inclusive (minimum weight of 50.0 kg at Screening)
Healthy, as determined by no clinically significant medical history, physical examination findings, 12-lead ECG findings, vital signs measurements, and laboratory results at screening, as judged by the investigator
Current opioid users who had used oral opioids for recreational (non-therapeutic) purposes, at least 10 times in the past year

Exclusion Criteria:

Drug or alcohol dependence within the last 12 months (except nicotine)
Subjects who had ever been in treatment for substance use disorders (except smoking cessation
History of presence of any clinically significant cardiac, neurologic, pulmonary, psychiatric, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, dermatologic, renal, or other major disease at screening, which in the opinion of the investigator, would have jeopardized the safety of the subject or the validity of the study results
History or presence of hypotension, judged to be clinically significant based on investigator judgement",M366 37.5 mg/1625 mg tablet by mouth,ChEMBL:CHEMBL413 | DrugBank:DB00877 | PubChem:134760597 | PubChem:138404388 | PubChem:21944094 | PubChem:5284616,Sirolimus,COC1CC2CCC(C)C(O)(O2)C(=O)C(=O)N2CCCCC2C(=O)OC(C(C)CC2CCC(O)C(OC)C2)CC(=O)C(C)C=C(C)C(O)C(OC)C(=O)C(C)CC(C)C=CC=CC=C1C,L01EG04 | L04AA10 | S01XA23,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0
NCT02712788,NCT02712788_EG000,No,All,Adult | Older Adult,Phase 2,2,"Inclusion Criteria:

Subjects ≥ 18 years of age
Aneurysmal subarachnoid hemorrhage, proven on CT angiogram or digital subtraction angiography
Aneurysm treated, either by endovascular embolization or surgical clip ligation
Evidence of increased velocities on transcranial dopplers (TCDs) and/or radiographic evidence of vasospasm as seen on angiogram
Cerebral vasospasm as demonstrated by patient's clinical exam (new focal deficit or change in mental status not attributable to any other cause)

Exclusion Criteria:

Recurrent subarachnoid hemorrhage
Untreated ruptured aneurysm, for any reason
Patients who die prior to treatment for aneurysm
Patients who are not able to complete at least 6 months of follow-up
Patients who are admitted already in vasospasm (i.e. a delayed admission)
Creatinine clearance less than 20 ml/min
Women with a positive pregnancy test or who are lactating
Other comorbidity which may adversely affect patient outcome, at the discretion of the principal investigator","Milrinone will be administered intravenously at an initial rate of 0.75mCg/kg/min and titrated based on symptoms in addition to hyperdynamic therapy and angiographic therapy as indicated per institutional protocol.

Milrinone",ChEMBL:CHEMBL189 | DrugBank:DB00235 | PubChem:4197,Milrinone,Cc1[nH]c(=O)c(C#N)cc1-c1ccncc1,C01CE02,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT02720107,NCT02720107_EG000,No,All,Adult | Older Adult,Phase 4,130,"Inclusion Criteria:

Written informed consent before any assessment was performed.
Randomized in study CFTY720DDE01 and received at least one dose of study drug (fingolimod) and completed the study.
Continuous intake of fingolimod after end of study CFTY720DDE01 with a maximum treatment interruption of 3 months in total before entering this study.
Parallel participation at study CFTY720DDE02 (Pangaea NIS) was allowed.

Exclusion criteriat:

Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human Chorionic Gonadotropin (hCG) laboratory test.
Patients with onset of an acute relapse had to postpone their evaluation until deemed stable from relapse by treating physician, but at least for 1 month since end of relapse.
Patients that received immunomodulating or immunosuppressive MS treatments other than fingolimod since completion of study CFTY720DDE01 as for example: Natalizumab,Alemtuzumab, Dimethyl fumarate, Teriflunomide, intravenous Immunoglobulins,Mitoxantrone, Methotrexate, Azathioprine or experimental immunomodulating-immunosuppressive therapies.",fingolimod 0.5 mg,ChEMBL:CHEMBL314854 | DrugBank:DB08868 | PubChem:107970,Fingolimod,CCCCCCCCc1ccc(CCC(N)(CO)CO)cc1,L04AA27,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02729701,NCT02729701_EG000,No,Female,Child | Adult,Phase 2,28,"Inclusion Criteria:

Women with vasomotor symptoms with a uterus who are postmenopausal or in late menopause transition
Body Mass Index (BMI) <36 kg/m2
Class I-III mammogram within 6 months of Random Periareolar Fine Needle Aspiration (RPFNA); If Class 0 or 4, must be resolved with additional procedures
If previously on oral contraceptives or hormone replacement, off for 8 weeks or more prior to baseline RPFNA; the exception is low dose vaginal hormones
Confirmed moderate risk of developing breast cancer
RPFNA results within study defined range
Kidney and liver function within study defined range
Willing and able to comply with study related procedures

Exclusion Criteria:

Previous biopsy showing evidence of breast cancer
Have a predisposition to or prior history of thromboembolism, deep venous thrombosis, pulmonary embolism, or stroke
History of renal or liver disease
Prior ovarian or endometrial cancer
Stopped or started hormone replacement within 8 weeks
Any other condition or intercurrent illness that in the opinion of the investigator makes the woman a poor candidate for RPFNA
Currently taking or have taken specific medications in the past 6 months
Participation on any chemoprevention trial within 6 months
Current illness which would make potential participant unsuitable for enrollment","Participants asked to take Duavee for 6 months while on the study.

Duavee: Once daily tablet of Duavee (Bazedoxifene (20 mg) plus conjugated estrogen (0.45 mg))",PubChem:85364158,Duavee,CC12CCC3C(=CCc4cc(OS(=O)(=O)O)ccc43)C1CCC2=O.CC12CCC3c4ccc(OS(=O)(=O)O)cc4CCC3C1CCC2=O.CC12CCc3c(ccc4cc(OS(=O)(=O)O)ccc34)C1CCC2=O.Cc1c(-c2ccc(O)cc2)n(Cc2ccc(OCCN3CCCCCC3)cc2)c2ccc(O)cc12,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02737930,NCT02737930_EG000,No,All,Adult | Older Adult,Phase 2,5,"Inclusion Criteria:

MRI-confirmed acute ischemic stroke resulting in an isolated homonymous visual field loss.

Exclusion Criteria:

Known hypersensitivity to fluoxetine or other selective serotonin reuptake inhibitors
National Institutes of Health Stroke Scale score greater than 5
Premorbid modified Rankin Scale score greater than 2
Premorbid monocular or binocular visual field deficits
Premorbid retinopathy or optic neuropathy
Premorbid depression
History of cognitive impairment, dementia, or neurodegenerative disorder
History of seizure disorder
History of mania or hypomania
History of hyponatremia
History of angle-closure glaucoma or elevated intraocular pressure
Current alcohol abuse or impaired liver function
Current use of an antidepressant medication
Current use of a medication likely to have an adverse interaction with fluoxetine
Current use of a medication likely to impair post-stroke recovery
Contraindication to MRI
Pregnancy or lactation
Hemorrhagic transformation of the index stroke, resulting in mass effect
Enrollment in another clinical trial at the time of the index stroke","20 mg fluoxetine capsule by mouth once daily for 90 days

Fluoxetine",ChEMBL:CHEMBL41 | DrugBank:DB00472 | PubChem:3386,Fluoxetine,CNCCC(Oc1ccc(C(F)(F)F)cc1)c1ccccc1,N06AB03 | N06CA03,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT02747875,NCT02747875_EG000,Accepts Healthy Volunteers,All,Child,Not Applicable,12,"Inclusion Criteria:

Age greater than or equal to 2 years and less than 8 years at the time of randomization.
Weight greater than 6 kg.
American Society of Anesthesiologists (ASA) physical status of ASA I, II, or III (Appendix I).
Informed consent to participate from the parent or legally authorized guardian.
Scheduled for congenital cardiac bypass surgery.

Exclusion Criteria

Subjects will not be eligible to participate in the study if any of the following exclusion criteria apply:

History or a family (parent or sibling) history of malignant hyperthermia.
Known significant hepatic disorders determined by medical history, medical record documentation, physical examination, or laboratory tests obtained during the routine preoperative cardiac surgery evaluation or cardiology visit (International Normalized Ratio (INR)>1.5).
Emergency Cardiac Surgery.
History of chronic nausea and/or vomiting.
Currently receiving inotropic agents or using a pacemaker.
Prexisting long QTc interval of greater than 460ms determined by medical history, medical record documentation, or electrocardiogram obtained during the routine preoperative cardiac surgery evaluation.
History of documented pulmonary hypertension, respiratory dysfunction, or requirement of supplemental oxygen therapy.
History of opioid abuse, addiction, or tolerance.
Obesity defined as a body weight greater than 130% of the ideal weight.
Participation in another clinical trial or any study that may interfere with participation in this trial.
History of allergic reaction to methadone or fentanyl.","Participants will receive 20 mcg/kg of fentanyl prior to surgical incision, over 20 minutes. The medication will be prepared as described and all research and staff personnel as well as the study participant will be blinded to treatment group assignment.

Fentanyl: The treatment phase will begin at the induction of general anesthesia and finish at the end of the surgical procedure. Under the direction of the cardiac anesthesiologist subjects will be premedicated and general anesthesia will be induced with standard anesthetic monitoring and management. Participants will receive 20 mcg/kg of fentanyl prior to surgical incision, over 20 minutes. General anesthesia will be maintained with inhalational anesthetics and paralytics. The subject will continue to be evaluated for hemodynamic stability, bleeding, and respiratory effort. The postoperative intensive care phase will begin at time of room admission and end at day three of hospital stay. All subjects will receive morphine or oxycodone analgesics and sedation medication based on the hospital's postoperative pain control and agitation protocol. Standard electronic documentation will be maintained throughout and include: medications, vital signs, and events.",ChEMBL:CHEMBL596 | DrugBank:DB00813 | PubChem:3345,Fentanyl,CCC(=O)N(c1ccccc1)C1CCN(CCc2ccccc2)CC1,N01AH01 | N01AH51 | N02AB03,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02747875,NCT02747875_EG001,Accepts Healthy Volunteers,All,Child,Not Applicable,14,"Inclusion Criteria:

Age greater than or equal to 2 years and less than 8 years at the time of randomization.
Weight greater than 6 kg.
American Society of Anesthesiologists (ASA) physical status of ASA I, II, or III (Appendix I).
Informed consent to participate from the parent or legally authorized guardian.
Scheduled for congenital cardiac bypass surgery.

Exclusion Criteria

Subjects will not be eligible to participate in the study if any of the following exclusion criteria apply:

History or a family (parent or sibling) history of malignant hyperthermia.
Known significant hepatic disorders determined by medical history, medical record documentation, physical examination, or laboratory tests obtained during the routine preoperative cardiac surgery evaluation or cardiology visit (International Normalized Ratio (INR)>1.5).
Emergency Cardiac Surgery.
History of chronic nausea and/or vomiting.
Currently receiving inotropic agents or using a pacemaker.
Prexisting long QTc interval of greater than 460ms determined by medical history, medical record documentation, or electrocardiogram obtained during the routine preoperative cardiac surgery evaluation.
History of documented pulmonary hypertension, respiratory dysfunction, or requirement of supplemental oxygen therapy.
History of opioid abuse, addiction, or tolerance.
Obesity defined as a body weight greater than 130% of the ideal weight.
Participation in another clinical trial or any study that may interfere with participation in this trial.
History of allergic reaction to methadone or fentanyl.","Participants will receive 0.3 mg/kg of methadone prior to surgical incision, over 20 minutes. The medication will be prepared as described and all research and staff personnel as well as the study participant will be blinded to treatment group assignment.

Methadone: The treatment phase will begin at the induction of general anesthesia and finish at the end of the surgical procedure. Under the direction of the cardiac anesthesiologist subjects will be premedicated and general anesthesia will be induced with standard anesthetic monitoring and management. Participants will receive 0.3 mg/kg of methadone prior to surgical incision, over 20 minutes. General anesthesia will be maintained with inhalational anesthetics and paralytics. The subject will continue to be evaluated for hemodynamic stability, bleeding, and respiratory effort. The postoperative intensive care phase will begin at time of room admission and end at day three of hospital stay. All subjects will receive morphine or oxycodone analgesics and sedation medication based on the hospital's postoperative pain control and agitation protocol. Standard electronic documentation will be maintained throughout and include: medications, vital signs, and events.",ChEMBL:CHEMBL350719 | ChEMBL:CHEMBL651 | DrugBank:DB00333 | DrugBank:DB15198 | PubChem:4095 | PubChem:643985,Methadone,CCC(=O)C(CC(C)N(C)C)(c1ccccc1)c1ccccc1,N02AC52 | N07BC02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0
NCT02752191,NCT02752191_EG001,No,All,Child,Phase 4,17,"Inclusion Criteria:

Male or female pediatric patients of all ethnicities (age newborn to 6 years) with known or suspected CHD with inconclusive echocardiographic exams and are referred for cardiovascular MRI for further evaluation of cardiac anatomy and function.
Written informed consent obtained from subject's legal representative/guardian(s) and ability for subject to comply with the requirements of the study

Exclusion Criteria:

Standard clinical contraindications to MRI, including subjects with cochlear implants and implanted cardiac devices
Subjects with past or current diagnosis of iron overload due to hereditary hemochromatosis or other causes (for subjects receiving Feraheme injection only).
Subjects with known hypersensitivity or allergy to iron oxide particles.
Subjects with renal insufficiency defined as estimated glomerular filtration rate (eGFR) < 40 mL/min/1.73m2 (for subjects receiving Ablavar injection only).
Subjects who are critically ill at the time of MRI and for whom the period of general anesthesia and separation from the critical care nursery or intensive care unit poses added risk as deemed by referring cardiologists, cardiac surgeons or the managing radiologist (for Part II only).
Other medical conditions, in the judgment of the clinician investigator, that would increase the risks to the child related to participation in the study.","gadofosveset, 0.03mmol/kg, one time bolus injection

gadofosveset: gadofosveset as an MRI contrast agent injected over several seconds",PubChem:158440 | PubChem:23724913,Gadofosveset,O.O=C([O-])CN(CCN(CC(=O)[O-])CC(COP(=O)([O-])OC1CCC(c2ccccc2)(c2ccccc2)CC1)N(CC(=O)[O-])CC(=O)[O-])CC(=O)[O-].[Gd+3].[Na+].[Na+].[Na+],V08CA11,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02761980,NCT02761980_EG003,Accepts Healthy Volunteers,Male,Adult,Phase 3,87,"Inclusion Criteria:

Healthy male subjects who, at the time of screening, are between 18 and 55 years of age, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests.
The subject must have a normal, stable body temperature at Screening and on Day 0. If the subject's oral temperature is not between 97.4°F and 98.8°F, then 2 additional oral temperature readings will be obtained within a 30 minute period. These 3 consecutive temperature readings must be between 97.4°F and 98.8°F, with the highest value within 0.4°F of the lowest temperature value.
Body Mass Index (BMI) of 17.5 to 37.0 kg/m2; and a total body weight 50 kg (110 lbs) at Screening.
The subject has demonstrably adequate veins, by visual inspection, for IV catheter insertion.

Exclusion Criteria:

Evidence or history of clinically significant laboratory abnormality, hematological, renal, endocrine, pulmonary, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (excluding untreated, asymptomatic, seasonal allergies at the time of dosing) within the last 5 years that may increase the risk associated with study participation.
Subjects with any gastrointestinal disorders (eg, gastrectomy, tracheostomy, esophageal surgeries, short gut syndrome, peptic ulcer disease, known or suspected obstructive disease, previous gastrointestinal surgery, felinization of the esophagus, hypomotility of the gastrointestinal track) that could affect the absorption, metabolism, or excretion of the study medication or affect the results of the ingestible thermometer.
Subjects at risk for excessive bleeding.
Subjects with a history of nasal polyps, angioedema, or significant or actively treated bronchospastic disease.
Screening supine blood pressure ≤90 or ≥140 mm Hg (systolic) or ≤50 or ≥90 mm Hg (diastolic), following at least 5 minutes of supine rest. If blood pressure (BP) is ≤90 or ≥140 mm Hg (systolic) or ≤50 or ≥90 mm Hg (diastolic), the BP should be repeated two more times and the average of the three consecutive BP values should be used to determine the subject's eligibility.
Screening supine 12 lead ECG demonstrating QTc >450 msec or a QRS interval >120 msec at Screening and on Day 1 prior to RSE administration. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated two more times and the average of the three consecutive QTc or QRS values should be used to determine the subject's eligibility.
The subject has a history of recurrent or acute or chronic infections of any type or any findings suggestive of occult infection, such as tuberculosis, sinusitis, urinary tract infection, respiratory tract or dental (abscess) infection, etc., or those with a positive QuantiFERON Tuberculosis, Hepatitis B surface antigen, Hepatitis C antibody, and/or Human immunodeficiency virus (HIV) test at Screening. Also excluded are subjects with frequent (more than 3 outbreaks per year), recurrent oral or genital herpes, recurrent herpes zoster, or any infection otherwise judged by the investigator to have the potential for exacerbation by participation in the study.
Subjects who have experienced cold/flu symptoms (ie, runny nose, cough, and/or fever) within 2 weeks prior to the first administration of study treatments.
Subjects with a reduction in heart rate to ≤50 beats per minute or deemed to be at high risk of syncope and/or hypotension per the clinical judgment of the investigator following a carotid sinus massage procedure.",Participants received single oral dose of acetaminophen 500 mg tablet during the treatment duration of 8 hours. Participants were discharged after completion of study treatment.,ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02764801,NCT02764801_EG000,No,All,Adult | Older Adult,Phase 3,103,"Inclusion Criteria:

Patients >= 21 years of age
Patient capable of making informed decisions regarding his/her treatment
Scheduled for TACE treatment of a HCC mass (lesions reported as Liver Imaging Reporting and Data Systems 4B or 5 or Organ Procurement and Transplantation Network 5a or 5b)
Negative pregnancy test in a female of child-bearing age.
Have an HCC mass viewable on grayscale B-mode ultrasound.

Exclusion Criteria:

Females who are pregnant or nursing.
Patients not eligible or scheduled for TACE of a HCC mass.
Patients who have received an investigational drug in the 30 days before study drug administration, or will receive one within 72 h after their final CEUS exam.
Patients who have received prior radioembolization (Y90) of the lesion of interest.
Patients with known or suspected cardiac shunts.
Patients with pulmonary hypertension or unstable cardiopulmonary conditions.
Patients who are medically unstable, patients who are seriously or terminally ill, and patients whose clinical course is unpredictable. For example:
Patients with unstable occlusive disease (e.g., crescendo angina)
Patients with clinically unstable cardiac arrhythmias
Patients with uncontrolled congestive heart failure (NYHA Class IV)","Patients receiving contrast-enhanced ultrasound for diagnosis of chemoembolization response.

Ultrasound contrast agent (Contrast-enhanced ultrasound): Intravenous injection of ultrasound contrast agent followed by saline flush though an angiocatheter in the arm or hand.

Logiq E9 Scanner (Contrast-enhanced ultrasound): Ultrasound scanning using a commercial scanner with a C1-5-D broad-spectrum convex transducer followed by a RAB2-5-D broad-spectrum real-time 4D transducer.",ChEMBL:CHEMBL1663 | DrugBank:DB00556 | PubChem:6432,Perflutren,FC(F)(F)C(F)(F)C(F)(F)F,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02769624,NCT02769624_EG000,No,All,Adult | Older Adult,Phase 2,14,"Inclusion Criteria:

Patients age 18 years and older
Single ventricle patients status post Fontan procedure

Exclusion Criteria:

Clinically unstable: these are patients who are experiencing new cardiovascular symptoms such as worsening shortness of breath, new onset arrhythmia, uncontrolled heart failure, or evidence of clinically significant cirrhosis or renal failure.
Evidence of Fontan pathway or intra cardiac obstruction as identified on prior clinically indicated imaging studies (echocardiography and MRI);
Evidence of left or right systemic ventricular systolic dysfunction with an Ejection fraction of <40% on either echocardiogram or MRI from previously documented clinical data;
Presence of uncontrolled arrhythmias;
Unable to perform exercise testing for any reason or if deemed by the PI or designee that exercise testing would not be in the best interest of the participant
Currently pregnant and/or breastfeeding
Patient unable to provide informed consent
BMI > 30 mg/m2","Participants may receive either treprostinil or placebo at visit 2. They will receive the opposite at visit 3.

If receiving treprostinil, a 18mcg dose (3 breaths) will be administered using the Tyvaso® (treprostinil) inhalation system. Tyvaso® (treprostinil) is supplied in 2.9 mL clear ampules packaged as four ampules in a foil pouch. Frequency and duration- 3 times over 1 study visit: baseline, 1.5 hrs. post baseline and then again 2 hrs later following maximal exercise testing.

If receiving placebo, a dose of 3 breaths of placebo will be administered using the Tyvaso® (treprostinil) inhalation system. Placebo will be supplied in matching ampules to treprostinil. Volume will match that of treprostinil. Frequency and duration- 3 times over 1 study visit: baseline, 1.5 hrs. post baseline and then again 2 hrs later following maximal exercise testing.",ChEMBL:CHEMBL1237119 | DrugBank:DB00374 | PubChem:6918140,Treprostinil,[H][C@@]12Cc3c(cccc3OCC(=O)O)C[C@]1([H])[C@@H](CC[C@@H](O)CCCCC)[C@H](O)C2,B01AC21,0.0,1.0,0.0,1.0,0.0,0.0,1.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT02772965,NCT02772965_EG000,No,All,Child | Adult,Phase 3,156,"Inclusion Criteria:

Pediatric Crohn's Disease (PCD) patients, < 21 years of age, ≥20 kg, initiating anti-TNF therapy with infliximab or adalimumab (including biosimilars).
Diagnosis of Crohn's Disease (CD) established confirmed by the treating clinician, and established by standard clinical criteria (radiography, endoscopy, histology).
Ability to provide parental permission and child assent (where applicable), or adult consent for patients ages 18-20.

Exclusion Criteria:

Prior use of anti-TNF or other biological therapy for CD
Lack of stable home address that study medications can be mailed to
Anticipated short length of follow up at study center (plans for family to move, transition to adult GI (gastrointestinal) provider, etc.). Patients expected to leave practice < 12 months from enrollment should not be enrolled.
Concurrent pelvic or abdominal abscess. A recent history of abdominal or pelvic abscess, which is controlled, does not exclude the subject.
Prior intra-abdominal surgery without a clinically significant relapse (i.e. patients starting on anti-TNF for post-op prophylaxis or for endoscopic recurrence only should not be included)
Receipt of a live virus vaccine within the last 30 days
Pregnancy, planning to become pregnant, or high risk of pregnancy as determined by the local investigator
Breastfeeding
Refusal to stay abstinent or utilize 2 forms of birth control while on study medication (for female patients)
BMI > 98% for gender and age
Known previous or concurrent malignancy (other than that considered surgically cured, with no evidence for recurrence for 5 years). A recent history of basal cell or squamous cell carcinoma, which is considered surgically cured, does not exclude the subject.Those with a recent history of colonic adenoma or dysplastic lesions should be excluded.
Known high alcohol consumption (more than seven drinks per week)
Patients with serum albumin < 2.5 g/dl
Patients with white blood cell count (WBC) < 3.0 x109th/L
Patients with platelet count < 100 x109th/L
Patients with initial elevation of liver enzymes (AST or ALT) > 1.5 times above normal limit
Patients with known active infection with Clostridium difficile (C. difficile) (untreated infection based on clinician assessment does not apply to colonization or infection controlled with current or prior treatment.)
Patients with pre-existing hepatic disease
Patients with pre-existing renal dysfunction (creatinine > 0.8 for children age<10, creatinine > 1.2 mg/dl for children age 10-18, and creatinine > 1.5 mg/dl for adults age 18 years and older).
Patients with a pre-existing chronic lung disease other than well controlled asthma
Current treatment with one of the following drugs: Probenecid (Probalan), Acitretin (Soriatane), Streptozocin (Zanosar), Azathioprine (Imuran, Azasan), 6-mercaptopurine (Purinethol, Purixan)
Other concerns about the patient/family's ability to participate in the study","Methotrexate (10, 12.5, or 15 mg), once weekly. Weight-based dosing. Ondansetron (4 mg), twice weekly, 1 hour prior to methotrexate dose and the morning after methotrexate dose.

Folic Acid (1 mg) daily

Methotrexate: 1) Oral methotrexate (MTX): The weekly dose will be 15 mg for children ≥ 40kg, 12.5 mg for children 30 to <40 kg, and 10 mg for children 20 to <30 kg. 2) A twice per week, 4mg dose of ondansetron will be provided as pre-treatment to prevent nausea (study provider may opt-out of this component based on clinical judgement). 3) A 1 mg dose of folic acid per day will be provided. This will help to reduce the risk of side effects in the MTX group.

Drug kits will contain a 3 month supply of each medication. Refills will be provided every 3 months until week 156 unless there is a failure to induce and maintain remission, development of unacceptable toxicity, pregnancy in a female participant, or failure of the participant to attend scheduled study visits.",ChEMBL:CHEMBL34259 | DrugBank:DB00563 | PubChem:126941,Methotrexate,CN(Cc1cnc2nc(N)nc(N)c2n1)c1ccc(C(=O)N[C@@H](CCC(=O)O)C(=O)O)cc1,L01BA01 | L04AX03,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT02774148,NCT02774148_EG000,No,All,Older Adult,Phase 4,1,"Inclusion Criteria:

Acute, isolated, unilateral femoral neck, intertrochanteric, and per trochanteric hip fractures confirmed by anteroposterior/lateral hip radiographs, computed tomography, or magnetic resonance imaging (MRI).
Age ≥ 65 years.
Low energy mechanism.
Hip fracture fixation performed within 48 hours of injury.
English speaking.
Anticipated medical optimization for operative fixation.
No other major trauma.

Exclusion Criteria:

Unable to provide informed consent (dementia, limited decision making capacity)
Admitted by medical service for significant co-morbidities
Retained hardware around the affected hip
Infection around the affected hip
Transfer patients with a length of stay > 24 hours at the transferring hospital
Known allergy to acetaminophen
Current use of narcotics
Receiving a regional anesthetic block at any point during the hospitalization
Known history of hepatic disease (hepatitis, cirrhosis)
Weight < 50kg
Prisoner
Involved in another clinical trial that would interfere with the intervention of this study","1,000mg Acetaminophen po every 8 hours until discharge.

PO Acetaminophen: The patient will receive 1,000mg po Acetaminophen every 8 hours.",ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02774148,NCT02774148_EG001,No,All,Older Adult,Phase 4,1,"Inclusion Criteria:

Acute, isolated, unilateral femoral neck, intertrochanteric, and per trochanteric hip fractures confirmed by anteroposterior/lateral hip radiographs, computed tomography, or magnetic resonance imaging (MRI).
Age ≥ 65 years.
Low energy mechanism.
Hip fracture fixation performed within 48 hours of injury.
English speaking.
Anticipated medical optimization for operative fixation.
No other major trauma.

Exclusion Criteria:

Unable to provide informed consent (dementia, limited decision making capacity)
Admitted by medical service for significant co-morbidities
Retained hardware around the affected hip
Infection around the affected hip
Transfer patients with a length of stay > 24 hours at the transferring hospital
Known allergy to acetaminophen
Current use of narcotics
Receiving a regional anesthetic block at any point during the hospitalization
Known history of hepatic disease (hepatitis, cirrhosis)
Weight < 50kg
Prisoner
Involved in another clinical trial that would interfere with the intervention of this study","1,000mg Acetaminophen IV every 8 hours until the patient has received 3 doses post-operatively. Then 1,000mg Acetaminophen po every 8 hours until discharge.

IV Acetaminophen: The patient will receive 1,00mg IV Acetaminophen every 8 hours until 3 doses have been received post-operatively.",ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02777268,NCT02777268_EG004,Accepts Healthy Volunteers,Male,Adult,Phase 1,16,"Inclusion Criteria:

Healthy male volunteers between 18 and 60 years of age, inclusive (at Screening Visit).
Subjects with a Body Mass Index (BMI) of 21-28.
Subjects with no clinically significant abnormal serum biochemistry, haematology and urine examination values within 14 days prior to the first dose of investigational medicinal product (IMP).
Subjects with a negative urinary drugs of abuse screen determined within 14 days prior to the first dose of IMP. A positive alcohol test may have been repeated at the discretion of the Investigator.
Subjects with negative human immunodeficiency virus (HIV) and hepatitis B surface antigen (Hep B) and hepatitis C virus antibody (Hep C) results.
Subjects with no clinically significant abnormalities in 12-lead electrocardiogram (ECG) determined within 14 days prior to the first dose of IMP.
Subjects with no clinically-significant deviation outside the normal ranges for blood pressure and pulse measurements.
Subjects (unless anatomically sterile or where abstaining from sexual intercourse was in-line with the preferred and usual lifestyle of the subject) and sexual partners used effective contraception methods during the trial and for 3 months after the last dose of IMP, for example; oral contraceptive + condom, intra-uterine device (IUD) + condom or diaphragm with spermicide + condom.
Subjects were available to complete the study.
Subjects satisfied a medical examiner about their fitness to participate in the study.
Subjects provided written informed consent to participate in the study.

Exclusion Criteria:

A clinically significant history of gastrointestinal disorder likely to influence drug absorption.
Receipt of regular medication within 14 days prior to the first dose of IMP (including high dose vitamins, dietary supplements or herbal remedies).
Receipt of any vaccination within 14 days prior to the first dose of IMP.
Evidence of renal, hepatic, central nervous system, respiratory, cardiovascular or metabolic dysfunction.
Presence of clinically significant infections (systemic fungal and viral infections, acute bacterial infections).
Current or previous history of tuberculosis.
A clinically significant history of previous allergy / sensitivity to hydrocortisone and/or dexamethasone.
A clinically significant history or family history of psychiatric disorders/illnesses.
A clinically significant history of drug or alcohol abuse.
Inability to communicate well with the Investigator (i.e., language problem, poor mental development or impaired cerebral function).
Participated in a New Chemical Entity clinical study within the previous 4 months or a marketed drug clinical study within the previous 3 months. (N.B. The washout period between trials was defined as the period of time elapsed between the last dose of the previous study and the first dose of the next study).
Subjects who had consumed more than 2 units of alcohol per day within 7 days prior to the first dose of IMP or had consumed any alcohol within the 48 hr period prior to the first dose of IMP.
Donation of 450 mL or more of blood within the previous 3 months.
Subjects who smoked (or ex-smokers who had smoked within 6 months prior to first dose of IMP).
Subjects who worked shifts (i.e. regularly alternated between days, afternoons and nights).","1 (10 mg) tablet

Hydrocortisone: Tablet",ChEMBL:CHEMBL389621 | DrugBank:DB00741 | PubChem:5754,Hydrocortisone,[H][C@@]12CC[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)CC[C@@]21C,A01AC03 | A07EA02 | C05AA01 | D07AA02 | D07BA04 | D07CA01 | D07XA01 | H02AB09 | R01AD60 | S01BA02 | S01BB01 | S01CA03 | S01CB03 | S02BA01 | S02CA03 | S03CA04,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT02778880,NCT02778880_EG001,No,All,Child,Phase 3,42,"Inclusion Criteria:

8 years to 17 years (up to the 18th birthday)
Presenting to emergency department with one or more extremity injuries
Visual analog scale score 35 mm or greater
Parent or legal guardian present and willing to provide written consent

Exclusion Criteria:

Received narcotic pain medication prior to arrival
Evidence of significant head, chest, abdomen, or spine injury
Glasgow coma score less than 15 or unable to self report pain score
Nasal trauma or aberrant nasal/airway anatomy
Active epistaxis
Allergy to ketamine, fentanyl or meperidine
Non-English speaking parent and/or child
History of psychosis
Postmenarchal female without a urine or serum assay documenting the absence of pregnancy
Brought in my juvenile detention center or in police custody
Pregnancy",Fentanyl 2 mcg/kg intranasally for one dose,ChEMBL:CHEMBL596 | DrugBank:DB00813 | PubChem:3345,Fentanyl,CCC(=O)N(c1ccccc1)C1CCN(CCc2ccccc2)CC1,N01AH01 | N01AH51 | N02AB03,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02781311,NCT02781311_EG002,No,Male,Adult,Phase 2,12,"Inclusion Criteria:

Participant has androgenetic alopecia (AGA)
Participant agrees to maintain current hair care regimen, refraining from hair weaving, hair colorants or dyes and non-study hair growth products during the study.

Exclusion Criteria:

History of hair loss for reasons other than AGA
Scarring of the scalp or any condition or disease of the scalp, hair or hair shaft
Use of products within 6 months of study start used continuously for at least 1 month that could impact hair growth
Hair-weaving within 6 months
Use of hair colorants or dyes within 6 months.","Finasteride 1 mg tablet, orally, once daily for 24 weeks.",ChEMBL:CHEMBL710 | DrugBank:DB01216 | PubChem:57363,Finasteride,[H][C@@]12CC[C@@]3([H])NC(=O)C=C[C@]3(C)[C@@]1([H])CC[C@]1(C)[C@@H](C(=O)NC(C)(C)C)CC[C@@]21[H],D11AX10 | G04CA51 | G04CA55 | G04CB01 | G04CB51,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,1.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT02798627,NCT02798627_EG000,No,All,Adult | Older Adult,Phase 2,27,"Inclusion Criteria:

Male and females, 18-65 years old.
Meets diagnostic criteria (DSM-V) for current diagnosis of cocaine use disorder, moderate to severe, by semi-structured interview.
In the past 30 days, used no less than $100-worth of cocaine
Speaks, understands, and prints in English.

Exclusion Criteria:

Meets DSM-V criteria for substance use disorder, moderate to severe, for a substance other than cocaine, alcohol or nicotine. Subjects with comorbid alcohol use disorder will be accepted if their alcohol use disorder is not severe enough to require a medical alcohol detoxification.
Needs treatment with any psychoactive medications (with the exception of diphenhydramine or melatonin, if necessary, for sleep).
Meets current or lifetime DSM-V criteria for schizophrenia or any psychotic disorder, or organic mental disorder.
Has another Axis I psychiatric disorder that in the opinion of the physician will interfere with completion of the study or place the patient at heightened risk through participation in the trial.
Has evidence of a history of significant hematological, pulmonary, endocrine, cardiovascular, renal or gastrointestinal disease.
Use of an investigational medication in the 30 days prior to randomization.

Is female and has a positive pregnancy test, is contemplating pregnancy in the next 6 months, is nursing, or is not using effective contraception (if relevant).

-","The initial dose of the NS2359 will be two mg once daily. Patients with difficult adverse events at the 2 mg dose will be allowed to reduce to 1 mg once daily. Subjects will participate in weekly cognitive behavioral relapse prevention psychotherapy from week 2 through week 9.

NS2359: NS2359 is a small molecule which inhibits the reuptake of dopamine, norepinephrine and serotonin with equal affinity.",PubChem:68470595,"8-Azabicyclo(3.2.1]octane, 3-(3,4-dichlorophenyl)-2-(methoxymethyl)-8-methyl-, (1R,2R,3S,5S)-",COCC1C(c2ccc(Cl)c(Cl)c2)CC2CCC1N2C,,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT02806947,NCT02806947_EG000,No,All,Child | Adult | Older Adult,Phase 2,58,"Inclusion Criteria:

Patients with standard-risk acute GVHD, according to refined Minnesota Criteria. Refined Minnesota Criteria are available at https://redcap.ahc.umn.edu/surveys/?s=bNmFhseJIf.

Standard-risk acute GVHD according to the refined Minnesota Risk Criteria requires meeting one of the criteria below:

Single organ involvement (Stage 1-3 skin, Stage 1 upper GI, or Stage 1-2 lower GI)
Multiple organ involvement (Stage 1-3 skin plus stage 1 upper GI, Stage 1-3 skin plus stage 1 lower GI, Stage 1-3 skin plus stage 1 lower GI plus stage 1 upper GI, Stage 1-3 skin plus stage 1-4 liver, or Stage 1 lower GI plus stage 1 upper GI)
Acute Minnesota Standard Risk GVHD requiring systemic immune suppressive therapy.
Acute GVHD developing after allogeneic hematopoietic cell transplantation using either bone marrow, peripheral blood, or umbilical cord blood. Recipients of non-myeloablative, reduced intensity conditioning and myeloablative transplants are eligible. All allogeneic donor sources are permitted, including siblings, unrelated donors, human leukocyte antigen (HLA)-haploidentical related donors and umbilical cord blood.
Patients NOT receiving systemic immune suppressive therapy for treatment of active GVHD (topical skin and GI corticosteroids are allowed).
Ability to tolerate oral or enterically-administered medications.
Patients of all ages.
Absolute neutrophil count (ANC) greater than 500/µL.
Biopsy confirmation of GVHD is not required. Enrollment should not be delayed for biopsy or pathology results unless local institutional practice mandates biopsy confirmation to make a GVHD treatment decision.
Written informed consent and/or assent from patient, parent or guardian.
Collection of a 5 ml blood sample (red top for serum) from the patient for Ann Arbor Scoring and ready to be shipped immediately after randomization.

Exclusion Criteria:

Patients receiving sirolimus (for any indication including GVHD prophylaxis) within 14 days of screening for enrollment.
Relapsed, progressing or persistent malignancy requiring withdrawal of systemic immune suppression.
Patients with acute GVHD developing after a donor lymphocyte infusion.
Active or recent (within 7 days) episode of transplant associated microangiopathy.
Patients with uncontrolled infections will be excluded. Infections are considered controlled if appropriate therapy has been instituted and, at the time of enrollment, no signs of progression are present. Progression of infection is defined as hemodynamic instability attributable to sepsis, new symptoms, worsening physical signs or radiographic findings attributable to infection. Persisting fever without other signs or symptoms will not be interpreted as progressing infection.
Patients unlikely to be available for evaluation at the transplant center on Day 28 and 56 of therapy.
A clinical presentation resembling de novo chronic GVHD or overlap syndrome developing before or present at the time of enrollment.
Patients receiving corticosteroids for any indication within 7 days before the onset of acute GVHD, except the following: Stable replacement doses of corticosteroids for adrenal insufficiency are permitted (e.g. hydrocortisone total dose of 10-12 mg/m^2/day or prednisone 5-7.5mg daily or equivalent). Corticosteroids administered as premedication before transfusion of blood products or before intravenous medications to prevent infusion reactions are allowed.
Patients who are pregnant or breastfeeding.
Females of childbearing potential (FCBP) or a man who has sexual contact with a FCBP and is unwilling to use effective birth control for the duration of the study.
Patients on dialysis.
Patients on mechanical ventilation.
Patients with severe hepatic sinusoidal obstruction syndrome who in the judgment of the treating physician are not expected to have normalized bilirubin by Day 56 after enrollment.
Patients with a history of hypersensitivity to sirolimus or any component of the formulation.","Sirolimus, a steroid-free therapy, will be administered after a diagnosis of standard-risk aGVHD is clinically established.

Sirolimus: Sirolimus will be administered with a starting dose of 6 mg for patients older than 12 years, or 5 mg/m^2 for patients ≤ 12 years. Trough levels will be routinely measured and sirolimus will be kept at maintenance dosing for target therapeutic levels for minimum duration through Day 56 post-randomization.",ChEMBL:CHEMBL413 | DrugBank:DB00877 | PubChem:134760597 | PubChem:138404388 | PubChem:21944094 | PubChem:5284616,Sirolimus,COC1CC2CCC(C)C(O)(O2)C(=O)C(=O)N2CCCCC2C(=O)OC(C(C)CC2CCC(O)C(OC)C2)CC(=O)C(C)C=C(C)C(O)C(OC)C(=O)C(C)CC(C)C=CC=CC=C1C,L01EG04 | L04AA10 | S01XA23,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02814175,NCT02814175_EG000,No,All,Adult | Older Adult,Phase 4,122,"Inclusion Criteria:

PsA diagnosis established at least 4 weeks prior to the date of the Screening visit and confirmed by ClASsification of Psoriatic Arthritis (CASPAR) criteria
Not in MDA at the time of screening
Has 3 or more tender and 3 or more swollen joints
Treated with methotrexate 15 mg (weekly) for at least 4 weeks

Exclusion Criteria:

Contraindications to adalimumab therapy and/or known hypersensitivity to adalimumab or its excipients
History of methotrexate intolerance/toxicity
Medical conditions(s) precluding methotrexate dose increase above 15 mg
Had prior exposure to any tumor necrosis factor (TNF) inhibitor, other mechanism of action biologic DMARD (bDMARD) or any systemic biologic agent in general",Methotrexate (MTX) escalated to 20 - 25 mg or highest tolerable dose every week (ew) (MTX 20 - 25 mg or highest tolerable dose ew),ChEMBL:CHEMBL34259 | DrugBank:DB00563 | PubChem:126941,Methotrexate,CN(Cc1cnc2nc(N)nc(N)c2n1)c1ccc(C(=O)N[C@@H](CCC(=O)O)C(=O)O)cc1,L01BA01 | L04AX03,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02814175,NCT02814175_EG002,No,All,Adult | Older Adult,Phase 4,15,"Inclusion Criteria:

PsA diagnosis established at least 4 weeks prior to the date of the Screening visit and confirmed by ClASsification of Psoriatic Arthritis (CASPAR) criteria
Not in MDA at the time of screening
Has 3 or more tender and 3 or more swollen joints
Treated with methotrexate 15 mg (weekly) for at least 4 weeks

Exclusion Criteria:

Contraindications to adalimumab therapy and/or known hypersensitivity to adalimumab or its excipients
History of methotrexate intolerance/toxicity
Medical conditions(s) precluding methotrexate dose increase above 15 mg
Had prior exposure to any tumor necrosis factor (TNF) inhibitor, other mechanism of action biologic DMARD (bDMARD) or any systemic biologic agent in general","Participants achieving MDA at Week 16 on MTX escalated to 20 -25 mg or highest tolerable dose ew, continued with the same MTX dose (MTX 20 - 25 mg or highest tolerable dose ew)",ChEMBL:CHEMBL34259 | DrugBank:DB00563 | PubChem:126941,Methotrexate,CN(Cc1cnc2nc(N)nc(N)c2n1)c1ccc(C(=O)N[C@@H](CCC(=O)O)C(=O)O)cc1,L01BA01 | L04AX03,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02814838,NCT02814838_EG000,No,All,Adult,Phase 2,50,"Inclusion Criteria:

Male and female patients aged 18-45 years, inclusive;
New-onset T1D (randomization within 100 days from 1st insulin administration);
Positive for at least one diabetes-related auto-antibody (anti-GAD; IAA, if obtained within 10 days of the onset of insulin therapy; IA-2 antibody; ZnT8);
Require, or has required at some time, insulin, with the exclusion of patients taking twice daily pre-mixed insulin or on insulin pump;
Residual β-cell function as per peak stimulated (MMTT) C-peptide level >0.6ng/mL (0.2nmol/L); MMTT should not be performed within one week of resolution of a diabetic ketoacidosis event;
Patient able to comply with all protocol procedures for the duration of the study, including scheduled follow-up visits and examinations;
Patients who have given written informed consent prior of any study-related procedure not part of standard medical care.

Exclusion Criteria:

Patients taking twice daily pre-mixed insulin or on insulin pump;
Any other chronic disease, including type 2 diabetes, apart from autoimmune hypothyroidism requiring thyroid hormone replacement only; patients with severe (myxedema) disease potentially requiring immunosuppressive therapy will be excluded;
Moderate to severe renal impairment as per calculated creatinine clearance (CLcr) < 60 mL/min according to the Cockcroft-Gault formula (Cockcroft-Gault, 1976);
Hepatic dysfunction defined by increased ALT/AST > 3 x upper limit of normal (ULN) and increased total bilirubin > 3 mg/dL [>51.3 μmol/L];
Hypoalbuminemia defined as serum albumin < 3 g/dL;
QTcF > 470 msec;
Complete Left Bundle Branch Block (LBBB), atrio-ventricular block (mobitz II 2nd degree or 2:1 atrio-ventricular block), complete heart block;
Electronic pacemaker positioned or implanted defibrillator;
History of significant cardiovascular disease;
Known hypersensitivity to non-steroidal antiinflammatory drugs;
Concomitant treatment with phenytoin, warfarin, sulphanylurea hypoglycemics (e.g. tolbutamide, glipizide, glibenclamide/glyburide, glimepiride, nateglinide) and high dose of amitriptyline (> 50 mg/day);
Previous (within 2 weeks prior to randomization) and concomitant treatment with metformin, sulfonylureas, glinides, thiazolidinediones, exenatide, liraglutide, DPP-IV inhibitors or amylin, or any medications known to influence glucose tolerance (e.g. β-blockers, angiotensin-converting enzyme inhibitors, interferons, quinidine antimalarial drugs, lithium, niacin, etc.);
Past (within 1 month prior to randomization) or current administration of any immunosuppressive medications (including oral, inhaled or systemically injected steroids) and use of any investigational agents, including any agents that impact the immune response or the cytokine system;
Pregnant or breast feeding women. Unwillingness to use effective contraceptive measures up to 2 months after the end of study drug administration (females and males). Effective contraceptive measures include an hormonal birth control (e.g. oral pills, long term injections, vaginal ring, patch); the intrauterine device (IUD); a double barrier method (e.g. condom or diaphragm plus spermicide foam).","Ladarixin oral capsule

Ladarixin: Ladarixin oral capsule",DrugBank:DB16212 | PubChem:11372270,Ladarixin,C[C@@H](C(=O)NS(C)(=O)=O)c1ccc(OS(=O)(=O)C(F)(F)F)cc1,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,1.0,1.0,0.0,1.0,0.0,1.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0
NCT02815397,NCT02815397_EG000,No,All,Adult | Older Adult,Phase 2,2,"Inclusion Criteria:

Male or female ≥ 18 years of age

Diagnosis of DLBCL as documented by medical records and with histology based on criteria established by the World Health Organization

subtyping is required for DLBCL
c-myc+ defined as presence of c-myc breaks by karyotype/FISH and/or IHC ≥ 40%; this includes double hits (with bcl-2 breaks found using cytogenetics/FISH) and/or double expressors (with bcl-2 protein expression ≥ 70% by IHC); increased copy number in itself is not considered positivity for c-myc
No prior therapy for diagnosis of DLBCL with exception of steroids
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0- 2 (Appendix B)
Life expectancy of at least 6 months
No history of medication dependent diabetes mellitus
No evidence of acute or chronic metabolic acidosis (baseline venous lactate ≤ 4)

Exclusion Criteria

Patient already on any class of anti-diabetic medication including metformin, insulin analogues, sulfonylureas, thiazolidinediones (TZDs) and the incretin-based therapies or clear need for therapeutic intervention based on fasting blood glucose
Known histological transformation from indolent non-Hodgkin Lymphoma (iNHL) or chronic lymphocytic leukemia (CLL) to an aggressive form of non-Hodgkin's lymphoma (NHL) (ie, Richter transformation)
Burkitt and/or precursor lymphoblastic leukemia/lymphoma.
Presence of known intermediate- or high-grade myelodysplastic syndrome
History of an active of treated non-lymphoid malignancy within the last 3 years excluding basal cell and squamous cell skin cancers
Evidence of ongoing systemic bacterial, fungal, or viral infection at the time of start of study drug.
Subjects who have currently active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver involvement with NHL or stable chronic liver disease per investigator assessment)
Renal insufficiency with creatinine > 1.5 x upper limit of normal (ULN) OR creatinine clearance of < 45 ml/min as calculated by the Cockcroft-Gault method
CNS or leptomeningeal involvement of lymphoma
HIV positive
Ongoing inflammatory bowel disease
Ongoing alcohol or drug addiction
Pregnancy or breastfeeding
History of prior allogeneic bone marrow progenitor cell or solid organ transplantation -","Metformin added to standard of care treatment for all patients

Metformin: given in addition to standard of care treatment",ChEMBL:CHEMBL1431 | DrugBank:DB00331 | PubChem:4091,Metformin,CN(C)C(=N)NC(=N)N,A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02819440,NCT02819440_EG000,Accepts Healthy Volunteers,All,Adult,Phase 2,61,"Inclusion Criteria:

Adults (ages 21-50)
Obesity (BMI ≥ 30 kg/m2)
Prediabetes on oral glucose tolerance test.

Exclusion Criteria:

Age <21 or > 50
BMI < 30 kg/m2
Systolic blood pressure (SBP) < 100, > 150 mmHg
Current anti-hypertensive medication use, including diuretics
Current use of organic nitrates
Current use of PDE-5 inhibitors (sildenafil, tadalafil, vardenafil)
History of reaction to PDE-5 inhibitors
Known HIV infection
Use of medications that strongly alter CYP3A4 activity
History of myocardial infarction, angina, uncontrolled cardiac arrhythmia, stroke, transient ischemic attack, or seizure
Known non-arteritic ischemic optic retinopathy (NAIOR)
History of hearing loss
Estimated glomerular filtration rate (eGFR) < 60 ml/min/1.73 m2 by the modified diet in renal disease (MDRD) equation
Hepatic transaminase (AST and ALT) levels greater than three times the upper limit of normal
Known pregnancy or breastfeeding or those unwilling to avoid pregnancy during the course of the study
History of priapism
Use in excess of four alcoholic drinks daily
History of diabetes mellitus or use of anti-diabetic medications
Known anemia (men, Hct < 38% and women, Hct <36%)
Menopause
Inability to exercise on a bicycle
Weight > 300 pounds","Subjects will be randomized to one of two arms. 100 obese adult subjects will be randomized to the Tadalafil arm following the screening visit. Beginning at their baseline visit, they will receive an oral daily dose of Tadalafil (20mg) that they will take for 12 weeks (through their completion of the study). After randomization has occurred, the active comparator subjects will undergo the following visit protocol: baseline visit (two half-days), an interim visit (6 weeks post-baseline), and a 12-week visit (two half-days).

Tadalafil: Tadalafil is an FDA approved, clinically-available drug that inhibits the enzyme phosphodiesterase type 5A (PDE5). Subjects who are randomized to this arm will be provided with 20mg of Tadalafil to take every day for 12 weeks, beginning at their baseline visit.",ChEMBL:CHEMBL779 | DrugBank:DB00820 | PubChem:110635,Tadalafil,[H][C@]12Cc3c([nH]c4ccccc34)[C@@H](c3ccc4c(c3)OCO4)N1C(=O)CN(C)C2=O,C02KX52 | C02KX54 | G04BE08 | G04CA54 | G04CB51,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT02819804,NCT02819804_EG000,No,All,Adult | Older Adult,Phase 1,1,"Inclusion Criteria:

Patients must have a histologically confirmed diagnosis of Ph+ ALL

Detection of one of the following must be present:

t(9;22)(q34;q11) or 3-way variant by metaphase cytogenetics
Breakpoint cluster region (BCR)-Abelson (ABL) positive status by molecular analysis with qualitative polymerase chain reaction (PCR) or fluorescence in situ hybridization (FISH)

Patients must have primary refractory ALL based on failure to achieve a hematologic or molecular remission after induction therapy with dasatinib and steroids or dasatinib and chemotherapy, or have relapsed after treatment with a tyrosine kinase inhibitor with or without chemotherapy

Note: Prior course of dasatinib and steroid induction therapy should have included dasatinib 140mg PO daily on days 1-84 and prednisone 60mg/m^2 (capped at 120mg, or equivalent steroid dose) on days 1-28; if patients were unable to tolerate full steroid dose during induction therapy they will still be eligible
Note: Patients with refractory or relapsed disease in the central nervous system will be eligible
Prior chemotherapy or tyrosine kinase inhibitor (TKI) treatment, aside from dasatinib, must be >= 7 days before first investigational agent dose
Patients must exhibit an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

Patients must have adequate organ and bone marrow function prior to registration, as defined below:

Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2 x institutional upper limit of normal (IULN)
Total bilirubin < 2.0 x IULN (unless Gilbert syndrome has been diagnosed); if leukemia infiltration of the liver is suspected to be causing liver function abnormalities the patient will still be eligible with principal investigator (PI) approval
Creatinine < 2 x IULN
Creatinine clearance > 40 mL/min (measured by Cockroft-Gault)

Females of child-bearing potential (FOCBP) must have a negative pregnancy test within 7 days of registration

Note: A FOCBP is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:

Has not undergone a hysterectomy or bilateral oophorectomy
Has had menses at any time in the preceding 12 consecutive months (and therefore has not been naturally postmenopausal for > 12 months)
Women must not be breastfeeding at the time of study registration

Women and men of reproductive potential should agree to use two effective means of birth control

For women, contraception should continue for 23 weeks after the last dose of nivolumab and 12 weeks after the last dose of dasatinib to allow complete clearance of drug and its principal metabolites from the body
For men, contraception should continue for 31 weeks after nivolumab and 12 weeks after dasatinib
Patients must have the ability to understand and the willingness to sign a written informed consent prior to registration on study

Exclusion Criteria:

Patients may not be receiving any other investigational agents within 5 half-lives of the drug (if known); if the half-life is not known, investigational agents should not be taken within two weeks
Patients are not eligible if they have an intolerance to most recent prior TKI (other than dasatinib) at the lowest possible effective dose, defined as a grade >= 3 toxicity considered at least possibly related to that TKI; patients are also excluded if they are intolerant or allergic to dasatinib and discontinued prior therapy due to a >= grade 2 treatment related adverse event
Patients must not have a history of a grade 4 anaphylactic reaction to monoclonal antibody therapy or known hypersensitivity reactions to drugs formulated with polysorbate 90
Patients must not have had any prior therapy with an anti-PD-1, anti-programmed cell death 1 ligand 1 (PD-L1), anti-programmed cell death 1 ligand 2 (PD-L2), anti-cluster of differentiation (CD)137 or anti-cytotoxic t-lymphocyte-associated protein 4 ligand (CTLA-4) antibody (or any antibody or drug specifically targeting T-cell costimulation or checkpoint pathways; for questions or uncertainties, please contact the PI or quality assurance manager (QAM)

Patients who have had allogeneic hematopoietic stem cell transplant (HSCT) are not eligible if they meet any of the following:

transplant is within 2 months from cycle 1, day 1 (C1D1)
Has clinically significant graft-versus-host disease requiring treatment
Has >= grade 3 persistent non-hematological toxicity related to the transplant
Concomitant use of strong inhibitors of the cytochrome p450, family 3, subfamily a, polypeptide 4 (CYP3A4) isoenzyme is not permitted; must have wash-out period of 5 times the half-life of the compound before first dasatinib dose
Concomitant use of QT prolonging agents strongly associated with torsades de pointes is not permitted
Patients who have a known dasatinib-resistant ABL-kinase mutation such as T315I are not eligible; for confirmation, please contact PI

Patients who have any serious or uncontrolled medical disorder that would impair the ability of the subject to receive protocol therapy are not eligible; these include, but are not limited to:

Active infection that is not well controlled
Known pleural or pericardial effusion at baseline
Clinically significant gastrointestinal disease or digestive dysfunction compromising absorption of dasatinib
Pulmonary arterial hypertension

Uncontrolled or significant cardiovascular disease, including:

Myocardial infarction within 6 months of enrollment date
Uncontrolled angina or congestive heart failure within 3 months of enrollment date
Left ventricular ejection fraction (LVEF) < 40%

Significant cardiac conduction abnormality, including:

History of clinically significant ventricular arrhythmia (such as ventricular tachycardia, ventricular fibrillation, or torsades de pointes)
History of second or third degree heart block (except for second degree type 1)
Corrected QT (QTc) interval > 500 msec, unless a cardiac pacemaker is present
Prior malignancy active within the previous 3 years, except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancers, superficial bladder cancer, or carcinoma in situ of the prostate, cervix or breast
Subjects with active, known or suspected autoimmune disease; (Note: Subjects with vitiligo, type I diabetes mellitus, hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll)
Psychiatric illness/social situations that would limit compliance with study requirements
Any other illness or condition that the treating investigator feels would interfere with study compliance or would compromise the patient's safety or study endpoints
Female patients who are pregnant or nursing are not eligible
Patients are not eligible if they have a known positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (hepatitis C virus [HCV] antibody) indicating acute infection; Note: Patients with evidence of chronic hepatitis B infection will be allowed to enroll if on appropriate suppressive medications under the direction of a hepatologist and with PI approval
Patients who are known to be positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) are not eligible
Patients must not have live vaccine therapies for prevention of infectious diseases within 28 days of first nivolumab dose
Patients who are unable to swallow oral medication are not eligible

Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including chronic prolonged systemic corticosteroids (defined as corticosteroid use of duration one month or greater), should be excluded; these include but are not limited to patients with a history of:

Immune related neurologic disease
Multiple sclerosis
Autoimmune (demyelinating) neuropathy
Guillain-Barre syndrome
Myasthenia gravis
Systemic autoimmune disease such as systemic lupus erythematosus (SLE)
Connective tissue diseases
Scleroderma
Inflammatory bowel disease (IBD)
Crohn's
Ulcerative colitis
Patients with a history of toxic epidermal necrolysis (TEN)
Stevens-Johnson syndrome
Anti-phospholipid syndrome NOTE: Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll","Patients receive dasatinib PO QD on days 1-28 and nivolumab IV over 30 minutes on days 8 and 22 of course 1 and on days 1 and 15 of subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Dasatinib: Given PO

Laboratory Biomarker Analysis: Correlative studies

Nivolumab: Given IV

Pharmacological Study: Correlative studies",ChEMBL:CHEMBL1421 | DrugBank:DB01254 | PubChem:3062316,Dasatinib,Cc1nc(Nc2ncc(C(=O)Nc3c(C)cccc3Cl)s2)cc(N2CCN(CCO)CC2)n1,L01EA02 | L01XE06,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,1.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT02822950,NCT02822950_EG000,No,All,Adult | Older Adult,Phase 1,10,"Inclusion Criteria:

Adult (≥18y/o) patients with a medical or post-surgical infection such as skin/soft tissue infections, urinary infections, IA infections and pneumonia (including VAP)
Patients requiring intensive care (critically ill patients) in the med/surg ICU (APACHE II score ≥ 15)
Patients prescribed Avycaz for their infection will receive FDA recommended dosages and times of administration
Written informed consent

Exclusion Criteria:

Pregnant Patients, patients older than 90 y/o, those with CrCl < 30 mL/min, patients with a BMI > 45 Kg/m2, patients unable to provide serum samples, and those with the risk of imminent death during the study","Ceftazadime/avibactam 2500 mg (1250 mg for CrCl 31-50 mL/min) IV over 120 minutes, every 8 hours [other antibiotics can also be administered as needed]. Patients will receive at least 3 doses (steady-state) of Avycaz prior to obtaining serum samples.

Ceftazidime/avibactam: Ceftazadime/avibactam dosing in ICU patients",PubChem:77050660 | PubChem:90643431,Avycaz,CC(C)(ON=C(C(=O)NC1C(=O)N2C(C(=O)[O-])=C(C[n+]3ccccc3)CSC12)c1csc(N)n1)C(=O)O.NC(=O)C1CCC2CN1C(=O)N2OS(=O)(=O)O,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02829983,NCT02829983_EG000,Accepts Healthy Volunteers,All,Adult,Not Applicable,20,"Inclusion Criteria:

diagnosis of Generalized Aggressive Periodontitis
presence of ≥20 teeth
presence of ≥ 6 sites presenting probing depth (PD) ≥5mm with bleeding on probing (BOP) and ≥2 sites with PD ≥7mm (including incisors and first molars, in addition to two other non-contiguous teeth between them)
good general health
<35 years of age
agree to participate in the study and sign a written consent

Exclusion Criteria:

pregnant or lactating
suffering from any other systemic disease (e.g. cardiovascular, diabetes, blood dyscrasias, immunodeficiency, etc) which could alter the course of periodontal disease
received antimicrobials in the previous 6 months
taking long-term anti-inflammatory drugs
received a course of periodontal treatment within the last 12 months
smoked","20 subjects that received one-stage full-mouth ultrasonic debridement (FMUD) associated with clarithromycin (500 mg - 12/12 hours) for 3 days.

Clarithromycin: Use of 500mg of Clarithromycin twice a day for 3 days

One-stage full-mouth ultrasonic debridement (FMUD): One session of Periodontal debridement using ultrasonic device.",ChEMBL:CHEMBL1741 | DrugBank:DB01211 | PubChem:84029,Clarithromycin,[H][C@]1(O[C@H]2[C@H](C)[C@@H](O[C@]3([H])O[C@H](C)C[C@H](N(C)C)[C@H]3O)[C@](C)(OC)C[C@@H](C)C(=O)[C@H](C)[C@@H](O)[C@](C)(O)[C@@H](CC)OC(=O)[C@@H]2C)C[C@@](C)(OC)[C@@H](O)[C@H](C)O1,A02BD04 | A02BD05 | A02BD06 | A02BD07 | A02BD09 | A02BD11 | A02BD12 | A02BD14 | J01FA09,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02832687,NCT02832687_EG001,No,All,Adult | Older Adult,Phase 4,47,"Inclusion Criteria:

Undergoing ambulatory laparoscopic cholecystectomy.
American Society of Anesthesiologists physical status 1, 2 or 3.-

Exclusion Criteria -

Cognitively impaired (by history) and unable or unwilling to consent
Chronic steroid or opioid user (as prescribed for a chronic systemic illness)
Parturient or nursing mother. Patients who have been informed by a physician that they have liver or kidney disease","Patients 50kg or more will receive either 1000mg IV acetaminophen with the first dose given preoperatively in the holding area followed by re-dosing every four hours from that point up to a maximum of 4 doses or 4000mg in 24 hours. Patients <50 kg will receive 12.5mg/kg to a maximum of 75 mg /per kg/per day as per the label dose with repeat dosing Q4 hours. Blinded medication will be prepared by research pharmacist in 100mL of normal saline

Acetaminophen: patients 50kg or more receive1000mg in 100milliliters of normal saline every 4 hours to a maximum dose 4000mg/24 hours. <50kg receive 12.5mg/kg to a maximum of 75mg/kg/24 hours.",ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0
NCT02839876,NCT02839876_EG000,No,All,Adult | Older Adult,Phase 4,31,"Inclusion Criteria:

Patients scheduled for elective, primary total hip replacement for osteoarthritis
American Society of Anesthesiologists (ASA) Physical Classification I-III
Weight 50 kg or greater
Body mass index 18-40 kg/m2

Exclusion Criteria:

Inability to consent to study
Inability to speak English
Pregnancy
Weight <50 kg
Revision hip replacement or emergency surgery
Contraindications to spinal anesthesia: coagulopathy or bleeding diathesis, local infection, allergy to local anesthetics
Allergies/intolerances/contraindications to any of the multimodal agents: acetaminophen, pregabalin, celecoxib, ketamine, or dexamethasone
Chronic pain from a separate source other than operative hip
Daily opioid equivalent use of 30 mg of morphine or greater at time of consent
History of heart failure
History of drug or alcohol abuse
Rheumatoid arthritis
Uncontrolled anxiety, schizophrenia or other psychiatric disorder that, in the opinion of the investigator, may interfere with the study assessments
Chronic malnutrition, renal or liver impairment
Hypersensitivity to acetaminophen or any of its excipients","Subjects receive 1000 mg acetaminophen IV immediately preoperatively, as well as at 6, 12, and 18 hours postoperatively. At the same time points, subjects will receive an oral placebo.

Intravenous acetaminophen: Subject receives 1 g acetaminophen by the intravenous route every 6 hours for 4 doses beginning in the preoperative holding area.",ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT02839876,NCT02839876_EG001,No,All,Adult | Older Adult,Phase 4,29,"Inclusion Criteria:

Patients scheduled for elective, primary total hip replacement for osteoarthritis
American Society of Anesthesiologists (ASA) Physical Classification I-III
Weight 50 kg or greater
Body mass index 18-40 kg/m2

Exclusion Criteria:

Inability to consent to study
Inability to speak English
Pregnancy
Weight <50 kg
Revision hip replacement or emergency surgery
Contraindications to spinal anesthesia: coagulopathy or bleeding diathesis, local infection, allergy to local anesthetics
Allergies/intolerances/contraindications to any of the multimodal agents: acetaminophen, pregabalin, celecoxib, ketamine, or dexamethasone
Chronic pain from a separate source other than operative hip
Daily opioid equivalent use of 30 mg of morphine or greater at time of consent
History of heart failure
History of drug or alcohol abuse
Rheumatoid arthritis
Uncontrolled anxiety, schizophrenia or other psychiatric disorder that, in the opinion of the investigator, may interfere with the study assessments
Chronic malnutrition, renal or liver impairment
Hypersensitivity to acetaminophen or any of its excipients","Subjects receive 1000 mg acetaminophen PO immediately preoperatively, as well as at 6, 12, and 18 hours postoperatively. At the same time points, subjects will receive an intravenous placebo.

Oral acetaminophen: Subject receives 1 g acetaminophen by the oral route every 6 hours for 4 doses beginning in the preoperative holding area.",ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02851303,NCT02851303_EG001,No,All,Child,Phase 4,13,"Inclusion criteria:

Born at University of New Mexico Hospital
Greater than 34 weeks gestation
Primary in-utero drug exposure was opioids other than buprenorphine
Maternal or infant urine drug screen positive for methadone and/or opioids on admission

Exclusion criteria:

Born prior to 34 weeks
Neonatal intensive care unit admission
Serious medical comorbidities
Primary substance exposure in-utero was buprenorphine, or was not opioids","Step 1: 0.7 mgs/Kg/24 hrs. divided by into six doses (q 4 hrs) is starting dose Step 2: Decrease dose by half, which is 50% of starting dose, EVERY 4 hours. Step 3: Same dose which is 50% of starting dose EVERY 6 hours. Step 4: Same dose which is 50% of starting dose EVERY 8 hours. Step 5: Same dose which is 50% of starting dose EVERY 12 hours. Step 6: Decrease dose by half, which is 25% of starting dose EVERY 12 hours. Step 7: Same dose which is 25% of starting dose q 24 hours

Methadone: Methadone wean protocol as described in arm description

Adverse events were recorded only for infants of each dyad.",ChEMBL:CHEMBL350719 | ChEMBL:CHEMBL651 | DrugBank:DB00333 | DrugBank:DB15198 | PubChem:4095 | PubChem:643985,Methadone,CCC(=O)C(CC(C)N(C)C)(c1ccccc1)c1ccccc1,N02AC52 | N07BC02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02861534,NCT02861534_EG000,No,All,Adult | Older Adult,Phase 3,2519,"Inclusion Criteria:

History of chronic HF (New York Heart Association [NYHA] Class II-IV) on standard therapy before qualifying HF decompensation
Previous HF hospitalization within 6 months prior to randomization or intravenous (IV) diuretic treatment for HF (without hospitalization) within 3 months.
Brain natriuretic peptide (BNP) levels: sinus rhythm-≥ 300 pg/mL; atrial fibrillation-≥ 500 pg/mL and N-terminal pro-Brain Natriuretic Peptide (NT-proBNP) levels: sinus rhythm- ≥ 1000 pg/mL; atrial fibrillation - ≥ 1600 pg/mL within 30 days prior to randomization
Left ventricular ejection fraction (LVEF) of <45% assessed within 12 months prior to randomization by any method
If female, is not of reproductive potential or agrees to avoid becoming pregnant while receiving study drug and for 14 days after the last dose of study drug by complying with one of the following: practice abstinence from heterosexual activity or use (or have her partner use) acceptable contraception during heterosexual activity.

Exclusion Criteria:

Clinically unstable at the time of randomization as defined by either the administration of any IV treatment within 24 hours prior to randomization, and/or systolic blood pressure (SBP) <100 mmHg or symptomatic hypotension
Current or anticipated use of long-acting nitrates or nitric oxide (NO) donors including isosorbide dinitrate, isosorbide 5-mononitrate, pentaerythritol tetranitrate, nicorandil or transdermal nitroglycerin (NTG) patch, and molsidomine
Current or anticipated use of phosphodiesterase type 5 (PDE5) inhibitors such as vardenafil, tadalafil, and sildenafil
Current use or anticipated use of a soluble guanylate cyclase (sGC) stimulator such as riociguat
Known allergy or sensitivity to any sGC stimulator
Awaiting heart transplantation (United Network for Organ Sharing Class 1A / 1B or equivalent), receiving continuous IV infusion of an inotrope, or has/anticipates receiving an implanted ventricular assist device
Primary valvular heart disease requiring surgery or intervention, or is within 3 months after valvular surgery or intervention
Hypertrophic obstructive cardiomyopathy
Acute myocarditis, amyloidosis, sarcoidosis, Takotsubo cardiomyopathy
Post-heart transplant cardiomyopathy
Tachycardia-induced cardiomyopathy and/or uncontrolled tachyarrhythmia
Acute coronary syndrome (unstable angina, non-ST elevation myocardial infarction [NSTEMI], or ST elevation myocardial infarction [(STEMI]) or coronary revascularization (coronary artery bypass grafting [CABG] or percutaneous coronary intervention [PCI]) within 60 days, or indication for coronary revascularization at time of randomization
Symptomatic carotid stenosis, transient ischemic attack (TIA) or stroke within 60 days
Complex congenital heart disease
Active endocarditis or constrictive pericarditis
Estimated glomerular filtration rate (eGFR) <15 mL/min/1.73 m2 or chronic dialysis
Severe hepatic insufficiency such as with hepatic encephalopathy
Malignancy or other non-cardiac condition limiting life expectancy to <3 years
Require continuous home oxygen for severe pulmonary disease
Current alcohol and/or drug abuse
Participated in another interventional clinical study and treatment with another investigational product ≤30 days prior to randomization or plans to participate in any other trial/investigation during the duration of this study
Mental or legal incapacitation and is unable to provide informed consent
Immediate family member (e.g., spouse, parent/legal guardian, sibling or child) who is involved with this study
Interstitial Lung Disease
Is pregnant or breastfeeding or plans to become pregnant or to breastfeed during the course of the study","Participants received a starting dose of 2.5 mg of vericiguat taken orally once daily with food, on a background of HF standard of care. The vericiguat dose was uptitrated to 5 mg and to 10 mg.",ChEMBL:CHEMBL4066936 | DrugBank:DB15456 | PubChem:54674461,Vericiguat,COC(=O)Nc1c(N)nc(-c2nn(Cc3ccccc3F)c3ncc(F)cc23)nc1N,C01DX22,1.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0
NCT02865460,NCT02865460_EG000,No,All,Adult | Older Adult,Phase 3,100,"Inclusion Criteria:

Male and female Veterans who were deployed in 1990 -1991 Gulf War.
Veterans who currently meet the Kansas Gulf War Study Case Definition for Gulf War Illness.
Veterans who were in good health based on medical history prior to 1990.
Veterans whose severity of illness is moderate to severe, evidenced by scoring less than 30 of 100 on the physical domain of SF36.

Exclusion Criteria:

Veteran has a condition that may interfere with the ability to accurately report symptoms, such as:

severe psychiatric problems
schizophrenia
bipolar disorder
major depression with psychotic or melancholic features
delusional disorders alcohol or drug dependence requiring hospitalization, or regular illegal drug use or other psychiatric condition requiring inpatient stay in the 6 months prior to study entry.
Has dementias of any type
Currently does not have exclusionary conditions that could reasonably be responsible for the symptoms in multi-symptom disorders, as determined by Investigator (based on Reeves et al.2003).
Is pregnant or breastfeeding or plans to become pregnant within the next 6 months.

Medical conditions excluded:

organ failure
defined rheumatologic inflammatory disorders
chronic active infections such as HIV, hepatitis B and C, or transplant
primary sleep disorders

Medications that could potentially impact immune function excluded:

steroids
immune-suppressives
nutraceuticals that are formulated to impact mitochondrial function or oxidative stress
Biologic response modifiers within 3 months of study entry.
Current use of Coumadin (given the vitamin K structural similarity of CoQ10)
Known allergy to CoQ10 and/or inactive ingredients of active and placebo soft gelatin capsules
Willingness to have 12 weeks of washout of current CoQ10, ubiquinol, or ubiquinone supplements will be required between the screening and baseline visits.
Common multivitamin preparations will be allowed if taken without change throughout the protocol.","Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking

Ubiquinol: Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking",DrugBank:DB11340 | PubChem:9962735,Ubiquinol,COc1c(O)c(C)c(C/C=C(\C)CC/C=C(\C)CC/C=C(\C)CC/C=C(\C)CC/C=C(\C)CC/C=C(\C)CC/C=C(\C)CC/C=C(\C)CC/C=C(\C)CCC=C(C)C)c(O)c1OC,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02870283,NCT02870283_EG000,No,All,Adult | Older Adult,Phase 4,107,"Inclusion Criteria:

ages between 18 and 65;
BD current acute mixed episode;
total capacity to understand and respond to self-applied instruments;
the presence of symptoms in the last 30 days;
abstinence for at least 30 days for drug addicts.

Exclusion Criteria:

presence of Organic Brain Syndrome (OBS);
pregnancy or lactation;
criteria for psychiatric hospitalization.","Subjects were randomized into three groups: (lithium, valproic acid, or carbamazepine).

Group (A) Started Lithium (900mg-1500mg)

Subjects evaluated for responsiveness every 2 weeks. Responsive to treatment patients remain in the same step. Max. step duration of 8 weeks.

First step: Monotherapy with Lithium (900-1500mg) Non responsive patients: 2nd step.

Second step: Randomization for lithium (900mg-1500mg) + valproic acid (1000mg-1500mg) OR lithium (900mg-1500mg) + carbamazepine (600mg-1200mg).

Non responsive patients: 3rd step.

Third step: Crossover lithium (900mg-1500mg) + valproic acid (1000mg-1500mg) X lithium (900mg-1500mg) + carbamazepine (600mg-1200mg).

Non responsive patients: 4th step.

Fourth step: Association with risperidone (1-6mg)

Lithium",ChEMBL:CHEMBL1200826 | DrugBank:DB14509 | PubChem:11125,LITHIUM CARBONATE,O=C([O-])[O-].[Li+].[Li+],,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02871011,NCT02871011_EG000,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 2,7,"Inclusion Criteria:

Positive clinical findings for moccasin, interdigital or bullous tinea pedis as determined by direct clinical examination
Must have a clinical symptom severity score of at least 20 on a possible 64 point scale
Written informed consent must be obtained from the subject.
Must ≥ 19 years of age, for study sites located in British Columbia. For other locations the subject must be ≥ 18 years of age, unless local laws dictate otherwise.
Must agree to avoid professional pedicures or application of any nail polish product or nail cosmetic to the toenails after the screening visit until the conclusion of the trial.
Must agree to take measures to avoid pregnancy during the 31 day study period

Exclusion Criteria:

Has a diagnosis of either psoriasis or eczema, in or immediately around the area under evaluation.
Has a visual diagnosis, by the investigator, of onychomycosis at a level, which in the opinion of the investigator could compromise the integrity of the study.
Use of topical antifungals e.g. (clotrimazole, ketoconazole,miconazole, oxiconazole- (Oxistat®, Glaxo Smith Kline), sulconazole, naftifine (Naftin®, Merz), terconazole, econazole nitrate (Spectazole®, Ortho-McNeil), butoconazole ,Fluconazole, ciclopirox olamine-(Loprox®), tolnaftate, haloprogin), Zeasorb, antibacterials and corticosteroids in the preceding 5 days of screening visit (Day 1) on or immediately around the area under evaluation.
Use of systemic corticosteroids in the preceding 7 days respectively, of screening visit (Day 1)
Use of systemic antifungals in the preceding 7 days of screening visit (Day1) including - (terbinafine - (Lamisil®, Novartis), Itraconazole - (Sporanox®, Janssen), fluconazole- (Diflucan®, Pfizer), ketoconazole, miconazole, griseofulvin (GrisPEG®), butoconazole, terconazole, Potassium iodide)
Has used any investigational drug(s) within 30 days preceding screening visit (Day 1)
Is pregnant or is a nursing mother
Is a woman of child bearing potential who is not using an adequate form of contraception (or abstinence)
Is < 19 years of age, for study sites located in British Columbia. For other locations subject is < 18 years of age, unless local laws dictate otherwise.
Suffers from a condition, which, in the opinion of the medical investigator, would compromise his/her safety and / or the quality of the data. Such conditions may include collagen vascular disease, diabetes mellitus, Cushing's Disease, hematological malignancy, chronic mucocutaneous candidiasis or atopy","Water, delivered as a footbath for 30 minutes, daily for 3 consecutive days.

Water: Delivered as a footbath",ChEMBL:CHEMBL1098659 | DrugBank:DB09145 | PubChem:10129877 | PubChem:24602 | PubChem:962,Water,O,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02871297,NCT02871297_EG000,No,All,Child | Adult,Phase 3,662,"Inclusion Criteria:

The participant is a male or female child aged ≥7 and <12 years or adolescent aged ≥12 and ≤18 years in the lead-in study (12709A and 12710A).
The participant must have completed Study 12709A or 12710A (Visit 12, Completion Visit) immediately prior to enrolment into this extension study.
The participant had a primary diagnosis of MDD at entry in study 12709A or 12710A, diagnosed according to DSM-5™.
The participant is indicated for long-term treatment with vortioxetine according to the clinical opinion of the Investigator.
For participants aged ≥7 and ≤17 years at the Baseline visit; the participant is able to understand the Informed Assent Form, and parent(s)/legal representative(s) are able to read and understand the Informed Consent Form.
For participants who turned 18 years during the lead-in study 12710A; the participant has signed the Informed Consent Form.

Exclusion Criteria:

The participant has been diagnosed with another psychiatric disorder (for example mania, bipolar disorder, schizophrenia or any psychotic disorder) during study 12709A or 12710A.
The participant has an attention-deficit/hyperactivity disorder (ADHD) that requires a pharmacological treatment other than a stimulant medication.

Other protocol-defined inclusion and exclusion criteria may apply","Participants initiated treatment with vortioxetine 5 mg/day orally for the first 2 days and thereafter they received 10 mg/day vortioxetine. Based on the response and dose-limiting AEs, vortioxetine dose could be up- or down-titrated with 5 mg/day but the maximum dose did not exceed 20 mg/day. The total duration of treatment was 26 weeks.",ChEMBL:CHEMBL2104993 | DrugBank:DB09068 | PubChem:9966051,Vortioxetine,Cc1ccc(Sc2ccccc2N2CCNCC2)c(C)c1,N06AX26,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02874924,NCT02874924_EG002,Accepts Healthy Volunteers,All,Older Adult,Phase 2,6,"Inclusion Criteria: age 70-95

participants will be in good health with all chronic diseases (hypertension, coronary artery disease, etc.) clinically stable.
participants must have adequate cognitive function to be able to give informed consent. This will be established by enrolling participants with CLOX 1 scores of ≥10.

Exclusion Criteria:

unstable ischemic heart disease
clinically significant pulmonary disease
history of immunodeficiency or receiving immunosuppressive therapy
history of a coagulopathy or receiving a medical condition requiring anticoagulation
an estimated glomerular filtration rate of <30ml/min
uncontrolled hypercholesteremia >350mg/dl;
uncontrolled hypertriglyceridemia >500mg/dl
diabetes
history of skin ulcers or poor wound healing
smoking
liver disease
treatment with drugs known to affect cytochrome P450 3A (diltiazem, erythromycin)","No placebo control; Rapamycin 1mg once daily for 8 weeks

Rapamycin: No placebo control in this substudy group",ChEMBL:CHEMBL413 | DrugBank:DB00877 | PubChem:134760597 | PubChem:138404388 | PubChem:21944094 | PubChem:5284616,Sirolimus,COC1CC2CCC(C)C(O)(O2)C(=O)C(=O)N2CCCCC2C(=O)OC(C(C)CC2CCC(O)C(OC)C2)CC(=O)C(C)C=C(C)C(O)C(OC)C(=O)C(C)CC(C)C=CC=CC=C1C,L01EG04 | L04AA10 | S01XA23,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02875067,NCT02875067_EG000,No,All,Adult | Older Adult,Phase 1 | Phase 2,6,"Inclusion Criteria:

Be willing and able to provide written informed consent/assent for the trial.
Be 18 years of age on day of signing informed consent.
Have measurable or evaluable disease, as defined in 2007 Revised Response Criteria for Malignant Lymphoma24 and have received at least two prior therapies. HL patients must not be currently eligible for autologous stem cell transplant.
Be willing to provide either archived tumor tissue or tissue from a newly obtained core or excisional biopsy of a tumor lesion. Newly-obtained is defined as a specimen obtained up to 6 weeks (42 days) prior to initiation of treatment on Day 1.
Have a performance status of 0 to 2 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.

Demonstrate adequate organ function as defined in Table 1, all screening labs should be performed within 14 days of treatment initiation.

Adequate Organ Function Laboratory Values:

Absolute neutrophil count (ANC): ≥1,000 /microliter (mcL)
Platelets: ≥75,000 / mcL
Hemoglobin: ≥9 g/dL or ≥5.6 mmol/L without transfusion or erythropoietin (EPO) dependency (within 7 days of assessment)
Serum creatinine OR: ≤1.5 X upper limit of normal (ULN) OR Measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl): ≥60 mL/min for subject with creatinine levels > 1.5 X institutional ULN
Serum total bilirubin: ≤ 1.5 X ULN OR
Direct bilirubin ≤ ULN for subjects with total bilirubin levels: >1.5 ULN
Aspartate aminotransferase (AST) / serum glutamic oxaloacetic transaminase (SGOT) and alanine aminotransferase (ALT)/ serum glutamic pyruvic transaminase (SGPT): ≤ 2.5 X ULN OR ≤ 5 X ULN for subjects with liver metastases
Albumin: >2.5 mg/dL
International Normalized Ratio (INR) or Prothrombin Time (PT): ≤1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants
Activated Partial Thromboplastin Time (aPTT): ≤1.5 X ULN unless subject is receiving anticoagulant therapy, as long as PT or PTT is within therapeutic range of intended use of anticoagulants

aCreatinine clearance should be calculated per institutional standard.

Female subject of childbearing potential should have two negative urine or serum pregnancy test, one at 10-14 days before first dose of study drug and another within 24 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year.
Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy.

Exclusion Criteria:

Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
Has a known history of active Bacillus Tuberculosis (TB)
Hypersensitivity to pembrolizumab or any of its excipients.
Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.

Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent.

Note: Subjects with ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the study.
Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability.
Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
Has known history of, or any evidence of active, non-infectious pneumonitis.
Has an active infection requiring systemic therapy.
Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of trial treatment.
Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.
Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C virus (HCV) (e.g., HCV Ribonucleic acid (RNA) [qualitative] is detected), or other active viral hepatitis. Patients with treated and resolved hepatitis B or C are eligible. Patients with active liver disease, except liver abnormalities directly attributable to lymphoma are ineligible,
Has received a live vaccine within 30 days of planned start of study therapy.","An intravenous infusion of 200 mg of pembrolizumab (MK3475) once every 3 weeks for a total of 4 infusions

Lenalidomide at either 15 mg, 10 mg or 20 mg (depending on which cohort patients are enrolled in) days 1-14 every 21 days

Pembrolizumab

Lenalidomide",ChEMBL:CHEMBL848 | DrugBank:DB00480 | PubChem:216326,Lenalidomide,Nc1cccc2c1CN(C1CCC(=O)NC1=O)C2=O,L04AX04,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02878798,NCT02878798_EG001,No,All,Adult | Older Adult,Phase 2,66,"Inclusion Criteria

Age 18-80
Diagnosis of confirmed symptomatic distal symmetric peripheral polyneuropathy based on the Toronto consensus criteria for probable neuropathy (the presence of unequivocal signs and symptoms of neuropathy)45.
Evidence of symptomatic neuropathy based on a screening visit NQOL-DN score of >9.

Metabolic syndrome based on modified ATPIII criteria. Specific criteria require 3 of the following 6 to be present at the screening visit.

Waist circumference >102 cm for men, >88 cm for women
Serum triglycerides of > 150 mg/dl
HDL < 40 mg/dl for men, < 50 mg/dl for women
Those with either a normal HDL or TRG who are taking a lipid lowering medication for this purpose
Blood pressure 130/85 mm Hg or use of anti-hypertension drug
Hyperglycemia based on American Diabetes Association (ADA) criteria at screening based on any one or more of the following: fasting plasma glucose > 100 mg/dL (5.6 mmol/L), 2-hour glucose tolerance test > 140 mg/dL (7.8 mmol/L), or hemoglobin A1c > 5.7% .
No current or prior history of therapy with topiramate.
If female of child-bearing potential (i.e., not surgically sterile or post-menopausal defined as age > 51 years without menses for ≥ 2 years), negative serum pregnancy test at screening and negative urine pregnancy test at baseline visit.
Women of child-bearing potential or men with sexual partners of childbearing potential be willing to use an acceptable method of birth control for the duration of the study and for 12 weeks following completion of study drug therapy. Acceptable methods of birth control include abstinence, oral contraceptives, the contraceptive patch, intra-uterine device, the contraceptive ring, and or barrier contraception such as condoms with spermicide.

Exclusion Criteria

CSS-PI clinical determination of an alternative cause for peripheral neuropathy (including but not limited to rheumatological disorders, Hepatitis B or C, breast cancer treated with neurotoxic chemotherapy within the past 15 years). All potential subjects will have screening neuropathy labs including assessment for diabetes (Hemoglobin A1c, oral glucose tolerance test), vitamin B12 level, and immunofixation47.
Type I diabetes or current use of insulin or use of insulin in the past 3 months.
HgA1c > 7.5%. Borderline screening labs can be repeated within two weeks with PPI approval.
History of recurrent nephrolithiasis, a single episode of nephrolithiasis within one year prior to screening, or use of ongoing preventative treatment.
Family history of a hereditary neuropathy in a first-degree relative.
Severe neuropathy: Utah Early Neuropathy Score > 24 at screening
Active foot ulceration or a history of a nontraumatic foot amputation.
ECG with QTc more than 450 ms in men, or 470 ms in women.
Risk of excessive bleeding at the skin biopsy site based on the clinical assessment of the CSS-PI.
Chronic corticosteroid use excluding topical or inhaled treatment.
Use of a carbonic anhydrase inhibitor (such as acetazolamide) due to risk of nephrolithiasis.
Planned bariatric surgery.
Use of other weight loss medications.
Use of scheduled opiates, or as needed opiate medications more than three times weekly.
Use of topical capsaicin products within 16 weeks of screening or at any time on study.
Medication change for neuropathy symptoms during the 8 weeks prior to screening; or anticipated change for the duration of study participation.
Current use of an intrathecal pain pump or spinal cord stimulator.
Screening laboratory creatinine ≥ 2.0 mg/dl.
Severe edema, dermatologic or lower extremity condition that would increase risk of skin biopsy.
Major depression, bipolar affective disorder, or other mental health disorders that are sufficiently severe to increase adverse event risk or impact neuropathy assessment in the opinion of the responsible site principal investigator.
Current suicidal ideation within one year prior to the baseline visit as evidenced by answering ""yes"" to Questions 4 or 5 on the suicidal ideation portion of the Columbia-Suicide Severity Rating Scale (C-SSRS).
Ataxia sufficiently severe to represent an unacceptable fall risk in the opinion of the site principal investigator.
A serious medical condition expected to dramatically shorten life span or prevent participation.
Any clinically significant condition or illness, which, in the opinion of the CSS-PI, would pose a risk to the subject or might confound the study including metabolic acidosis, bone marrow suppression, blood dyscrasias, bleeding disorder, or closed angle glaucoma.
History of alcohol or drug abuse within the past two years, or existing neuropathy related to past drug or alcohol abuse.
History of malignancy within five years prior to study enrollment, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.
A history of epilepsy.
An inability to understand or cooperate with the procedures of the study.
Pregnant, or intending to become pregnant, or breastfeeding.","Oral topiramate

topiramate: Oral topiramate at a target dose of 50mg twice daily.",ChEMBL:CHEMBL220492 | DrugBank:DB00273 | PubChem:5284627,Topiramate,[H][C@@]12OC(C)(C)O[C@]1([H])CO[C@@]1(COS(N)(=O)=O)OC(C)(C)O[C@]12[H],A08AA51 | N03AX11,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT02880137,NCT02880137_EG000,No,All,Child | Adult | Older Adult,Phase 4,36,"Inclusion:

Cardiac transplant recipients (> or equal to 10 months post transplant)
Clinically followed at Mayo Clinic, Rochester Minnesota

Exclusion:

Standard contraindications to the use of ultrasound contrast and pharmacologic stress
Recent (< 3 months) hospitalization for heart failure, acute coronary syndrome or allograft rejection
Multi-organ transplant Known or suspected right-to-left, bi-directional, or transient right-to-left cardiac shunts
Hypersensitivity to perflutren","RTMPE with Perflutren Lipid Microsphere (DEFINITY) is a safe and feasible non-invasive technique commonly used to diagnose coronary disease, and offers an attractive alternative for CAV detection.

Perflutren Lipid Microsphere: Definity (injectible suspension ultrasound contrast agent) will be diluted with saline for both Pediatric and Adult subjects. For pediatric subjects under 60kg (kilogram), the dose will be 20 MicroL/kg (MicroLiter/kilogram) diluted to the same concentration used in the adult dosing. Hand Injections will be performed at baseline, Pre-peak, and peak perfusion stages.

RTMPE: Utilizes intravenous administration of biologically-inert microbubbles to assess myocardial perfusion and has demonstrated utility for identifying small vessel coronary artery disease.",ChEMBL:CHEMBL1663 | DrugBank:DB00556 | PubChem:6432,Perflutren,FC(F)(F)C(F)(F)C(F)(F)F,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02882074,NCT02882074_EG000,No,All,Adult | Older Adult,Not Applicable,85,"Inclusion Criteria:

Age 40 - 85 years old
Scheduled for elective aortic valve replacement with or without coronary artery bypass grafting with or without additional minor surgical procedure.
Written, informed consent for participation in this investigation.

Exclusion Criteria:

Patients with Raynaud's disease or other disease associated with upper extremity vascular insufficiency,
Inability to perform EndoPAT exam (inability to lie still for 15 min, or significant finger deformity),
Patients with renal failure with oliguria or anuria not related to hypovolemia.
Patients receiving dialysis.
Patients with preoperative renal insufficiency (Creatinine > 1.6 mg/dL)
Anticipated deep hypothermic circulatory arrest
Known hypersensitivity or allergy to hydroxyethyl starch or the excipients of hydroxyethyl starch
Clinical conditions with volume overload (e.g., patients in pulmonary edema or congestive heart failure)
Patients with severe hypernatremia or severe hyperchloremia
Patients with intracranial bleeding
Pregnant or breast feeding women
Critically ill adult patients, including patients with sepsis, due to increased risk of mortality and renal replacement therapy, (e.g. patients who are hospitalized in the intensive care unit prior to surgery)
Severe liver disease
Pre-existing coagulation or bleeding disorders
Any contraindications to proposed interventions.","Human albumin 5% during surgery.

Human albumin: human albumin 5% during surgery",ChEMBL:CHEMBL1663 | DrugBank:DB00556 | PubChem:6432,Perflutren,FC(F)(F)C(F)(F)C(F)(F)F,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02883400,NCT02883400_EG001,No,All,Adult | Older Adult,Phase 4,8,"Inclusion Criteria:

liver transplant

Exclusion Criteria:

dual organ transplant","spironolactone

Spironolactone: spironolactone 25 mg up to 50 mg",ChEMBL:CHEMBL1393 | DrugBank:DB00421 | PubChem:5833,Spironolactone,[H][C@]12CC[C@]3(C)[C@]4(CCC(=O)O4)CC[C@@]3([H])[C@]1([H])[C@]([H])(SC(C)=O)CC1=CC(=O)CC[C@@]12C,C03DA01,1.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02899156,NCT02899156_EG000,No,All,Adult | Older Adult,Phase 4,22,"Inclusion Criteria:

critically ill adults
RASS score of -3 to 0 after receiving benzodiazepine therapy
CAM-ICU positive
no benzodiazepine therapy within the previous 12 hours

Exclusion Criteria:

contraindications to flumazenil including hypersensitivity
receipt of benzodiazepines for control of potentially life-threatening conditions (e.g., control of intracranial pressure or status epilepticus)
active seizure disorder or on current anti-convulsant therapy for history of seizure disorder. Seizures secondary to alcohol withdrawal will NOT be excluded.
history of traumatic brain injury complicated by seizures
acute episode (within prior 30 days) of severe traumatic brain injury
history of structural lesion (e.g. subarachnoid hemorrhage, cerebrovascular accident, intra-parenchymal hemorrhage) complicated by seizures
acute episode (within prior 14 days) of structural lesion (e.g. subarachnoid hemorrhage, cerebrovascular accident, intra-parenchymal hemorrhage)
brain tumor complicated by seizure
history of anoxic brain injury
third-degree burn with total body surface area (TBSA) burn greater than 20%
chronic benzodiazepine (clonazepam:lorazepam:diazepam approximately 4:8:40 mg per day) for 7 consecutive days with no taper
chronic delirium that is attributable to other causes
anticipated to transfer to lower level of care within 24 hours
admitted for polysubstance overdose as determined by initial drug toxicity screening
recent exposure (prior 7 days) to pro-convulsant medications (identified via medication list, medication reconciliation performed by PI/pharmacy medication reconciliation team, or urine drug screening)
children, incarcerated individuals, and pregnant women
unable to provide consent and the legally authorized representative is unable to provide consent","The flumazenil continuous infusion is started at an initial dose of 0.1 mg/hr., and can be titrated up to a maximum of 0.3 mg/hr. Dose titrations may occur every 60 minutes to maintain RASS scores of 0 to +1. The maximum rate is 0.3 mg/hr.

Flumazenil",ChEMBL:CHEMBL407 | DrugBank:DB01205 | PubChem:3373,Flumazenil,CCOC(=O)c1ncn2c1CN(C)C(=O)c1cc(F)ccc1-2,V03AB25,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02902172,NCT02902172_EG000,Accepts Healthy Volunteers,Female,Child | Adult,Phase 4,36,"Inclusion Criteria:

vaginal delivery
diagnosis of chronic hypertension, chronic hypertension with superimposed preeclampsia
preeclampsia without severe features
preeclampsia with severe features gestational hypertension without severe range blood pressures
gestational hypertension with severe range blood pressures
singleton pregnancies

Exclusion Criteria:

Cesarean Delivery
no diagnosis of hypertensive disorder
chronic or acute renal disease
allergy to ibuprofen or acetaminophen
lupus
multiple order pregnancies (twins, triplets)
Narcotic addiction/ in treatment for substance abuse/ current prescription drug user/ current use of illegal drugs",Women receiving acetaminophen for primary pain control following vaginal delivery.,ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02911701,NCT02911701_EG000,Accepts Healthy Volunteers,Female,Adult | Older Adult,Phase 4,50,"Inclusion Criteria:

ability to give informed consent
diagnosis of a ""severe"" hypertensive disorder of pregnancy:
preeclampsia with severe features
chronic hypertension with superimposed preeclampsia with severe features
HELLP syndrome: hemolysis, elevated liver function tests, low platelets
eclampsia
not yet delivered or less than 6 hours after delivery

Exclusion Criteria:

current incarceration
serum creatinine > 1.0 mg/dL or suspicion of acute kidney injury
AST (aspartate aminotransferase) >200 unit/L
ALT (alanine aminotransferase) > 200 unit/L
known allergy or sensitivity to NSAIDs or acetaminophen
delivery > 6 hours prior to enrollment
chronic kidney disease
chronic liver disease
prior liver transplant
chronic infectious hepatitis
gastritis
gastro-esophageal reflux disease (GERD)
peptic ulcer disease
bleeding disorder
provider feels that participation is not in the best interest of the patient","Study participants randomized to the acetaminophen group will receive 650mg of acetaminophen orally every 6 hours during their postpartum hospital stay.

Acetaminophen",ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02912195,NCT02912195_EG001,No,All,Adult | Older Adult,Phase 4,16,"Inclusion Criteria:

Subject has severe pain (NRS ≥7)
Subject has anticipated ED stay of ≥1 hour

Exclusion Criteria:

High acuity trauma patients
Patients deemed to critically ill by ED provider
Active psychosis
Pregnancy
History of heart block or bradycardia
Allergy to lidocaine or amide type local anesthetic
History of seizures","ED provider will choose an appropriate dose of intravenous morphine for the patient.

At 20 and 40 minutes, participants can elect to receive morphine 4mg IV as a rescue analgesic.

Intravenous morphine: Emergency department provider chooses appropriate dose of intravenous morphine",PubChem:6321225,Morphine sulfate pentahydrate,CN1CCC23c4c5ccc(O)c4OC2C(O)C=CC3C1C5.CN1CCC23c4c5ccc(O)c4OC2C(O)C=CC3C1C5.O.O.O.O.O.O=S(=O)(O)O,,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT02912455,NCT02912455_EG000,No,All,Adult | Older Adult,Phase 4,11,"Inclusion Criteria:

Post Roux-n-Y gastric bypass (RYGB) surgery and sleeve gastrectomy (SG) patients who underwent surgery >1 and <15 years ago in the Cleveland surrounding area
Age 20-75 years of age
Type II Diabetes Mellitus (D2M) diagnosis (history, medication usage, biochemical criteria) prior to and after surgery; after surgery, defined by a single HbA1c of greater or equal to 6.5% at consent and screening.
Metformin patients must have an HbA1c greater than or equal to 6.5% but less than or equal to 10% at randomization; for diet controlled patients (i.e. not on any T2D medication), HbA1c must be greater than or equal to 6.5% at randomization.
Patient reporting of improvement in T2D status or objective improvements in T2D status at any time post-surgery.
estimated glomerular filtration rate (eGFR) ≥ 60mL/min prior to randomization
Has the ability and willingness to provide informed consent.
Is able to understand the options and to comply with the requirements of each program
Female subject agrees to have a serum pregnancy test at screening. A negative serum pregnancy test result is required prior to randomization.
Female patients must agree to use a reliable method of contraception for 6 months or duration of intervention
Patients taking an anti-diabetic medication, except insulin, are eligible and must agree to washout for 8 weeks prior to the randomization visit.

Exclusion Criteria:

Type 1 diabetes indicated by history of diabetic ketoacidosis and lack of remission in response to bariatric surgery
Other post bariatric procedures (banding, duodenal switch, biliopancreatic diversion)
Current use of insulin.
End organ diabetic complications (renal failure, cardiomyopathy, severe neuropathy/foot ulcers)
Documented severe or unstable depression/anxiety or eating disorder that would not enable patient to adhere to anti-diabetic treatment
Clinical contraindications to use canagliflozin, i.e., history of bladder cancer, Child-Pugh class C","Subjects randomized to study drug will be assigned a six month course starting on canagliflozin 100 mg for two weeks titrated up to 300 mg daily (n= 24).

canagliflozin: encapsulated (gelatin capsule).",DrugBank:DB08907 | PubChem:24812758,Canagliflozin,[H][C@@]1(c2ccc(C)c(Cc3ccc(-c4ccc(F)cc4)s3)c2)O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O,A10BD16 | A10BK02,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02912650,NCT02912650_EG003,No,All,Adult,Phase 3,165,"Inclusion Criteria:

Outpatients who have undergone surgical extraction of 3 or more third molars, of which at least 2 must be a partial or complete bony mandibular impaction.
Subject must have at least moderate pain on the 4-point categorical scale, confirmed by at least 50 mm on the 100 mm VAS PSR scale within approximately 5 hours (i.e., less than or equal to 5 hours, 15 minutes) after surgery is completed.
Female subjects are not pregnant or breast feeding.
Informed consent.

Exclusion Criteria:

Presence or history of any significant hepatic, renal, endocrine, cardiovascular, neurological, psychiatric, gastrointestinal, pulmonary, hematologic, or metabolic disorder determined by the Investigator to place the subject at increased risk, including the presence or history within 2 years of screening.
Acute localized dental alveolar infection at the time of surgery that could confound the post-surgical evaluation.
Hypersensitivity to ibuprofen, naproxen, aspirin, or any other NSAID; or to APAP, tramadol, other opioids, or to their combinations.","Participants received a single oral dose of acetaminophen 650 mg tablet, during the 12 hours study.",ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02913612,NCT02913612_EG000,No,All,Child,Phase 2,44,"Inclusion Criteria

Documented informed consent from legal guardian
0-84 days postnatal age at time of first study dose or when enrolled into the non-intervention cohort.

Clinical diagnosis of superficial cutaneous or mucosal infantile hemangioma (must include all of the following):

Superficial lesion in the dermis
Thin <2 mm in thickness
Small >=5 cm at its longest dimension and <=10cm2
Involves skin or keratinized mucosa

Exclusion Criteria

History of previous treatment with any pharmacologic or laser therapy for IH
Ongoing therapy with an oral beta blocker or oral corticosteroid (e.g., cardiac arrhythmia, adrenal insufficiency, upper airway obstruction, tetralogy of fallot (TOF), hypertension, reactive airways disease)
IH that requires systemic therapy (defined by dynamic complication scale >3)
IH of the non-keratinized mucosa
Infants with more than one hemangioma that requires therapy
Hemodynamically significant cardiovascular disease, as determined by the investigator
Known allergy to beta blockers or vehicle
Heart rate <100 beats per minute at screening visit
Known prenatal or postnatal diagnosis of 2nd/3rd degree atrioventricular block
History of Reactive Airways Disease (RAD)
Any condition which would make the participant, in the opinion of the investigator unsuitable for the study.","Subjects assigned to this arm will be randomized to 0.25% timolol for 180 days. If during the 180 days the subject is considered a treatment failure, the subject will be unblinded. If the subject is on 0.25% timolol they will be changed to 0.5% timolol.

0.25% Timolol Maleate Gel Forming Solution: 50:50 Randomized 0.25% Timolol Maleate Gel Forming Solution",PubChem:5281056,Timolol Maleate,CC(C)(C)NCC(O)COc1nsnc1N1CCOCC1.O=C(O)C=CC(=O)O,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT02913612,NCT02913612_EG001,No,All,Child,Phase 2,51,"Inclusion Criteria

Documented informed consent from legal guardian
0-84 days postnatal age at time of first study dose or when enrolled into the non-intervention cohort.

Clinical diagnosis of superficial cutaneous or mucosal infantile hemangioma (must include all of the following):

Superficial lesion in the dermis
Thin <2 mm in thickness
Small >=5 cm at its longest dimension and <=10cm2
Involves skin or keratinized mucosa

Exclusion Criteria

History of previous treatment with any pharmacologic or laser therapy for IH
Ongoing therapy with an oral beta blocker or oral corticosteroid (e.g., cardiac arrhythmia, adrenal insufficiency, upper airway obstruction, tetralogy of fallot (TOF), hypertension, reactive airways disease)
IH that requires systemic therapy (defined by dynamic complication scale >3)
IH of the non-keratinized mucosa
Infants with more than one hemangioma that requires therapy
Hemodynamically significant cardiovascular disease, as determined by the investigator
Known allergy to beta blockers or vehicle
Heart rate <100 beats per minute at screening visit
Known prenatal or postnatal diagnosis of 2nd/3rd degree atrioventricular block
History of Reactive Airways Disease (RAD)
Any condition which would make the participant, in the opinion of the investigator unsuitable for the study.","Subjects assigned to this arm will be randomized to 0.5% timolol for 180 days. If during the 180 days the subject is considered a treatment failure, the subject will be unblinded. If the subject is on 0.5% timolol the treating physician will decide to either continue 0.5% timolol or withdraw the subject and begin an alternative treatment.

0.5% Timolol Maleate Gel Forming Solution: 50:50 Randomized 0.5% Timolol Maleate Gel Forming Solution",PubChem:5281056,Timolol Maleate,CC(C)(C)NCC(O)COc1nsnc1N1CCOCC1.O=C(O)C=CC(=O)O,,0.0,0.0,0.0,0.0,0.0,1.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT02918409,NCT02918409_EG002,No,All,Adult | Older Adult,Phase 4,24,"Inclusion Criteria:

Male or female ≥ 18 years of age at Visit 1.

Documentation of CF diagnosis as evidenced by one or more clinical features consistent with the CF phenotype and one or more of the following criteria:

Sweat chloride equal or greater than 60 mEq/L by quantitative pilocarpine iontophoresis test.
Two well-characterized mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene
Abnormal nasal potential difference (NPD) as measured by a change in NPD in response to a low chloride solution and isoproterenol of less than -5 mV.
Documentation of the presence of an acute pulmonary exacerbation, based on CF Foundation guidelines, as diagnosed by a faculty member of the Denver Adult CF Program.
Respiratory culture(s) demonstrating evidence of Pseudomonas aeruginosa or Achromobacter species airway infection.
Subject is able to produce sputum, undergo phlebotomy, and provide written consent.
The subject's treating physician has determined that they should receive either tobramycin or colistin intravenously as one of the designated agents for their APE treatment. Subjects who are able to receive either tobramycin or colistin as part of their antibiotic regimen will be randomized into one of three arms. If a treating physician deems that a subject cannot receive tobramycin due to vestibular toxicity, ototoxicity or bacterial resistance, the subject will be randomized to either standard or PK-adjusted colistin.

Exclusion Criteria:

Concomitant administration of bactrim (due to effects on creatinine).
Concomitant administration of inhaled colistin for patients in the colistin PK arm, as this will create inaccuracies in colistin sputum concentration measurements.
Patients being treated for B. cepacia, due to colistin resistance by the pathogen.
Presence of chronic renal insufficiency, with abnormal baseline creatinine >1.2mg/dL.
Presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the patient or the quality of the data.
Inability to perform reproducible spirometry.
Inability to expectorate sputum. -","Subjects receive IV tobramycin 8-10 mg/kg/day with once daily dosing for 14 days. Peaks and troughs are drawn with the second dose of tobramycin, and the drug is infused over 30 minutes

Tobramycin",ChEMBL:CHEMBL1747 | DrugBank:DB00684 | PubChem:36294,Tobramycin,NC[C@H]1O[C@H](O[C@H]2[C@H](O)[C@@H](O[C@H]3O[C@H](CO)[C@@H](O)[C@H](N)[C@H]3O)[C@H](N)C[C@@H]2N)[C@H](N)C[C@@H]1O,J01GB01 | S01AA12,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02920918,NCT02920918_EG000,No,All,Adult | Older Adult,Phase 4,17,"Major Inclusion Criteria:

Symptomatic stable heart failure (New York Heart Association (NYHA) functional classification II-III) with reduced left ventricular ejection fraction (LVEF) ≤40%
Peak exercise limited by shortness of breath and associated with a respiratory exchange ratio (RER) >1.00 (reflecting maximal aerobic effort);
Poorly controlled Type 2 Diabetes Mellitus (T2DM)(HbA1c levels between 7.0% and 10.0% if on a treatment regimen including insulin, or between 6.5% and 10.0% if not on an insulin regimen);
Eighteen years of age or older.

Major Exclusion Criteria:

Type I diabetes;
Open label treatment with Sodium-GLucose coTransporter (SGLT)-2 inhibitors (within the past 3 months);
Current treatment with thiazolidinedione (within the past 3 months);
Chronic Renal Disease defined as Glomerular Filtration Rate (GFR) <50 ml•min-1/1.73m2 according to local laboratory
Pregnancy or of child-bearing potential or lactating;
Active or recent (within 2 weeks) genital/urinary infection;
Concomitant conditions or treatment which would affect completion or interpretation of the study (i.e, physical inability to walk or run on a treadmill
Inability to give informed consent.

Exclusion criteria specific to the cardiac magnetic resonance (CMR) substudy.

Estimated GFR <60 ml•min-1/1.73m2
Implantable cardioverter defibrillator, pacemaker or other implantable metal device not compatible with CMR scanning;
Severe claustrophobia, inability to lay flat for up to 60 minutes, or other contraindication to CMR scanning.","Canagliflozin will be administered orally in pill form at 100 mg, daily for 12 weeks.

Canagliflozin",DrugBank:DB08907 | PubChem:24812758,Canagliflozin,[H][C@@]1(c2ccc(C)c(Cc3ccc(-c4ccc(F)cc4)s3)c2)O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O,A10BD16 | A10BK02,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT02929667,NCT02929667_EG000,No,All,Adult | Older Adult,Phase 2,11,"Inclusion Criteria:

Adult patients aged 18 or older
Patients with epilepsy
Native English speaker or adequate fluency in English to provide informed consent.
Female patients of child-bearing potential must be using an acceptable method of contraception, and willing to refrain from sexual intercourse during the study.

Exclusion Criteria:

Progressive neurological disease.
Clinical diagnosis of bipolar disease, panic disorder, psychosis or severe depression, or PHQ-9 score > 20
Patients with prior hospitalization related to depression or Electroconvulsive therapy.
History of suicidal ideation or intent in past or present
Clinical history or laboratory evidence of hepatic or renal insufficiency.
Pregnant or lactating women.
Current heavy alcohol use (>14 drinks per week for men or >7 drinks per week for women) or) known medical disorder related to alcohol use or current illicit drug use, other than marijuana and its derivatives.
Patients with recent use (<1 month) or already taking fluoxetine or other selective serotonin reuptake inhibitors (SSRIs).
Concurrent use of monoamine oxidase inhibitors, antipsychotic agents, antidepressant agents other than SSRIs or frequent use of triptan agents (>2/week).
History of a previous allergic reaction or adverse effects with fluoxetine, hypersensitive reaction-anaphylaxis; laryngeal edema; hives
History of serotonin syndrome.
History of uncontrolled pulmonary or cardiac illness.
Patients with hypercapnic ventilatory response (HCVR) slope of > 2.0
Patients with known prolong QT interval
Patients with family history of prolong QT interval
Patients with family history of sudden cardiac death under the age of 40 in a first degree relative.","Subjects randomized to treatment arm will receive fluoxetine with titration schedule consisting of 10 mg per day for 1 week, 20 mg per day for 1 week, 40 mg per day for 2 weeks, 20 mg per day for 1 week and 10 mg per day for 1 week. Then stop.

Fluoxetine: Standard 6 weeks titration, starting 10 mg per day.",ChEMBL:CHEMBL41 | DrugBank:DB00472 | PubChem:3386,Fluoxetine,CNCCC(Oc1ccc(C(F)(F)F)cc1)c1ccccc1,N06AB03 | N06CA03,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02931253,NCT02931253_EG000,No,All,Adult | Older Adult,Phase 2,6,"Inclusion Criteria:

All individuals diagnosed with Atrial Fibrillation and choosing to undergo a rhythm control strategy at Robert Packer Hospital with a BMI ≥ 27 will be eligible for the study. All subjects must be able to understand and willing to sign a written informed consent document.

Exclusion Criteria:

Individuals who are already taking metformin or other antidiabetic medications including insulin, have a diagnosis of diabetes, have a known allergy or FDA-labeled contraindication to taking metformin, eGFR below 30 mL/min per 1.73 m2 or other clinical diagnosis of advanced renal disease,, have acute or chronic metabolic acidosis (serum bicarbonate <22 mEq/L), have a history of significant alcohol use (>2 drinks/day on average), have a history of hepatic dysfunction (serum bilirubin 1.5X greater than the upper limit of normal), have a history of New York Heart Association (NYHA) Class III or IV heart failure, or are pregnant will be excluded from the trial.","Metformin 500 mg daily initiated 6 weeks prior to scheduled ablation.

Metformin increased to 2000 mg daily (1000 mg twice a day) as tolerated over the initial 3 weeks.

Metformin: Metformin will be started as one pill (500 mg metformin) once a day with a meal. If the subject has no side effects from this dose, the dose will be increased to two pills (1000 mg) twice a day to be taken with meals.",ChEMBL:CHEMBL1431 | DrugBank:DB00331 | PubChem:4091,Metformin,CN(C)C(=N)NC(=N)N,A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02932475,NCT02932475_EG000,No,Female,Adult,Phase 3,397,"Inclusion Criteria:

Maternal age 18-45 years
Singleton pregnancy with no known fetal anomalies
Gestational age between 10weeks 0 days and 22 weeks 6 days by menstrual dating confirmed by ultrasound, or ultrasound alone
Clinical diagnosis of preexisting T2DM requiring medical treatment (oral agent or insulin)
Clinical diagnosis of diabetes diagnosed between 10 weeks and < 20 weeks 6 days gestation
Willing to start insulin therapy and discontinue oral hypoglycemic pills other than study pills
Able to swallow pills

Exclusion Criteria:

Clinical diagnosis of pre-existing renal disease, defined as creatinine > 1.5 mg/dL
Clinical history of lactic acidosis
Known allergy to metformin
Participation in another study that could affect primary outcome
Delivery planned at non-MOMPOD study locations
Unwillingness to use insulin treatment or follow prenatal care doctor's instructions for insulin and blood glucose monitoring",Metformin 1000 mg twice a day,ChEMBL:CHEMBL1431 | DrugBank:DB00331 | PubChem:4091,Metformin,CN(C)C(=N)NC(=N)N,A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02932904,NCT02932904_EG002,Accepts Healthy Volunteers,All,Adult,Phase 4,91,"Inclusion Criteria:

Is sexually active and has been in a steady relationship and plans to remain in that relationship for the duration of the study.
Has a body mass index (BMI) of 18 to 35 kg/m^2, inclusive, at the Screening and Baseline Visits.
If female, has a regular menstrual cycle.
Has normal sexual functioning, as defined by a Changes in Sexual Functioning Questionnaire (CSFQ-14) total score >47 (men) or >41 (women) at the Screening and Baseline Visits.
If females, taking allowed hormonal contraceptives is on a stable dose for ≥3 months prior to the Baseline Visit and continues on the stable dose for the duration of the study.

Exclusion Criteria:

Has received vortioxetine and/or paroxetine in a previous clinical study or as a therapeutic agent.
Is positive for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibodies, or human immunodeficiency virus (HIV) at the Screening Visit or has any known sexually transmitted diseases.
Has glycosylated hemoglobin (HbA1c) ≥7% at the Screening Visit.
Has a clinically significant abnormal electrocardiogram (ECG) at the Screening Visit.
Has a known history of or currently has increased intraocular pressure or is at risk of acute narrow-angle glaucoma.
Has a history of depression or any other psychiatric illness.
Has a significant risk of suicide according to the investigator's clinical judgment, or has made a suicide attempt in the previous 6 months.
Has current sexual dysfunction, or a history of a diagnosis or treatment of sexual dysfunction.
Has had a surgical or medical procedure on reproductive/genitourinary organs (excluding uncomplicated vasectomy and tubal ligation).
If female, has polycystic ovarian syndrome.
Has hypogonadism or has a free testosterone value outside the normal range at the Screening Visit that is indicative of hypogonadism.
Has a thyroid-stimulating hormone (TSH) value outside the normal range at the Screening Visit that is deemed clinically significant by the investigator.","Vortioxetine 10 mg, overencapsulated tablets, orally, once daily for up to 5 weeks.",ChEMBL:CHEMBL2104993 | DrugBank:DB09068 | PubChem:9966051,Vortioxetine,Cc1ccc(Sc2ccccc2N2CCNCC2)c(C)c1,N06AX26,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02932904,NCT02932904_EG003,Accepts Healthy Volunteers,All,Adult,Phase 4,91,"Inclusion Criteria:

Is sexually active and has been in a steady relationship and plans to remain in that relationship for the duration of the study.
Has a body mass index (BMI) of 18 to 35 kg/m^2, inclusive, at the Screening and Baseline Visits.
If female, has a regular menstrual cycle.
Has normal sexual functioning, as defined by a Changes in Sexual Functioning Questionnaire (CSFQ-14) total score >47 (men) or >41 (women) at the Screening and Baseline Visits.
If females, taking allowed hormonal contraceptives is on a stable dose for ≥3 months prior to the Baseline Visit and continues on the stable dose for the duration of the study.

Exclusion Criteria:

Has received vortioxetine and/or paroxetine in a previous clinical study or as a therapeutic agent.
Is positive for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibodies, or human immunodeficiency virus (HIV) at the Screening Visit or has any known sexually transmitted diseases.
Has glycosylated hemoglobin (HbA1c) ≥7% at the Screening Visit.
Has a clinically significant abnormal electrocardiogram (ECG) at the Screening Visit.
Has a known history of or currently has increased intraocular pressure or is at risk of acute narrow-angle glaucoma.
Has a history of depression or any other psychiatric illness.
Has a significant risk of suicide according to the investigator's clinical judgment, or has made a suicide attempt in the previous 6 months.
Has current sexual dysfunction, or a history of a diagnosis or treatment of sexual dysfunction.
Has had a surgical or medical procedure on reproductive/genitourinary organs (excluding uncomplicated vasectomy and tubal ligation).
If female, has polycystic ovarian syndrome.
Has hypogonadism or has a free testosterone value outside the normal range at the Screening Visit that is indicative of hypogonadism.
Has a thyroid-stimulating hormone (TSH) value outside the normal range at the Screening Visit that is deemed clinically significant by the investigator.","Vortioxetine 10 mg, overencapsulated tablets, orally, once daily for up to 1 week followed by vortioxetine 20 mg, overencapsulated tablets, orally, once daily from Week 2, up to 4 weeks.",ChEMBL:CHEMBL2104993 | DrugBank:DB09068 | PubChem:9966051,Vortioxetine,Cc1ccc(Sc2ccccc2N2CCNCC2)c(C)c1,N06AX26,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02934698,NCT02934698_EG000,No,Female,Adult | Older Adult,Phase 3,2,"Inclusion Criteria:

Subjects are >18 years of age and able to provide informed consent.
Subjects reside in the US and are willing to be treated with ivacaftor.
Subjects have the splicing mutation of interest.
Subjects are willing and able to perform requirements of the study.

Exclusion Criteria:

There are no relevant exclusion criteria for this n-of-2 study.","There is only one arm to this study. The two sisters with Cystic Fibrosis will both receive Ivacaftor for 6 months for their treatment.

Ivacaftor: Subjects will be treated with ivacaftor for 6 months and followed for 7 months and will undergo assessments along the way to measure sweat chloride and sputum amounts.",ChEMBL:CHEMBL2010601 | DrugBank:DB08820 | DrugBank:DB15141 | PubChem:16220172 | PubChem:71470491,Ivacaftor,CC(C)(C)c1cc(C(C)(C)C)c(NC(=O)c2c[nH]c3ccccc3c2=O)cc1O,R07AX02 | R07AX30 | R07AX31 | R07AX32,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT02939079,NCT02939079_EG000,No,All,Adult,Phase 2 | Phase 3,25,"Inclusion Criteria:

Patients with relapsing-remitting multiple sclerosis according to McDonald's criteria (2010)
Age between 18 and 45 years
Expanded Disability Status Scale (EDSS) between 0-5
History of at least one relapse during the last year
Intolerance or serious complications when receiving interferons
Not receiving interferons in the last two months
Not having relapse in the last 30 days
Negative pregnancy test
History of varicella or varicella vaccination, or positive test for anti-varicella antibodies
Not to take any medication or dietary complement without permission of the physician
Filling informed consent

Exclusion Criteria:

Having chronic and infectious diseases
History of cardiovascular diseases
Taking corticosteroids in the last 30 days
Taking chemotherapy agents such as Cyclophosphamide
Patients who have taken fingolimod before
Patients who experience relapse during the study","Fingolimod 0.5 mg capsule daily by mouth and Fish Oil 1 g capsule daily by mouth for one year.

Fingolimod: Produced by Osveh ® Pharm Company in Iran

Fish Oil: produced by Zahravi ® Pharm Company in Iran",ChEMBL:CHEMBL314854 | DrugBank:DB08868 | PubChem:107970,Fingolimod,CCCCCCCCc1ccc(CCC(N)(CO)CO)cc1,L04AA27,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02954848,NCT02954848_EG001,No,All,Adult | Older Adult,Phase 3,238,"Inclusion Criteria:

In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
The participant signs and dates a written informed consent form prior to the initiation of any study procedures.
The participant with NERD.

The participant is endoscopically confirmed to have the modified Los Angeles (LA) Classification Grade N or M at the start of the run-in period (Visit 1).

To allow efficacy evaluation in the participants with Grade N as well as in those with Grade M, the target number of participants in each grade is at least 30% of the total number of participants. Enrollment of patients with either Grade N or M will end when the number of enrolled participants with each grade exceeds 332, or 70% of the total planned number of participants.

The participant experiences recurrent heartburn, on at least 2 days a week over the last 3 weeks prior to the start of the run-in period (Visit 1).
The participant is either a male or female outpatient with a minimum age of 20 years at the time of informed consent signing. However, participants who are hospitalized only for examination purposes are also allowed to participate.
A female participant of childbearing potential agrees to use routinely adequate contraception from signing of informed consent throughout the duration of the study, and for 4 weeks after the last dose of study drug.
The participant's compliance to the study drug has been good (75% or better) in the run-in period.
The participant has experienced heartburn on at least 2 days in the last 1 week prior to randomization.
The participant has appropriately provided in the patient's diary all the required information during the run-in period.

Exclusion Criteria:

The participant has received any investigational compound within 84 days prior to the first dose of study drug.
The participant has received TAK-438 in a previous clinical study or as a therapeutic agent, except one with experience of receiving TAK-438 as an adjunct therapy for H. pylori eradication, who can be enrolled in this study.
The participant is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in conduct of this study (eg, spouse, parent, child, sibling) or may consent under duress.
The participant has donated at least 400 mL of blood within the 90 days prior to the start of the run-in period (Visit 1).
Endoscopic examination for entering this study fails to diagnose NERD within 84 days before the start of the run-in period (Visit 1).
The participant has any complications affecting the esophagus, including Barrett's esophagus (3 cm or more, long segment Barrett's esophagus [LSBE]), eosinophilic esophagitis, esophageal varices, scleroderma, viral or fungal infection, and esophageal stenosis; a history of radiation therapy or cryotherapy for the esophagus; or caustic or physiochemical trauma (eg, esophageal sclerotherapy). However, participants with Barrett's mucosa (less than 3 cm, short segment Barrett's esophagus [SSBE]) or Schatzki's ring (a mucosal tissue ring lining the inferior esophageal sphincter) are permitted to participate.
The participant has a history of surgery or treatment affecting gastroesophageal reflux, including fundoplication and mechanical dilatation for esophageal stenosis (except Schatzki's ring), or a history of gastric or duodenal surgery (except endoscopic removal of benign polyps).
The participant has acute upper gastrointestinal bleeding or gastric or duodenal ulcer, characterized by a defective mucosa with white coating, within 30 days prior to the start of the run-in period (Visit 1). However, participants with gastric or duodenal erosion are permitted to participate.
The participant has acute gastritis or acute exacerbation of chronic gastritis.
The participant has, or has a history of, Zollinger-Ellison syndrome or gastric acid hypersecretion disorders.
The participant has, or has a history of chest pain due to cardiac disease, or has chest pain suspectedly caused by cardiac disease within 1 year prior to the start of the run-in period (Visit 1).
The participant has any other concurrent upper gastrointestinal symptoms more severe than heartburn.
The participant has depression.
The participant has, has a history of, or is suspected of functional upper gastrointestinal disorders, such as functional dyspepsia and functional heartburn diagnosed by the Rome IV criteria.
The participant has a history of hypersensitivity or allergies to TAK-438 (including the formulation excipients).
The participant has a history or complication of drug abuse (defined as any illicit drug use) or of alcohol abuse within 1 years prior to the start of the run-in period (Visit 1).
The participant requires any excluded medications or treatments.
The female participant who is pregnant, is lactating, or is intending to become pregnant or to donate ova any time between the informed consent signing and 4 weeks after the last dose of study drug.
The participant has any serious neurological, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, endocrinological, or hematologic diseases.
The participant needs surgery requiring hospitalization during the course of the study, or surgery requiring hospitalization is scheduled for the participant during the course of the study.
The participant has a history of malignancy or is treated for malignancy within 5 years prior to the start of the run-in period (Visit 1). However, participants who have recovered completely from cutaneous basal cell carcinoma or from cervical carcinoma in situ are permitted to participate.
The participant has acquired immunodeficiency syndrome (AIDS) or hepatitis, is a human immunodeficiency virus (HIV) carrier, or tested positive for the hepatitis B virus surface antigen (HBsAg) or the hepatitis C virus (HCV) antibody. However, participants who tested negative for HCV antigen or HCV-RNA are permitted to participate.

The participant has any of the following abnormal clinical laboratory test values at the start of the run-in period (Visit 1):

Creatinine > 2 mg/dL.
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > upper limit of normal (ULN).
Bilirubin (Total bilirubin) > ULN.","TAK-438 placebo-matching tablets, orally, once daily after breakfast for 1 week in run-in period followed by TAK-438 10 mg tablets, orally, once daily after breakfast for up to 4 weeks in treatment period.",ChEMBL:CHEMBL2079130 | DrugBank:DB11739 | PubChem:15981397,Vonoprazan,CNCc1cc(-c2ccccc2F)n(S(=O)(=O)c2cccnc2)c1,A02BC08 | A02BD14 | A02BD15,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02955186,NCT02955186_EG000,Accepts Healthy Volunteers,All,Adult,Phase 2,33,"Inclusion Criteria:

Ages 21-50
Able to read English at 6th grade level or higher and to complete study evaluations
Regular alcohol drinker

Exclusion Criteria:

Individuals who are seeking alcohol treatment
Medical conditions that would contraindicate the use of saracatinib
Regular use of other substances","Participants will take 125 mg of saracatinib daily for 8 days.

Saracatinib: Saracatinib 125 mg once per day for 8 days",ChEMBL:CHEMBL217092 | DrugBank:DB11805 | PubChem:10302451,Saracatinib,CN1CCN(CCOc2cc(OC3CCOCC3)c3c(Nc4c(Cl)ccc5c4OCO5)ncnc3c2)CC1,,0.0,1.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT02960659,NCT02960659_EG000,No,All,Child | Adult,Phase 1 | Phase 2,13,"INCLUSION CRITERIA:

Youth must self-identify as African-American and identify both parents as African-American
Age 12-25 years
Pubertal or post-pubertal: Girls Tanner stage IV-V breast; Boys Testicular volume 11-25cc
Diagnosis of type 2 diabetes of less than or equal to 5 years duration, as per American Diabetes Association Criteria
Hemoglobin A1C <9% at study initiation
Negative to mild ketonuria without acidosis (negative or 1+ ketones on urinalysis)
Negative test for diabetes-related autoantibodies (glutamic acid decarboxylase 65 and tyrosine phosphatase-related islet antigen 2 (IA-2))
Willing and able to take daily medications and check blood glucose levels at least twice per day or wear a continuous glucose monitoring device (CGM).

EXCLUSION CRITERIA:

Pregnancy or breastfeeding
Allergy to study medications
Allergy to milk protein
Chronic insulin therapy
Treatment with other medications which are known to affect the parameters under study (for example sodium glucose transporter 2 (SGLT-2) inhibitors, dipeptidyl peptidase-4 (DPP-IV) inhibitors, non-selective beta blockers).
Metabolic derangement such as metabolic acidosis, severe hyperglycemia (fasting blood glucose greater than or equal to 200mg/dL), and/or liver enzymes > three times the upper limit of normal.
Personal or family history of medullary thyroid cancer or Multiple Endocrine Neoplasia syndrome type 2
Any other condition that, in the opinion of the investigators, will increase risk to the subject, or impede the accurate collection of study-related data.
Body weight greater than or equal to 450 lbs
Body weight less than or equal to 58kg
Serum triglyceride concentrations greater than or equal to 500mg/dl
Hemoglobin concentration <10g/dL","Standard release metformin (500 mg tablets) was initiated and titrated to maximum dose of metformin 1000 mg twice daily over 3 weeks and continued for 12 weeks

Metformin: Metformin 500mg oral tablet",ChEMBL:CHEMBL1431 | DrugBank:DB00331 | PubChem:4091,Metformin,CN(C)C(=N)NC(=N)N,A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02964585,NCT02964585_EG000,No,All,Adult | Older Adult,Phase 4,34,"Inclusion Criteria:

Age 30-70 years
Currently treated with any combination of the following anti-diabetic therapies: metformin (1-2 grams), insulin, GLP-1 agonists, a DPP-IV inhibitor, or sulfonylureas
Hemoglobin A1C (HbA1C) between 7.0% and 10.0%
Body Mass Index (BMI) between 25 and 39.9 kg/m^2 (both inclusive)

Exclusion Criteria:

Type 1 diabetes
History of hyperosmolar nonketotic coma
History of diabetic ketoacidosis in the last 3 months
Abnormal CBC that is judged by physician to be unsafe to enroll or low hematocrit (<28 UNITS).
History of pancreatitis
History of diabetic ketoacidosis in the last 3 months
History of cancer (except basal cell carcinoma and cancer that is cured or not active or being treated in the past 5 years)
Heart attack or stroke within 6 months of screening
Clinically significant coronary and/or peripheral vascular disease that would be unsafe to enroll in the study.
Statin use started or dose change in the last 3 months
CKD Stages 3,4 and 5
Use of oral or injectable anti-diabetic medication other than any combination of the following anti-diabetic therapies: metformin (1-2 grams), insulin, GLP-1 agonists, a DPP-IV inhibitor, or sulfonylureas currently, or in the past 1 month.
Use of consistent long-term steroid medication (oral, inhaled, injected) within the last 3 months
Uncontrolled inflammatory disease, or current chronic use of anti-inflammatory drugs within the last 3 months. **This will be judged on a case by case basis by the PI**
Implanted devices (e.g., pacemakers) that may interact with Body Composition scale
Untreated Systolic Blood Pressure > 150 mmHg and diastolic Blood Pressure > 90 mmHg
Active wounds or recent surgery within 3 months
Untreated hyper/hypothyroidism

Physical and Laboratory Test Findings:

Pre-existing liver disease and/or ALT and AST >2.5X's UNL
Serum creatinine levels ≥2.0
Estimated CrCl < 60 mL/min (measured by eGFR value)
Triglycerides >450 mg/dL

Allergies and Adverse Drug Reactions:

Subjects with a history of any serious hypersensitivity reaction to Cana or another SGLT2 inhibitor.

Sex and Reproductive Status:

Women in reproductive age group will be included in the study but encouraged to use contraceptive method to avoid pregnancy within 16 weeks of study duration.
Women who are pregnant or breast-feeding will be excluded.

Other Exclusion Criteria:

Prisoners or subjects who are involuntarily incarcerated.
Subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness.
Patients who are active smokers
Patients who are pregnant
Nursing women
Post-menopausal women who are on estrogen hormone replacement therapy will be excluded.
Patients on low dose oral contraceptives will be allowed to participate as these formulations contain very low amounts of estrogens.
Eligibility criteria for this study have been carefully considered to ensure the safety of the study subjects and to ensure that the results of the study can be used. It is imperative that subjects fully meet all eligibility criteria.","100 mg of Canagliflozin for 16 weeks

Canagliflozin: 100 mg",DrugBank:DB08907 | PubChem:24812758,Canagliflozin,[H][C@@]1(c2ccc(C)c(Cc3ccc(-c4ccc(F)cc4)s3)c2)O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O,A10BD16 | A10BK02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02967458,NCT02967458_EG000,No,Male,Adult | Older Adult,Phase 2,55,"Inclusion Criteria:

Subject must be scheduled for a clinically indicated needle biopsy of the prostate based upon an elevated PSA, abnormal digital rectal examination, or based upon active surveillance of prostate cancer.
Subject must be able and willing to give written informed consent for a contrast enhanced ultrasound study of the prostate.
Subject must be a male at least 18 years of age when informed consent is obtained.
Subject must have a life expectancy that exceeds the duration of the clinical trial.

Exclusion Criteria:

Participant in a clinical trial involving an investigational drug within the past 30 days.
Prior allergic reaction to the ultrasound contrast agent Definity™
Previous treatment for PCa.
Clinically unstable, severely ill, or moribund.","Patients who are scheduled for a clinically indicated prostate biopsy, and who are able to undergo contrast enhanced transrectal ultrasound will be included in this single arm study. Each of the study subjects will receive in intravenous infusion of a microbubble contrast agent known as Definity™, (Perflutren Lipid Microsphere, Lantheus Medical Imaging, Inc; N. Billerica, MA). Based upon our previous experience, two vials of Perflutren Lipid Microsphere will be mixed and diluted in 50 ml of normal saline, yielding a concentration of 49.4 μl/ml. For the purpose of contrast-enhanced imaging, Perflutren Lipid Microsphere will be infused over approximately 10-12 minutes, during which time ultrasound imaging and biopsy will be performed.

Perflutren Lipid Microsphere Intravenous Suspension: The intravenous administration of Perflutren Lipid Microsphere will provide enhancement of vascular tissue when performing subharmonic prostate ultrasound imaging. This enhancement will be used",ChEMBL:CHEMBL1663 | DrugBank:DB00556 | PubChem:6432,Perflutren,FC(F)(F)C(F)(F)C(F)(F)F,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02971839,NCT02971839_EG001,No,All,Adult | Older Adult,Phase 2,2,"Inclusion Criteria:

18 years of age or older
Has a confirmed diagnosis of CF with at least one allele of the following CFTR gating mutations: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, and S549R.
Has been stable on Kalydeco therapy for at least 3 months prior to screening
Has FEV1 ≥ 60% of predicted normal for age, sex, and height at screening and baseline (Day 1) assessments
Weighs at least 40 kg at screening
Patients of either gender and women of childbearing potential must be willing to use a medically highly effective form of birth control during the treatment period and 30 days after the last dose of study treatment.

Exclusion Criteria:

Acute upper respiratory infection or lower respiratory infection, pulmonary exacerbation, or changes in therapy within 4 weeks of study treatment
Uncontrolled type 2 diabetes, or uncontrolled CF-related diabetes
History of hepatitis C or chronic active hepatitis B infection
History of pulmonary tuberculosis, non-tuberculosis mycobacterial infections or allergic bronchopulmonary aspergillosis (ABPA) treated during screening or within 2 years prior to screening
Colonization with B. cenocepacia, B. dolosa, B. multivorans, and/or M. abcessus within 2 years prior to Screening
Abnormal liver function
History of abnormal renal function
History of prolonged QTcF > 450 msec for males or QTcF > 470 msec for females
History of solid organ or hematological transplantation
Using any inhibitor or inducer of cytochrome P450/3A during the study or within 30 days of screening
Women who are pregnant or lactating, or have plans to become pregnant during the study or within 1 month following the last dose",Participants received VX-561 100 mg orally once daily for 28 days.,ChEMBL:CHEMBL2010601 | DrugBank:DB08820 | DrugBank:DB15141 | PubChem:16220172 | PubChem:71470491,Ivacaftor,CC(C)(C)c1cc(C(C)(C)C)c(NC(=O)c2c[nH]c3ccccc3c2=O)cc1O,R07AX02 | R07AX30 | R07AX31 | R07AX32,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02971839,NCT02971839_EG002,No,All,Adult | Older Adult,Phase 2,2,"Inclusion Criteria:

18 years of age or older
Has a confirmed diagnosis of CF with at least one allele of the following CFTR gating mutations: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, and S549R.
Has been stable on Kalydeco therapy for at least 3 months prior to screening
Has FEV1 ≥ 60% of predicted normal for age, sex, and height at screening and baseline (Day 1) assessments
Weighs at least 40 kg at screening
Patients of either gender and women of childbearing potential must be willing to use a medically highly effective form of birth control during the treatment period and 30 days after the last dose of study treatment.

Exclusion Criteria:

Acute upper respiratory infection or lower respiratory infection, pulmonary exacerbation, or changes in therapy within 4 weeks of study treatment
Uncontrolled type 2 diabetes, or uncontrolled CF-related diabetes
History of hepatitis C or chronic active hepatitis B infection
History of pulmonary tuberculosis, non-tuberculosis mycobacterial infections or allergic bronchopulmonary aspergillosis (ABPA) treated during screening or within 2 years prior to screening
Colonization with B. cenocepacia, B. dolosa, B. multivorans, and/or M. abcessus within 2 years prior to Screening
Abnormal liver function
History of abnormal renal function
History of prolonged QTcF > 450 msec for males or QTcF > 470 msec for females
History of solid organ or hematological transplantation
Using any inhibitor or inducer of cytochrome P450/3A during the study or within 30 days of screening
Women who are pregnant or lactating, or have plans to become pregnant during the study or within 1 month following the last dose",Participants received VX-561 150 mg orally once daily for 28 days.,ChEMBL:CHEMBL2010601 | DrugBank:DB08820 | DrugBank:DB15141 | PubChem:16220172 | PubChem:71470491,Ivacaftor,CC(C)(C)c1cc(C(C)(C)C)c(NC(=O)c2c[nH]c3ccccc3c2=O)cc1O,R07AX02 | R07AX30 | R07AX31 | R07AX32,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT02972632,NCT02972632_EG000,No,All,Adult | Older Adult,Phase 4,122,"Inclusion Criteria:

Is suffering from Major Depressive Disorder (MDD) as the primary psychiatric diagnosis.
Has been or is currently being treated with an approved antidepressant (monotherapy) for 6 weeks or longer at an adequate therapeutic dose. Participants currently on an antidepressant at Screening will be discontinued in a manner that is consistent with labeling recommendations and conventional medical practice.
The antidepressant treatment must be on-going at time of Screening or have been discontinued within the 6 weeks prior to Screening.
Is considered appropriate for a change in antidepressant medication based on Investigator judgment in collaboration with the participant.
Has scores on Patient Health Questionnaire (PHQ-9) ≥5 and Clinical Global Impression Scale Severity (CGI-S ≥4).

Exclusion Criteria:

Has discontinued prior antidepressant treatment greater than 6 weeks from Screening.
Is considered to be at imminent risk for hospitalization due to severe depression in the opinion of the investigator. Recent hospitalization due to MDD within 3 months prior to Screening is exclusionary also.
Has a significant risk of suicide according to the Investigator's clinical judgment or has made an actual suicide attempt in the previous 6 months prior to Screening or scores ""yes"" on items 4 or 5 in the past 6 months on the Suicidal Ideation section of the Columbia Suicide Severity Rating Scale (C-SSRS).
Is considered to be treatment resistant, defined as participants with MDD who have not responded to 2 or more separate different antidepressant monotherapy trials of adequate dose and duration (6 weeks or longer) in their current episode. History of only responding to combination or augmentation therapy in previous major depressive episode (MDEs) is also considered evidence of treatment resistant depression.

Has 1 or more of the following:

Current or history of: manic or hypomanic episode, schizophrenia or any other psychotic disorder, including schizoaffective disorder, major depression with psychotic features, bipolar depression with psychotic features, obsessive compulsive disorder, mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in Diagnostic and Statistical Manual of Mental Disorders (DSM-5) as determined by the investigator.
Current diagnosis or history of alcohol or other substance abuse or dependence (excluding nicotine or caffeine). The participants must have a negative urine drug screen (UDS) at Screening and Baseline, this includes benzodiazepines and opiates (including oxycodone) for which there is no prescription.
Presence or history of a clinically significant neurological disorder (including epilepsy) as determined by the investigator.
Neurodegenerative disorder (Alzheimer disease, Parkinson disease, multiple sclerosis, Huntington disease, etc).
Has a known history of acute narrow-angle glaucoma or is at risk of acute narrow-angle glaucoma.
Has a known unstable thyroid disorder or a thyroid-stimulating hormone value outside the normal range based on medical history that is deemed clinically significant by the investigator.
Has active hepatitis B or a known history of hepatitis C virus.
Has a known history of human immunodeficiency virus infection.
Has a history of gastric bypass.
Has previously or is currently participating in this study or another vortioxetine or LuAA21004 study.
Is receiving or who have started receiving formal cognitive or behavioral therapy, systematic psychotherapy within 30 days from screening or plan to initiate such therapy during the study.","Vortioxetine 10 mg, tablets, orally, once daily up to 12 weeks. Dose was increased or decreased as per investigator's discretion.",ChEMBL:CHEMBL2104993 | DrugBank:DB09068 | PubChem:9966051,Vortioxetine,Cc1ccc(Sc2ccccc2N2CCNCC2)c(C)c1,N06AX26,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02973048,NCT02973048_EG001,No,Female,Adult,Phase 3,17,"Inclusion Criteria :

American Society of Anesthesiologists physical status (ASA) < III
Age 18-40 year
Body Weight <110 kg
Height between 160 and 175 cm
Gestational age>37 SA
Elective cesarean delivery
Singleton pregnancy
Non complicated pregnancy
Signed informed consent obtained prior to any study specific assessments and procedures

Exclusion Criteria:

Twin pregnancy
History of 2 cesarean section or more
Diabetes and gestational diabetes
Placenta praevia
Congenital foetal abnormality
Intrauterine growth retardation
Patient in labour
Membrane rupture
Known allergy to local anaesthetics
Standard contraindications to neuraxial block.
Disagreement of the patient
Neurological impairment
Gestational low blood pressure
Pre eclampsia and eclampsia","Hyperbaric prilocaine 2% will be administered at the dose of 50 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.

Hyperbaric prilocaine: The dose of 50 mg of hyperbaric prilocaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.",ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02974114,NCT02974114_EG001,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 4,7,"Inclusion Criteria

Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
Aged between 18-65 years.
Participant is male or female.
Understands and is willing, able and likely to comply with all study procedures and restrictions.
Adequately completes cognition and mobility familiarisation tasks in the opinion of the investigator.
Good general and mental health with, in the opinion of the investigator or medically qualified designee: No clinically significant and relevant abnormalities in medical history or upon physical examination; absence of any condition that might impact on the participant's safety or wellbeing or affect the individual's ability to understand and follow study procedures and requirements; BMI >18.5 and <30 kg/m2
VISIT 1 ONLY - Has experienced a minimum of two recurrent, acute pain episodes within the past 3 months or is currently suffering from a flare up episode of recurrent, acute pain; VISIT 2 ONLY - A score ≥5 to question 6 (rated on scale 0-10) on the Brief Pain Inventory - Short Form and participants presenting with only one of the following pain types: Joint (Knee, Hip); Back; Headache; Period.

Exclusion Criteria

Women who are pregnant (Visit 1), women of child bearing potential who test positive on a urine pregnancy test (Visit 1 or Visit 2), females of non-child bearing potential will not be required to complete urinary pregnancy test, post-menopausal females not requiring a pregnancy test will be defined as: Age ≥ 50 years with spontaneous cessation of menses for 12 or more months or age < 55 years and spontaneous menses within the past 1 year, but currently amenorrheic.
Women who are currently breast-feeding.
In the opinion of the medical designee, participant suffers from medical condition(s) that may be aggravated due to testing procedures or may impact the interpretation or integrity of data. Conditions related to renal, hepatic, respiratory, blood, immune systems or heart dysfunction will be considered.
Participant is colour blind.
Current (within 14 days of the start of the study) or regular use of any prescription, over-the-counter (OTC), herbal medicine unless the medication has been approved by the study physician. OTC analgesics for pain relief and vitamin supplements are permitted only until 48 hours prior to study visits; Current or in the 30 days prior to dosing use of any drug, food, herbal product, or dietary supplement known to induce or inhibit hepatic drug metabolism (e.g. barbiturates, theophylline, cimetidine, or erythromycin) ;Use of analgesics and anti-inflammatory drugs 48 hours prior to dosing at Visit 2; Known to be taking any other medication which could counteract with paracetamol and/or caffeine; Current or past use of anti-depressants or psychoactive drugs within the previous 2-years.
Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
Positive breath alcohol test at Visit 2 and positive urine drugs of abuse test at Visit 2.
Participation in another clinical study (including cosmetic studies) or receipt of an investigational product within 7 days of the screening visit or previous participation and randomization in this study.
Participant has excessive frequent caffeine intake equivalent to 6 cups of brewed coffee or 12 cups of tea per day; Unwilling to abstain from any caffeine products from 4 hours prior to the visit on assessment days (Visit 2 and 3); Current Smoker (or regular nicotine consumption): Participant smokes more than 3 cigarettes per day (or equivalent for e-cigarettes, chewing tobacco or pipes). Investigator will ensure there is no impact of withdrawal effect from those with nicotine dependence; Current Alcohol Consumer: Participant consumes greater than 21 units of alcohol per week (male) and 14 units per week (female) (e.g. Spirit 25ml = 1 unit / AlcoPop 275ml = 1.5 unit / Bottle of beer 330 ml = 1.7 unit / Glass of wine 175ml = 2.1 unit / Pint of beer 568 ml = 3 unit).
Members of the study site staff or members of their immediate family.
Any participant who in the opinion of the investigator should not take part in this study.",All the participants in this arm received test product (containing 500 mg of paracetamol). All the participants took 2 tablets at once orally with 200 mL of water.,ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT02978508,NCT02978508_EG001,No,All,Child | Adult | Older Adult,Phase 3,70,"Inclusion Criteria:

Male or non-pregnant, non-lactating female subject at least 12 years of age or older.
Subject must have a positive identification for mites, eggs, or mite fecal matter by microscopic examination of a skin scraping.
Subjects must have at least two of the three following: a) excoriations and inflammatory papules with a typical distribution pattern and localization (webbed spaces of the fingers, flexor surfaces of the wrists, elbows, axillae, belt line, feet, skin surface of external genitalia, or areolae); b) presence of burrows; c) family or contacts with moderate to severe itching which increases during the night.
Subjects must be willing to make every effort to immediately disinfect clothes, towels, and linens and all potentially infected household items upon diagnosis of infestation to prevent re-infestation.
All household members with prolonged physical contact with the subject must be willing to attend Baseline visit and receive treatment with standard of care if deemed necessary by the Investigator in order to prevent re-infestation of the subject enrolled.
Subject or representative must read and sign an Institutional Review Board/Independent Ethics Committee (IRB/IEC) approved Informed Consent Form (ICF); for minor subjects (18 years or younger in most states) the parent or legal guardian should sign the ICF and the child will be required to sign the Assent Form that will written in such a way as to be understandable to a child.
Subject must be able to apply study product to self. If the subject is a child, then parent/guardian will apply study product to him/her.

Exclusion Criteria:

Females who are pregnant as shown in a urine pregnancy test at the Baseline visit, prior to randomization, or lactating, or of childbearing potential (for purpose of this study a female of childbearing potential is considered to be not surgically sterile or postmenopausal for at least 1 year) who are not using or do not agree to use an acceptable form of contraception (oral /implant /injectable /transdermal contraceptives, intrauterine device (IUD), condom, diaphragm, or abstinence) during the study, or who intends to become pregnant during the study; contraceptive method must also be consistent throughout the study.
Treatment for scabies <4 weeks prior to enrollment, including permethrin, benzyl alcohol, lindane, crotamiton, malathion, and ivermectin.

Use of prohibited medications:

Topical or oral scabicidal/antiparasitic treatment including: permethrin, benzyl alcohol, benzyl benzoate, lindane, crotamiton, malathion, ivermectin, precipitated sulfur, albendazole, keratolytic cream, tea tree oil, or oil of the leaves of Lippia multiflora Moldenke within 28 days of visit 2.
Systemic corticosteroids (including inhaled steroids) taken within 14 days of visit 2.
Topical corticosteroids including hydrocortisone taken within 24 hours of visit 2.
Topical antipruritics, including antihistamines within 24 hours of any study visits.
Oral antihistamine including diphenhydramine (Benadryl) taken within 24 hours of any study visits.
Topical antibiotics including mupirocin taken within 24 hours of any study visits.
Patients with immunosuppressive disorders requiring therapy, severe systemic disease, history of HIV infection and/or seizures.
Patients with crusted/Norwegian scabies.
Presence of underlying skin disease that would obscure evaluation of the papules and burrows associated with scabies infection as determined by the Investigator.
Presence of severe cutaneous bacterial or fungal infections requiring therapy (including systemic and topical antibiotics) as determined by the Investigator.
Sensitivity or allergy to Permethrin Cream or any of its components, synthetic pyrethroids, pyrethrin, chrysanthemums or ragweed.
A recent (less than 1 year) history of alcoholism, drug abuse, or other problems which would likely make the subject unreliable for the study.
Participation in another investigational study or using any investigational product within the 30 days prior to the Baseline visit.
Participation of family member, or another member of the household (including regular bedmates) in the current study.
Total number of bedmates and family members with prolonged physical contact is greater than 6 (including study subject).
Any employees of the clinic, investigators, or family members of the study staff.
Patients who in the opinion of the Investigator would be non-compliant with the requirements of the study protocol.","Elimite™ 60g, topical, marketed by Prestium Pharma, Inc. (""Prestium""), the branded subsidiary of Renaissance Pharma, maximum of two doses over 28 day treatment duration.

Elimite: Subjects on RLD will receive a maximum of two doses, 60 g each, during the study. The first dose will be applied on Day 1 in an outpatient setting, after the visit to the clinical site (preferably in the evening). The second dose will be applied on Day 14±2 only if retreatment is necessary.",ChEMBL:CHEMBL1525 | DrugBank:DB04930 | PubChem:40326 | PubChem:62086,Permethrin,CC1(C)C(C=C(Cl)Cl)C1C(=O)OCc1cccc(Oc2ccccc2)c1,P03AC04 | P03AC54,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02981446,NCT02981446_EG001,No,All,Adult | Older Adult,Phase 3,185,"Inclusion Criteria:

Patients with open angle glaucoma or ocular hypertension in both eyes

Exclusion Criteria:

Patients at risk of progression of visual field loss
Patients with severe visual field defect
Patients with any diseases that preclude participation in this study for safety reasons","Latanoprost ophthalmic solution: Latanoprost ophthalmic solution will be taken one drop, once daily for 3 months in both eyes.",ChEMBL:CHEMBL1051 | DrugBank:DB00654 | PubChem:5311221,Latanoprost,CC(C)OC(=O)CCC/C=C\C[C@@H]1[C@@H](CC[C@@H](O)CCc2ccccc2)[C@H](O)C[C@@H]1O,S01EE01 | S01EE51,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02986659,NCT02986659_EG000,No,All,Older Adult,Phase 4,30,"Inclusion Criteria:

Age 65 - 79

Must meet criteria from one or more of the following groups:

Group 1 (Can have 1 or 2 of these, but not all 3)

History of coronary artery disease (MI/heart attack, stroke, heart failure, or peripheral artery disease)
Cancer, with no active treatment in the last year
MCI (MoCA >18<26 -inclusive of 1 point if <12 years of education Group 2
Decline physical function (walking speed < 1 m/s) Group 3 (Either or both)
Abdominal obesity (>88cm women, >102cm men) AND hypertension (treated or resting blood pressure >140/90
Abdominal obesity (>88cm women, >102cm men) AND hyperlipidemia (treated or fasting total cholesterol >240 English literacy Willing to provide informed consent

Exclusion Criteria:

eGFR <45
Type 2 diabetes (HbA1c>6.5) or type 1 diabetes
Any tobacco or nicotine product use in the past year
Low vitamin B12 Levels (< 300 pg/mL)
Self-reported severe difficulty or inability to walk 400m or climb 10 steps (from Q 2 and 19 on PAT-D)
Self-reported difficulty or inability to perform basic ADL functions (from Q 10, 13, 14, 16 on PAT-D)
Excessive alcohol use (>14 drinks/week)
Cancer requiring treatment in past year (except skin)
Dementia - diagnosed and/or MoCA score <18
Parkinson's or other neurological disease
Chronic liver disease or cirrhosis
End stage renal disease or on dialysis
Rheumatic conditions (Rheumatoid arthritis, lupus, and any other autoimmune disease the -PI deems them to be ineligible for)
Thyroid problems the PI deems them to be ineligible for
Gout
Involved in another interventional study
Hemoglobin <8 or diagnosed with anemia
Recent unintentional weight change (+/- 10 lbs. in the last 12 months)
BMI <18.5
Likely to not follow the protocol
PI deems unfit to participate
Already taking Metformin or any other drug intended to treat diabetes","Metformin dosing at 425, 850 and 1700 mg with GLUCOPHAGE® (metformin hydrochloride) Tablets. Treatment with metformin will be initiated at a dose of 425 mg (half pill) taken orally once a day at night for 7 days. After the week, the participant will be called to assess tolerance and will be asked to increase dose to one pill at night at a dose of 850 mg for one week. At the end of the second week, participants will be called again and if they tolerated the second dose, they will be asked to take two 850 mg pills, one in the morning and one at night, for a total dose of 1700 mg which is within the range of the usual effective dose of 1500 to 2000 mg/day for the remainder of the 3 months.",ChEMBL:CHEMBL1431 | DrugBank:DB00331 | PubChem:4091,Metformin,CN(C)C(=N)NC(=N)N,A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02994940,NCT02994940_EG000,No,All,Child,Phase 4,74,"Inclusion Criteria:

Patients ages 3 years to 17 years scheduled for tonsillectomy and adenoidectomy for obstructive sleep apnea with or without additional minor procedures such as sleep endoscopy, unilateral or bilateral myringotomy, insertion of tympanostomy tubes and/or ear exam. ( Minor additional procedures that are frequently combined with tonsillectomy and adenoidectomy but are not commonly considered to have pain that is significantly greater than the tonsillectomy and adenoidectomy).

Exclusion Criteria:

Patients who meet University of California Davis Children's Hospital (UCDCH) criteria for Pediatric Intensive Care Unit (PICU) admission: on home oxygen pre-operatively, exhibit airway obstruction when awake (stertor above larynx, stridor at larynx), sleep study with apnea hypoxia index greater than 25 or sleep oxygen saturation nadir <80%, cardiac disease, difficult intubation.
Patients with a known allergy to acetaminophen
Patients with known hepatic insufficiency or severe hepatic disease
Patients with known Glucose-6-phosphate dehydrogenase (G6PD) deficiency
Patients who are malnourished (ie lower levels of glutathione)
Patients with severe renal impairment as defined by calculated creatinine clearance <20 ml/min (per modified Schwarz equation)
Patients who are pregnant","Group 1 will receive oral acetaminophen 30mg/kg 30-60 minutes prior to scheduled surgery time . Group 1 patients will receive placebo IV infusion just prior to surgery incision.

Acetaminophen",ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT02994940,NCT02994940_EG001,No,All,Child,Phase 4,74,"Inclusion Criteria:

Patients ages 3 years to 17 years scheduled for tonsillectomy and adenoidectomy for obstructive sleep apnea with or without additional minor procedures such as sleep endoscopy, unilateral or bilateral myringotomy, insertion of tympanostomy tubes and/or ear exam. ( Minor additional procedures that are frequently combined with tonsillectomy and adenoidectomy but are not commonly considered to have pain that is significantly greater than the tonsillectomy and adenoidectomy).

Exclusion Criteria:

Patients who meet University of California Davis Children's Hospital (UCDCH) criteria for Pediatric Intensive Care Unit (PICU) admission: on home oxygen pre-operatively, exhibit airway obstruction when awake (stertor above larynx, stridor at larynx), sleep study with apnea hypoxia index greater than 25 or sleep oxygen saturation nadir <80%, cardiac disease, difficult intubation.
Patients with a known allergy to acetaminophen
Patients with known hepatic insufficiency or severe hepatic disease
Patients with known Glucose-6-phosphate dehydrogenase (G6PD) deficiency
Patients who are malnourished (ie lower levels of glutathione)
Patients with severe renal impairment as defined by calculated creatinine clearance <20 ml/min (per modified Schwarz equation)
Patients who are pregnant","Group 2 will receive placebo oral medication at approximately 30-60 minutes prior to scheduled surgery. Group 2 patients will receive IV acetaminophen 15 mg/kg just prior to surgery incision.

Acetaminophen",ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03002506,NCT03002506_EG000,No,All,Adult | Older Adult,Phase 4,6,"Inclusion Criteria:

Male and female subjects, ages 18-80 years, of all racial and ethnic origins.
Non-English Spanish speakers will be included in the study.
We are recruiting 12 patients with thermal burn injuries (percent total body surface area burned >/= 20%). Patients will be at least five days from the date of the burn injury.
Patients will have central venous or arterial line access.
Patients will be already be receiving standard of care antimicrobial therapy for a suspected infection.

Exclusion Criteria:

Pregnant or nursing or unwilling to use a reliable contraception method during the study. The effects of ceftolozane and tazobactam on pregnancy are unknown. In addition, the metabolic changes that accompany pregnancy may alter the concentration-time profile of ceftolozane and tazobactam, so that the pregnancy and post-partum state would be a confounding variable.
Abnormal liver function tests: transaminases >10 times upper limit of normal, Alkaline phosphatase >5 times upper limit of normal, total bilirubin >5 times upper limit of normal.
History of allergies to beta-lactam antibiotics.
Patients unwilling to comply with study procedures.
Current or previous participation within 28 days of enrollment in another research study that involves the use of medication, contrast, or any other compound that may alter blood count and/or blood chemistry (liver function, kidney function or electrolyte balance), unless waved by principal investigator (PI).
Donation of 450mL (one unit) of blood or more within 8 weeks (56 days) prior to study enrollment, unless waved by PI.
Creatinine clearance < 30 ml/min as estimated by the Cockcroft-Gault equation.
Patients who are receiving piperazillin/tazobactam or have received piperacillin/tazobactam within the past 48 hours.
Patients who are receiving vasopressors.
Patients with a total body weight < 60 kg or > 130 kg.","One dose of 3 grams ceftolozane/tazobactam will be administered to each study participant.

Ceftolozane/tazobactam: Single dose of 2 grams/1 gram intravenously administered over 60 minutes.",PubChem:86291594,Zerbaxa,CC1(Cn2ccnn2)C(C(=O)O)N2C(=O)CC2S1(=O)=O.Cn1c(N)c(NC(=O)NCCN)c[n+]1CC1=C(C(=O)[O-])N2C(=O)C(NC(=O)C(=NOC(C)(C)C(=O)O)c3nsc(N)n3)C2SC1,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03008369,NCT03008369_EG000,No,All,Adult | Older Adult,Phase 2,3,"Inclusion Criteria:

Histologically or cytologically confirmed malignant secretory or non-secretory pheochromocytoma or paraganglioma that is unresectable and deemed inappropriate for alternative local regional therapeutic approaches
Measurable disease
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2
Life expectancy > 24 weeks
Absolute neutrophil count (ANC) >= 1500/mm^3
White blood cell (WBC) count >= 3,000/mm^3
Platelet count >= 100,000/mm^3
Hemoglobin >= 9.0 g/dL (5.6 mmol/L); NOTE: transfusions are not allowed =< 7 days prior to registration
Total bilirubin =< 1.5 X upper limit of normal (ULN) (or total bilirubin =< 3.0 X ULN with direct bilirubin =< 1.5 X ULN in patients with well-documented Gilbert's Syndrome)
Aspartate transaminase (AST/serum glutamic oxaloacetic transaminase [SGOT]) =< 2.5 X ULN
Creatinine =< 1.5 x ULN
Urine protein/creatinine ratio =< 1 OR 24-hour urine protein < 1.5 gram
Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only
Blood pressure (BP) < 150 mmHg (systolic) and < 90 mmHg (diastolic); initiation or adjustment of BP medication is permitted prior to registration provided that the average of three BP readings at a visit prior to registration is < 150/90 mmHg; NOTE: all patients with secretory pheochromocytoma or paraganglioma are REQUIRED to: 1) be evaluated in consultation by a hypertension specialist with specific experience in the management of hypertension in the setting of catecholamine-secreting tumors (usually an endocrinologist, nephrologist, or a cardiologist), and in the setting of hormone-associated hypertension) receive alpha- and beta-adrenergic blockade for at least 7-14 days prior to initiation of lenvatinib; the hypertension specialist of record for each patient should be committed to closely following the patient during the clinical study with evaluation by said specialist required at cycle 1 and 2 and thereafter on an as needed basis
Provide written informed consent
Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)
Ability to complete questionnaire(s) by themselves or with assistance

Exclusion Criteria:

Any of the following:

Pregnant women
Nursing women
Men or women of childbearing potential who are unwilling to employ adequate contraception
Chemotherapy/systemic therapy, radiotherapy, immunotherapy or surgery =< 21 days prior to registration or kinase inhibitor therapy =< 14 days prior to registration or failure to recover from toxicities (to grade 1 or below) from treatment; NOTE: concurrent therapy with octreotide is allowed providing that tumor progression on this therapy has been demonstrated; concurrent therapy with bisphosphonates (e.g. zoledronic acid) or denosumab is also allowed; NOTE: an unlimited number of prior chemotherapeutic or biologic therapies for malignant pheochromocytoma or paraganglioma is permitted; this includes prior anti-angiogenesis therapies such as tyrosine kinase inhibitors
Active or uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Receiving any other investigational agent
Current use of warfarin for any reason; NOTE: if patient can be safely transitioned to another anticoagulant, they may be eligible provided other criteria are satisfied

Any of the following:

Correct QT (QTc) prolongation (defined as a QTc interval >= 500 msecs)
Left ventricular ejection fraction (LVEF) < institutional lower limits of normal (LLN)
Frequent ventricular ectopy
Evidence of ongoing myocardial ischemia
Receiving any medications or substances with risk of torsades de pointes; NOTE: medications or substances with known risk of torsades de pointes are prohibited; consult pharmacist for review if needed
Known active and/or untreated brain metastases
Known severe allergic or other prohibitive reactions to other tyrosine kinase inhibitors (TKI)
Prior treatment with lenvatinib

Any of the following conditions:

Active peptic ulcer disease
Inflammatory bowel disease (e.g., ulcerative colitis, Crohn's disease) or other gastrointestinal conditions which increase the risk of perforation
History of new abdominal fistula, gastrointestinal perforation or intra-abdominal abscess =< 84 days prior to registration; NOTE: enrollment of patients with chronic/canalized fistulous tracts (present for > 84 days) is allowed
Serious or non-healing wound, ulcer, or bone fracture
History of familial QTc prolongation syndrome

Any of the following conditions =< 6 months prior to registration:

Cerebrovascular accident (CVA) or transient ischemic attack (TIA)
Serious or unstable cardiac arrhythmia
Admission for unstable angina or myocardial infarction
Cardiac angioplasty or stenting
Coronary artery bypass graft surgery
Pulmonary embolism, untreated deep venous thrombosis (DVT) or DVT which has been treated with therapeutic anticoagulation =< 30 days
Arterial thrombosis
Symptomatic peripheral vascular disease
Other active malignancy =< 2 years prior to registration; EXCEPTIONS: non-melanotic skin cancer or carcinoma-in-situ of the cervix; NOTE: if there is a history of prior malignancy, they must not be receiving other specific treatment for their cancer; NOTE: adjuvant anti-estrogen/hormonal therapy for breast cancer is allowed",Patients receive lenvatinib PO once daily on days 1-28. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Lenvatinib: Given PO Quality-of-Life Assessment: Ancillary studies,ChEMBL:CHEMBL1289601 | DrugBank:DB09078 | PubChem:9823820,Lenvatinib,COc1cc2nccc(Oc3ccc(NC(=O)NC4CC4)c(Cl)c3)c2cc1C(N)=O,L01EX08 | L01XE29,0.0,0.0,0.0,0.0,1.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,1.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0
NCT03010683,NCT03010683_EG001,Accepts Healthy Volunteers,All,Adult | Older Adult,Not Applicable,60,"Inclusion Criteria:

Patients with type 2 diabetes mellitus (T2DM) without coronary artery disease (CAD)
Patients with T2DM and CAD.
Obese patients (BMI >30 Kg/m²) with abnormal oral glucose tolerance test (OGTT)

Exclusion Criteria:

valvular heart disease
congestive heart failure
peripheral vascular disease
liver or kidney failure
history of alcohol or drug abuse",Antidiabetic drug - biguanide class (Glucophage) 1000 mg twice daily per os,ChEMBL:CHEMBL1431 | DrugBank:DB00331 | PubChem:4091,Metformin,CN(C)C(=N)NC(=N)N,A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03011567,NCT03011567_EG002,No,Female,Adult | Older Adult,Not Applicable,202,"Inclusion Criteria:

Delivery occurred at equal to or greater than 24 0/7 weeks gestational age
Patient receiving care with the Women's Perinatal Group (Maternal Fetal Medicine practice) or Obstetric Clinic resident services
Diagnosis of a hypertensive disorder of pregnancy (HDP), including the following:
Gestational hypertension
Preeclampsia without severe features
Preeclampsia with severe features
Hemolysis, Elevated Liver Enzymes, Low Platelet (HELLP) Syndrome
Eclampsia

Exclusion Criteria:

Diagnosis of chronic hypertension or documentation of elevated blood pressures before 20 weeks gestational age.
Severe hypertension: Patients with at least one severe blood pressure measurement (systolic >160mmHg or diastolic >105mmHg) prior to randomization
Renal dysfunction (Serum creatinine measurement >1.3mg/dL during the current pregnancy)
Low platelet count (recorded measurement <50,000 during hospital admission)
Significant liver dysfunction (AST or ALT >500)
Known sensitivities to ibuprofen or acetaminophen
Use of therapeutic doses of anticoagulation (low dose anticoagulation used for routine prophylaxis of venous thromboembolism is acceptable)
Postpartum hemorrhage requiring transfusion","This arm will be assigned a postpartum analgesic regimen with acetaminophen.

Acetaminophen: Participants will receive acetaminophen for postpartum mild pain relief",ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03011567,NCT03011567_EG003,No,Female,Adult | Older Adult,Not Applicable,202,"Inclusion Criteria:

Delivery occurred at equal to or greater than 24 0/7 weeks gestational age
Patient receiving care with the Women's Perinatal Group (Maternal Fetal Medicine practice) or Obstetric Clinic resident services
Diagnosis of a hypertensive disorder of pregnancy (HDP), including the following:
Gestational hypertension
Preeclampsia without severe features
Preeclampsia with severe features
Hemolysis, Elevated Liver Enzymes, Low Platelet (HELLP) Syndrome
Eclampsia

Exclusion Criteria:

Diagnosis of chronic hypertension or documentation of elevated blood pressures before 20 weeks gestational age.
Severe hypertension: Patients with at least one severe blood pressure measurement (systolic >160mmHg or diastolic >105mmHg) prior to randomization
Renal dysfunction (Serum creatinine measurement >1.3mg/dL during the current pregnancy)
Low platelet count (recorded measurement <50,000 during hospital admission)
Significant liver dysfunction (AST or ALT >500)
Known sensitivities to ibuprofen or acetaminophen
Use of therapeutic doses of anticoagulation (low dose anticoagulation used for routine prophylaxis of venous thromboembolism is acceptable)
Postpartum hemorrhage requiring transfusion","This arm will be assigned a postpartum analgesic regimen with acetaminophen.

Acetaminophen: Participants will receive acetaminophen for postpartum mild pain relief",ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03018704,NCT03018704_EG001,No,All,Adult | Older Adult,Phase 4,79,"Inclusion Criteria:

self-identification as African American;
age 18 to 70 years, inclusive;
average weekly ethanol consumption of >24 standard drinks for men or >18 standard drinks for women, with a weekly average of > 2 heavy drinking days (men: > 5 standard drinks; women: > 4 standard drinks) during the month before screening;
a current diagnosis of moderate or severe AUD (i.e., meeting at least 4 of 11 DSM-5 AUD criteria);
expressed goal to reduce or stop drinking;
able to read English at the 6th grade or higher level and without gross cognitive impairment;
women of child-bearing potential (i.e., who have not had a hysterectomy, bilateral oophorectomy, tubal ligation or are less than two years postmenopausal), must be non-lactating, practicing a reliable method of birth control, and have a negative urine pregnancy test prior to initiation of treatment
willing and able to provide signed, informed consent to participate in the study.

Exclusion Criteria:

a current, clinically significant physical disease or abnormality on the basis of medical history, physical examination, or routine laboratory evaluation, including direct bilirubin elevations of >110% or a transaminase elevation >300% of normal;
history of nephrolithiasis;
history of glaucoma;
current serious psychiatric illness (i.e., schizophrenia, bipolar disorder, severe or psychotic major depression, antisocial personality disorder, or imminent suicide or violence risk);
current moderate-to-severe alcohol withdrawal requiring pharmacological treatment (see Section D.4.a. regarding alcohol detoxification);
current DSM-IV diagnosis of drug use disorder (other than nicotine or cannabis) or a urine drug screen positive for recent use of opioids, cocaine, or amphetamines (may be repeated once and if the result is negative on repeat it is not exclusionary);
a history of hypersensitivity to TOP;
current regular treatment with more than one antidepressant or any treatment with a tricyclic antidepressant;
current treatment with a psychotropic medication (with the exception of antidepressants where monotherapy is allowable), including medications that, when combined with alcohol or TOP, present a risk of overdose or significant adverse effect (e.g., chronic opioid use) (of note we will allow subjects to discontinue medications that have no demonstrated therapeutic effect in order to enroll - amount of time off of the medication will be a clinical decision left to the discretion of the study physician investigators);
current treatment with TOP or a medication approved for AUD;
considered to be unsuitable candidates for receipt of an investigational drug;
treatment with carbonic anhydrase inhibitors, due to the added risk of metabolic acidosis,
Body Mass Index (BMI) of less than 18.5.
untreated gout as topiramate has been shown in one study to increase uric acid.
current treatment with dolutegravir.","Topiramate an FDA approved anticonvulsant has been shown effective in the treatment of alcohol use disorder but there is no data supporting use in minority patients.

Topiramate: anticonvulsant medication",ChEMBL:CHEMBL220492 | DrugBank:DB00273 | PubChem:5284627,Topiramate,[H][C@@]12OC(C)(C)O[C@]1([H])CO[C@@]1(COS(N)(=O)=O)OC(C)(C)O[C@]12[H],A08AA51 | N03AX11,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03020966,NCT03020966_EG000,No,All,Adult | Older Adult,Phase 4,154,"Inclusion criteria:

Adult
Scheduled for an elective primary THA with a participating surgeon,
Planned for Combined Spinal Epidural anesthesia (CSE) and Patient Controlled Epidural Analgesia (PCEA)
English-speaking
Patients that did not receive pre-operative opioids

Exclusion criteria:

Hepatic or renal insufficiency, as defined by abnormal readings on liver and kidney functioning tests.
Hypersensitivity or contraindication to protocol medication
Contraindication for CSE and PCEA
Incapable to provide consent/answer questions in English
Revision or urgent surgery
Receiving Periarticular Injections
History of opioid use
Patients on disability or worker's compensation","Patient group receiving 1000mg of oral acetaminophen and an intravenous placebo

Acetaminophen: Oral acetaminophen, intravenous placebo",ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03020966,NCT03020966_EG001,No,All,Adult | Older Adult,Phase 4,154,"Inclusion criteria:

Adult
Scheduled for an elective primary THA with a participating surgeon,
Planned for Combined Spinal Epidural anesthesia (CSE) and Patient Controlled Epidural Analgesia (PCEA)
English-speaking
Patients that did not receive pre-operative opioids

Exclusion criteria:

Hepatic or renal insufficiency, as defined by abnormal readings on liver and kidney functioning tests.
Hypersensitivity or contraindication to protocol medication
Contraindication for CSE and PCEA
Incapable to provide consent/answer questions in English
Revision or urgent surgery
Receiving Periarticular Injections
History of opioid use
Patients on disability or worker's compensation","Patient group receiving 1000mg of intravenous acetaminophen and an oral placebo

Acetaminophen: Intravenous acetaminophen, oral placebo",ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03033108,NCT03033108_EG000,No,All,Adult | Older Adult,Phase 2,7,"Inclusion Criteria, including, but not limited to:

Clinical diagnosis of macular atrophy (MA) secondary to Stargardt disease (STGD) in one or both eyes
At least 2 pathogenic mutations of the ABCA4 gene
Early Treatment Diabetic Retinopathy Study BCVA of ≥ 20 letters (approximately ≥ 20/400 Snellen) in the study eye
Adequate clarity of ocular media and adequate pupillary dilation to permit good quality imaging of MA in the study eye
Able and willing to provide written informed consent before undergoing any study-related procedures
Able to reliably administer oral medication by self or with available assistance

Exclusion Criteria, including, but not limited to:

Macular atrophy associated with a condition other than STGD in either eye.
Presence in either eye of an active ocular disease that in the opinion of the Investigator compromises or confounds visual function.
History of any intraocular or ocular surface surgery in either eye within 3 months of screening.
Current or previous participation in an interventional study to treat STGD using gene therapy or stem cell therapy at any time, or participation in an interventional study of a vitamin A derivative ≤3 months prior to screening.
Pre-specified laboratory abnormalities at screening
Presence of other medical or ophthalmic disease, physical examination finding, or clinical laboratory finding that in the opinion of the Investigator may contraindicate the use of an investigational drug and place the subject at risk
Current or history of cancer (except for adequately treated basal cell or squamous cell carcinoma of the skin) within 1 year of screening
History of myocardial infarction, stroke, unstable ischemic heart disease, uncontrolled cardiac arrhythmia, or hospitalization for congestive heart failure within 6 months of screening.
Anticipated hospitalization for a medical/surgical procedure(s) that could result in interruption/premature cessation of study treatment or participation.
Electrocardiogram with a clinically significant abnormal finding
Female subjects who are pregnant or lactating
Female subjects of childbearing potential or male subjects who are not surgically sterile who are not willing to practice a medically accepted method of birth control with their sexual partner from screening through 30 days after the final dose of study drug","lowest dose of once-daily oral emixustat

Emixustat: Once daily, tablet for oral administration",ChEMBL:CHEMBL2107821 | DrugBank:DB12608 | PubChem:25221720,Emixustat,NCC[C@@H](O)c1cccc(OCC2CCCCC2)c1,,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT03033108,NCT03033108_EG001,No,All,Adult | Older Adult,Phase 2,9,"Inclusion Criteria, including, but not limited to:

Clinical diagnosis of macular atrophy (MA) secondary to Stargardt disease (STGD) in one or both eyes
At least 2 pathogenic mutations of the ABCA4 gene
Early Treatment Diabetic Retinopathy Study BCVA of ≥ 20 letters (approximately ≥ 20/400 Snellen) in the study eye
Adequate clarity of ocular media and adequate pupillary dilation to permit good quality imaging of MA in the study eye
Able and willing to provide written informed consent before undergoing any study-related procedures
Able to reliably administer oral medication by self or with available assistance

Exclusion Criteria, including, but not limited to:

Macular atrophy associated with a condition other than STGD in either eye.
Presence in either eye of an active ocular disease that in the opinion of the Investigator compromises or confounds visual function.
History of any intraocular or ocular surface surgery in either eye within 3 months of screening.
Current or previous participation in an interventional study to treat STGD using gene therapy or stem cell therapy at any time, or participation in an interventional study of a vitamin A derivative ≤3 months prior to screening.
Pre-specified laboratory abnormalities at screening
Presence of other medical or ophthalmic disease, physical examination finding, or clinical laboratory finding that in the opinion of the Investigator may contraindicate the use of an investigational drug and place the subject at risk
Current or history of cancer (except for adequately treated basal cell or squamous cell carcinoma of the skin) within 1 year of screening
History of myocardial infarction, stroke, unstable ischemic heart disease, uncontrolled cardiac arrhythmia, or hospitalization for congestive heart failure within 6 months of screening.
Anticipated hospitalization for a medical/surgical procedure(s) that could result in interruption/premature cessation of study treatment or participation.
Electrocardiogram with a clinically significant abnormal finding
Female subjects who are pregnant or lactating
Female subjects of childbearing potential or male subjects who are not surgically sterile who are not willing to practice a medically accepted method of birth control with their sexual partner from screening through 30 days after the final dose of study drug","middle dose of once-daily oral emixustat

Emixustat: Once daily, tablet for oral administration",ChEMBL:CHEMBL2107821 | DrugBank:DB12608 | PubChem:25221720,Emixustat,NCC[C@@H](O)c1cccc(OCC2CCCCC2)c1,,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT03033108,NCT03033108_EG002,No,All,Adult | Older Adult,Phase 2,7,"Inclusion Criteria, including, but not limited to:

Clinical diagnosis of macular atrophy (MA) secondary to Stargardt disease (STGD) in one or both eyes
At least 2 pathogenic mutations of the ABCA4 gene
Early Treatment Diabetic Retinopathy Study BCVA of ≥ 20 letters (approximately ≥ 20/400 Snellen) in the study eye
Adequate clarity of ocular media and adequate pupillary dilation to permit good quality imaging of MA in the study eye
Able and willing to provide written informed consent before undergoing any study-related procedures
Able to reliably administer oral medication by self or with available assistance

Exclusion Criteria, including, but not limited to:

Macular atrophy associated with a condition other than STGD in either eye.
Presence in either eye of an active ocular disease that in the opinion of the Investigator compromises or confounds visual function.
History of any intraocular or ocular surface surgery in either eye within 3 months of screening.
Current or previous participation in an interventional study to treat STGD using gene therapy or stem cell therapy at any time, or participation in an interventional study of a vitamin A derivative ≤3 months prior to screening.
Pre-specified laboratory abnormalities at screening
Presence of other medical or ophthalmic disease, physical examination finding, or clinical laboratory finding that in the opinion of the Investigator may contraindicate the use of an investigational drug and place the subject at risk
Current or history of cancer (except for adequately treated basal cell or squamous cell carcinoma of the skin) within 1 year of screening
History of myocardial infarction, stroke, unstable ischemic heart disease, uncontrolled cardiac arrhythmia, or hospitalization for congestive heart failure within 6 months of screening.
Anticipated hospitalization for a medical/surgical procedure(s) that could result in interruption/premature cessation of study treatment or participation.
Electrocardiogram with a clinically significant abnormal finding
Female subjects who are pregnant or lactating
Female subjects of childbearing potential or male subjects who are not surgically sterile who are not willing to practice a medically accepted method of birth control with their sexual partner from screening through 30 days after the final dose of study drug","highest dose of once-daily oral emixustat

Emixustat: Once daily, tablet for oral administration",ChEMBL:CHEMBL2107821 | DrugBank:DB12608 | PubChem:25221720,Emixustat,NCC[C@@H](O)c1cccc(OCC2CCCCC2)c1,,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03047980,NCT03047980_EG000,No,All,Child | Adult,Phase 2 | Phase 3,10,"Inclusion Criteria:

Male or female patients ages 3 to 31 years of age, inclusive.

Cognitive impairment as defined by the following:

SWS cognitive neuroscore of ≥ 1

Ability to participate in direct neuropsychological and developmental testing.
English as primary language.
Stable anti-epileptic drugs (no changes in medications except dose for >3 months).
Adequate renal function. GFR must be greater than 50 ml/min/m2 as determined by the Schwartz Formula for children and MDRD for adults: http://www.nkdep.nih.gov/professionals/gfr_calculators/index.htm
If female and of child bearing potential, documentation of a negative pregnancy test prior to enrollment determined by a urine test is required. Sexually active pre-menopausal female patients (and female partners of male patients) must use adequate contraceptive measures, excluding estrogen containing contraceptives, while on the study drug. Abstinence will be considered an adequate contraceptive measure.
INR ≤1.5 (Anticoagulation is allowed if target INR ≤ 1.5 on a stable dose of warfarin or on a stable dose of LMW heparin for >2 weeks.)

Adequate liver function as shown by:

Serum bilirubin ≤ 1.5x ULN
ALT and AST ≤ 2.5x ULN
Written informed consent according to local guidelines. Local guidelines for subject assent will also be followed.
Stable dose of medications affecting the cytochrome P 450 3A4 (CYP3A4) and p glycoprotein (P gp) systems for at least 3 months prior to consent.

Exclusion Criteria:

Allergy to sirolimus or other rapamycin analogues.
Patients with seizures secondary to metabolic, toxic, infectious or psychogenic disorder, drug abuse or current seizures related to an acute medical illness.
Inability to keep follow-up appointments, maintain close contact with Principal Investigators, and/or complete all necessary studies to maintain safety.
Patients in need of immediate major surgical intervention.
Concurrent severe and/or uncontrolled medical disease, which could compromise participation in the pilot study (e.g. uncontrolled diabetes, uncontrolled hypertension, severe infection, severe malnutrition, chronic liver or renal disease, active upper GI tract ulceration, impaired or restrictive pulmonary function, pneumonitis or pulmonary infiltrates).
Chronic treatment with systemic steroids or another immunosuppressive agent. Patients with endocrine deficiencies are allowed to receive physiologic or stress doses of steroids if necessary. Inhaled steroids are allowed.
Known history of HIV seropositivity or known immunodeficiency. Testing is not required unless a condition is suspected.
Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of sirolimus (e.g. ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection). A gastric tube or nasogastric tube is allowed.
Patients with an active, bleeding diathesis.
Patients with uncontrolled hyperlipidemia: fasting serum cholesterol > 300 mg/dL AND fasting triglycerides > 2.5 x ULN.
Patients who have had a major surgery or significant traumatic injury within four weeks of study entry. Patients who have not recovered from the side effects of any major surgery (defined as requiring general anesthesia) or patients that may require major surgery during the course of the pilot study.
Patients with a prior history of organ transplant.
Patients who have received live attenuated vaccines within one week of start of sirolimus and during the pilot study.
Patients who have a history of malignancy.
Patients who are currently part of or have participated in any clinical investigation with an investigational drug within one month prior to enrollment.
Patients being treated with felbamate, unless treatment has been continuous for ≥ one year.
Patients currently receiving anticancer therapies or who have received anticancer therapies within four weeks of study entry (including chemotherapy, radiation therapy, antibody based therapy, etc.).","All subjects will receive the sirolimus oral solution to be taken at home twice daily and will be treated on an outpatient basis. The drug will be taken for six months.

Sirolimus: Low dose oral sirolimus",ChEMBL:CHEMBL413 | DrugBank:DB00877 | PubChem:134760597 | PubChem:138404388 | PubChem:21944094 | PubChem:5284616,Sirolimus,COC1CC2CCC(C)C(O)(O2)C(=O)C(=O)N2CCCCC2C(=O)OC(C(C)CC2CCC(O)C(OC)C2)CC(=O)C(C)C=C(C)C(O)C(OC)C(=O)C(C)CC(C)C=CC=CC=C1C,L01EG04 | L04AA10 | S01XA23,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0
NCT03051256,NCT03051256_EG000,No,All,Adult | Older Adult,Phase 2,19,"Inclusion Criteria:

Males between 18 and 65 years of age, inclusive; and females between 18 and 65 years of age, inclusive, who are >1 year postmenopausal.
Diagnosed with recurrent MDD as defined by the Diagnostic and Statistical Manual, Fifth Edition (DSM-5), and confirmed by the Mini International Neuropsychiatric Interview, Version 7.0.2 (MINI).
Diagnosed with a current MDE lasting 8 weeks to 36 months as defined by the DSM-5 and confirmed by the MINI.
Treated with an adequate dosage of a SSRI, SNRI, or bupropion during the current MDE for at least 8 weeks prior to Screening with the same, adequate dosage for the last 4 weeks. Minimum adequate doses are defined in the (ATRQ). The maximum dose allowed for paroxetine is 40 mg QD, for fluoxetine is 60 mg QD, and for sertraline is 200 mg QD.
Have experienced an inadequate response to 1 to 3 courses of treatment with an antidepressant medication in the current episode, as defined as <50% improvement with an antidepressant medication at doses listed on the SAFER Interview Criteria: State versus trait; Assessability; Face validity; Ecological validity; and Rule of three Ps (pervasive, persistent, and pathological).
Hamilton Depression Rating Scale-17 (HAM-D-17) ≥19 at Screening and Check-in (Day -1).
BMI between 18.0 and 35.0 kg/m2, inclusive, and a minimum weight of 50.0 kg.
Per the Investigator's judgment, able to meet all study requirements, including the confined/inpatient portion of the study, adherence with both approved ADT and study drug regimen, and completion of all assessments and all scheduled visits.
Male patients of reproductive potential must be using and willing to continue using medically acceptable contraception, from Screening and for at least 2 months after the last study drug administration.
Must be able to read, speak, and understand English and must provide written informed consent prior to the initiation of any protocol-specific procedures.

Exclusion Criteria:

History or presence of clinically significant abnormality as assessed by physical examination, medical history, 12-lead ECG, vital signs, or laboratory values, which in the opinion of the Investigator would jeopardize the safety of the patient or the validity of the study results, including torsades de pointes, any bradyarrhythmias, or uncompensated heart failure.
Chronic use of prescribed opioids (i.e., >120 days in a 6-month period) up to 6 months prior to Screening or any recreational use of opioids.
Evidence of clinically significant hepatic or renal impairment, including ALT or AST >1.5 x upper limit of normal (ULN), bilirubin >1 x ULN, or endocrine laboratory values (including clinically significant thyroid parameters, i.e., thyroid stimulating hormone [TSH], triiodothyronine [T3], and thyroxine [T4]).
History or family history of sudden unexplained death or long QT syndrome (measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle).
Any 12-lead ECG with repeated demonstration of QTc ≥450 msec or a QRS interval >120 msec at Screening.
History of clinically diagnosed hypotension requiring treatment.
History or presence of any condition in which an opioid is contraindicated (e.g., significant respiratory depression, acute or severe bronchial asthma or hypercarbia, bronchitis, or has/is suspected of having paralytic ileus).
No more than 3 prescribed doses of an opioid within the 6 months prior to Screening and no use at all within the last month.
Use of an antipsychotic, anticonvulsant, or mood stabilizer, regardless of indication, within the 3 months prior to Screening.
History of allergy or hypersensitivity to methadone or related drugs (e.g., opioids).
Positive test for hepatitis B or HIV. Patients with a positive hepatitis C test may be considered for inclusion with approval from the Medical Monitor.
Any current and primary psychiatric disorder, as defined as a condition that is the primary focus of distress and/or treatment, other than MDD.
Any lifetime history of bipolar I or II disorder, any psychotic disorder, post-traumatic stress disorder, borderline personality disorder, antisocial personality disorder, obsessive compulsive disorder, eating disorder, intellectual disability, or pervasive developmental disorder.
History in the past 12 months of a primary diagnosis of anxiety disorder or panic disorder not related to the current MDE.
Current diagnosis of alcohol or substance use disorder, as defined by DSM-5, at Screening or within the 12 months prior to Screening. Patients with the following diagnoses within the past 12 months, however, may be included at the Investigator's discretion: mild alcohol use disorder, mild cannabis use disorder, and any severity tobacco use disorder.
A confirmed positive result on the urine drug/alcohol screen at Screening or Check-in. If the urine drug/alcohol screen is positive at Screening, retesting or rescreening may be scheduled with prior approval from the Medical Monitor.
Patients who, in the Investigator's judgment, are at significant risk for suicide. A patient with a Columbia-Suicide Severity Rating Scale (C-SSRS) ideation score of 4 or 5 within the last 6 months or any suicide attempt within the past year must be excluded, as should a patient with an ideation score of 4 or 5 or any suicide attempt at the Check-in or Baseline Visit.
Patients with a 20% improvement between Screening and Check-in (Day -1) on the HAM-D-17.
Patients who did not safely discontinue medications prohibited.
Patients receiving new onset psychotherapy (individual, group, marriage, or family therapy) within 2 months prior to Screening or plans to start at any time during participation in the study.
Patients who have received electroconvulsive therapy (ECT), repetitive transcranial magnetic stimulation (rTMS), or vagus nerve stimulation (VNS) or who have participated in a ketamine study within the last 6 months.
Patients with any clinically significant neurological, hepatic, renal, metabolic, hematological, immunological, cardiovascular, pulmonary, chronic pain, or gastrointestinal disorder. Medical conditions that are minor or well-controlled may be permitted if they will not increase the safety risk to the patient or compromise interpretation of the safety or efficacy endpoints.
Patients taking fluvoxamine or St. John's Wort.
Patients who have participated in a clinical study with an investigational medication in the past 6 months, or who have participated in more than 4 clinical studies with investigational medications in the past 2 years.","Loading dose of REL-1017 75 mg of powder in 100 mL of cranberry juice on Day 1, Maintenance dose of REL-1017 25 mg of powder in 100 mL cranberry juice daily on Days 2-7.

REL-1017: REL-1017 administered as an oral solution. Patients continued to take the first line stable dose of antidepressant medication.",ChEMBL:CHEMBL350719 | ChEMBL:CHEMBL651 | DrugBank:DB00333 | DrugBank:DB15198 | PubChem:4095 | PubChem:643985,Methadone,CCC(=O)C(CC(C)N(C)C)(c1ccccc1)c1ccccc1,N02AC52 | N07BC02,0.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT03054740,NCT03054740_EG001,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 4,30,"Inclusion Criteria:

Any outpatient ordered to undergo a Nuclear Medicine Stress Test and is required to have IV access for injection of Radiopharmaceuticals

Exclusion Criteria:

If it is the first time the patient has had an intravenous catheter inserted
Any patient who is or may be pregnant
Any patient who is breast-feeding
Any patient who has taken a narcotic, sedative and/or anti-anxiety medication within 8 hours of intervention time.
Any patient who has a known diagnosis of Raynaud's Syndrome or Carpal Tunnel Syndrome.
Any patient who has an allergy or hypersensitivity to Ethyl Chloride.
Any patient under the age of 18 and/or any patient over the age of 85
Any patient who is illiterate
Any patient who is non-English speaking
Any patient with prior experience with a vapocoolant spray.","Drug: Sterile Water

Nature's Tears: Sterile water mist will be administered 1-2 sprays prior to intravenous access",ChEMBL:CHEMBL1098659 | DrugBank:DB09145 | PubChem:10129877 | PubChem:24602 | PubChem:962,Water,O,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03062488,NCT03062488_EG000,Accepts Healthy Volunteers,All,Child,Early Phase 1,51,"Inclusion Criteria:

Patients who are 24 months through 7 years of age
Patients who weigh <50 kg
Patients who are able to take PO medications
Patients who are ASA Classification I and II
Patients who are found to be a candidate after clinical review of detailed History and Physical Exam, review of Polysomnogram or Pediatric Sleep Questionnaire
Patients who are scheduled for routine adenoidectomy or tonsillectomy with or without adenoidectomy not in conjunction with another invasive or diagnostic procedure
Patients who meet clinical indications for surgery
Family and patient must be proficient in English to understand consent, post-operative instructions, and facilitate the assessment after emergence of anesthesia

Exclusion Criteria:

Children with a history of developmental delay or psychological disorders that may be at higher risk for EA as determined by study physician after review of history and problem list in EMR
Patients with previous hypersensitivity to oral or intravenous acetaminophen, fentanyl or any of its components or ingredients in placebo,
Patients with severe hepatic impairment or severe active hepatic disease
Patients with previous history of Malignant Hyperthermia or susceptibility to volatile anesthetics agents like sevoflurane
Any patient who weighs >50 Kg.
Any patient that requires premedication. Versed may contribute to an increase in EA. Premedication is reserved when parental presence is not feasible or for very anxious children.
Patients unable to take PO (acetaminophen or placebo) will be excluded from the study.
Children with severe symptomatic sleep apnea that require post-operative hospitalization.
Severe symptomatic sleep apnea is defined as a- patients who has a pre-operative polysomnogram and a calculated Apnea-Hypoxia Index greater than 10 b- patients with high scoring in Pediatric Sleep Questionnaire (PSQ)
Patients with severe symptoms and findings in physical exam that require post-operative hospital admission.
Patients and/or families not proficient in English
Participant is currently participating or has within the previous 30 days, participated in another clinical trial/research study","2 mcg/Kg of fentanyl

Fentanyl: single modal analgesia",ChEMBL:CHEMBL596 | DrugBank:DB00813 | PubChem:3345,Fentanyl,CCC(=O)N(c1ccccc1)C1CCN(CCc2ccccc2)CC1,N01AH01 | N01AH51 | N02AB03,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03063255,NCT03063255_EG001,No,All,Adult | Older Adult,Phase 4,60,"Inclusion Criteria:

Patients ≥ 18 years of age
Planned TURBT for unilateral or bilateral posterolateral bladder tumors
Ability to understand and provide informed consent

Exclusion Criteria:

Patient refusal or inability to provide informed consent
True allergy, not sensitivity, to local anesthetics
True allergy, not sensitivity, Propofol
True allergy, not sensitivity, general anesthetic agents
Pregnancy
Severe hepatic impairment
Evidence of infection at or near the proposed needle insertion site
Any sensorimotor deficit of the lower extremity, whether acute or chronic
Inability to walk without assistance
Lower extremity joint replacement surgery in the preceding six months","Comparing the incidence of adductor spasm in patients undergoing general anesthesia with neuromuscular blocking agents.

Neuromuscular block: Subjects allocated to the neuromuscular block group will be monitored for the incidence of block and procedure-related adverse events. In addition to clinical observation, a Nerve Integrity Monitor (Medtronic) will be used to detect adductor spasm using continuous electromyography. Electrodes will be placed on the thigh to objectively detect and record instances of adductor spasm. One hour after arrival to PACU or when discharge criteria are met (whichever comes first), repeat dynamometer measurements and TUG tests will be performed. Patients will be called 24-48 hours post procedure to inquire about falls or evidence of nerve injury, as well as patient satisfaction.",ChEMBL:CHEMBL1201244 | DrugBank:DB00728 | PubChem:441290,Rocuronium,[H][C@@]12CC[C@]3([H])[C@]([H])(CC[C@]4(C)[C@@H](OC(C)=O)[C@@H]([N+]5(CC=C)CCCC5)C[C@@]34[H])[C@@]1(C)C[C@H](N1CCOCC1)[C@@H](O)C2,M03AC09,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03071744,NCT03071744_EG000,No,All,Adult | Older Adult,Phase 2,6,"Inclusion Criteria:

Patient has the ability to understand and the willingness to sign a written informed consent.
Pathologically-confirmed solid tumor or hematologic malignancy with symptomatic bone metastases.
Patient is planned to receive hypofractionated palliative radiation ≤ 10 fractions.
Patient must be opioid-tolerant (greater than or equal to 60mg morphine or equivalent) and on a stable dose of oral opioids for greater than or equal to 1 week. Stable baseline opioid dosage defined as a dosage that does not fluctuate by more than 50% from the average dosage over one week prior to screening.
Patient must be on a stable dose of adjuvant pain therapies for one week prior to screening (i.e. steroids, NSAIDs, anticonvulsants, pharmaceutical cannabinoids, tricyclic antidepressants).
Patient is ≥ 18 years of age.
Both men and women of all races and ethnic groups are eligible for this trial.
ECOG Performance Status ≤ 3

Women of child-bearing potential and men with partners of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 28 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately

A woman of child-bearing potential is any female (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
Has not undergone a hysterectomy or bilateral oophorectomy; or
Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)Women of child-bearing potential has negative pregnancy test prior to initiating study drug dosing.

Exclusion Criteria:

Patient is currently receiving or has received another investigational agent within 30 days or monoamine oxidase inhibitor within 14 days prior to Lazanda administration.
Patients who require immobilization with a thermoplastic mask for radiation treatment.
Patient is planned to receive interventional procedures (i.e. surgery) that may affect study outcomes.
Patient has a history of hypersensitivity to fentanyl or opioids.
Patient is pregnant or nursing. There is a potential for congenital abnormalities and for this regimen to harm nursing infants.
Patient is being treated with oxymetazoline for allergic rhinitis or has a disorder or current medication use likely to adversely affect normal functioning of the nasal mucosa.
Patient has uncontrolled or rapidly escalating background pain.
Patient has bradyarrhythmia.
Patient is considered medically unstable.

Patient is thought to be at risk for misuse, abuse, addiction or overdose for Schedule II controlled substance, as evidenced by the following:

An Opioid Risk Tool (ORT) score of greater/less than or equal to 8.
A review of the California Prescription Control Monitoring Program (PDMP) Controlled Substance Utilization Review and Evaluation System (CURES) report demonstrates multiple prescribing providers and/or multiple pharmacies in the last 30 days. The CURES report will also be used to verify opioid use, opioid dose, and current prescribing providers.","Study drug, Lazanda, will be self-administered intranasally during this study. The dose of Lazanda is not predicted from the daily maintenance dose of opioid used to manage persistent cancer pain and must be determined by dose titration. The minimal effective intranasal dose from the radiation therapy simulation will be the dose used as pre-medication prior to any further radiation therapy fractions (up to 10 fractions).

Lazanda should be administered 15 (T-15) minutes prior to laying on the hard surface for each simulation visit. If the response to the titrated Lazanda dose markedly changes, an adjustment of dose may be necessary to ensure that an appropriate dose is maintained as deemed by the investigator.

Lazanda: Lazanda is supplied in glass bottles, containing 8 sprays of 100 mcL containing 100 mcg/100 mcL or 400 mcg/100 mcL concentration solution.",ChEMBL:CHEMBL596 | DrugBank:DB00813 | PubChem:3345,Fentanyl,CCC(=O)N(c1ccccc1)C1CCN(CCc2ccccc2)CC1,N01AH01 | N01AH51 | N02AB03,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT03085485,NCT03085485_EG000,No,All,Adult | Older Adult,Phase 2,29,"Inclusion Criteria:

Male or Female age 40-80
A Clinical diagnosis of COPD as defined by GOLD
At Least a 10 pack year smoking history
Exhibit symptoms of chronic bronchitis as defined by the Medical Research Council
FEV1% predicted ≥ 35% and ≤70% Post Bronchodilator
Clinically stable in the last 4 weeks with no evidence of COPD exacerbation
Weight of 40 kg-120 kg
Willingness to use at least one form of acceptable birth control including abstinence, condom with spermicide, or hormonal contraceptives from time of signing ICF through study follow up visit
Willing to monitor blood glucose if known history of diabetes mellitus requiring insulin or medical therapy
Element of CFTR Dysfunction, as defined by Sweat Chloride > 30 mEq/L)

Exclusion Criteria:

Current Diagnosis of Asthma
Known Diagnosis of Cystic Fibrosis
Use of Continuous Oxygen Therapy of greater than 2 liters per minute - patients on 2 liters of Oxygen or less will be excluded if they have been hospitalized for COPD in the prior year or had more than 2 exacerbations requiring steroids and/or antibiotics in the prior year.
Documented history of drug abuse within the last year
Subjects should not have a pulmonary exacerbation or changes in therapy for pulmonary disease within 28 days before receiving the first dose of study drug.
Cirrhosis or elevated liver transaminases > 3X ULN
GFR < 50 estimated by Cockroft-Gault
Any illness or abnormal lab finding that, in the opinion of the investigator might confound the results of the study or pose an additional risk in administering study drug to the subject.
Pregnant or Breastfeeding
Subjects taking moderate or strong inhibitors or inducers of CYP3A4, including certain herbal medications and grapefruit juice. (Excluded medications and foods including the drugs and foods listed in the IRB HSP application.)
Uncontrolled Diabetes
Recent (e.g 1year) arterial thrombotic events (peripheral arterial disease, thrombotic stroke)
Clinically significant arrhythmias requiring anti-arrhythmic agent(s) or conduction abnormalities that in the opinion of the investigator that affect patient safety such as the abnormalities listed below (patients with stable coronary artery disease are eligible) : (1) Angina symptoms (2) History of MI (3) Revascularization procedure in the last year prior to screening (4) Clinically significant congestive heart failure (known LVEF <= 45%, cor pulmonale, diastolic heart failure, etc)","Ivacaftor, 150 mg PO every 12 hrs for 84 days

Ivacaftor 150 MG: Ivacaftor is a CFTR potentiator",ChEMBL:CHEMBL2010601 | DrugBank:DB08820 | DrugBank:DB15141 | PubChem:16220172 | PubChem:71470491,Ivacaftor,CC(C)(C)c1cc(C(C)(C)C)c(NC(=O)c2c[nH]c3ccccc3c2=O)cc1O,R07AX02 | R07AX30 | R07AX31 | R07AX32,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT03085836,NCT03085836_EG001,Accepts Healthy Volunteers,All,Adult,Phase 1,11,"Inclusion Criteria:

Is a healthy adult male or female Chinese participant.
Is aged 18 to 45 years, inclusive, at the time of signing the informed consent form.
Weighs at least 50 kilogram (kg) and has a body mass index (BMI) between 19 and 26 kilogram per square meter (kg/m^2), inclusive at Screening (Check-In Day -1).
Is willing to abstain from caffeine and alcohol from 72 hours before first dose (Day 1) until the Follow-up Visit on Day 18.
Is willing to abstain from strenuous exercise from 72 hours before first dose (Day 1) until the Follow-up Visit on Day 18.
Is willing to provide a sample for pharmacogenetic analysis (for cytochrome [CYP2C19] genotyping).

Exclusion Criteria:

Has uncontrolled, clinically significant cardiovascular disease or other abnormality, which may impact the ability of the participant to participate or potentially confound the study results.
Is lactose intolerant or has a known hypersensitivity to any component of the formulation of TAK-438.
Has poor peripheral venous access.
Has donated or lost 400 milliliter (mL) or more of his or her blood volume (including plasmapheresis), or had a transfusion of any blood product within 90 days prior to Day 1; or participant has donated or lost more than 200 mL or more of his or her blood in the last 28 days.
Has a history of symptomatic gastroesophageal reflux disease (GERD), Erosive Esophagitis, duodenal ulcer (DU), gastric ulcer (GU), dyspepsia, Barrett's Esophagus, or Zollinger-Ellison (ZE) syndrome or has current or recent (within 6 months) gastrointestinal disease that would be expected to influence the absorption of drugs.","TAK-438 20 mg, tablet, orally, once daily on Days 1, 3 to 9. Participants were required to fast for a minimum of 10 hours prior administration of assigned treatment.",ChEMBL:CHEMBL2079130 | DrugBank:DB11739 | PubChem:15981397,Vonoprazan,CNCc1cc(-c2ccccc2F)n(S(=O)(=O)c2cccnc2)c1,A02BC08 | A02BD14 | A02BD15,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03085836,NCT03085836_EG002,Accepts Healthy Volunteers,All,Adult,Phase 1,10,"Inclusion Criteria:

Is a healthy adult male or female Chinese participant.
Is aged 18 to 45 years, inclusive, at the time of signing the informed consent form.
Weighs at least 50 kilogram (kg) and has a body mass index (BMI) between 19 and 26 kilogram per square meter (kg/m^2), inclusive at Screening (Check-In Day -1).
Is willing to abstain from caffeine and alcohol from 72 hours before first dose (Day 1) until the Follow-up Visit on Day 18.
Is willing to abstain from strenuous exercise from 72 hours before first dose (Day 1) until the Follow-up Visit on Day 18.
Is willing to provide a sample for pharmacogenetic analysis (for cytochrome [CYP2C19] genotyping).

Exclusion Criteria:

Has uncontrolled, clinically significant cardiovascular disease or other abnormality, which may impact the ability of the participant to participate or potentially confound the study results.
Is lactose intolerant or has a known hypersensitivity to any component of the formulation of TAK-438.
Has poor peripheral venous access.
Has donated or lost 400 milliliter (mL) or more of his or her blood volume (including plasmapheresis), or had a transfusion of any blood product within 90 days prior to Day 1; or participant has donated or lost more than 200 mL or more of his or her blood in the last 28 days.
Has a history of symptomatic gastroesophageal reflux disease (GERD), Erosive Esophagitis, duodenal ulcer (DU), gastric ulcer (GU), dyspepsia, Barrett's Esophagus, or Zollinger-Ellison (ZE) syndrome or has current or recent (within 6 months) gastrointestinal disease that would be expected to influence the absorption of drugs.","TAK-438 20 mg, tablet, orally, twice daily on Days 1, 3 to 9. Participants were required to fast for a minimum of 10 hours prior to breakfast, followed by administration of assigned treatment 0.5 hours after breakfast and dinner.",ChEMBL:CHEMBL2079130 | DrugBank:DB11739 | PubChem:15981397,Vonoprazan,CNCc1cc(-c2ccccc2F)n(S(=O)(=O)c2cccnc2)c1,A02BC08 | A02BD14 | A02BD15,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03088800,NCT03088800_EG001,No,All,Child,Phase 2,90,"Inclusion Criteria:

ages 3-17 years old presenting to the pediatric ED
treating physician deems patient required ibuprofen Tylenol or both for pain relief

Exclusion Criteria:

documented or suspected pregnancy, (2)
parental refusal,
allergies to NSAIDS or APAP
inability to tolerate oral medications or contraindications to oral medication route
received analgesics within 4 hours prior to ED presentation
inability to use pain scales","Oral APAP at 15 mg/kg and placebo of equal volume

APAP: Oral APAP at 15mg/kg dose",ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03092934,NCT03092934_EG001,No,All,Adult | Older Adult,Phase 1 | Phase 2,2,"Inclusion Criteria:

Have received at least 1 but no more than 4 prior systemic therapies
Have adequate organ function
Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale
Have estimated life expectancy greater than or equal to (≥)12 weeks
Have fully recovered from radiation therapy or surgery, and are recovering from any acute adverse effects of other cancer therapies
Have discontinued all chemotherapy, investigational therapy, molecularly-targeted therapy, and cancer-related hormonal therapy at least 14 days prior, biologic or immunotherapeutic therapy at least 21 days prior, or mitomycin-C or nitrosoureas at least 6 weeks prior
Female participants with reproductive potential agree to use 2 forms of highly effective contraception during the study and for the following 3 months
Male participants must use a barrier method of contraception during the study and for the following 3 months

Phase 1

Have evidence of a solid tumor that is locally advanced and/or metastatic (excluding primary brain tumor)

Phase 2

Have disease measurable by Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1

Have evidence of a solid tumor that is locally advanced and/or metastatic, and in:

Small Cell Lung Cancer (SCLC), must have failed platinum-containing therapy
Breast Cancer, be Estrogen Receptor positive and/or Progesterone Receptor positive, but Human Epidermal Growth Factor Receptor 2 (HER2) negative, and must have failed a hormone therapy and a Cyclin-dependent kinase 4/6 (CDK4/6) inhibitor
Triple negative breast cancer (TNBC) and failed standard therapy
Squamous cell cancers of the head neck associated with the human papilloma virus (HPV), and have failed standard therapy
Other solid tumor type that has been approved by the sponsor

Exclusion Criteria:

Have symptomatic central nervous system (CNS) metastasis (unless asymptomatic and not current receiving corticosteroids) or a primary tumor of the CNS
Have a medical condition that precludes participation (swallowing disorder, organ transplant, pregnant or nursing, HIV, active Hepatitis B or C, cardiac disease, history of major surgery in upper gastrointestinal (GI) tract or GI disease, hypokalemia, hypomagnesaemia or hypocalcaemia that cannot be controlled)",50 mg LY3295668 BID administered orally in 21-day cycles.,DrugBank:DB18019,LY3295668,Cc1cc(Nc2ccc(F)c(C[C@@]3(C(=O)O)CCN(Cc4cccc(Cl)c4F)[C@H](C)C3)n2)n[nH]1,,1.0,0.0,0.0,0.0,0.0,1.0,1.0,1.0,0.0,0.0,1.0,1.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT03093324,NCT03093324_EG000,No,All,Adult | Older Adult,Phase 3,253,"Key Inclusion Criteria:

Capable of understanding and complying with the protocol
Has a confirmed diagnosis of RRMS
Neurologically stable with no evidence of relapse within 30 days prior to randomization
Agrees to use an acceptable method of contraception for the duration of the study and for 30 days after any study drug administration, or is surgically sterile or post-menopausal

Key Exclusion Criteria:

Have any finding(s) that would compromise the safety of the subject, affect the subject's ability to adhere to the protocol visit schedule or to fulfill visit requirements, or would make the subject unsuitable for participation in the study
Diagnosis of primary progressive, secondary progressive, or progressive relapsing MS
History of clinically significant cardiovascular, pulmonary, GI, dermatologic, psychiatric, neurologic (other than MS), endocrine, renal, and/or other major disease that would preclude participation in a clinical trial
History of GI surgery (except appendectomy that occurred more than 6 months prior to screening
History of clinically significant recurring or active gastrointestinal symptoms (eg, nausea, diarrhea, dyspepsia, constipation) within 3 months of screening
Chronic use (7 days) of medical therapy to treat any GI symptoms within 1 month of screening Has a clinically significant medical condition or observed abnormality at screening
History of a myocardial infarction, including a silent myocardial infarction or unstable angina
History of clinically significant drug or alcohol abuse within the past year prior to screening
Clinically significant history of suicidal ideation or suicidal behavior in the last 12 months
Subject is pregnant or breastfeeding or plans to become pregnant or begin breastfeeding at any point during the study and for 30 days after any study drug administration
Prior use of Dimethyl Fumarate (DMF)

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.","Participants received ALKS 8700 231 milligrams (mg) along with ALKS 8700-matching placebo, oral capsules, twice daily (BID), for Week 1, followed by administration of ALKS 8700 462 mg, oral capsules, BID, for Week 2 to 5.",ChEMBL:CHEMBL3989944 | DrugBank:DB14783 | PubChem:73330464,DIROXIMEL FUMARATE,COC(=O)/C=C/C(=O)OCCN1C(=O)CCC1=O,L04AX09,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0
NCT03096353,NCT03096353_EG000,No,All,Adult,Early Phase 1,29,"-INCLUSION CRITERIA:

All subjects must be:

Between 18 and 50 years old.
Right-handed (on Edinburgh Handedness Inventory).
Fluent in English.
Able to provide written informed consent.

EXCLUSION CRITERIA:

Overall exclusion criteria for the study:

Unable to comply with study procedures (or does not rate stimuli as tolerable) or unable to schedule visits promptly (including inability to schedule the second session within approximately 14 days of the first session)
Pregnancy or breastfeeding.
Use of recreational drugs in the past month (e.g., marijuana, methylenedioxymethamphetamine (MDMA, 'ecstasy' or 'Molly'), Lysergic acid diethylamide (LSD), cocaine, methamphetamine, heroin, prescription and/or opioids).
Congenital lower limb deficiency or amputation.
Peripheral neuropathy, dermatological condition such as scars or burns, or has had a tattoo in the testing region within the previous four weeks that might influence cutaneous sensibility.
Women who consume more than 7 alcoholic beverages per week, and men who consume more than 14 drinks per week.
Current chronic pain condition or has had chronic pain in the past year (painful condition lasting more than six months), including ongoing treatment with medications for neuropathic pain (e.g. gabapentin, tricyclic antidepressants, pregabalin, tramadol)
Major medical condition, such as kidney, liver, cardiovascular (including blood clots, hypertension, preexisting cardiac arrhythmia), autonomic, pulmonary, or neurological problems (e.g., seizure disorder ) or a chronic systemic disease (e.g., diabetes).
Current diagnosis or pharmacological treatment of psychiatric disorders such as major depression, major anxiety-related problems, post-traumatic stress syndrome, bipolar disorder, psychosis, attention-deficit/hyperactivity disorder or current or lifetime alcohol or substance abuse disorders (as identified in study #16-AT-0077)
Participant has metal in his/her body which would make having an MRI scan unsafe, such as pacemakers, medication pumps, aneurysm clips, metallic prostheses (including metal pins and rods, heart valves or cochlear implants), shrapnel fragments, permanent eye liner or small metal fragments in the eye that welders and other metal workers may have.
Participant is uncomfortable in small closed spaces (has claustrophobia) so that he/she would feel uncomfortable in the MRI machine or cannot lie comfortably flat on his/her back for up to 75 minutes in the MRI scanner.
Participants weighs more than 550 lbs.
Participant has taken any pain medication other than an over-the-counter NSAIDs or acetaminophen within the last month or for more than one month on a continual basis within last six months.
Previous participation in 13-AT-0143 (related study).
NIH employees who are subordinates, relatives, or co-workers of the investigators, or NCCIH Division of Intramural Research (DIR) employees.
Participants using medications that play into opioid pathways (e.g. loperamide or dextromethorphan), that could potentially interact with naloxone (naltrexone, methylnaltrexone, droperidol, fenfluramine and clonidine)
Participant using any herbal supplements (such as yohimbine) due to risk of unknown dangerous interaction as there is no data for herbal preparations and naloxone.
Participant has allergies to naloxone or similar drugs.

EXCLUSION CRITERIA FOR INIDIVIDUAL STUDY SESSION:

Has consumed alcohol within 24 hours, shows signs of alcohol withdrawal syndrome, or has behavioral signs of intoxication will be excluded immediately and not have the possibility to reschedule their session.

Used topical pain-relieving creams in the testing area (e.g. methylsalicylate, capsaicin) within 24 hours of testing or used non-steroidal anti-inflammatory drugs (NSAIDS, e.g. aspirin, ibuprofen), acetaminophen, or naproxen within 3 days of testing*.

To be determined during the pre-session screening. Participants who cannot refrain from these activities may have their session rescheduled up to two times. If the participant is found non-compliant during the second rescheduled appointment, he or she will be excluded from the study.","During MRI session participant underwent sensory stimulus testing followed by bolus and infusion doses of naloxone (0.05 mg/kg bodyweight). When infusion levels reached stability, sensory testing was performed again.",ChEMBL:CHEMBL80 | DrugBank:DB01183 | PubChem:5284596,Naloxone,C=CCN1CC[C@]23c4c5ccc(O)c4O[C@H]2C(=O)CC[C@@]3(O)[C@H]1C5,A06AH04 | N02AA53 | N02AA55 | N02AX51 | V03AB15,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03108482,NCT03108482_EG001,No,All,Adult | Older Adult,Phase 3,183,"Inclusion Criteria:

Subject must have signed consent before study entry.
Subject must be at least 18 years old, scheduled to undergo primary unilateral first metatarsal osteotomy with internal fixation with no additional collateral procedure.

Male and female subjects are eligible. If female, subject must be either not of childbearing potential (defined as postmenopausal for at least 1 year or surgically sterile [bilateral tubal ligation, bilateral oophorectomy, or hysterectomy]) or practicing 1 of the following effective methods of birth control:

Hormonal methods such as oral, implantable, injectable, vaginal ring, or transdermal contraceptives.
Total abstinence from sexual intercourse since the last menses before study medication administration.
Intrauterine device
Double-barrier method (condoms, sponge, or diaphragm with spermicidal jellies or cream).

Women must use effective methods of birth control from 6 weeks before administration of study medication until 4 weeks after the last administration.

If female and of childbearing potential, subject must be non-lactating and non pregnant (has negative serum pregnancy test results at Screening and negative urine test on the day of surgery prior to surgery).
Subject must have a body weight of 45 kg or more and a body mass index (BMI) of 40 kg/m2 or less.
Subject must have a qualifying pain score of ≥5 and <9 on the 0-10 NPRS at rest as a result of turning off the popliteal sciatic block for bunionectomy to be eligible for randomization.
Subject must be in good physical health in the investigator's judgment.
Subject must be sufficiently alert to understand and communicate intelligibly with the study observer.

Exclusion Criteria:

Subject's Baseline pain is <5 or >9 on a 0-10 NPRS.
Subject received any analgesic medication other than short-acting pre-operative or intra-operative anesthetic agents before the end of bunionectomy surgical procedure. Subjects who received any analgesic medication immediately after the bunionectomy surgical procedure was completed and before study medication is administered will also be excluded, with the exception of ketorolac 30 mg intravenously supplemental analgesia during the continuous infusion period and up until 1:00 A.M.
Subject has a history of seizures or alcohol abuse (eg, drinks >4 units of alcohol per day, a unit being equal to 8 oz. beer, 3 oz. wine, 1 oz. spirits) within the past 5 years, has a history of prescription/illicit drug abuse within 6 months before dosing with study medication, or has positive results on the urine drug screen or alcohol breath test indicative of illicit drug or alcohol abuse.
Subject has a history of or positive test results for human immunodeficiency virus or hepatitis B or C.
Subject has an active malignancy of any type, or has been diagnosed with cancer within 5 years before Screening (excluding successfully treated squamous or basal cell carcinoma of the skin).
Subject is currently receiving anticoagulants (eg, heparin or warfarin) or antiplatelets (except aspirin ≤325 mg/day).
Subject has received a course of systemic (either oral or parenteral) or intra-articular corticosteroids within 3 months before Screening (inhaled nasal steroids and topical corticosteroids are allowed).
Subject has any ongoing condition, other than one associated with the current primary, unilateral, first metatarsal bunionectomy, that, in the investigator's opinion, could generate levels of pain sufficient to confound assessments of post-operative pain (eg, severe osteoarthritis of the target joint or extremity, fibromyalgia, rheumatoid arthritis, moderate to severe headache, diabetic foot pain or neuropathy).
Subject has been receiving or has received chronic (defined as daily use for >2 weeks) opioid (oral codeine, dextromoramide, dihydrocodeine, oxycodone, or morphine-like anti-tussive) therapy defined as >15 morphine equivalents units per day for more than 3 out of 7 days per week over a 1-month period within 12 months of surgery, or has been treated chronically with opioid analgesic (buprenorphine, nalbuphine, or pentazocine) or NSAIDs within 30 days before Screening.
Subject received a long-acting Non-Steroidal Anti-Inflammatory Drug (NSAID) within 4 days before initiation of study medication (except aspirin ≤325 mg/day), or a short-acting NSAID within 1 day.
Subject is under long-term treatment with opioid agonist-antagonists.
Subject has used drugs with enzyme-inducing properties, such as rifampicin and St. John's Wort, or any drug known to be a strong inhibitor or inducer of CYP3A4, CYP2C9, or CYP2D6 within 3 weeks before surgery.
Subject is pregnant or lactating.
Subject had any complication during primary bunionectomy surgery.
Subject has received monoamine oxidase inhibitors, tricyclic antidepressants, neuroleptics, or other drugs that reduce the seizure threshold within 4 weeks of study entry.
Subject has a history or evidence of a clinically significant (in the investigator's opinion) gastrointestinal (GI) event within 6 months before Screening or has any history of peptic or gastric ulcers or GI bleeding.
Subject has clinically significant renal or hepatic disease, as indicated by clinical laboratory assessment (results ≥3 times the upper limit of normal for any liver function test, including aspartate aminotransferase, alanine aminotransferase, bilirubin, and lactate dehydrogenase, or creatinine ≥1.5 times the upper limit of normal). Laboratory tests may be repeated once at Screening to rule out laboratory error.
Subject has any clinically significant laboratory or 12-lead electrocardiogram (ECG) finding at Screening that, in the opinion of the investigator, contraindicates study participation (eg, QTc >450 msec [male] or >470 msec [female]).
Subject has a known history of allergic reaction or clinically significant intolerance to acetaminophen, aspirin, opioids, or any NSAIDs; history of NSAID induced bronchospasm (subjects with the triad of asthma, nasal polyps, and chronic rhinitis are at greater risk for bronchospasm and should be considered carefully) or to the ingredients of the study medication, or any other drugs used in the study, including anesthetics and antibiotics that may be required on the day of surgery.
Subject has received anti-depressive medication with serotonin-norepinephrine reuptake inhibitors (SNRIs; milnacipran, duloxetine, venlafaxine), diet pills (including fenfluramine and phentermine) or methylphenidate (Ritalin®), or other similar medications for attention deficit hyperactivity disorder (ADHD) within 4 weeks of study entry. Subjects receiving selective serotonin reuptake inhibitors (SSRIs) may be included provided they have been on a stable dose for 60 days prior to study participation and plan to remain on that dose throughout the study.
Subject is at risk in terms of precautions, warnings, and contraindications in the package insert for Ultram® (tramadol hydrochloride) or Celebrex® (celecoxib).
Subject has a known coagulation disorder.
Subject has history of or current medical, surgical, post-surgical, or psychiatric condition that would confound interpretation of safety, tolerability, or efficacy, (eg, uncontrolled diabetes mellitus, uncontrolled hypertension, hemodynamic instability, or respiratory insufficiency, cancer or palliative care).
Subject received an experimental drug or used an experimental medical device within 30 days prior to Screening or has previously participated in this trial.
Subject is unable to comply with the requirements of the study or, in the investigator's opinion, should not participate in the study.","Tramadol: One tablet of 50 mg every 6 hours. The total daily dose was 200 mg of tramadol.

Tramadol (Ultram®): Tramadol: One immediate release oral over-encapsulated tablet of 50 mg, every 6 hours for 48 hours.",ChEMBL:CHEMBL1237044 | DrugBank:DB00193 | PubChem:33741,Tramadol,COc1cccc(C2(O)CCCCC2CN(C)C)c1,N02AJ13 | N02AJ14 | N02AJ16 | N02AX02,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03110354,NCT03110354_EG001,No,All,Adult | Older Adult,Phase 1,4,"Inclusion Criteria:

Has AML or ALL and failed any prior induction therapy regimen or have relapsed after prior therapy
Has Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Has adequate renal and hepatic function
Had at least 14 days for prior treatment to clear the body before initiation of DS-3201b administration (except for hydroxyurea that needs only 2 days for clearance)
Able to provide written informed consent, comply with protocol visits and procedures, be able to take oral medication, and not have any active infection or comorbidity that would interfere with therapy.
Agrees to use an adequate method of contraception during the study and until 3 months after the last treatment.
Is willing to provide bone marrow biopsies and comply with protocol-defined evaluations
Has a life expectancy of at least 3 months

Exclusion Criteria:

Has presence of central nervous system (CNS) involvement of leukemia or a history of CNS leukemia
Has a second concurrent active primary malignancy such as solid tumor or lymphoma under active treatment
Has refractory nausea and vomiting, malabsorption, biliary shunt, significant bowel resection, graft versus- host disease (GVHD) significantly affecting gut motility or absorption, or any other condition that would preclude adequate absorption of DS- 3201b in the opinion of the treating physician and/or principal investigator (PI)
Has an uncontrolled infection requiring intravenous antibiotics, antivirals, or antifungals, known human immunodeficiency virus infection, or tested positive for active hepatitis B or C infection
Has a concomitant medical condition that would increase the risk of toxicity, in the opinion of the Investigator or Sponsor
Has unresolved toxicities from previous anticancer therapy
Has received hematopoietic stem cell transplantation (HSCT) within 60 days of the first dose of DS-3201b
Has received concomitant treatment with a strong inhibitor or inducer of cytochrome P450 (CYP)3A4/5 within 7 days of first receipt of DS-3201b
Has consumed herbs/fruits that may have an influence on pharmacokinetics (PK) of DS-3201b from 3 days (14 days for St. John's wort) prior to the start of the study and throughout the entire study
Had major surgery within 4 weeks before study drug treatment
Has prolonged corrected QT interval by Fridericia's method (QTcF) at rest, where the mean QTcF interval is > 450 milliseconds (ms) based on triplicate electrocardiograms (ECGs)
Is pregnant or breastfeeding
Has substance abuse or medical, psychological, or social conditions that, in the opinion of the Investigator, may interfere with the subject's participation in the clinical study or evaluation of the clinical study results
Has received prior treatment with enhancer of zeste homolog (EZH) inhibitor",Participants who received 150 mg DS-3201b administered orally to participants with AML or ALL.,DrugBank:DB18314 | PubChem:126481870,Valemetostat,[H][C@]1([C@@]2(C)Oc3c(Cl)cc(C(=O)NCc4c(C)cc(C)[nH]c4=O)c(C)c3O2)CC[C@H](N(C)C)CC1,,1.0,1.0,0.0,0.0,0.0,1.0,1.0,1.0,0.0,0.0,1.0,1.0,1.0,1.0,1.0,0.0,1.0,0.0,1.0,0.0,1.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT03116841,NCT03116841_EG000,No,All,Adult | Older Adult,Phase 4,3,"Inclusion Criteria:

Participants who completed the initial treatment with PPIs (esomeprazole, omeprazole, rabeprazole, or lansoprazole) and have received high dose PPIs (esomeprazole 20 mg, omeprazole 20 mg, rabeprazole 10 mg, or lansoprazole 30 mg) for more than 8 weeks at the time of informed consent as maintenance treatment for LA Classification Grades A to D reflux esophagitis.
Participants who have heartburn and/or regurgitation.

Participants with reflux esophagitis related sleep disturbance, fulfilling at least one of following in a week before the baseline/start of administration.

Difficulty in falling asleep for > = 3 nights
Nocturnal awaking or early morning awaking for > = 3 nights
Participants whose heartburn and/or regurgitation at the time of informed consent were alleviated from initial treatment.
Participants with PSQI global score > = 6.0
Participants who, in the opinion of the investigator, are capable of understanding the content of the study and complying with the protocol requirements.
Participants who can sign and date an informed consent form and information sheet prior to the initiation of the study procedures.
Male or female participants aged 20 years or older at the time of informed consent.
Therapeutic category: Ambulatory

Exclusion Criteria:

Participants with Zollinger-Ellison syndrome.
Participants with diseases that affect sleep (chronic obstructive pulmonary disease, bronchitis asthma, sleep apnea syndrome, mental disorder, etc.)
Nightshift workers.
Participants who have a plan to travel beyond three time zones during the study.
Participants with a history of, concurrent, or suspicious functional dyspepsia or functional heartburn based on Rome IV criteria.
Participants with history of surgery or treatment affecting gastroesophageal reflux (fundoplication or dilation for esophageal stenosis [except for Schatzki's ring], etc.).
Participants with an esophagus-related complication (eosinophilic esophagitis, esophageal varices, scleroderma, viral or fungal infection, esophageal stenosis, etc.), a history of radiotherapy or cryotherapy of the esophagus, a caustic or physiochemical trauma (esophageal sclerotherapy, etc.). However, participants with Schatzki's ring (mucosal tissue ring around inferior esophageal sphincter) or Barrett's esophagus are allowed to be included.
Participants with a history of gastrectomy, gastrointestinal resection, or vagotomy.
Participants who took antidepressant agents or anti-anxiety agents within 8 weeks before the time of informed consent.
Participants who took H2 receptor antagonist within 8 weeks before the time of informed consent.
Participants planning to take prohibited concomitant medications during the study period.

Participants who have any of the following abnormal clinical laboratory test values at the screening (VISIT 1):

Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > upper limit of normal (ULN)
Bilirubin (Total bilirubin) > ULN
Participants with a malignant tumor.
Participants who are pregnant, breast-feeding, possibly pregnant, or planning to become pregnant.
Participants who have serious renal diseases.
Participants with the conditions listed under administration contraindication in the vonoprazan package insert.
Participants participating in other clinical studies.
Participants who have been determined as inappropriate participants by the investigator.","Vonoprazan 20 mg, orally, once daily, for up to 8 weeks.",ChEMBL:CHEMBL2079130 | DrugBank:DB11739 | PubChem:15981397,Vonoprazan,CNCc1cc(-c2ccccc2F)n(S(=O)(=O)c2cccnc2)c1,A02BC08 | A02BD14 | A02BD15,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03117140,NCT03117140_EG000,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 4,160,"Inclusion Criteria:

Patients who have or are:

Orthopedics service patients having shoulder surgery
ASA(American Society of Anesthesiologists) class I, II, or III.
Patients at least 18 years old but less than 71 years old.
Patients giving informed consent.

Non-Emergency Surgery

Exclusion Criteria:

Patients who have or are:

An inability to cooperate during the block placement.
Neuropathy of the planned extremity to block
Diabetes
Documented Kidney Disease
Documented Liver Disease
A lack of or inability to give informed consent.
Currently incarcerated.
Pregnant","Plain Ropivacaine 0.75%, (225 mg) total volume 32 cc for interscalene block given pre-operatively

Ropivacaine 0.75%: Only ropivacaine 0.75% is administered for this arm of the interscalene block",PubChem:53262281,Naropin,CCC[NH+]1CCCCC1C(=O)Nc1c(C)cccc1C.O.[Cl-],,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03117517,NCT03117517_EG000,No,Female,Adult,Early Phase 1,106,"Inclusion Criteria:

Clinically diagnosed patients of PCOS.
Must Swallow the tablet(s).
Must give informed consent.

Exclusion Criteria:

Women with cushing syndrome, hyperprolactinemia.
Late onset congenital adrenal hyperplasia, androgen-producing tumors, pregnancy.
Insulin dependent diabetes.
Thyroid disease.
Medications that alters the biochemical or hormonal profile.","Drug intervention: Metformin 500 mg tablet twice orally for 3 months

Metformin: Metformin (1000 mg)",ChEMBL:CHEMBL1431 | DrugBank:DB00331 | PubChem:4091,Metformin,CN(C)C(=N)NC(=N)N,A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03122860,NCT03122860_EG000,No,All,Adult | Older Adult,Phase 2,106,"Inclusion Criteria:

Ambulatory
Diagnosis of femorotibial OA in the target knee by standard American College of Rheumatology (ACR) criteria at screening (clinical AND radiographic criteria); OA of the knee is not to be secondary to any rheumatologic conditions (e.g., rheumatoid arthritis)
Pain compatible with OA of the knee(s) for at least 26 weeks prior to screening
Primary source of pain throughout the body is due to OA in the target knee
Willingness to use an electronic diary on a daily basis in the evening for the screening period and 24-week study duration
Negative drug test for opioids and drugs of abuse, except alcohol and marijuana, at screening
Subjects with depression or anxiety must be clinically stable for 12 weeks prior to screening, and, if on treatment for depression or anxiety, be on 12 weeks of stable therapy
Full understanding of the requirements of the study and willingness to comply with all study visits and assessments
Subjects must have read and understood the informed consent form, and must have signed it prior to any study-related procedure being performed

Exclusion Criteria:

Women who are pregnant, lactating, or have a positive pregnancy result at screening
Women of child bearing potential who are sexually active and are not willing to use a highly effective method of birth control during the study period
Males who are sexually active and have a partner who is capable of becoming pregnant, neither of whom have had surgery to become sterilized or whom are not using a highly effective method of birth control
Body mass index (BMI) > 35
Partial or complete joint replacement in either knee
Currently requires regular use of ambulatory assistive devices (e.g., wheelchair, parallel bars, walker, canes, or crutches) or use of a lower extremity prosthesis, and/or a structural knee brace
Previous participation in a Samumed clinical trial investigating SM04690
Any surgery (e.g., arthroscopy) in either knee within 26 weeks prior to screening
Any planned surgery during the study period
History of malignancy within the last 5 years; however, subjects with prior history of in situ cancer or basal or squamous cell skin cancer are eligible if completely excised. Subjects with other malignancies are eligible if they have been continuously disease free for at least 5 years prior to any study injection
Comorbid conditions that could affect study endpoint assessments of the target knee, including, but not limited to, rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus, gout or pseudogout, and fibromyalgia
Any diagnosed psychiatric condition that includes, but is not limited to, a history of mania, bipolar disorder, psychotic disorder, schizophrenia, schizoaffective disorder, major depressive disorder, or generalized anxiety disorder
Participation in a clinical research trial that included the receipt of an investigational product or any experimental therapeutic procedure, or an observational research trial related to osteoarthritis within 8 weeks prior to any study injection, or planned participation in any such trial
Treatment of the target knee with intra-articular glucocorticoids (e.g., methylprednisolone) within 12 weeks prior to screening
Any intra-articular injection into the target knee with a therapeutic aim including, but not limited to, viscosupplementation (e.g., hyaluronic acid), platelet-rich plasma (PRP), and stem cell therapies within 24 weeks prior to screening; treatment of the target knee with intra-articular glucocorticoids greater than 12 weeks prior to screening is allowed
Treatment with systemic glucocorticoids greater than 10 mg prednisone or the equivalent per day within 4 weeks prior to screening
Effusion of the target knee clinically requiring aspiration within 12 weeks prior to screening
Use of electrotherapy, acupuncture, and/or chiropractic treatments for knee OA within 4 weeks prior to screening
Any known active infections, including urinary tract infection, upper respiratory tract infection, sinusitis, suspicion of intra-articular infection, hepatitis B or hepatitis C infection, and/or infections that may compromise the immune system such as human immunodeficiency virus (HIV) at study start
Use of centrally acting analgesics (e.g., duloxetine) within 12 weeks prior to screening
Use of anticonvulsants within 12 weeks prior to screening, unless used for seizure or migraine prophylaxis
Subjects requiring the usage of opioids >1x per week within 12 weeks prior to screening
Use of topical local anesthetic agents (gels, creams, or patches such as the Lidoderm patch) for the treatment of knee OA within 7 days of screening",Single intra-articular injection of 0.03 mg SM04690 in 2 mL vehicle,ChEMBL:CHEMBL4297639 | DrugBank:DB14883 | PubChem:135565709,Adavivint,CC(C)CC(=O)Nc1cncc(-c2ccc3[nH]nc(-c4nc5c(-c6cccc(F)c6)cncc5[nH]4)c3c2)c1,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03122860,NCT03122860_EG001,No,All,Adult | Older Adult,Phase 2,104,"Inclusion Criteria:

Ambulatory
Diagnosis of femorotibial OA in the target knee by standard American College of Rheumatology (ACR) criteria at screening (clinical AND radiographic criteria); OA of the knee is not to be secondary to any rheumatologic conditions (e.g., rheumatoid arthritis)
Pain compatible with OA of the knee(s) for at least 26 weeks prior to screening
Primary source of pain throughout the body is due to OA in the target knee
Willingness to use an electronic diary on a daily basis in the evening for the screening period and 24-week study duration
Negative drug test for opioids and drugs of abuse, except alcohol and marijuana, at screening
Subjects with depression or anxiety must be clinically stable for 12 weeks prior to screening, and, if on treatment for depression or anxiety, be on 12 weeks of stable therapy
Full understanding of the requirements of the study and willingness to comply with all study visits and assessments
Subjects must have read and understood the informed consent form, and must have signed it prior to any study-related procedure being performed

Exclusion Criteria:

Women who are pregnant, lactating, or have a positive pregnancy result at screening
Women of child bearing potential who are sexually active and are not willing to use a highly effective method of birth control during the study period
Males who are sexually active and have a partner who is capable of becoming pregnant, neither of whom have had surgery to become sterilized or whom are not using a highly effective method of birth control
Body mass index (BMI) > 35
Partial or complete joint replacement in either knee
Currently requires regular use of ambulatory assistive devices (e.g., wheelchair, parallel bars, walker, canes, or crutches) or use of a lower extremity prosthesis, and/or a structural knee brace
Previous participation in a Samumed clinical trial investigating SM04690
Any surgery (e.g., arthroscopy) in either knee within 26 weeks prior to screening
Any planned surgery during the study period
History of malignancy within the last 5 years; however, subjects with prior history of in situ cancer or basal or squamous cell skin cancer are eligible if completely excised. Subjects with other malignancies are eligible if they have been continuously disease free for at least 5 years prior to any study injection
Comorbid conditions that could affect study endpoint assessments of the target knee, including, but not limited to, rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus, gout or pseudogout, and fibromyalgia
Any diagnosed psychiatric condition that includes, but is not limited to, a history of mania, bipolar disorder, psychotic disorder, schizophrenia, schizoaffective disorder, major depressive disorder, or generalized anxiety disorder
Participation in a clinical research trial that included the receipt of an investigational product or any experimental therapeutic procedure, or an observational research trial related to osteoarthritis within 8 weeks prior to any study injection, or planned participation in any such trial
Treatment of the target knee with intra-articular glucocorticoids (e.g., methylprednisolone) within 12 weeks prior to screening
Any intra-articular injection into the target knee with a therapeutic aim including, but not limited to, viscosupplementation (e.g., hyaluronic acid), platelet-rich plasma (PRP), and stem cell therapies within 24 weeks prior to screening; treatment of the target knee with intra-articular glucocorticoids greater than 12 weeks prior to screening is allowed
Treatment with systemic glucocorticoids greater than 10 mg prednisone or the equivalent per day within 4 weeks prior to screening
Effusion of the target knee clinically requiring aspiration within 12 weeks prior to screening
Use of electrotherapy, acupuncture, and/or chiropractic treatments for knee OA within 4 weeks prior to screening
Any known active infections, including urinary tract infection, upper respiratory tract infection, sinusitis, suspicion of intra-articular infection, hepatitis B or hepatitis C infection, and/or infections that may compromise the immune system such as human immunodeficiency virus (HIV) at study start
Use of centrally acting analgesics (e.g., duloxetine) within 12 weeks prior to screening
Use of anticonvulsants within 12 weeks prior to screening, unless used for seizure or migraine prophylaxis
Subjects requiring the usage of opioids >1x per week within 12 weeks prior to screening
Use of topical local anesthetic agents (gels, creams, or patches such as the Lidoderm patch) for the treatment of knee OA within 7 days of screening",Single intra-articular injection of 0.07 mg SM04690 in 2 mL vehicle,ChEMBL:CHEMBL4297639 | DrugBank:DB14883 | PubChem:135565709,Adavivint,CC(C)CC(=O)Nc1cncc(-c2ccc3[nH]nc(-c4nc5c(-c6cccc(F)c6)cncc5[nH]4)c3c2)c1,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03122860,NCT03122860_EG002,No,All,Adult | Older Adult,Phase 2,106,"Inclusion Criteria:

Ambulatory
Diagnosis of femorotibial OA in the target knee by standard American College of Rheumatology (ACR) criteria at screening (clinical AND radiographic criteria); OA of the knee is not to be secondary to any rheumatologic conditions (e.g., rheumatoid arthritis)
Pain compatible with OA of the knee(s) for at least 26 weeks prior to screening
Primary source of pain throughout the body is due to OA in the target knee
Willingness to use an electronic diary on a daily basis in the evening for the screening period and 24-week study duration
Negative drug test for opioids and drugs of abuse, except alcohol and marijuana, at screening
Subjects with depression or anxiety must be clinically stable for 12 weeks prior to screening, and, if on treatment for depression or anxiety, be on 12 weeks of stable therapy
Full understanding of the requirements of the study and willingness to comply with all study visits and assessments
Subjects must have read and understood the informed consent form, and must have signed it prior to any study-related procedure being performed

Exclusion Criteria:

Women who are pregnant, lactating, or have a positive pregnancy result at screening
Women of child bearing potential who are sexually active and are not willing to use a highly effective method of birth control during the study period
Males who are sexually active and have a partner who is capable of becoming pregnant, neither of whom have had surgery to become sterilized or whom are not using a highly effective method of birth control
Body mass index (BMI) > 35
Partial or complete joint replacement in either knee
Currently requires regular use of ambulatory assistive devices (e.g., wheelchair, parallel bars, walker, canes, or crutches) or use of a lower extremity prosthesis, and/or a structural knee brace
Previous participation in a Samumed clinical trial investigating SM04690
Any surgery (e.g., arthroscopy) in either knee within 26 weeks prior to screening
Any planned surgery during the study period
History of malignancy within the last 5 years; however, subjects with prior history of in situ cancer or basal or squamous cell skin cancer are eligible if completely excised. Subjects with other malignancies are eligible if they have been continuously disease free for at least 5 years prior to any study injection
Comorbid conditions that could affect study endpoint assessments of the target knee, including, but not limited to, rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus, gout or pseudogout, and fibromyalgia
Any diagnosed psychiatric condition that includes, but is not limited to, a history of mania, bipolar disorder, psychotic disorder, schizophrenia, schizoaffective disorder, major depressive disorder, or generalized anxiety disorder
Participation in a clinical research trial that included the receipt of an investigational product or any experimental therapeutic procedure, or an observational research trial related to osteoarthritis within 8 weeks prior to any study injection, or planned participation in any such trial
Treatment of the target knee with intra-articular glucocorticoids (e.g., methylprednisolone) within 12 weeks prior to screening
Any intra-articular injection into the target knee with a therapeutic aim including, but not limited to, viscosupplementation (e.g., hyaluronic acid), platelet-rich plasma (PRP), and stem cell therapies within 24 weeks prior to screening; treatment of the target knee with intra-articular glucocorticoids greater than 12 weeks prior to screening is allowed
Treatment with systemic glucocorticoids greater than 10 mg prednisone or the equivalent per day within 4 weeks prior to screening
Effusion of the target knee clinically requiring aspiration within 12 weeks prior to screening
Use of electrotherapy, acupuncture, and/or chiropractic treatments for knee OA within 4 weeks prior to screening
Any known active infections, including urinary tract infection, upper respiratory tract infection, sinusitis, suspicion of intra-articular infection, hepatitis B or hepatitis C infection, and/or infections that may compromise the immune system such as human immunodeficiency virus (HIV) at study start
Use of centrally acting analgesics (e.g., duloxetine) within 12 weeks prior to screening
Use of anticonvulsants within 12 weeks prior to screening, unless used for seizure or migraine prophylaxis
Subjects requiring the usage of opioids >1x per week within 12 weeks prior to screening
Use of topical local anesthetic agents (gels, creams, or patches such as the Lidoderm patch) for the treatment of knee OA within 7 days of screening",Single intra-articular injection of 0.15 mg SM04690 in 2 mL vehicle,ChEMBL:CHEMBL4297639 | DrugBank:DB14883 | PubChem:135565709,Adavivint,CC(C)CC(=O)Nc1cncc(-c2ccc3[nH]nc(-c4nc5c(-c6cccc(F)c6)cncc5[nH]4)c3c2)c1,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03122860,NCT03122860_EG003,No,All,Adult | Older Adult,Phase 2,106,"Inclusion Criteria:

Ambulatory
Diagnosis of femorotibial OA in the target knee by standard American College of Rheumatology (ACR) criteria at screening (clinical AND radiographic criteria); OA of the knee is not to be secondary to any rheumatologic conditions (e.g., rheumatoid arthritis)
Pain compatible with OA of the knee(s) for at least 26 weeks prior to screening
Primary source of pain throughout the body is due to OA in the target knee
Willingness to use an electronic diary on a daily basis in the evening for the screening period and 24-week study duration
Negative drug test for opioids and drugs of abuse, except alcohol and marijuana, at screening
Subjects with depression or anxiety must be clinically stable for 12 weeks prior to screening, and, if on treatment for depression or anxiety, be on 12 weeks of stable therapy
Full understanding of the requirements of the study and willingness to comply with all study visits and assessments
Subjects must have read and understood the informed consent form, and must have signed it prior to any study-related procedure being performed

Exclusion Criteria:

Women who are pregnant, lactating, or have a positive pregnancy result at screening
Women of child bearing potential who are sexually active and are not willing to use a highly effective method of birth control during the study period
Males who are sexually active and have a partner who is capable of becoming pregnant, neither of whom have had surgery to become sterilized or whom are not using a highly effective method of birth control
Body mass index (BMI) > 35
Partial or complete joint replacement in either knee
Currently requires regular use of ambulatory assistive devices (e.g., wheelchair, parallel bars, walker, canes, or crutches) or use of a lower extremity prosthesis, and/or a structural knee brace
Previous participation in a Samumed clinical trial investigating SM04690
Any surgery (e.g., arthroscopy) in either knee within 26 weeks prior to screening
Any planned surgery during the study period
History of malignancy within the last 5 years; however, subjects with prior history of in situ cancer or basal or squamous cell skin cancer are eligible if completely excised. Subjects with other malignancies are eligible if they have been continuously disease free for at least 5 years prior to any study injection
Comorbid conditions that could affect study endpoint assessments of the target knee, including, but not limited to, rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus, gout or pseudogout, and fibromyalgia
Any diagnosed psychiatric condition that includes, but is not limited to, a history of mania, bipolar disorder, psychotic disorder, schizophrenia, schizoaffective disorder, major depressive disorder, or generalized anxiety disorder
Participation in a clinical research trial that included the receipt of an investigational product or any experimental therapeutic procedure, or an observational research trial related to osteoarthritis within 8 weeks prior to any study injection, or planned participation in any such trial
Treatment of the target knee with intra-articular glucocorticoids (e.g., methylprednisolone) within 12 weeks prior to screening
Any intra-articular injection into the target knee with a therapeutic aim including, but not limited to, viscosupplementation (e.g., hyaluronic acid), platelet-rich plasma (PRP), and stem cell therapies within 24 weeks prior to screening; treatment of the target knee with intra-articular glucocorticoids greater than 12 weeks prior to screening is allowed
Treatment with systemic glucocorticoids greater than 10 mg prednisone or the equivalent per day within 4 weeks prior to screening
Effusion of the target knee clinically requiring aspiration within 12 weeks prior to screening
Use of electrotherapy, acupuncture, and/or chiropractic treatments for knee OA within 4 weeks prior to screening
Any known active infections, including urinary tract infection, upper respiratory tract infection, sinusitis, suspicion of intra-articular infection, hepatitis B or hepatitis C infection, and/or infections that may compromise the immune system such as human immunodeficiency virus (HIV) at study start
Use of centrally acting analgesics (e.g., duloxetine) within 12 weeks prior to screening
Use of anticonvulsants within 12 weeks prior to screening, unless used for seizure or migraine prophylaxis
Subjects requiring the usage of opioids >1x per week within 12 weeks prior to screening
Use of topical local anesthetic agents (gels, creams, or patches such as the Lidoderm patch) for the treatment of knee OA within 7 days of screening",Single intra-articular injection of 0.23 mg SM04690 in 2 mL vehicle,ChEMBL:CHEMBL4297639 | DrugBank:DB14883 | PubChem:135565709,Adavivint,CC(C)CC(=O)Nc1cncc(-c2ccc3[nH]nc(-c4nc5c(-c6cccc(F)c6)cncc5[nH]4)c3c2)c1,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03131713,NCT03131713_EG001,No,All,Adult | Older Adult,Phase 3,101,"Inclusion Criteria:

Adult patients undergoing Mohs micrographic surgery for non-melanoma skin cancers (basal cell carcinoma and squamous cell carcinoma)

Exclusion Criteria:

history of liver transplant, hepatitis, or cirrhosis, those required to be NPO for subsequent closure by other surgical specialties, or those with known allergy to acetaminophen","The intervention group, in addition to usual care, will receive Acetaminophen 1000mg and commercially available carbohydrate drink (two pouches of Gatorade Prime Sports Fuel drink containing 50gm carbohydrate in approximately 250ml fluid total) at the beginning of the surgery.

Acetaminophen: Acetaminophen 1000mg",ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03134703,NCT03134703_EG000,No,All,Child,Phase 2,11,"Methadone Treatment Group:

Inclusion criteria:

Baby is diagnosed with neonatal abstinence syndrome;
Mother under the care of Operation PAR;
Mother resides in Pinellas or Pasco county at the time of enrollment and is expected to throughout the infant's methadone treatment period;
Mother has been deemed by PAR officials as being compliant with the detoxification program;
Mother has completed induction methadone treatment and has had no changes in medication dosage of 10% or greater in the two weeks preceding delivery;
Mother has been prescreened and deemed adequate candidate by the demonstration project team members;
No known concerns from Florida Department of Children and Families regarding the infant's ability to return to the home;
Newborns ≥ 37 0/7 weeks gestation;
Newborns transferred to JHACH within 72 hours from birth;
Newborns ≥ 2.5 kg weight at birth;
Informed parental consent.

Exclusion Criteria:

Major congenital anomalies;
Major concomitant medical illness including planned antibiotic treatment for greater than 3 days or NPO status;
Infants who are being placed for adoption;
Infants in significant pain requiring narcotic medication for comfort (for example those with a fracture);
Infants whose maternal UDS at the time of delivery is positive for any other drug of abuse beside opiates.
Mother with hearing or language impairment

Comparison Group:

Inclusion Criteria:

Baby is diagnosed with neonatal abstinence syndrome;
Newborns ≥ 37 0/7 weeks gestation;
Newborns transferred to JHACH within 72 hours from birth;
Newborns ≥ 2.5 kg weight at birth;
Informed parental consent.

Exclusion Criteria:

Infant not requiring pharmacologic treatment for NAS;
Major congenital anomalies;
Major concomitant medical illness including planned antibiotic treatment for greater than 3 days or NPO status;
Infants who are being placed for adoption;
Infants in significant pain requiring narcotic medication for comfort (for example those with a fracture);
Mother with hearing or language impairment;
Infants known upon admission who will be placed into state custody or sheltered.","NAS infants treated for withdrawal symptoms with methadone

Methadone: Infants in the Methadone Treatment Group will receive the study drug, methadone, instead of morphine to treat withdrawal symptoms from Neonatal Abstinence Syndrome (NAS)",ChEMBL:CHEMBL350719 | ChEMBL:CHEMBL651 | DrugBank:DB00333 | DrugBank:DB15198 | PubChem:4095 | PubChem:643985,Methadone,CCC(=O)C(CC(C)N(C)C)(c1ccccc1)c1ccccc1,N02AC52 | N07BC02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03137537,NCT03137537_EG000,No,All,Adult | Older Adult,Phase 2,12,"Inclusion Criteria:

Survivors of mediastinal lymphoma (either Non-Hodgkin's Lymphoma or Hodgkin's Lymphoma) with no active malignancy
Prior mediastinal or mantle radiation ≥ 5 years prior to enrollment in the study
Age 18-80 years.

Participants must have normal organ function as defined below:

AST(SGOT)/ALT(SGPT) ≤2.5 × institutional upper limit of normal
creatinine clearance ≥ 15 mL/min/1.73 m2 for participants with creatinine levels above institutional normal.
Normal sinus rhythm with resting heart rate ≥ 80 bpm on screening EKG
Based on findings in animals, ivabradine may cause fetal harm when administered to a pregnant woman. For this reason, women of child-bearing potential must agree to use adequate contraception.
Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

Participants who are receiving any other investigational agents.
History of allergic reaction to ivabradine.
Participants receiving any medications or substances that are inhibitors or inducers of cytochrome P450 3A4 are ineligible.
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, acute coronary syndrome, symptomatic known coronary artery disease, severe valvular heart disease, active malignancy, or psychiatric illness/social situations that would limit compliance with study requirements.
Pregnant women are excluded from this study because ivabradine is an agent with the potential for teratogenic effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with ivabradine, breastfeeding should be discontinued if the mother is treated with ivabradine.
HIV-positive participants on combination antiretroviral therapy.
Patients with systolic blood pressure < 90 mm Hg.
Patients with sick-sinus syndrome, sino-atrial block, third degree heart block, atrial fibrillation, and those with permanent pacemakers.
Patients with other established indications for ivabradine: stable, symptomatic chronic HF with a left ventricular ejection fraction ≤ 35% and in sinus rhythm with a resting HR ≥ 70 bpm, who are taking maximally tolerated doses of beta-blockers or have contraindications to beta-blocker use.
Patients with severe hepatic dysfunction (Child Pugh Class C).
Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.","Ivabradine will be administered for a total of 6 weeks
Ivabradine is taken orally twice daily
Dosage will be adjusted according to physician determination

Ivabradine: lower heart rate in heart failure patients.",ChEMBL:CHEMBL471737 | DrugBank:DB09083 | PubChem:132999,Ivabradine,COc1cc2c(cc1OC)CC(=O)N(CCCN(C)C[C@H]1Cc3cc(OC)c(OC)cc31)CC2,C01EB17 | C07FX05 | C07FX06,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03139240,NCT03139240_EG000,Accepts Healthy Volunteers,Female,Adult,Phase 4,86,"Inclusion Criteria:

Aged 18 years or older
Seeking elective medical abortion
In good health
Pregnancy with intrauterine gestational sac up to 10 0/7 weeks, dated by ultrasound
Able and willing to receive text messages via phone
Literate in English
Able and willing to give informed consent and agree to the study terms
Have assistance at home; no motor vehicle use while taking study medications

Exclusion Criteria:

Lack of access to cell phone and texting capabilities
Early pregnancy failure
Contraindications to the study medications: Oxycodone, Ibuprofen
Contraindications to medical abortion with Mifepristone or Misoprostol
History of methadone or heroin use
Used alcohol in the past 24 hours
Used marijuana >4 times per week
Any opioid in the past 30 days
Using additional pain medications","Oxycodone 10mg oral: Oxycodone 10mg oral given for pain control in addition to standard of care medications in women undergoing medical abortion

Women with a gestational age <7 weeks and women with a gestational age 7-10w0d randomized to oxycodone 10mg oral",ChEMBL:CHEMBL656 | DrugBank:DB00497 | PubChem:5284603,Oxycodone,COc1ccc2c3c1O[C@H]1C(=O)CC[C@@]4(O)[C@@H](C2)N(C)CC[C@]314,N02AA05 | N02AA55 | N02AA56 | N02AJ17 | N02AJ18 | N02AJ19,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03173456,NCT03173456_EG003,No,All,Adult,Phase 2,600,"Inclusion Criteria:

Patients ages 21 through 64 years of age
Complaint of acute musculoskeletal pain in one or more extremity, defined as distal to and including the shoulder or hip joints.
Pain of less than seven days duration
Patient speaks Spanish or English
The clinician plans to treat the patient in the ED with oral analgesics and is willing to treat the patient with opioid analgesics or up to 800 mg ibuprofen and 1000 mg acetaminophen
Patient is going to receive imaging of the painful extremity
Clinician judges patient to have capacity to provide informed consent

Exclusion Criteria:

Patient does not have cell phone or cannot receive a verification phone call on their cell phone while in the ED
Any use of methadone currently or previously
Chronic condition requiring frequent pain management such as arthritis, sickle cell disease, fibromyalgia, or any neuropathy
History of an adverse reaction to any of the study medications
Opioids taken in the past 24 hours
Ibuprofen or acetaminophen taken in past 24 hours
Any other prescribed or over the counter topical or oral analgesics taken in past 24 hrs
Pregnancy by either urine or serum human chorionic gonadotropin testing
Breastfeeding per patient report
History of peptic ulcer disease
Medical condition that might affect metabolism of opioid analgesics, acetaminophen, or ibuprofen such as hepatitis, renal insufficiency, hypo- or hyperthyroidism, Addison's, or Cushing's disease
Lacerations,
Multiple injuries
Taking any medicine that might interact with one of the study medications, such as antidepressant SSRI's or tricyclics, antipsychotics, anti-malaria medications quinidine or halofantrine, amiodarone or dronedarone, diphenhydramine, celecoxib, ranitidine, cimetidine, ritonavir, terbinafine, or St John's Wort","5 mg hydrocodone + 300 mg acetaminophen

hydrocodone/APAP: Hydrocodone/Acetaminophen 5 Mg-300 Mg oral tablet",ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03176953,NCT03176953_EG000,No,All,Adult | Older Adult,Phase 2 | Phase 3,50,"Inclusion Criteria:

Veterans of the U.S. military and/or Reserve/National Guard members,
at least 18 years of age,
survivors of a psychological trauma meeting DSM-5 criterion A, and are at least one month post-trauma,
have current DSM-5 diagnoses of AUD and PTSD based on semi-structured diagnostic interviews,
have at least 20 days of heavy drinking (>= 5 drinks/day for men and >= 4/drinks per day for women) in the last 90 days spent in a non-restricted environment and meet criteria for heavy drinking at least 4 days in the last 30 days prior to screening,
are not currently receiving trauma-focused psychotherapy,
are literate in English and intend to stay in the San Diego area during the study,
are willing to attend psychotherapy, medication, and assessment sessions,
trying or planning to try to cut down on or abstain from alcohol,
for females of childbearing potential, agree to use an approved form of contraception for the duration of the study, including hormonal contraceptives (e.g., oral contraceptives or implantable devices), intrauterine device (IUD), or double barrier methods (e.g., diaphragm with spermicidal condom); barrier method is preferred as topiramate may make birth control less effective,
Individuals with clinically significant renal disease and/or impaired renal function, as defined by clinically significant elevation of blood urea nitrogen (BUN) or creatinine or an estimated creatinine clearance of < 60 mL/min, can be included with physician approval, however the dosing schedule and maximum dose will be adjusted in accordance with FDA prescribing guidelines,
if individual is on another addiction medication, they should be on a stable approved addiction medication dose (at least two weeks before starting study drug) throughout the study,
are capable of giving informed consent.

Exclusion Criteria:

Subjects known to have clinically significant unstable medical or psychiatric conditions, where participation is deemed by investigators and study physicians to be risky, including but not limited to:

AST and/or ALT >5 times the upper limit of the normal range and/or an increased serum bilirubin >2 times the upper limit of normal.
Seizure disorders
have been treated with Topiramate for any reason in the past and discontinued the drug due to hypersensitivity reaction
in the opinion of the investigator, should not be enrolled because of the precautions, warnings, or contraindications listed on the Topiramate package insert, (e.g., certain types of glaucoma),
are pregnant, lactating, or plan to become pregnant during the period of participation in the study
in the judgment of the investigator, represent a significant risk of suicidal or homicidal behavior","psychotherapy plus active medication

topiramate: active medication

prolonged exposure: psychotherapy",ChEMBL:CHEMBL220492 | DrugBank:DB00273 | PubChem:5284627,Topiramate,[H][C@@]12OC(C)(C)O[C@]1([H])CO[C@@]1(COS(N)(=O)=O)OC(C)(C)O[C@]12[H],A08AA51 | N03AX11,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT03178942,NCT03178942_EG000,No,All,Child | Adult | Older Adult,Phase 3,129,"Inclusion Criteria:

Male or non-pregnant, non-lactating female, 2 years of age or older.
If female and of childbearing potential, prepared to abstain from sexual intercourse or use a reliable method of contraception during the study (e.g., double barrier methods, intrauterine device (IUD), oral, transdermal or injected hormonal contraceptives). Female patients using hormonal contraceptives should have been on the same product/dosing regimen for at least 28 days before baseline and should not change this regimen during the study.
Signed informed consent that meets all criteria of current FDA and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) regulations. For patients who are considered minors in the state the study is being conducted (< 18 years in most states) the parent or legal guardian should sign the consent form and the child will be required to sign a patient ""assent"" form, as appropriate. Patients 11-17 years of age will read and sign an Independent Review Board (IRB)-approved assent form and patients 6-10 years of age will provide verbal assent. Patients 2-5 years of age will be exempt from providing assent based on the child's comprehension and cognitive skills.
Clinical diagnosis of active scabies by presence of a burrow and/or typical scabietic lesions at the classic sites of infestation.
Parasitological confirmation of clinical diagnosis with demonstration under light microscope of mites and/or their products (larvae, eggs or fecal material).
Symptom score of 2 or 3 on a 4-point rating scale of 0-3 for nocturnal itching/pruritus.
Ability to apply or have study product applied as directed. If patient is a child, then parent/guardian will apply study product to him/her.

Exclusion Criteria:

Patients who are pregnant, lactating, or planning to become pregnant during the study.
Any systemic or dermatologic disorder that, in the opinion of the Investigator, will interfere with the study results or increase the risk of adverse events (AEs).
Known hypersensitivity to permethrin cream or any of its components.
Use of any systemic or topical acaricide or ectoparasiticide within one month before Screening.
Patient has signs of a systemic infection or is receiving systemic therapy for an infectious disease.
Patients with severe cutaneous bacterial or fungal infections requiring therapy (including systemic and topical antibiotics) or coexisting dermatological disorder that could interfere with the diagnosis and subsequent monitoring of scabies) or heavily crusted with lesions consistent with Norwegian scabies.
Patients with an underlying immunodeficient state (including prolonged treatment with corticosteroids), immunosuppressive disorders requiring therapy, severe systemic disease and history of HIV infection.
Any condition, medical, psychological, or social, that, in the Investigator's opinion, would interfere with participation in the study.
Family members of employees of the clinic or Investigator.
Patients who, in the opinion of the Investigator, would be non-compliant with the requirements of the study protocol.
Patients whose close personal contacts will not or are not willing to comply with standard of care for Scabies management.
Receipt of any drug as part of a research study within 30 days before Screening.
History of seizures.
Use of systemic corticosteroids within two weeks before Screening.
Use of topical corticosteroids within one week before Screening.
Previous participation in this study.","Reference: Elimite™ Cream (permethrin) 5% (Prestium Pharma, Inc.)

Elimite™ Cream (permethrin) 5%: Permethrin Cream 5%",ChEMBL:CHEMBL1525 | DrugBank:DB04930 | PubChem:40326 | PubChem:62086,Permethrin,CC1(C)C(C=C(Cl)Cl)C1C(=O)OCc1cccc(Oc2ccccc2)c1,P03AC04 | P03AC54,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03180619,NCT03180619_EG000,No,All,Adult | Older Adult,Phase 2,78,"Key Inclusion Criteria:

All Participants (Parts A and B):

Adult male or non-pregnant female individuals
Documented evidence of chronic HBV infection
Alanine aminotransferase (ALT) ≤ 10 × upper limit of normal (ULN)

Part A Only (renal impairment):

Maintained on TDF and/or other OAV treatment(s) for CHB for at least 48 weeks and with viral suppression (HBV deoxyribonucleic acid [DNA] < lower limit of quantitation [LLOQ]) for ≥ 6 months prior to screening

All individuals must have HBV DNA < 20 International units per milliliter (IU/mL) at screening by central laboratory
Both Hepatitis B e-Antigen (HBeAg) positive and negative individuals are eligible to participate
Moderate renal impairment (30 milliliters per minute [mL/min] ≤ estimated glomerular filtration rate by the cockcroft-gault formula [eGFRcg] ≤ 59 mL/min), severe renal impairment (15 mL/min ≤ eGFRcg < 30 mL/min) or end stage renal disease (ESRD) (eGFR < 15 mL/min) maintained on hemodialysis (HD)
Stable renal function (for participants with moderate or severe impairment): serum creatinine measured at least once within three months prior to screening. The measurement difference between the value measured within three months prior to screening versus the screening value must be ≤ 25% of the screening value

Part B Only (hepatic impairment):

Maintained on TDF and/or other OAV(s) for CHB for at least 48 weeks and with viral suppression (HBV DNA < LLOQ) for ≥ 6 months prior to screening

All individuals must have HBV DNA < 20 IU/mL at screening by central laboratory
Both HBeAg positive and negative individuals are eligible to participate
Child-pugh-turcotte (CPT) score of 7-12 (inclusive) OR a past history of CPT score ≥ 7 and any CPT score ≤ 12 at screening
eGFRCG ≥ 30 mL/min using the Cockcroft-Gault equation

Key Exclusion Criteria:

All Individuals (Parts A & B):

Women who are breastfeeding or who believe they may wish to become pregnant during the course of the study
Males and females of reproductive potential who are unwilling to use an ""effective"", protocol-specified method(s) of contraception during the study
Co-infection with hepatitis C virus (HCV), human immunodeficiency virus (HIV), or hepatitis D virus (HDV)
Prior Interferon (IFN) use within 6 months of screening
Evidence of hepatocellular carcinoma
Received solid organ or bone marrow transplant
Significant cardiovascular, pulmonary, or neurological disease
Malignancy within 5 years prior to screening, with the exception of specific cancers that are cured by surgical resection (basal cell skin cancer, etc.). Individuals under evaluation for possible malignancy are not eligible
Currently receiving therapy with immunomodulators (e.g. corticosteroids), nephrotoxic agents, or agents capable of modifying renal excretion
Known hypersensitivity to study drugs, metabolites, or formulation excipients
Current alcohol or substance abuse judged by the investigator to potentially interfere with individual's compliance
Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the individual unsuitable for the study or unable to comply with dosing requirements.

Part A Only (Renal Impairment):

Current or historical evidence of clinical hepatic decompensation (e.g., ascites, encephalopathy or variceal hemorrhage)

Abnormal hematological and biochemical parameters, including:

Hemoglobin < 9 grams per deciliter (g/dL)
Absolute neutrophil count < 750/cubic millimeter (mm^3)
Platelets ≤ 50,000/mm^3
Aspartate aminotransferase (AST) > 10 × ULN
Albumin < 3.0 g/dL
Total bilirubin > 2.5 × ULN
International normalized ratio of prothrombin time (INR) > 1.5 × ULN (unless stable on anticoagulant regimen)
Individuals with ESRD (i.e. eGFRcg < 15 mL/min) not on HD, or those on other forms of renal replacement therapy (i.e. peritoneal dialysis)

Part B Only (Hepatic Impairment):

Active variceal bleeding within 6 months or prior placement of a portosystemic shunt (such as transjugular intrahepatic portosystemic shunt [TIPS])
History of hepatorenal syndrome, hepatopulmonary syndrome, Grade 3 or Grade 4 hepatic encephalopathy, or spontaneous bacterial peritonitis within 6 months of screening
Grade 2 hepatic encephalopathy at screening
Model for end-stage liver disease (MELD) score ≥ 30

Abnormal hematological and biochemical parameters, including

Absolute neutrophil count < 750/mm^3
Platelets < 30,000/mm^3
Hemoglobin < 8.0 g/dL

Note: Other protocol defined Inclusion/Exclusion criteria may apply.","Participants with CHB and moderate or severe renal impairment who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or other OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.",ChEMBL:CHEMBL1534 | DrugBank:DB00140 | PubChem:493570,Riboflavin,Cc1cc2nc3c(=O)[nH]c(=O)nc-3n(C[C@H](O)[C@H](O)[C@H](O)CO)c2cc1C,A11HA04 | S01XA26,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,1.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT03182725,NCT03182725_EG001,No,All,Adult | Older Adult,Phase 3,37,"Inclusion Criteria:

Subjects aged 18-65.
Subjects must have POTS diagnosis (Hyperadrenergic Subtype with NE> 600pg/ml))
Subjects with no structural heart disease
Subject with no arrhythmias
Subjects with norepinephrine levels greater than 600 pg/ml
Subjects with normal CBC, Metabolic, and thyroid levels

Exclusion Criteria:

Thyroid or adrenal disorders
Drugs that interfere with Ivabradine (example: Cytochrome P450 drugs)
Presentation of peripheral edema and discolored toes with peripheral autonomic neuropathy. Symptoms include: legs (reduced hair growth, cramps), toes (blue color), legs/feet (wounds, ulcers that do not heal), and muscles (numbness, heaviness)
Subjects who have had a history of systemic illnesses (acute or chronic infectious); autoimmune/ inflammatory disease, cancer, COPD, anemia, diabetes, or psychiatric illness
Subjects with resting heart rate< 60beats/min, atrial fibrillation, advanced AV blocks, sinus disease, and acute decompensated heart failure and severe hepatic impairment.
Smokers or alcohol abuse
Pregnant or breastfeeding mothers
Woman of childbearing potential who are unwilling to use highly effective contraception during treatment and for an additional one month after discontinuing the study drug","Patient will consume one dose of Ivabradine twice a day for one month.

Ivabradine: Ivabradine is prescribed for treatment of chronic heart failure through inhibition of the f-channels (If) within the sinoatrial node.",ChEMBL:CHEMBL471737 | DrugBank:DB09083 | PubChem:132999,Ivabradine,COc1cc2c(cc1OC)CC(=O)N(CCCN(C)C[C@H]1Cc3cc(OC)c(OC)cc31)CC2,C01EB17 | C07FX05 | C07FX06,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03196076,NCT03196076_EG000,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 2,25,"Inclusion Criteria:

To be eligible for the present study, patients must meet the following criteria:

Able to provide written informed consent
Willing to comply with protocol requirements
At least 18 years of age
Have kidney disease, defined as either chronic kidney disease (CKD) II-V, determined by estimated glomerular filtration rate (GFR) of <90 and derived from serum creatinine measurements, or albuminuria/proteinuria, determined by albumin to creatinine ratio or protein to creatinine ratio of >30mg/gm within 3 months of recruitment, or on dialysis or having received a kidney transplant or have biopsy proven kidney disease. In these latter cases, blood and urine tests are not necessary.
Have at least one kidney lesion identified but incompletely characterized on a non-contrasted US, CT, or MR exam for which the patient's provider recommends follow-up studies or further evaluation with additional imaging test(s).

Exclusion Criteria:

Patients who meet any of the following criteria will be excluded for enrollment:

Critically ill or medically unstable and whose critical course during the observation period would be unpredictable (e.g., chronic obstructive pulmonary disease (COPD) requiring oxygen)
Known hypersensitivity to sulfur hexafluoride or to any component of perflutren lipid (Definity®)
Right to left shunt, severe pulmonary hypertension (Pulmonary artery pressure >90mmHg), or adult respiratory distress syndrome

Active cardiac disease including any of the following:

Severe congestive heart failure (class IV in accordance with the classification of the New York Heart Association)
Unstable angina
Severe arrhythmia (i.e., ventricular tachycardia, flutter fibrillation; ventricular premature complexes occurring close to the preceding T-wave, multifocal complexes)
Myocardial infarction within 14 days prior to the date of proposed Definity® administration
Uncontrolled systemic hypertension (systolic blood pressure (BP)>180 mm Hg and/or diastolic BP>100 mm Hg despite optimal medical management)
Is in an intensive care setting
Has an unstable neurological disease (e.g., cerebrovascular accident (including transient ischemic attacks (TIAs) within the 3 months before signing of informed consent
Has undergone an invasive procedure on kidney lesion (e.g., tissue biopsy, surgery, nonsurgical cytoreductive procedure) since identification of lesion via US without contrast

Has any other medical condition or other circumstances that would significantly decrease the chances of obtaining reliable data or of achieving the study objectives such as:

Mental illness
Drug abuse
Female patient who is pregnant or lactating (the possibility of pregnancy has to be excluded by negative point of care (POC), serum or urine beta-human chorionic gonadotropin (Β-HCG) results, obtained within 24 hours before the perflutren lipid administration, or on the basis of patient history, e.g., tubal ligation, hysterectomy or a minimum of 1 year without menses)
Obesity that limits obtainment of acceptable images","Healthy subjects will be imaged using contrast-enhanced ultrasound (perflutren) for image optimization prior to enrolling clinical patients.

Perflutren Lipid microsphere: Perflutren will be administered in a bolus or continuous infusion using the dosing range and administration type within the perflutren prescribing information.Once perflutren lipid has been administered, the transducer is maintained in a constant position over the area of interest to show the target lesion in order to assess the enhancement pattern during the early, mid and late vascular phases. Images will also be taken of kidney parenchyma in a suitable longitudinal plane.If there are multiple lesions in one subject requiring a second dose, the subject will have the option to undergo a 2nd contrast-enhanced study 30-minutes after the initial contrast dose, per dosing instructions in the package insert.",ChEMBL:CHEMBL1663 | DrugBank:DB00556 | PubChem:6432,Perflutren,FC(F)(F)C(F)(F)C(F)(F)F,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03196076,NCT03196076_EG001,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 2,25,"Inclusion Criteria:

To be eligible for the present study, patients must meet the following criteria:

Able to provide written informed consent
Willing to comply with protocol requirements
At least 18 years of age
Have kidney disease, defined as either chronic kidney disease (CKD) II-V, determined by estimated glomerular filtration rate (GFR) of <90 and derived from serum creatinine measurements, or albuminuria/proteinuria, determined by albumin to creatinine ratio or protein to creatinine ratio of >30mg/gm within 3 months of recruitment, or on dialysis or having received a kidney transplant or have biopsy proven kidney disease. In these latter cases, blood and urine tests are not necessary.
Have at least one kidney lesion identified but incompletely characterized on a non-contrasted US, CT, or MR exam for which the patient's provider recommends follow-up studies or further evaluation with additional imaging test(s).

Exclusion Criteria:

Patients who meet any of the following criteria will be excluded for enrollment:

Critically ill or medically unstable and whose critical course during the observation period would be unpredictable (e.g., chronic obstructive pulmonary disease (COPD) requiring oxygen)
Known hypersensitivity to sulfur hexafluoride or to any component of perflutren lipid (Definity®)
Right to left shunt, severe pulmonary hypertension (Pulmonary artery pressure >90mmHg), or adult respiratory distress syndrome

Active cardiac disease including any of the following:

Severe congestive heart failure (class IV in accordance with the classification of the New York Heart Association)
Unstable angina
Severe arrhythmia (i.e., ventricular tachycardia, flutter fibrillation; ventricular premature complexes occurring close to the preceding T-wave, multifocal complexes)
Myocardial infarction within 14 days prior to the date of proposed Definity® administration
Uncontrolled systemic hypertension (systolic blood pressure (BP)>180 mm Hg and/or diastolic BP>100 mm Hg despite optimal medical management)
Is in an intensive care setting
Has an unstable neurological disease (e.g., cerebrovascular accident (including transient ischemic attacks (TIAs) within the 3 months before signing of informed consent
Has undergone an invasive procedure on kidney lesion (e.g., tissue biopsy, surgery, nonsurgical cytoreductive procedure) since identification of lesion via US without contrast

Has any other medical condition or other circumstances that would significantly decrease the chances of obtaining reliable data or of achieving the study objectives such as:

Mental illness
Drug abuse
Female patient who is pregnant or lactating (the possibility of pregnancy has to be excluded by negative point of care (POC), serum or urine beta-human chorionic gonadotropin (Β-HCG) results, obtained within 24 hours before the perflutren lipid administration, or on the basis of patient history, e.g., tubal ligation, hysterectomy or a minimum of 1 year without menses)
Obesity that limits obtainment of acceptable images","Patients with kidney lesions will be imaged using contrast-enhanced ultrasound with perflutren.

Perflutren Lipid microsphere: Perflutren will be administered in a bolus or continuous infusion using the dosing range and administration type within the perflutren prescribing information.Once perflutren lipid has been administered, the transducer is maintained in a constant position over the area of interest to show the target lesion in order to assess the enhancement pattern during the early, mid and late vascular phases. Images will also be taken of kidney parenchyma in a suitable longitudinal plane.If there are multiple lesions in one subject requiring a second dose, the subject will have the option to undergo a 2nd contrast-enhanced study 30-minutes after the initial contrast dose, per dosing instructions in the package insert.",ChEMBL:CHEMBL1663 | DrugBank:DB00556 | PubChem:6432,Perflutren,FC(F)(F)C(F)(F)C(F)(F)F,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03198871,NCT03198871_EG000,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 4,76,"Inclusion Criteria:

Male or Female
18 years of age or older
patients scheduled for elective colorectal, pancreatic, and other major abdominal procedure.
Patient consent will be obtained preoperatively for eligible study participants.

Exclusion Criteria:

Patients who refuse to participate in the study or part of any other enhanced recovery after surgery (ERAS) research protocol.
Patients with a documented allergy to acetaminophen.
Chronic alcoholism
Hypovolemia
Chronic malnutrition
Preoperative renal insufficiency (creatinine clearance less than or equal to 30ml/min) or hemodialysis
Patients with a history of hepatic impairment, history of hepatic impairment or active hepatic disease
severe chronic pain condition that required daily preoperative opioid dependence
Patients with pre-existing dementia and/or other neuropsychiatric conditions impeding accurate assessment of pain scores or other study measures will be excluded.","Acetaminophen group: Half of subjects enrolled will be randomized to the acetaminophen group

Acetaminophen Injectable Product: The interventional group will receive 1 gram intravenous acetaminophen at the start of wound closure to be repeated every 6 hours for 48 hours postoperatively",ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03212326,NCT03212326_EG000,No,All,Adult | Older Adult,Not Applicable,24,"Inclusion Criteria:

Subject is 18 years of age or older
Subject is undergoing catheter ablation of likely reentrant VT
Planned use of intracardiac echocardiography (ICE)
Subject is willing to sign and date the study informed consent form

Exclusion Criteria:

Contraindication to Perflutren (Optison) echo contrast
Known right-to-left, bidirectional, or transient right-to-left cardiac shunts
Known hypersensitivity to Perflutren, blood, blood products or albumin
Subject has medical condition that would limit study participation (as per MD discretion)
Subject is pregnant
Inability to give informed consent","Perflutren echo contrast is infused to enhance intracardiac echo imaging recorded during catheter ablation of ventricular tachycardia. We will compare areas that appear to be myocardial scar on ultrasound with areas of abnormal electrical signals obtained by direct catheter mapping.

Perflutren Lipid Microsphere Intravenous Suspension [DEFINITY]: Perflutren 1.3mL diluted in 50 mL is infused intravenously, and intracardiac echo imaging is recorded to analyze for areas of possible myocardial scar, which is then compared with areas of abnormal electrical signal via direct catheter mapping which is performed during ablation of ventricular tachycardia.",ChEMBL:CHEMBL1663 | DrugBank:DB00556 | PubChem:6432,Perflutren,FC(F)(F)C(F)(F)C(F)(F)F,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03216902,NCT03216902_EG002,No,All,Adult | Older Adult,Phase 2,44,"Inclusion Criteria:

Provide signed written informed consent
Diagnosis of POAG or OHT in both eyes
Qualifying corrected visual acuity in each eye
Qualifying central corneal thickness in each eye
Qualifying Day 1 IOP measurement at 3 time-points in both eyes
Qualifying Anterior chamber angle

Exclusion Criteria:

History of ocular surgery specifically intended to lower IOP
Subjects who cannot safely discontinue use of ocular hypotensive medications during the wait/washout period
Advanced glaucoma in either eye
Any corneal abnormality or other condition interfering with or preventing reliable Goldmann applanation tonometry
Any ocular surgery or ocular laser treatment within 90 days prior to Visit 1 (Screening) and throughout the study in either eye
Females who are pregnant, nursing, or planning a pregnancy",0.005% Latanoprost Ophthalmic Solution: 0.005% Latanoprost Ophthalmic Solution dosed once daily for 12 weeks,ChEMBL:CHEMBL1051 | DrugBank:DB00654 | PubChem:5311221,Latanoprost,CC(C)OC(=O)CCC/C=C\C[C@@H]1[C@@H](CC[C@@H](O)CCc2ccccc2)[C@H](O)C[C@@H]1O,S01EE01 | S01EE51,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03235479,NCT03235479_EG000,No,All,Adult | Older Adult,Phase 3,546,"Key Inclusion Criteria:

Patient has at least 1 year history of migraines (with or without aura), consistent with a diagnosis according to the International Classification of Headache Disorder, 3rd Edition, Beta version[1] including the following:

Not more than 8 attacks of moderate or severe intensity per month within last 3 months
Consistent migraine headaches of at least 2 migraine headache attacks of moderate or severe intensity in each of the 3 months prior to the Screening Visit and maintains this requirement during the Screening Period
Less than 15 days with headache (migraine or non-migraine) per month in each of the 3 months prior to the Screening Visit and maintains this requirement during the Screening Period
Patients on prophylactic migraine medication are permitted to remain on therapy provided they have been on a stable dose for at least 3 months prior to study entry.
Patients with contraindications for use of triptans may be included provided they meet all other study entry criteria.

Key Exclusion Criteria:

Patient history of HIV disease
Patient history with current evidence of uncontrolled, unstable or recently diagnosed cardiovascular disease, such as ischemic heart disease, coronary artery vasospasm, and cerebral ischemia. Patients with Myocardial Infarction (MI), Acute Coronary Syndrome (ACS),Percutaneous Coronary Intervention (PCI), cardiac surgery, stroke or transient ischemic attack (TIA) during the 6 months prior to screening.
Uncontrolled hypertension (high blood pressure), or uncontrolled diabetes (however patients can be included who have stable hypertension and/or diabetes for 3 months prior to being enrolled)
Patient has a current diagnosis of major depression, other pain syndromes, psychiatric conditions (eg, schizophrenia), dementia, or significant neurological disorders (other than migraine) that, in the Investigator's opinion, might interfere with study assessments
Patient has a history of gastric, or small intestinal surgery, or has a disease that causes mal-absorption
The patient has a history or current evidence of any significant and/or unstable medical conditions (eg, history of congenital heart disease or arrhythmia, known suspected infection, hepatitis B or C, or cancer) that, in the investigator's opinion, would expose them to undue risk of a significant adverse event (AE) or interfere with assessments of safety or efficacy during the course of the trial
History of, treatment for, or evidence of, alcohol or drug abuse within the past 12 months or patients who have met DSM-V criteria for any significant substance use disorder within the past 12 months from the date of the screening visit.",Participants were administered a single oral dose of 75 mg of rimegepant on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.,ChEMBL:CHEMBL2178422 | DrugBank:DB12457 | PubChem:51049968,Rimegepant,N[C@@H]1c2cccnc2[C@H](OC(=O)N2CCC(n3c(=O)[nH]c4ncccc43)CC2)CC[C@H]1c1cccc(F)c1F,N02CD06,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03237845,NCT03237845_EG000,No,All,Adult | Older Adult,Phase 3,543,"Key Inclusion Criteria:

Patient has at least 1 year history of migraines (with or without aura), consistent with a diagnosis according to the International Classification of Headache Disorder, 3rd Edition, Beta version[1] including the following:

Not more than 8 attacks of moderate or severe intensity per month within last 3 months
Consistent migraine headaches of at least 2 migraine headache attacks of moderate or severe intensity in each of the 3 months prior to the Screening Visit and maintains this requirement during the Screening Period
Less than 15 days with headache (migraine or non-migraine) per month in each of the 3 months prior to the Screening Visit and maintains this requirement during the Screening Period
Patients on prophylactic migraine medication are permitted to remain on therapy provided they have been on a stable dose for at least 3 months prior to study entry.
Patients with contraindications for use of triptans may be included provided they meet all other study entry criteria.

Key Exclusion Criteria:

Patient history of HIV disease
Patient history with current evidence of uncontrolled, unstable or recently diagnosed cardiovascular disease, such as ischemic heart disease, coronary artery vasospasm, and cerebral ischemia. Patients with Myocardial Infarction (MI), Acute Coronary Syndrome (ACS),Percutaneous Coronary Intervention (PCI), cardiac surgery, stroke or transient ischemic attack (TIA) during the 6 months prior to screening.
Uncontrolled hypertension (high blood pressure), or uncontrolled diabetes (however patients can be included who have stable hypertension and/or diabetes for 3 months prior to being enrolled)
Patient has a current diagnosis of major depression, other pain syndromes, psychiatric conditions (eg, schizophrenia), dementia, or significant neurological disorders (other than migraine) that, in the Investigator's opinion, might interfere with study assessments
Patient has a history of gastric, or small intestinal surgery, or has a disease that causes malabsorption.
The patient has a history or current evidence of any significant and/or unstable medical conditions (eg, history of congenital heart disease or arrhythmia, known suspected infection, hepatitisB or C, or cancer) that, in the investigator's opinion, would expose them to undue risk of a significant adverse event (AE) or interfere with assessments of safety or efficacy during the course ofthe trial
History of, treatment for, or evidence of, alcohol or drug abuse within the past 12 months or patients who have met DSM-V criteria for any significant substance use disorder within thepast 12 months from the date of the screening visit.",Participants were administered a single oral dose of 75 mg of rimegepant tablet on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.,ChEMBL:CHEMBL2178422 | DrugBank:DB12457 | PubChem:51049968,Rimegepant,N[C@@H]1c2cccnc2[C@H](OC(=O)N2CCC(n3c(=O)[nH]c4ncccc43)CC2)CC[C@H]1c1cccc(F)c1F,N02CD06,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03241342,NCT03241342_EG001,No,Female,Adult | Older Adult,Phase 2,163,"Key Inclusion Criteria:

SUI symptoms of at least 6 months duration
Predominant SUI as determined at the Screening Visit using the Medical, Epidemiological, and Social Aspects of Aging (MESA) urinary questionnaire.
24-Hour pad weight > 3 g during the screening period
A minimum of 1 and no more than 15 SUI episodes on any single day AND no fewer than 9 total SUI episodes over 3 days during the screening period
Positive bladder stress test conducted during the Screening Visit

Key Exclusion Criteria:

History of pelvic radiation treatment
History of urethral diverticula
History of urethral sling or anterior prolapse repair
Treatment with urethral bulking agents and/or other SUI procedure or surgery within the 6 months prior to the Screening Visit
Known vesicoureteral reflux, vaginal prolapse beyond the introitus, or other significant pelvic floor abnormalities
Urinary incontinence of neurogenic etiology
Morbidly obese (defined as 100 pounds over ideal body weight, or body mass index 40 or greater)
Chronic hepatitis
Hepatic cirrhosis
Evidence of active infection with hepatitis B or hepatitis C
History of human immunodeficiency virus (HIV) infection
Subjects with a history of breast or endometrial cancer","Study drug will be provided as softgel capsules in blister packaging, labeled and designed to protect study blinding. All subjects will take 2 softgel capsules orally, once daily.

GTx 024: Study drug is an opaque, white to off-white, size 5, oval Softgel capsule containing the active ingredient GTx-024.",ChEMBL:CHEMBL1738889 | DrugBank:DB12078 | PubChem:11326715,Enobosarm,C[C@](O)(COc1ccc(C#N)cc1)C(=O)Nc1ccc(C#N)c(C(F)(F)F)c1,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT03241485,NCT03241485_EG001,No,All,Adult | Older Adult,Phase 4,79,"Inclusion Criteria:

• patient undergoing elective robotic myocardial revascularization without anticipated use of cardiopulmonary bypass and with anticipated intraoperative tracheal extubation.

Exclusion Criteria:

Emergency surgery
Preoperative use of inotropes/IABP
Preoperative use of opoids
Ejection fraction less than 40%
Anticipated use of cardiopulmonary bypass
Previous cardiothoracic surgery
Anticipated postoperative tracheal intubation
severe pulmonary disease
morbid obesity (BMI >35 kg/m2)
severe hepatic impairment
severe renal dysfunction (creatinine > 1.5)
any contraindication to intrathecal injection (patient refusal, difficult patient anatomy, pre-existing coagulopathy, morphine allergy)",5 micrograms/kilogram of intrathecal morphine.,PubChem:6321225,Morphine sulfate pentahydrate,CN1CCC23c4c5ccc(O)c4OC2C(O)C=CC3C1C5.CN1CCC23c4c5ccc(O)c4OC2C(O)C=CC3C1C5.O.O.O.O.O.O=S(=O)(O)O,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03257358,NCT03257358_EG000,No,All,Adult | Older Adult,Phase 4,163,"Inclusion Criteria:

Diagnosis of relapsing forms of Multiple Sclerosis
Patients who started commercially prescribed fingolimod therapy 0.5mg per day OR patients already on commercially prescribed fingolimod 0.5mg per day continuously for ≥ 2 years

Exclusion Criteria (per USPI):

Patients who in the last 6 months experienced myocardial infarction, unstable angina, stroke, transient ischemic stroke, decompensated heart failure requiring hospitalization or Class III/IV heart failure
History or presence of Mobitz Type II second-degree or third-degree atrioventricular block or sick sinus syndrome, unless patient had a functioning pacemaker
Baseline QTc interval ≥ 500 msec
Treatment with Class Ia or Class III anti-arrhythmic drugs
Patients who had a hypersensitivity reaction to fingolimod or any of the excipients",RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day,ChEMBL:CHEMBL314854 | DrugBank:DB08868 | PubChem:107970,Fingolimod,CCCCCCCCc1ccc(CCC(N)(CO)CO)cc1,L04AA27,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT03257358,NCT03257358_EG001,No,All,Adult | Older Adult,Phase 4,217,"Inclusion Criteria:

Diagnosis of relapsing forms of Multiple Sclerosis
Patients who started commercially prescribed fingolimod therapy 0.5mg per day OR patients already on commercially prescribed fingolimod 0.5mg per day continuously for ≥ 2 years

Exclusion Criteria (per USPI):

Patients who in the last 6 months experienced myocardial infarction, unstable angina, stroke, transient ischemic stroke, decompensated heart failure requiring hospitalization or Class III/IV heart failure
History or presence of Mobitz Type II second-degree or third-degree atrioventricular block or sick sinus syndrome, unless patient had a functioning pacemaker
Baseline QTc interval ≥ 500 msec
Treatment with Class Ia or Class III anti-arrhythmic drugs
Patients who had a hypersensitivity reaction to fingolimod or any of the excipients",RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years,ChEMBL:CHEMBL314854 | DrugBank:DB08868 | PubChem:107970,Fingolimod,CCCCCCCCc1ccc(CCC(N)(CO)CO)cc1,L04AA27,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03258710,NCT03258710_EG000,No,All,Adult | Older Adult,Phase 4,75,"Inclusion Criteria:

Subjects must be 20 to 69 years of age inclusive, at the time of signing the informed consent

Male and female subjects. A female subject is eligible to participate if she is not pregnant and not breastfeeding, and at least one of the following conditions applies:

Not a woman of childbearing potential (WOCBP), OR
A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 4 days after the last dose of study treatment
Capable of giving signed informed consent form (ICF)
Subjects with chronic hepatitis B (CHB) (excluding hospitalized subjects)
Subjects treated with ETV for at least 2 years prior to initiation of study treatment.
The serum HBV-DNA level at screening is below the limit of quantitation (< 2.1 Log10 copies/milliliter [mL] or < 20 international unit [IU]/mL).
Subjects with serum HBeAg positive at screening

Meet either of the following serum HBsAg levels at screening:

Serum HBsAg 80 < to < 800 IU/mL and fluctuation range is equal or more than -0.1 Log10 IU/mL per year
Serum HBsAg >=800 IU/mL

Meet all of the following criteria at screening:

Creatinine clearance (CLcr) >=70 mL/minute. CLcr is calculated using the following Cockcroft-Gault formula.

Male: CLcr = (body weight in kilogram [kg] multiplied by [140 minus age in years]) divided by (72 multiplied by serum creatinine [milligram {mg}/deciliter {dL}]) Female: CLcr = CLcr (male) multiplied by 0.85

Hemoglobin >= 8 gram/dL
WBC >=1000 per cubic millimeter (mm^3)

Exclusion Criteria:

QTc > 450 millisecond (msec) or > 480 msec for subjects with bundle branch block
Received any interferon or Hepatitis B vaccine therapy within 24 weeks prior to initiation of the study treatment.
Received overdose of nonsteroidal anti-inflammatory drugs (NSAIDs) (excluding temporary or topical use) within 7 days prior to initiation of the study treatment.

Received any of the following drugs within 8 weeks prior to initiation of the study treatment (excluding topical products such as ointment and/or cream etc).

Drugs causing renal impairment (examples: aminoglycosides, amphotericin B, vancomycin, foscarnet, cisplatin, pentamidine, tacrolimus, cyclosporine, some contrast mediums [ionic high-osmolar contrast media, ionic low-osmolar contrast media]
Competitors of renal excretion (except temporary use, example: probenecid)
Immunosuppressants (examples: azathioprine, cycolphosphamide) or chemotherapeutics (example: etoposide)
Glucocorticoid preparation
Received TDF, Adefovir pivoxil (ADV) or Tenofovir Alafenamide Fumarate (TAF) within 2 years prior to initiation of the study treatment
Participation in another clinical study within 6 months prior to screening, or planned participation in another clinical study simultaneously with this study.
Co-infection with human immunodeficiency virus (HIV) or hepatitis C virus (HCV)
Subjects with serious complication other than compensated CHB (cancer, significant renal, cardiovascular, pulmonary, or neurological disease, uncontrollable diabetes, etc.)
Received or have a plan for solid organ or bone marrow transplantation
Has proximal tubulopathy.
Subjects with decompensated CHB who meet the following: direct bilirubin > 1.5 times upper limit of normal (ULN), Prothrombin Time (PT) < 60%, platelets < 75,000/mm3 and serum albumin < 3.0 g/dL
Autoimmune hepatitis (Antinuclear titer > 1:160), excluding CHB
Subjects with or suspected of having hepatocellular carcinoma (HCC) (including both primary and metastatic) from diagnostic imaging at screening, or with serum alpha-fetoprotein (AFP) > 50 nanogram (ng)/mL at screening
History of HCC (except subjects who underwent resection or received curative treatment by radiofrequency, and with AFP <=10 ng/mL at screening)
Woman who is pregnant, possibly pregnant, lactating or planning a pregnancy during the study period.
Psychiatry disorder or cognitive disorder that may affect the subject's ability to give informed consent or to follow specified study procedures.
Subjects with a history of alcohol or drug abuse
Subjects whom the investigator (or sub-investigator) considers ineligible for the study.
Subjects with hypersensitivity to study treatments or their components, nucleoside and/or nucleotide analogues. Subjects with drug allergy that, in the investigator's (sub-investigator's) [or medical monitor's] opinion, labeled contraindication for participation in the study, or other allergy.","Participants with on-going ETV treatment were switched to TDF treatment on Day 1. Participants then started with TDF on the day ETV was discontinued, without any overlapping treatment periods. All participants received one tablet of TDF 300 milligram (mg) once daily orally for 96 weeks.",PubChem:5486830 | PubChem:6398764,Tenofovir Disoproxil Fumarate,CC(C)OC(=O)OCOP(=O)(COC(C)Cn1cnc2c(N)ncnc21)OCOC(=O)OC(C)C.O=C(O)C=CC(=O)O,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT03258723,NCT03258723_EG000,No,All,Adult,Phase 4,114,"Inclusion Criteria:

BMI>25 or WC>88/102cm
No history of type I or type II diabetes or gestational diabetes
Not on blood sugar altering medication
Ability to attend weekly sessions
HbA1c 6-6.4%

Exclusion Criteria:

Pregnant
eGFR<45 mL/min/1.73 m2
Prescribed Metformin and randomized to the control arm","Highest risk pre-diabetic patients

Lifestyle Intervention: The lifestyle intervention consists of a series of workshops adapted from the East Harlem Partnerships for Diabetes Prevention that discuss diabetes prevention, finding and affording healthy foods, label reading, physical activity, planning a healthy plate, making traditional foods healthy and portion control.

The newly launched East Harlem Diabetes Prevention (EHDP) project's mobile app, iHEED will be used by intervention participants to help reinforce the content they learn during the workshop series.

Metformin: At 6 months, intervention participants who have not been able to lose weight or bring their HbA1c below the high risk range of 6% (determined by point-of-care testing) will have Metformin prescribed by their provider. Metformin will be prescribed at 500mg twice a day. If no change is seen at 12 months follow up, the dose will be increased to 850mg twice a day.",ChEMBL:CHEMBL1431 | DrugBank:DB00331 | PubChem:4091,Metformin,CN(C)C(=N)NC(=N)N,A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03261401,NCT03261401_EG002,Accepts Healthy Volunteers,All,Adult,Phase 1,6,"Inclusion Criteria:

Adult men and women of non-childbearing potential, with total body weight greater than or equal to 50.0 kilogram and body mass index (BMI) between 19.0 kilogram per meter square(kg/m^2) and 29.9 kg/m^2.
Healthy as assessed by the Investigator with no clinically significant abnormality identified on physical examination or laboratory evaluation and no active clinically significant disorder, condition, infection or disease that would pose a risk to participant safety or interfere with the trial evaluation, procedures, or completion.
Other protocol defined inclusion criteria could apply.

Exclusion Criteria:

Participants with history or presence of clinically relevant respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological dermatological, connective tissue diseases or disorders.
Participants with history of relevant drug hypersensitivity, ascertained or presumptive allergy/hypersensitivity to the active drug substance and/or formulation ingredients; history of serious allergic reactions leading to hospitalization or any other allergic reaction in general, which the Investigator considers may affect the safety of the participant and/or outcome of the trial.
Participants who have any history of malaria.
Participants who have participated in a previous malaria vaccine trial.
Participants who have participated in a previous human malaria challenge trial.",Participants received SAD of 100 mg M5717 on Day 1 after 8 hours fasting-period followed by a 4-hour post-dose fast.,PubChem:71748268,6-fluoro-2-(4-(morpholinomethyl)phenyl)-N-(2-(pyrrolidin-1-yl)ethyl)quinoline-4-carboxamide,O=C(NCCN1CCCC1)c1cc(-c2ccc(CN3CCOCC3)cc2)nc2ccc(F)cc12,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0
NCT03261401,NCT03261401_EG003,Accepts Healthy Volunteers,All,Adult,Phase 1,6,"Inclusion Criteria:

Adult men and women of non-childbearing potential, with total body weight greater than or equal to 50.0 kilogram and body mass index (BMI) between 19.0 kilogram per meter square(kg/m^2) and 29.9 kg/m^2.
Healthy as assessed by the Investigator with no clinically significant abnormality identified on physical examination or laboratory evaluation and no active clinically significant disorder, condition, infection or disease that would pose a risk to participant safety or interfere with the trial evaluation, procedures, or completion.
Other protocol defined inclusion criteria could apply.

Exclusion Criteria:

Participants with history or presence of clinically relevant respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological dermatological, connective tissue diseases or disorders.
Participants with history of relevant drug hypersensitivity, ascertained or presumptive allergy/hypersensitivity to the active drug substance and/or formulation ingredients; history of serious allergic reactions leading to hospitalization or any other allergic reaction in general, which the Investigator considers may affect the safety of the participant and/or outcome of the trial.
Participants who have any history of malaria.
Participants who have participated in a previous malaria vaccine trial.
Participants who have participated in a previous human malaria challenge trial.",Participants received SAD of 200 mg M5717 on Day 1 after 8 hours fasting-period followed by a 4-hour post-dose fast.,PubChem:71748268,6-fluoro-2-(4-(morpholinomethyl)phenyl)-N-(2-(pyrrolidin-1-yl)ethyl)quinoline-4-carboxamide,O=C(NCCN1CCCC1)c1cc(-c2ccc(CN3CCOCC3)cc2)nc2ccc(F)cc12,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03261401,NCT03261401_EG004,Accepts Healthy Volunteers,All,Adult,Phase 1,6,"Inclusion Criteria:

Adult men and women of non-childbearing potential, with total body weight greater than or equal to 50.0 kilogram and body mass index (BMI) between 19.0 kilogram per meter square(kg/m^2) and 29.9 kg/m^2.
Healthy as assessed by the Investigator with no clinically significant abnormality identified on physical examination or laboratory evaluation and no active clinically significant disorder, condition, infection or disease that would pose a risk to participant safety or interfere with the trial evaluation, procedures, or completion.
Other protocol defined inclusion criteria could apply.

Exclusion Criteria:

Participants with history or presence of clinically relevant respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological dermatological, connective tissue diseases or disorders.
Participants with history of relevant drug hypersensitivity, ascertained or presumptive allergy/hypersensitivity to the active drug substance and/or formulation ingredients; history of serious allergic reactions leading to hospitalization or any other allergic reaction in general, which the Investigator considers may affect the safety of the participant and/or outcome of the trial.
Participants who have any history of malaria.
Participants who have participated in a previous malaria vaccine trial.
Participants who have participated in a previous human malaria challenge trial.",Participants received SAD of 400 mg M5717 on Day 1 after 8 hours fasting-period followed by a 4-hour post-dose fast.,PubChem:71748268,6-fluoro-2-(4-(morpholinomethyl)phenyl)-N-(2-(pyrrolidin-1-yl)ethyl)quinoline-4-carboxamide,O=C(NCCN1CCCC1)c1cc(-c2ccc(CN3CCOCC3)cc2)nc2ccc(F)cc12,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03261401,NCT03261401_EG005,Accepts Healthy Volunteers,All,Adult,Phase 1,6,"Inclusion Criteria:

Adult men and women of non-childbearing potential, with total body weight greater than or equal to 50.0 kilogram and body mass index (BMI) between 19.0 kilogram per meter square(kg/m^2) and 29.9 kg/m^2.
Healthy as assessed by the Investigator with no clinically significant abnormality identified on physical examination or laboratory evaluation and no active clinically significant disorder, condition, infection or disease that would pose a risk to participant safety or interfere with the trial evaluation, procedures, or completion.
Other protocol defined inclusion criteria could apply.

Exclusion Criteria:

Participants with history or presence of clinically relevant respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological dermatological, connective tissue diseases or disorders.
Participants with history of relevant drug hypersensitivity, ascertained or presumptive allergy/hypersensitivity to the active drug substance and/or formulation ingredients; history of serious allergic reactions leading to hospitalization or any other allergic reaction in general, which the Investigator considers may affect the safety of the participant and/or outcome of the trial.
Participants who have any history of malaria.
Participants who have participated in a previous malaria vaccine trial.
Participants who have participated in a previous human malaria challenge trial.",Participants received SAD of 600 mg M5717 on Day 1 after 8 hours fasting-period followed by a 4-hour post-dose fast.,PubChem:71748268,6-fluoro-2-(4-(morpholinomethyl)phenyl)-N-(2-(pyrrolidin-1-yl)ethyl)quinoline-4-carboxamide,O=C(NCCN1CCCC1)c1cc(-c2ccc(CN3CCOCC3)cc2)nc2ccc(F)cc12,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT03261401,NCT03261401_EG006,Accepts Healthy Volunteers,All,Adult,Phase 1,6,"Inclusion Criteria:

Adult men and women of non-childbearing potential, with total body weight greater than or equal to 50.0 kilogram and body mass index (BMI) between 19.0 kilogram per meter square(kg/m^2) and 29.9 kg/m^2.
Healthy as assessed by the Investigator with no clinically significant abnormality identified on physical examination or laboratory evaluation and no active clinically significant disorder, condition, infection or disease that would pose a risk to participant safety or interfere with the trial evaluation, procedures, or completion.
Other protocol defined inclusion criteria could apply.

Exclusion Criteria:

Participants with history or presence of clinically relevant respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological dermatological, connective tissue diseases or disorders.
Participants with history of relevant drug hypersensitivity, ascertained or presumptive allergy/hypersensitivity to the active drug substance and/or formulation ingredients; history of serious allergic reactions leading to hospitalization or any other allergic reaction in general, which the Investigator considers may affect the safety of the participant and/or outcome of the trial.
Participants who have any history of malaria.
Participants who have participated in a previous malaria vaccine trial.
Participants who have participated in a previous human malaria challenge trial.",Participants received SAD of 1000 mg M5717 on Day 1 after 8 hours fasting-period followed by a 4-hour post-dose fast.,PubChem:71748268,6-fluoro-2-(4-(morpholinomethyl)phenyl)-N-(2-(pyrrolidin-1-yl)ethyl)quinoline-4-carboxamide,O=C(NCCN1CCCC1)c1cc(-c2ccc(CN3CCOCC3)cc2)nc2ccc(F)cc12,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT03261401,NCT03261401_EG009,Accepts Healthy Volunteers,All,Adult,Phase 1,1,"Inclusion Criteria:

Adult men and women of non-childbearing potential, with total body weight greater than or equal to 50.0 kilogram and body mass index (BMI) between 19.0 kilogram per meter square(kg/m^2) and 29.9 kg/m^2.
Healthy as assessed by the Investigator with no clinically significant abnormality identified on physical examination or laboratory evaluation and no active clinically significant disorder, condition, infection or disease that would pose a risk to participant safety or interfere with the trial evaluation, procedures, or completion.
Other protocol defined inclusion criteria could apply.

Exclusion Criteria:

Participants with history or presence of clinically relevant respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological dermatological, connective tissue diseases or disorders.
Participants with history of relevant drug hypersensitivity, ascertained or presumptive allergy/hypersensitivity to the active drug substance and/or formulation ingredients; history of serious allergic reactions leading to hospitalization or any other allergic reaction in general, which the Investigator considers may affect the safety of the participant and/or outcome of the trial.
Participants who have any history of malaria.
Participants who have participated in a previous malaria vaccine trial.
Participants who have participated in a previous human malaria challenge trial.",Participants in SAD received an oral dose of 2100 mg M5717 on Day 1 after 8 hours fasting-period followed by a 4-hour post-dose fast.,PubChem:71748268,6-fluoro-2-(4-(morpholinomethyl)phenyl)-N-(2-(pyrrolidin-1-yl)ethyl)quinoline-4-carboxamide,O=C(NCCN1CCCC1)c1cc(-c2ccc(CN3CCOCC3)cc2)nc2ccc(F)cc12,,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03261401,NCT03261401_EG010,Accepts Healthy Volunteers,All,Adult,Phase 1,6,"Inclusion Criteria:

Adult men and women of non-childbearing potential, with total body weight greater than or equal to 50.0 kilogram and body mass index (BMI) between 19.0 kilogram per meter square(kg/m^2) and 29.9 kg/m^2.
Healthy as assessed by the Investigator with no clinically significant abnormality identified on physical examination or laboratory evaluation and no active clinically significant disorder, condition, infection or disease that would pose a risk to participant safety or interfere with the trial evaluation, procedures, or completion.
Other protocol defined inclusion criteria could apply.

Exclusion Criteria:

Participants with history or presence of clinically relevant respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological dermatological, connective tissue diseases or disorders.
Participants with history of relevant drug hypersensitivity, ascertained or presumptive allergy/hypersensitivity to the active drug substance and/or formulation ingredients; history of serious allergic reactions leading to hospitalization or any other allergic reaction in general, which the Investigator considers may affect the safety of the participant and/or outcome of the trial.
Participants who have any history of malaria.
Participants who have participated in a previous malaria vaccine trial.
Participants who have participated in a previous human malaria challenge trial.",Participants received single oral dose of 150 mg M5717 (eight days after the administration of intravenous malaria inoculum) on Day 1 after 8 hours fasting-period followed by a 4-hour post-dose fast.,PubChem:71748268,6-fluoro-2-(4-(morpholinomethyl)phenyl)-N-(2-(pyrrolidin-1-yl)ethyl)quinoline-4-carboxamide,O=C(NCCN1CCCC1)c1cc(-c2ccc(CN3CCOCC3)cc2)nc2ccc(F)cc12,,1.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,1.0,1.0,1.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT03261401,NCT03261401_EG011,Accepts Healthy Volunteers,All,Adult,Phase 1,8,"Inclusion Criteria:

Adult men and women of non-childbearing potential, with total body weight greater than or equal to 50.0 kilogram and body mass index (BMI) between 19.0 kilogram per meter square(kg/m^2) and 29.9 kg/m^2.
Healthy as assessed by the Investigator with no clinically significant abnormality identified on physical examination or laboratory evaluation and no active clinically significant disorder, condition, infection or disease that would pose a risk to participant safety or interfere with the trial evaluation, procedures, or completion.
Other protocol defined inclusion criteria could apply.

Exclusion Criteria:

Participants with history or presence of clinically relevant respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological dermatological, connective tissue diseases or disorders.
Participants with history of relevant drug hypersensitivity, ascertained or presumptive allergy/hypersensitivity to the active drug substance and/or formulation ingredients; history of serious allergic reactions leading to hospitalization or any other allergic reaction in general, which the Investigator considers may affect the safety of the participant and/or outcome of the trial.
Participants who have any history of malaria.
Participants who have participated in a previous malaria vaccine trial.
Participants who have participated in a previous human malaria challenge trial.",Participants received single oral dose of 400 mg M5717 (eight days after the administration of intravenous malaria inoculum) on Day 1 after 8 hours fasting-period followed by a 4-hour post-dose fast.,PubChem:71748268,6-fluoro-2-(4-(morpholinomethyl)phenyl)-N-(2-(pyrrolidin-1-yl)ethyl)quinoline-4-carboxamide,O=C(NCCN1CCCC1)c1cc(-c2ccc(CN3CCOCC3)cc2)nc2ccc(F)cc12,,1.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0
NCT03296553,NCT03296553_EG001,No,All,Adult | Older Adult,Phase 2,19,"Inclusion Criteria:

Patients will be included with AIDS naïve to antiretroviral therapy and severe KS, who accept to participate and who sign the letter of informed consent.
The following are the KS severity criteria: pulmonary compromise, and/or digestive tract compromise, and/or disseminated cutaneous, and/or lymphadenopathic compromise with generalized lymphedema.

Exclusion Criteria:

Patients with another synchronic malignant neoplasm
Patients receiving corticosteroids
Patients with active hepatitis B and/or hepatitis C
Patients with KS limited to skin with less than 30 lesions.
Patients with APACHE II score ≥15 points.","Standard treatment with cART according to current HIV Therapy Mexican guidelines.

Antiretroviral Combinations: Patients will receive standard antiretroviral treatment as recommended

20 control patients included

1 eliminated

19 patients included finally",ChEMBL:CHEMBL839 | DrugBank:DB00521,CARTEOLOL,CC(C)(C)NCC(O)COc1cccc2c1CCC(=O)N2,C07AA15 | S01ED05 | S01ED55,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03297112,NCT03297112_EG000,No,Female,Adult | Older Adult,Early Phase 1,12,"Inclusion Criteria:

Be diagnosed with an adnexal mass
Be scheduled for surgery to remove the adnexal mass
Be clinically stable
If a female of child-bearing potential, must have a negative pregnancy test
Be conscious and able to comply with study procedures
Have read and signed the Institutional Review Board (IRB)-approved informed consent form for participating in the study

Exclusion Criteria:

Females who are pregnant or nursing
Patients who have received an investigational drug in the 30 days before study drug administration, or will receive one within 72 hours (h) afterwards
Patients with known or suspected right-to-left, bi-directional, or transient right-to-left cardiac shunts
Patients with pulmonary hypertension or unstable cardiopulmonary conditions
Patients currently on chemotherapy or with other primary cancers requiring systemic or hepatic loco-regional treatment

Patients who are clinically unstable, patients who are seriously or terminally ill with a life expectancy of less than 1 month, and patients whose clinical course are unpredictable; for example:

Patients on life support or in a critical care unit
Patients with unstable occlusive disease (e.g., crescendo angina)
Patients with clinically unstable cardiac arrhythmias, such as recurrent ventricular tachycardia
Patients with uncontrolled congestive heart failure (New York Heart Association [NYHA] class IV)
Patients with recent cerebral hemorrhage
Patients who have undergone surgery within 24 hours prior to the study sonographic examination
Patients with a history of anaphylactic allergy to Definity, manifested by one or more of the following symptoms: generalized urticaria, difficulty in breathing, swelling of the mouth and throat, hypotension, or shock
Patients with congenital heart defects
Patients with severe emphysema, pulmonary vasculitis, or a history of pulmonary emboli
Patients with respiratory distress syndrome
Patients with thrombosis within the splenic vein","Patients receive perflutren lipid microspheres IV. After 15 minutes, patients receive perflutren lipid microspheres IV again over 5 minutes and undergo contrast-enhanced subharmonic ultrasound imaging over 60 minutes.

Perflutren Lipid Microspheres: Given IV

Contrast-Enhanced Subharmonic Ultrasound Imaging: Undergo contrast-enhanced subharmonic ultrasound imaging",ChEMBL:CHEMBL1663 | DrugBank:DB00556 | PubChem:6432,Perflutren,FC(F)(F)C(F)(F)C(F)(F)F,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03302416,NCT03302416_EG000,Accepts Healthy Volunteers,All,Adult,Early Phase 1,19,"Inclusion Criteria:

Males or females between 18 and 40 years old

Exclusion Criteria:

Current DSM-5 psychiatric disorders
Binge drinking as defined in NIAAA criteria in the past month
Recreational abuse of opiates, sedative-hypnotics, cocaine, amphetamines, MDMA, and PCP, as well as cannabis use
Currently on any prescription medical or psychotropic medication;
Current or past severe medical, endocrine, cardiovascular, immunological or neurological illnesses
Currently pregnant or breast-feeding;
History of radioactivity exposure via prior nuclear medicine studies or occupational exposure in past twelve months
Metallic objects in the body that are contraindicated for MRI;
First-degree relative with psychosis or mood disorders","Baseline condition and Post-hydrocortisone (1 mg/Kg, intravenous) condition

Hydrocortisone

[C-11]NOP-1A",ChEMBL:CHEMBL389621 | DrugBank:DB00741 | PubChem:5754,Hydrocortisone,[H][C@@]12CC[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)CC[C@@]21C,A01AC03 | A07EA02 | C05AA01 | D07AA02 | D07BA04 | D07CA01 | D07XA01 | H02AB09 | R01AD60 | S01BA02 | S01BB01 | S01CA03 | S01CB03 | S02BA01 | S02CA03 | S03CA04,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03303469,NCT03303469_EG000,No,All,Adult | Older Adult,Phase 2,3,"Inclusion Criteria:

Adult (> 18 years of age) patients with documented HCC tumor mass >3cm, who are scheduled to undergo TACE with additional selective internal radiation therapy (SIRT)
The appropriate criteria for inclusion for this patient population are:
Biopsy or radiological diagnosis of HCC (defined as Organ Procurement and Transplantation Network (OPTN*) Category 5 lesion either on CT or MRI)
Scheduled for TACE (using doxorubicin-eluting beads) + SBRT
Willingness to undergo PET/CT
Able to lie on the imaging table for up to 1 hour.
Able to provide signed informed consent.
Women with childbearing potential must have a negative urine Beta-Human Chorionic Gonadotropin (β-hCG) test day of procedure

Exclusion Criteria:

Estimated life expectancy <12 months or serious medical co-morbidities that would preclude definitive local therapy
Unable to lie on the imaging table
Age less than 18 years.
Pregnancy or lactation
Inability or unwillingness to provide informed consent.
Weight >500 lbs (the weight limit of the tomograph gantry table)","FMISO imaging at baseline, post-TACE and post-SBRT

FMISO: FMISO PET/CT imaging at baseline

FMISO: FMISO PET/CT post TACE

FMISO: FMISO PET/CT post SBRT",DrugBank:DB14830 | PubChem:450173 | PubChem:92242,Fluoromisonidazole F-18,O=[N+]([O-])c1nccn1CC(O)CF,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03305055,NCT03305055_EG001,No,All,Adult | Older Adult,Phase 4,2,"Inclusion Criteria:

Total Body Surface Area (TBSA) greater than or equal to 2%; Less than or equal to 40% TBSA
English speaking
pain in emergency room during initial wound evaluation (on admission) greater than 5 /10
estimated length of stay greater than or equal to 5 days

Exclusion Criteria:

requiring endotracheal intubation and sedation,
severe hearing impairment,
cognitive impairment status - Mini-Mental State Examination (MMSE) </=20,
diminished capacity unable to provide informed consent;
Past Medical History (PMH): insensate (eg. spinal cord injury, peripheral neuropathy)
Safety: contraindication (e.g., potential drug interactions or medical comorbidities)","Usual care group

Saline Loading Dose (Low Dose, Slow Infusion) =

• An identical volume of saline as that in 0.3 mg/kg of ketamine. Initiated approximately 10 minutes before wound care start, pump set to deliver slowly over approximately 5 minutes, (i.e., same time/rate as STUDY DRUG GROUP receives ketamine loading dose), … Then, ...

Fentanyl Loading Dose (UC, injection) =

• 1 mcg / kg: This is given to participants in both Group 1 and Group 2 initiated <1 minute prior to wound care.

Saline (Placebo, Infusion) = • Identical volume of fluid as that in 2.5 mcg/kg/min of ketamine; Pump initiates infusion immediately after the fentanyl Loading Dose and continued for session duration. The nurse determines session end, then turns off infusion.

FENTANYL PRN DOSE = 1 mcg / kg. Provided when participant requires additional pain medication.

Fentanyl: Information included in arm descriptions",ChEMBL:CHEMBL596 | DrugBank:DB00813 | PubChem:3345,Fentanyl,CCC(=O)N(c1ccccc1)C1CCN(CCc2ccccc2)CC1,N01AH01 | N01AH51 | N02AB03,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT03309007,NCT03309007_EG000,No,All,Adult | Older Adult,Phase 3,13,"Inclusion Criteria:

Adults with prediabetes (defined as an A1c of 5.7-6.4%)
BMI between 27 and 40 kg/m2 (inclusive).

Exclusion Criteria:

Prior treatment with metformin or other diabetes medications,
Pregnancy,
Significant renal dysfunction (Serum Creatinine > 1.3 mg/dl for women, > 1.4 mg/dl for men),
Severe hepatic dysfunction (aspartate amnotransferease [AST] or alanine aminotransferase [ALT] > 3 times the upper limit of normal),
Ongoing alcohol or substance abuse,
Inflammatory bowel disease,
Ongoing glucocorticoid therapy,
Or inability to render informed consent.","Metformin started at 500 mg po twice daily (BID), and then titrated up to 1000 mg po q morning (AM) and 500 po q evening (PM) over the course of 1 month, as tolerated.

Metformin: Total daily dose titrated up to 1500 mg po q day over the course of 4 weeks and continued for a total exposure of 12 weeks.",ChEMBL:CHEMBL1431 | DrugBank:DB00331 | PubChem:4091,Metformin,CN(C)C(=N)NC(=N)N,A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03309657,NCT03309657_EG000,No,All,Adult | Older Adult,Phase 1 | Phase 2,10,"Inclusion Criteria:

Patients with any infection requiring treatment with ceftolozane/tazobactam and who have met the following criteria:

Age >18 years
The presence of an indwelling external ventricular drain (EVD) or requiring EVD insertion due to obstructive hydrocephalus/subarachnoid haemorrhage

Exclusion Criteria:

Known or suspected allergy to penicillins and cephalosporins
Pregnancy
Receiving renal replacement therapy
Glomerular filtration rate less than 10 mL/min
Receiving piperacillin/tazobactam or having received piperacillin/tazobactam in the past 7 days before enrolment","Infected patients with external intraventricular drain will receive a single dose of Ceftolozane/ tazobactam (3000mg) over 1 hour and will undergo blood , csf and urine sampling at specific times over an 8 hour period.

Ceftolozane/tazobactam: IV ceftolozane 2000mg /tazobactam 1000mg once only",PubChem:86291594,Zerbaxa,CC1(Cn2ccnn2)C(C(=O)O)N2C(=O)CC2S1(=O)=O.Cn1c(N)c(NC(=O)NCCN)c[n+]1CC1=C(C(=O)[O-])N2C(=O)C(NC(=O)C(=NOC(C)(C)C(=O)O)c3nsc(N)n3)C2SC1,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03323801,NCT03323801_EG000,No,Male,Adult,Phase 2,10,"Inclusion Criteria: Infertile men with azoospermia on at least two semen analyses separated by at least one week, and no pregnancy with partner with normal cycles and normal hysterosalpingogram despite >1 year of unprotected intercourse.

-

Exclusion Criteria: hypogonadotropic hypogonadism (that might respond to gonadotropin injections); use of anabolic steroids,illicit drugs, or consumption of more than 4 alcoholic beverages daily; current therapy with retinoic acid (eg Accutane) or vitamin A- of use of isotretinoin within eight weeks of start of dosing;phenytoin, or medication containing tetracycline; personal history of serious psychiatric disorders, score of greater than 15 on the PHQ9 (mood) questionnaire; elevated serum serum triglycerides or other abnormal serum chemistry values; history of inflammatory bowel disease or bone disease; not living within catchment area; participation in another clinical trial

-","20 mg 13-cis retinoic acid twice daily (BID) with means for 32 weeks

13-cis retinoic acid: Accutane is used for the treatment of severe acne",ChEMBL:CHEMBL38 | ChEMBL:CHEMBL547 | ChEMBL:CHEMBL705 | DrugBank:DB00523 | DrugBank:DB00755 | DrugBank:DB00982 | PubChem:444795 | PubChem:449171 | PubChem:5282379,Tretinoin,CC(C=CC1=C(C)CCCC1(C)C)=CC=CC(C)=CC(=O)O,D10AD01 | D10AD04 | D10AD51 | D10AD54 | D10BA01 | D11AH04 | L01XF01 | L01XF02,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03332095,NCT03332095_EG001,No,All,Child,Phase 1 | Phase 2,45,"Inclusion Criteria:

Weight greater than or equal 35 kg at entry
If not of legal age to provide independent informed consent: Parent or guardian was willing and able to provide written informed consent for study participation; in addition, when applicable per local Institutional Review Board / Ethics Committee (IRB/EC) policies and procedures, potential participant was willing and able to provide written informed assent for study participation. If of legal age to provide independent informed consent as determined by site Standard Operating Procedures (SOPs) and consistent with site IRB/EC policies and procedures: Potential participant was willing and able to provide written informed consent for study participation
Confirmed HIV-1-infection based on documented testing of two samples collected at different time points. More information on this criterion can be found in the protocol.
Antiretroviral therapy (ART) exposure, virologic suppression, and resistance requirements, as follows:

Cohort 1

ART exposure requirements, based on individual or parent/guardian's report and, if available, confirmed by medical records:
At entry, receiving combination ART with raltegravir (RAL) or dolutegravir (DTG) plus 2 nucleoside reverse transcriptase inhibitors (NRTIs); AND
At entry, had not received non-nucleoside reverse transcriptase inhibitors (NNRTIs), protease inhibitor (PIs), or cobicistat within the previous 30 days; AND
Virologic suppression, as documented in medical records and as defined by:
One or more HIV RNA polymerase chain reaction (PCR) result below the level of quantification (BLLQ) within 15 months prior to enrollment, AND
If any HIV RNA PCR tests had been done within 3 months prior to enrollment, all results were below the level of quantification, AND
HIV RNA PCR result less than 40 copies/mL at screening, performed as per the protocol.

Cohort 2 ART-naive

ART exposure requirements, based on individual or parent/guardian's report and, if available, confirmed by medical records:
At entry, received no antiretrovirals (ARVs) for treatment of HIV infection including investigational agents (prior receipt of ARVs for prevention of perinatal transmission was permitted); AND
Screening genotypic resistance test results indicated susceptibility to doravirine (DOR), tenofovir disoproxil fumarate (TDF), and lamivudine (3TC) (see the protocol for more information; result must be available prior to enrollment), performed as per the protocol; AND
If available, as documented in medical records, any prior genotypic resistance test result indicated susceptibility to DOR, TDF, and 3TC (see the protocol for more information).

Note: For individuals that were re-screened, the genotypic resistance test did not need to be repeated.

Cohort 2 ART-experienced

ART exposure requirements, based on individual or parent/guardian's report and, if available, confirmed by medical records:
No previous history of change in ARVs due to clinical or virologic failure, in the opinion of the site investigator or designee; AND
Virologic suppression, as documented in medical record and as defined by:
One or more HIV RNA PCR result BLLQ within 15 months prior to enrollment, AND
If any HIV RNA PCR tests had been done within 3 months prior to enrollment, all results were below the level of quantification, AND
HIV RNA PCR result less than 40 copies/mL at screening (see the protocol for more information); AND
If available, as documented in medical records, any prior genotypic resistance test result indicated susceptibility to DOR, TDF, and 3TC (see the protocol for more information).

Note: This group of ARV-experienced, virologically suppressed participants were only enrolled once there was data from the adult switch studies indicating virologic efficacy and safety (see the protocol for more information). Sites were informed via a Clarification Memorandum when ART-experienced participants could be enrolled. A single, unconfirmed HIV-1 RNA result greater than or equal to the level of quantification but less than 500 copies/mL, between 3 and 15 months, prior to enrollment was not exclusionary as long as the other criteria for documentation of virologic suppression were met.

Grade 2 or lower hemoglobin, aspartate aminotransferase (AST), alanine transaminase (ALT), alkaline phosphatase, and lipase on specimens obtained at screening
For Cohort 2 only, grade 2 or lower creatinine, proteinuria, and glycosuria on specimens obtained at screening
Estimated glomerular filtration rate (eGFR) greater than or equal to 60 mL/min/1.73 m^2, on specimens obtained at screening, based on the Schwartz equation. More information on this criterion can be found in the protocol.
For females who had reached menarche or who were engaging in sexual activity (self-reported), negative pregnancy test at entry
For females engaging in sexual activity that could lead to pregnancy (self-reported), agreed to use two effective, medically accepted birth control methods while on study and for two weeks after permanently discontinuing study drug
For males engaging in sexual activity that could lead to pregnancy (self-reported), agreed to use condoms while on study and for two weeks after permanently discontinuing study drug
Able and willing to swallow available formulation(s) (tablet or, as available, oral granules).

Exclusion Criteria:

• Evidence of decompensated liver disease manifested by the presence of or a history of ascites, esophageal or gastric variceal bleeding, hepatic encephalopathy, or other signs or symptoms of advanced liver diseases.

Note: Individuals with chronic hepatitis B who had grade 2 or lower ALT and AST and had no significant impairment of hepatic synthetic function (significant impairment of hepatic synthetic function was defined as a serum albumin less than 2.8 mg/dL or an international normalized ratio (INR) greater than 1.7 in the absence of another explanation for the abnormal laboratory value) were eligible.

• For Cohort 2 only, detectable hepatitis C virus (HCV) by RNA PCR or current or planned treatment with direct antiviral agent for HCV.

Note: HCV antibody positivity but undetectable by HCV RNA PCR results were permitted.

Presence of any active AIDS-defining opportunistic infection
History of malignancy (ever), with the exception of localized malignancies such as squamous cell or basal cell carcinoma of the skin
Clinical evidence of pancreatitis, as determined by the clinician (at entry)
Use of nafcillin, dicloxacillin, or any of the prohibited medications, within 30 days prior to study entry (see the protocol for a complete list of prohibited medications)
For females, currently breastfeeding an infant at entry
Enrolled in another clinical trial of an investigational agent, device, or vaccine
Unlikely to adhere to the study procedures or keep appointments, in the opinion of the site investigator or designee
Used, or anticipates using, chronic systemic immunosuppressive agents or systemic interferon (e.g., for treatment of HCV infection) within 30 days prior to study entry.

Note: Systemic corticosteroids (e.g., prednisone or equivalent up to 2 mg/kg/day) for replacement therapy or short courses (less than or equal to 30 days) were permitted. See the protocol for a complete list of prohibited medications.

Diagnosed with current active tuberculosis and/or was currently being treated with a rifampicin-containing regimen
Individual had any other condition, that in the opinion of the site investigator or designee, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving study objectives","Participants received DOR/3TC/TDF from Day 0 through Week 96. Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF): DOR/3TC/TDF administered orally as a fixed-dose combination (as a tablet, 100 mg/300 mg/300 mg) once daily.",ChEMBL:CHEMBL2364608 | DrugBank:DB12301 | PubChem:58460047,Doravirine,Cn1c(Cn2ccc(C(F)(F)F)c(Oc3cc(Cl)cc(C#N)c3)c2=O)n[nH]c1=O,J05AG06 | J05AR24,1.0,0.0,0.0,0.0,0.0,1.0,1.0,1.0,1.0,0.0,1.0,1.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,1.0,1.0,1.0,1.0,0.0,0.0,1.0,0.0
NCT03335163,NCT03335163_EG000,Accepts Healthy Volunteers,Female,Adult,Phase 1,48,"Inclusion Criteria:

Healthy women, who have had an ENG implant for 12-36 months at the time of enrollment;
Will maintain their implant during the study without modifications.

Exclusion Criteria:

Women who are taking any medications or supplements known to be

Cytochrome P-450 enzyme inducers, inhibitors, or substrates, and
are not willing to abstain from any of these medications or supplements during the entire course of the study.
Women with liver disease (i.e. hepatitis, fatty liver disease), and
Women with abnormal liver or renal function, or
Women with abnormal electrolytes on their screening blood work.","Healthy women using an ENG implant for at least 12 months and no greater than 36 months will be administered a 6 week titration schedule of topiramate to a max dose of 200mg bid by the final week.

Topiramate: Topiramate - Participants will undergo a 6 week titrated regimen of oral topiramate to reach a maximum dose of 400mg per day:

Week 1 - topiramate PO 25mg daily Week 2 - topiramate PO 25mg twice daily Week 3 - topiramate PO 50mg twice daily Week 4 - topiramate PO 100mg twice daily Week 5 - topiramate PO 150mg twice daily Week 6 - topiramate PO 200mg twice daily",ChEMBL:CHEMBL220492 | DrugBank:DB00273 | PubChem:5284627,Topiramate,[H][C@@]12OC(C)(C)O[C@]1([H])CO[C@@]1(COS(N)(=O)=O)OC(C)(C)O[C@]12[H],A08AA51 | N03AX11,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03335566,NCT03335566_EG000,No,All,Adult | Older Adult,Phase 3,424,"Inclusion Criteria: Participants may be included in the study if they meet all of the following criteria:

Participant has at least 1 untreated focal liver lesions (FLL) but =<8 lesions (excluding cysts) <10 centimeter (cm) in diameter confirmed in a diagnostic examination performed in the past month (or past 3 months if lesion is benign) that can be visualised by non- contrast-enhanced (CE) ultrasound
Participant has had a dynamic CE-computed tomography (CE-CT) or CE-magnetic resonance imaging (CE-MRI) examination within the past month or is scheduled to have one in the month following inclusion in the study and the original images (or copies thereof) are/will be available. (This inclusion criterion does not apply for participants enrolled as training cases. Investigators will be asked to submit standard of truth/ reference diagnosis for training cases whenever possible, since the cases may be used for training and testing the blinded readers prior to the blinded read)
Participant is a 20- to 80-year-old inpatient or outpatient referred for an ultrasound examination of the liver
Participant is able and willing to comply with study procedures and will give their signed and dated informed consent
The participant, if female, is either surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy), postmenopausal (cessation of menses for more than 1 year), or non-lactating, or if of childbearing potential the results of a serum or urine human chorionic gonadotropin pregnancy test, performed on the day of investigational medicinal product (IMP) administration (with the result known before IMP administration), are negative

Exclusion Criteria:

The participant has an acute clinically fatal condition (i.e., not expected to survive for at least 6 months)
The participant has previously received Sonazoid™ or has received SonoVue® within the past 30 days
The participant has undergone or is undergoing systemic or loco-regional chemotherapy, or radiation therapy
The participant is participating in another clinical trial with an unregistered medicinal product, or less than 30 days have passed since completing participation in such a trial
The participant has a history of allergies to eggs or egg products (i.e., manifested by full body rash, respiratory difficulty, oral or laryngeal swelling, hypotension or shock)
The participant has known hypersensitivity to sulphur hexafluoride or to any of the components of SonoVue®
The participant has undergone or plans to undergo liver biopsy or surgery within the 24 hours before or after this examination
The participant has undergone or plans to undergo an examination with a contrast agent (i.e., iodinated x-ray contrast agent, magnetic resonance imaging (MRI) contrast agent or another ultrasound contrast agent) within the 24 hours before or after this examination
The participant is considered to be unsuitable to participate in the study by the investigator
The participant is known to have a right-to-left shunt, severe pulmonary hypertension (pulmonary artery pressure >90 millimeter of mercury (mmHg) or uncontrolled systemic hypertension
The participant has a recent acute coronary syndrome or clinically unstable ischaemic cardiac disease, including: evolving or ongoing myocardial infarction, typical angina at rest within the last 7 days, significant worsening of cardiac symptoms within the last 7 days, recent coronary artery intervention or other factors suggesting clinical instability (e.g., recent deterioration of electrocardiogram [ECG], laboratory or clinical findings), acute cardiac failure, Class III/IV cardiac failure, or severe rhythm disorders
The participant has adult respiratory distress syndrome, severe emphysema, pulmonary vasculitis, or a history of pulmonary emboli
The participant has known thrombosis within the liver, portal, or mesenteric veins",Participants received single I.V bolus injection of Sonazoid™ 0.12 µL MB/kg body weight.,ChEMBL:CHEMBL2104979 | DrugBank:DB12821 | PubChem:9638,Perflubutane,FC(F)(F)C(F)(F)C(F)(F)C(F)(F)F,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03339401,NCT03339401_EG000,No,All,Child | Adult,Phase 2,20,"Inclusion Criteria:

Subjects were high-risk allogeneic hematopoietic cell transplant (HCT) recipients aged 2 months to <18 years (<26 years in the United States) who met adenovirus (AdV) viremia criteria within 7 days of randomization (Day 1), and all other eligibility criteria. High-risk was defined as having received 1 of the following:

A T cell-depleted graft:

Ex vivo T cell depletion via positive selective (e.g., CD34+ cell) or negative selection (e.g., T cell receptor α/β or CD3+ cell removal by column filtration); or
Serotherapy with ATG (cumulative dose of ≥3 mg/kg rabbit-derived ATG or ≥30 mg/kg of equine-derived ATG) administered within 10 days prior to transplant or at any time post-transplant and prior to Day 1; or
Serotherapy with alemtuzumab administered within 30 days prior to transplant or at any time post-transplant and prior to Day 1; or
A cord blood graft from an unrelated donor with or without T cell depletion, or
A T cell-replete graft from a haploidentical donor with high-dose cyclophosphamide (e.g., cumulative dose of ≥100 mg/kg) administered at any time post-transplant and prior to Day 1.

Subjects must have had qualifying AdV viremia within 100 days of transplant, which was defined as having either:

Confirmed AdV viremia of ≥1000 copies/mL on 2 consecutive AdV DNA polymerase chain reaction (PCR) test results drawn ≥48 hours apart from the designated central virology laboratory, with the second result being greater than the first; or
A single AdV viremia result of ≥10,000 copies/mL from the designated central virology laboratory Subjects who were previously treated with intravenous (IV) cidofovir (CDV) could have a cumulative exposure to IV CDV of no more than 10 mg/kg within 21 days prior to Day 1.

Written informed consent (and assent, where applicable) to participate in the study was obtained from each subject and his/her legal guardian(s) in accordance with national or local law and institutional practice.

Exclusion Criteria:

Any United States National Institutes of Health (NIH)/National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade 4 diarrhea (i.e., life-threatening consequences with urgent intervention indicated) within 7 days prior to Day 1.
Any CTCAE Grade 2 or 3 diarrhea (i.e., increase of ≥4 stools/day over baseline [pre-transplant] diarrheal output), unless attributed to AdV, within 7 days prior to Day 1.
NIH Stage 4 acute graft versus host disease (GVHD) of the skin (i.e., generalized erythroderma with bullous formation) within 7 days prior to Day 1.
NIH Stage ≥2 acute GVHD of the liver (i.e., bilirubin >3 mg/dL [SI: >51 µmol/L]) within 7 days prior to Day 1.
NIH Stage ≥2 acute GVHD of the gut (i.e., diarrhea >556 mL/m2/day for pediatric patients [or >1000 mL/day for young adults at centers in the United States only], or severe abdominal pain with or without ileus) within 7 days prior to Day 1.
Poor clinical prognosis (including active malignancy or use of vasopressors other than low dose (e.g., ≤5 µg/kg/min) dopamine for renal perfusion within 7 days prior to Day 1.
Requirement for mechanical ventilation within 7 days prior to Day 1 or requirement for sustained oxygen delivery for >24 hours within 7 days prior to Day 1.
Concurrent HIV, active hepatitis B virus, or hepatitis C virus infection.
Specified out of range laboratory results (including alanine aminotransferase >5x the upper limit of normal [ULN], aspartate aminotransferase >5x ULN, total bilirubin >3 mg/dL [SI: >51 µmol/L], or prothrombin time-international normalized ratio >2x ULN) within 7 days prior to Day 1.
Estimated creatinine clearance <30 mL/min or use of renal replacement therapy within 7 days prior to Day 1.
Previous receipt of BCV at any time or receipt of CDV (IV or intravesicular) or letermovir within 48 hours prior to Day 1.
Received any anti-AdV-specific cell-based therapy within 6 weeks prior to Day 1 or previously received an anti-AdV vaccine at any time.

When applicable, female subjects of childbearing potential (i.e., not pre-menarche) were not pregnant or breastfeeding, and if sexually active, agreed to use 2 acceptable forms of contraception, 1 of which must have been a barrier method and the other a highly-effective method of contraception. Male subjects, if sexually active and capable of fathering a child, agreed to use a barrier method of contraception while enrolled in the study and for at least 90 days after the last dose of BCV.","Brincidofovir (BCV) for the treatment of adenovirs (AdV) infection in high-risk pediatric allogeneic hematopoietic cell transplant (HCT) recipients.

Brincidofovir (BCV) treatment began no later than 100 days post-transplant and was to continue for a maximum of 16 weeks. Brincidofovir (BCV) was discontinued once AdV viremia was confirmed undetectable.

Subjects who did NOT receive concurrent cyclosporine on Day 1:

If ≥48kg body weight, one 100mg oral tablet BIW (or 10mL of 10mg/mL oral suspension if unable to take tablets).
If <48kg body weight, 2mg/kg oral volume of 10mg/mL oral suspension BIW.

Subjects who received cyclosporine on Day 1 (or initiated cyclosporine at any time):

1.4mg/kg (maximum of 70mg) oral volume of 10mg/mL oral suspension BIW.
2mg/kg (maximum of 100mg) oral volume of 10mg/mL oral suspension BIW if discontinued cyclosporine.",ChEMBL:CHEMBL203321 | DrugBank:DB12151 | PubChem:483477,Brincidofovir,CCCCCCCCCCCCCCCCOCCCOP(=O)(O)CO[C@H](CO)Cn1ccc(N)nc1=O,J05AB17,1.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,1.0,1.0,1.0,0.0,1.0,1.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,1.0,0.0,0.0,1.0,1.0
NCT03348423,NCT03348423_EG001,No,All,Adult | Older Adult,Phase 2,15,"Inclusion Criteria:

Voluntarily provide written informed consent
Be planned to undergo a selected office-based or outpatient procedure
Be naïve to the planned procedure, i.e. no repeated or revision procedures
Not pregnant or planning to become pregnant, or using appropriate contraceptive measures.

Exclusion Criteria:

Known allergy to any study treatment or excipient
Have another painful physical condition or anxiety related diagnosis that may confound study assessments
Evidence of a clinically significant finding on physical examination, laboratory assessment, or ECG
Have signs or a history of significant nasal condition that may interfere with intranasal drug delivery","Intravenous Fentanyl

Fentanyl: IN Placebo + IV Fentanyl",ChEMBL:CHEMBL596 | DrugBank:DB00813 | PubChem:3345,Fentanyl,CCC(=O)N(c1ccccc1)C1CCN(CCc2ccccc2)CC1,N01AH01 | N01AH51 | N02AB03,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT03349775,NCT03349775_EG000,No,All,Adult | Older Adult,Early Phase 1,10,"Inclusion Criteria:

Age 30-80 years
History of obesity and current BMI ≥ 25 kg/ m2 for study volunteers or BMI ≥ 25 kg/ m2 for those with clinically indicated CPET or known HFpEF
History of Dyspnea (Grade 1 or more)
Able to provide informed consent and willing to comply with study

Exclusion Criteria:

History of diabetes mellitus
History of primary pulmonary arterial hypertension
History of moderate to severe COPD
History of severe Obstructive Sleep apnea
History of renal disease (eGFR< 45 mL/min/1.732)
History of severe liver disease
History of cardiovascular disease (recent heart attack or stroke) except known HFpEF
History of blood clot in lung
History of Splenectomy
History of Active Cancer
Platelets count of < 75,000
International normalized ration (INR) of > 1.5
History of recent anemia (HB < 9g/dL)
Current use of Metformin
Prior LVEF < 50% on echocardiogram
Indication of severe valvular disease on echo
Pregnant or planning to become pregnant in next 4 months
History of HIV infection","Metformin: 500mg tablet orally twice daily for 1 week, followed by two 500mg tablets orally twice daily for a total of 3 months.",ChEMBL:CHEMBL1431 | DrugBank:DB00331 | PubChem:4091,Metformin,CN(C)C(=N)NC(=N)N,A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT03351114,NCT03351114_EG000,No,All,Adult | Older Adult,Phase 2,8,"Inclusion Criteria:

>= 18 years of age
Clinical diagnosis of morphea.
<20% Total body surface area involvement.
Does not require systemic immunosuppressive therapy for morphea.
No immunosuppressive systemic therapy 1 month prior to starting the study (methotrexate, mycophenolate mofetil, azathioprine, cyclosporine, cyclophosphamide, prednisone >=10 mg PO daily).
No immunomodulating topical therapy (topical steroids or topical calcineurin inhibitor), and no topical vitamin D analogue, 2 weeks prior to starting study.
No allergy to crisaborole or vehicle.
No known renal disease
Able to give informed consent.

Exclusion Criteria:Subjects fulfilling any of the following criteria are not eligible for inclusion in this study.

Clinical diagnosis of depression or history of suicidal ideation.
Pregnant or breastfeeding women, with pregnant women being defined as the state of a female after conception until the termination of gestation, confirmed by a positive urine human chorionic gonadotropin (hCG) laboratory test. Women with a positive urine hCG at any time during the study will be withdrawn from the study.","Crisaborole 2% ointment applied to affected skin twice per day.

Crisaborole: Apply Crisaborole 2% ointment to affected skin twice per day.",ChEMBL:CHEMBL484785 | DrugBank:DB05219 | PubChem:44591583,Crisaborole,N#Cc1ccc(Oc2ccc3c(c2)COB3O)cc1,D11AH06,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03359174,NCT03359174_EG000,No,All,Adult | Older Adult,Phase 2,2,"Inclusion Criteria:

Males and females ages 18-80
Diagnosis of large-duct PSC based on ERCP or MRCP, or liver biopsy findings without alternative explanation for findings, for at least 6 months.
Serum ALP levels persistently more than 1.5 x upper limit of normal over the past 6 months.
Ursodeoxycholic acid therapy must be discontinued for at least 3 months.
At least 2 forms of barrier protection for males and females of child-bearing age.

Exclusion Criteria:

Small duct PSC, overlap with autoimmune hepatitis, IgG4 disease or secondary sclerosing cholangitis.
Any malignancy, presently or within the past 5 years, except adequately treated non-melanoma skin cancer, carcinoma in situ of the cervix or in situ prostate cancer.
Viral hepatitis including hepatitis A, B, C, D, E.
Decompensated cirrhosis, or planned liver transplantation.
Recent diagnostic or therapeutic biliary manipulation (endoscopic, radiologic) within the past 3 months.
Ascending Cholangitis requiring antibiotics within the past 3 months.
Uncontrolled IBD, or IBD requiring the use of steroids.
Acute or Chronic Kidney Disease with serum creatinine > 2 mg/dL.
Allergy to ATRA or vitamin A compounds.","Fixed low dose of ATRA 10 mg twice daily for 24 weeks.

All-trans retinoic acid: Fixed low dose of ATRA 10 mg twice daily for 24 weeks.",ChEMBL:CHEMBL38 | ChEMBL:CHEMBL547 | ChEMBL:CHEMBL705 | DrugBank:DB00523 | DrugBank:DB00755 | DrugBank:DB00982 | PubChem:444795 | PubChem:449171 | PubChem:5282379,Tretinoin,CC(C=CC1=C(C)CCCC1(C)C)=CC=CC(C)=CC(=O)O,D10AD01 | D10AD04 | D10AD51 | D10AD54 | D10BA01 | D11AH04 | L01XF01 | L01XF02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03365635,NCT03365635_EG000,No,All,Adult | Older Adult,Phase 4,6,"Inclusion Criteria:

Hemodialysis patient
> age 18 years old
Hepatitis C antibody positive and Hepatitis C RNA Quantification positive
Hepatitis C genomes 1a, 1b, or 4
Prior Interferon , ribavirin treatment failures , partial responders, or intolerance to these treatment allowed to enroll
Not of reproductive potential - hemodialysis patients must have no menses for 12 months
Males with partners of reproductive potential as along a 2 reliable forms of contraception are used simultaneously during treatment and for 6 months after completion of treatment
Ability to understand the study procedures, alternative treatments available, risks of participating in the study, and voluntarily agree to participate

Exclusion Criteria:

Currently undergoing active treatment for HCV with a direct acting antiviral or have previously successfully been treated with a direct acting antiviral
Have moderate or severe hepatic disease - Child-Pugh B or C
Have evidence of decompensated liver disease manifested by ascites, gastric or variceal bleeding, hepatic encephalopathy, or other signs/symptoms of advanced liver disease
Co-administration of known heaptotoxic drugs including but not limited to : etofoxine, isoniazid, nitrofurantoin, phenytoin
Use of strong CYP3A/P-gp inhibitors, organic acid transporting polypeptide 1B1/3 inhibitors, strong inducers of cytochrome 450 3A (CYP3A), efavirenz, or other drugs which may interact with elbasvir/grazoprevir as per package insert
history of substance abuse with alcohol, intravenous drugs, psychotropics, narcotics, cocaine use within 1 year of screening for study
history of any condition, pre-study lab abnormality, or ECG abnormality or history of any illness which in the opinion of the investigators might confound the results of the study or pose additional risks from the administration of elbasvir/grazoprevir
Have evidence of history of chronic hepatitis not caused by HCV including but not limited to nonalcoholic steatohepatitis (NASH), drug induced hepatitis, and autoimmune hepatitis","Genotype 1a - treatment naive without NS5A polymorphism - Drug Intervention : Oral administration Elbasvir (50mg)/Grazoprevir (100mg) one tablet per day for 12 weeks

Elbasvir 50 MG / Grazoprevir 100 MG [Zepatier]: Same as described in arm description",ChEMBL:CHEMBL1643 | DrugBank:DB00811 | PubChem:37542,Ribavirin,NC(=O)c1ncn([C@@H]2O[C@H](CO)[C@@H](O)[C@H]2O)n1,J05AP01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03365635,NCT03365635_EG001,No,All,Adult | Older Adult,Phase 4,6,"Inclusion Criteria:

Hemodialysis patient
> age 18 years old
Hepatitis C antibody positive and Hepatitis C RNA Quantification positive
Hepatitis C genomes 1a, 1b, or 4
Prior Interferon , ribavirin treatment failures , partial responders, or intolerance to these treatment allowed to enroll
Not of reproductive potential - hemodialysis patients must have no menses for 12 months
Males with partners of reproductive potential as along a 2 reliable forms of contraception are used simultaneously during treatment and for 6 months after completion of treatment
Ability to understand the study procedures, alternative treatments available, risks of participating in the study, and voluntarily agree to participate

Exclusion Criteria:

Currently undergoing active treatment for HCV with a direct acting antiviral or have previously successfully been treated with a direct acting antiviral
Have moderate or severe hepatic disease - Child-Pugh B or C
Have evidence of decompensated liver disease manifested by ascites, gastric or variceal bleeding, hepatic encephalopathy, or other signs/symptoms of advanced liver disease
Co-administration of known heaptotoxic drugs including but not limited to : etofoxine, isoniazid, nitrofurantoin, phenytoin
Use of strong CYP3A/P-gp inhibitors, organic acid transporting polypeptide 1B1/3 inhibitors, strong inducers of cytochrome 450 3A (CYP3A), efavirenz, or other drugs which may interact with elbasvir/grazoprevir as per package insert
history of substance abuse with alcohol, intravenous drugs, psychotropics, narcotics, cocaine use within 1 year of screening for study
history of any condition, pre-study lab abnormality, or ECG abnormality or history of any illness which in the opinion of the investigators might confound the results of the study or pose additional risks from the administration of elbasvir/grazoprevir
Have evidence of history of chronic hepatitis not caused by HCV including but not limited to nonalcoholic steatohepatitis (NASH), drug induced hepatitis, and autoimmune hepatitis","Genotype 1a - treatment naiive with NS5A polymorphism - Oral administration of Elbasvir/Grazoprevir one tablet daily and ribavirin (200 mg) daily for 16 weeks weeks

Elbasvir 50 MG / Grazoprevir 100 MG [Zepatier]: Same as described in arm description",ChEMBL:CHEMBL1643 | DrugBank:DB00811 | PubChem:37542,Ribavirin,NC(=O)c1ncn([C@@H]2O[C@H](CO)[C@@H](O)[C@H]2O)n1,J05AP01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03365635,NCT03365635_EG002,No,All,Adult | Older Adult,Phase 4,6,"Inclusion Criteria:

Hemodialysis patient
> age 18 years old
Hepatitis C antibody positive and Hepatitis C RNA Quantification positive
Hepatitis C genomes 1a, 1b, or 4
Prior Interferon , ribavirin treatment failures , partial responders, or intolerance to these treatment allowed to enroll
Not of reproductive potential - hemodialysis patients must have no menses for 12 months
Males with partners of reproductive potential as along a 2 reliable forms of contraception are used simultaneously during treatment and for 6 months after completion of treatment
Ability to understand the study procedures, alternative treatments available, risks of participating in the study, and voluntarily agree to participate

Exclusion Criteria:

Currently undergoing active treatment for HCV with a direct acting antiviral or have previously successfully been treated with a direct acting antiviral
Have moderate or severe hepatic disease - Child-Pugh B or C
Have evidence of decompensated liver disease manifested by ascites, gastric or variceal bleeding, hepatic encephalopathy, or other signs/symptoms of advanced liver disease
Co-administration of known heaptotoxic drugs including but not limited to : etofoxine, isoniazid, nitrofurantoin, phenytoin
Use of strong CYP3A/P-gp inhibitors, organic acid transporting polypeptide 1B1/3 inhibitors, strong inducers of cytochrome 450 3A (CYP3A), efavirenz, or other drugs which may interact with elbasvir/grazoprevir as per package insert
history of substance abuse with alcohol, intravenous drugs, psychotropics, narcotics, cocaine use within 1 year of screening for study
history of any condition, pre-study lab abnormality, or ECG abnormality or history of any illness which in the opinion of the investigators might confound the results of the study or pose additional risks from the administration of elbasvir/grazoprevir
Have evidence of history of chronic hepatitis not caused by HCV including but not limited to nonalcoholic steatohepatitis (NASH), drug induced hepatitis, and autoimmune hepatitis","Genotype 1b-treatment naive - Oral administration of Elbasvir/Grazoprevir one daily for 12 weeks

Elbasvir 50 MG / Grazoprevir 100 MG [Zepatier]: Same as described in arm description",ChEMBL:CHEMBL1643 | DrugBank:DB00811 | PubChem:37542,Ribavirin,NC(=O)c1ncn([C@@H]2O[C@H](CO)[C@@H](O)[C@H]2O)n1,J05AP01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03365635,NCT03365635_EG003,No,All,Adult | Older Adult,Phase 4,6,"Inclusion Criteria:

Hemodialysis patient
> age 18 years old
Hepatitis C antibody positive and Hepatitis C RNA Quantification positive
Hepatitis C genomes 1a, 1b, or 4
Prior Interferon , ribavirin treatment failures , partial responders, or intolerance to these treatment allowed to enroll
Not of reproductive potential - hemodialysis patients must have no menses for 12 months
Males with partners of reproductive potential as along a 2 reliable forms of contraception are used simultaneously during treatment and for 6 months after completion of treatment
Ability to understand the study procedures, alternative treatments available, risks of participating in the study, and voluntarily agree to participate

Exclusion Criteria:

Currently undergoing active treatment for HCV with a direct acting antiviral or have previously successfully been treated with a direct acting antiviral
Have moderate or severe hepatic disease - Child-Pugh B or C
Have evidence of decompensated liver disease manifested by ascites, gastric or variceal bleeding, hepatic encephalopathy, or other signs/symptoms of advanced liver disease
Co-administration of known heaptotoxic drugs including but not limited to : etofoxine, isoniazid, nitrofurantoin, phenytoin
Use of strong CYP3A/P-gp inhibitors, organic acid transporting polypeptide 1B1/3 inhibitors, strong inducers of cytochrome 450 3A (CYP3A), efavirenz, or other drugs which may interact with elbasvir/grazoprevir as per package insert
history of substance abuse with alcohol, intravenous drugs, psychotropics, narcotics, cocaine use within 1 year of screening for study
history of any condition, pre-study lab abnormality, or ECG abnormality or history of any illness which in the opinion of the investigators might confound the results of the study or pose additional risks from the administration of elbasvir/grazoprevir
Have evidence of history of chronic hepatitis not caused by HCV including but not limited to nonalcoholic steatohepatitis (NASH), drug induced hepatitis, and autoimmune hepatitis","Genotype 1a or 1b - prior treatment with INF or HCV NS3/4A protease inhibitor - oral administration of Elbasvir/Grazoprevir and ribavirin each once daily for 12 weeks

Elbasvir 50 MG / Grazoprevir 100 MG [Zepatier]: Same as described in arm description",ChEMBL:CHEMBL1643 | DrugBank:DB00811 | PubChem:37542,Ribavirin,NC(=O)c1ncn([C@@H]2O[C@H](CO)[C@@H](O)[C@H]2O)n1,J05AP01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03365635,NCT03365635_EG004,No,All,Adult | Older Adult,Phase 4,6,"Inclusion Criteria:

Hemodialysis patient
> age 18 years old
Hepatitis C antibody positive and Hepatitis C RNA Quantification positive
Hepatitis C genomes 1a, 1b, or 4
Prior Interferon , ribavirin treatment failures , partial responders, or intolerance to these treatment allowed to enroll
Not of reproductive potential - hemodialysis patients must have no menses for 12 months
Males with partners of reproductive potential as along a 2 reliable forms of contraception are used simultaneously during treatment and for 6 months after completion of treatment
Ability to understand the study procedures, alternative treatments available, risks of participating in the study, and voluntarily agree to participate

Exclusion Criteria:

Currently undergoing active treatment for HCV with a direct acting antiviral or have previously successfully been treated with a direct acting antiviral
Have moderate or severe hepatic disease - Child-Pugh B or C
Have evidence of decompensated liver disease manifested by ascites, gastric or variceal bleeding, hepatic encephalopathy, or other signs/symptoms of advanced liver disease
Co-administration of known heaptotoxic drugs including but not limited to : etofoxine, isoniazid, nitrofurantoin, phenytoin
Use of strong CYP3A/P-gp inhibitors, organic acid transporting polypeptide 1B1/3 inhibitors, strong inducers of cytochrome 450 3A (CYP3A), efavirenz, or other drugs which may interact with elbasvir/grazoprevir as per package insert
history of substance abuse with alcohol, intravenous drugs, psychotropics, narcotics, cocaine use within 1 year of screening for study
history of any condition, pre-study lab abnormality, or ECG abnormality or history of any illness which in the opinion of the investigators might confound the results of the study or pose additional risks from the administration of elbasvir/grazoprevir
Have evidence of history of chronic hepatitis not caused by HCV including but not limited to nonalcoholic steatohepatitis (NASH), drug induced hepatitis, and autoimmune hepatitis","(e) Genotype 4 - treatment naive - oral administration of Elbasvir/Grazoprevir one daily for 12 weeks

Elbasvir 50 MG / Grazoprevir 100 MG [Zepatier]: Same as described in arm description",ChEMBL:CHEMBL1643 | DrugBank:DB00811 | PubChem:37542,Ribavirin,NC(=O)c1ncn([C@@H]2O[C@H](CO)[C@@H](O)[C@H]2O)n1,J05AP01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03365635,NCT03365635_EG005,No,All,Adult | Older Adult,Phase 4,6,"Inclusion Criteria:

Hemodialysis patient
> age 18 years old
Hepatitis C antibody positive and Hepatitis C RNA Quantification positive
Hepatitis C genomes 1a, 1b, or 4
Prior Interferon , ribavirin treatment failures , partial responders, or intolerance to these treatment allowed to enroll
Not of reproductive potential - hemodialysis patients must have no menses for 12 months
Males with partners of reproductive potential as along a 2 reliable forms of contraception are used simultaneously during treatment and for 6 months after completion of treatment
Ability to understand the study procedures, alternative treatments available, risks of participating in the study, and voluntarily agree to participate

Exclusion Criteria:

Currently undergoing active treatment for HCV with a direct acting antiviral or have previously successfully been treated with a direct acting antiviral
Have moderate or severe hepatic disease - Child-Pugh B or C
Have evidence of decompensated liver disease manifested by ascites, gastric or variceal bleeding, hepatic encephalopathy, or other signs/symptoms of advanced liver disease
Co-administration of known heaptotoxic drugs including but not limited to : etofoxine, isoniazid, nitrofurantoin, phenytoin
Use of strong CYP3A/P-gp inhibitors, organic acid transporting polypeptide 1B1/3 inhibitors, strong inducers of cytochrome 450 3A (CYP3A), efavirenz, or other drugs which may interact with elbasvir/grazoprevir as per package insert
history of substance abuse with alcohol, intravenous drugs, psychotropics, narcotics, cocaine use within 1 year of screening for study
history of any condition, pre-study lab abnormality, or ECG abnormality or history of any illness which in the opinion of the investigators might confound the results of the study or pose additional risks from the administration of elbasvir/grazoprevir
Have evidence of history of chronic hepatitis not caused by HCV including but not limited to nonalcoholic steatohepatitis (NASH), drug induced hepatitis, and autoimmune hepatitis","Genotype 4 -prior treatment - oral administration of Elbasvir/Grazoprevir and ribavirin each once per day for 16 weeks

Elbasvir 50 MG / Grazoprevir 100 MG [Zepatier]: Same as described in arm description",ChEMBL:CHEMBL1643 | DrugBank:DB00811 | PubChem:37542,Ribavirin,NC(=O)c1ncn([C@@H]2O[C@H](CO)[C@@H](O)[C@H]2O)n1,J05AP01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03380091,NCT03380091_EG001,Accepts Healthy Volunteers,Female,Adult,Phase 4,5,"Inclusion Criteria:

Polycystic Ovary Syndrome diagnosis (Rotterdam Criteria)
Vitamin D insufficiency (serum Vitamin D <30 ng/mL)
Insulin resistance
Mild or greater severity of depression by Beck Depression Inventory-II

Exclusion Criteria:

Current metformin use
Vitamin D supplementation of > 50,000 IU following confirmation of Vitamin D insufficiency
Insulin-dependent diabetes mellitus
Pregnancy or breastfeeding
Untreated hypothyroidism
Current active substance abuse
Other major medical comorbidity: renal or hepatic dysfunction, severe pulmonary
Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data","Metformin 1000 mg PO bid

Metformin: Oral medication daily",ChEMBL:CHEMBL1431 | DrugBank:DB00331 | PubChem:4091,Metformin,CN(C)C(=N)NC(=N)N,A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03394924,NCT03394924_EG000,No,All,Adult | Older Adult,Phase 2,31,"Inclusion Criteria:

An informed consent document signed and dated by the subject.
Male and female subjects of any ethnic origin between the ages of 18 and 75 years, inclusive

Male or female with a diagnosis of PBC by at least two of the following criteria:

History of ALP above ULN for at least six months
Positive Anti-Mitochondrial Antibodies (AMA) titers (>1/40 on immunofluorescence or M2 positive by enzyme linked immunosorbent assay (ELISA) or positive PBC-specific antinuclear antibodies)
For subjects with no documented liver biopsy performed within 2 years, subjects must undergo a transient elastography (Fibroscan) showing liver stiffness < 14.0 kPA
Must be on a stable dose of UDCA12-20 mg/kg/day for at least 6 months prior to Screening or intolerant of UDCA in the opinion of the Investigator (no UDCA for at least 12 weeks prior to Screening)
Alkaline Phosphatase (ALP) ≥ 1.67 × ULN and/or total bilirubin >ULN but < 2×ULN (<2.4 mg/dL)
Subjects must have Screening laboratory values for Hepatitis B surface antigen (HBsAg), anti-HCV antibodies and HCV RNA negative and Human Immunodeficiency Virus (HIV) 1 and 2 antibodies (Ab) as seronegative. Note: subjects previously infected by chronic hepatitis C and treated with direct acting antivirals (DAAs) with sustained virologic response (SVR) for at least 3 years will be allowed.
Female subjects of childbearing potential must agree to use two effective methods of contraception from the date of Screening until 90 days after the last dose of EDP-305.
All male participants who have not had a vasectomy must use effective contraception from Day -1 to 90 days after their last dose of study drug.
Male subjects must agree to refrain from sperm donation from the date of Screening until 90 days after their last dose of study drug
Screening body mass index (BMI) of ≥18 kg/m2
Subject must be willing and able to adhere to the assessments, visit schedule, prohibitions and restrictions, as described in this protocol

Exclusion Criteria:

Laboratory Screening Results:

AST >5 x ULN
ALT >5 x ULN
Patients with Gilbert's syndrome will not be allowed due to interpretability of bilirubin levels
Total white blood cells (WBC) <3000 cells/mm3
Absolute neutrophil count (ANC) <1500 cells/mm3
Platelet count <140,000/mm3
Prothrombin time (international normalized ratio, INR) >1.2
Serum creatinine >2 mg/dL or creatinine clearance <60 mL/min (based on Cockroft-Gault Method)
Suspected to have relevant nonalcoholic fatty liver disease (NAFLD) as based on the judgment of the Investigator at Screening
Use of immunosuppressants known to have an effect on the liver of patients with PBC (eg, colchicine, methotrexate, azathioprine, or systemic steroids) in the three months preceding screening
Current use of fibrates, including fenofibrates. Note: Subjects who discontinued fibrates for at least 3 months before Screening can participate
Use of an experimental treatment for PBC within the past 6 months
Co-existing liver or biliary diseases, such as primary sclerosing cholangitis, choledocholithiasis, acute or chronic hepatitis, autoimmune hepatitis, alcoholic liver disease, nonalcoholic steatohepatitis (NASH), acute infection of bile duct system or gall bladder, history of gastrointestinal bleeding (secondary to portal hypertension), cirrhosis, cholangiocarcinoma diagnosed or suspected liver cancers
Cirrhosis with or without complications, including history or presence of: spontaneous bacterial peritonitis, hepatocellular carcinoma
Hepatorenal syndrome (type I or II) or Screening serum creatinine > 2 mg/dL (178 μmol/L)
Prior variceal hemorrhage, uncontrolled encephalopathy, Child-Pugh Class A, B and C, esophageal varices, or refractory ascites within the previous 6 months of Screening (defined as date informed consent signed)
Medical conditions that may cause nonhepatic increases in ALP (e.g., Paget's disease)
Use of a new statin regimen from Screening and throughout study duration. NOTE: Subjects on a stable dose of statins for at least 3 months prior to Screening are allowed. No dose modification during the study will be allowed.
Use of immunosuppressants (eg, systemic corticosteroids) for more than 2 consecutive weeks in duration within 1 year prior to Screening.",Participants took EDP-305 1 mg as an oral tablet once daily for 12 weeks.,PubChem:121428882,"US10208081, Example 3",CCC1C(O)C2C3CCC(C(C)CCNC(=O)NS(=O)(=O)c4ccc(C(C)(C)C)cc4)C3(C)CCC2C2(C)CCC(O)CC12,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT03394924,NCT03394924_EG001,No,All,Adult | Older Adult,Phase 2,28,"Inclusion Criteria:

An informed consent document signed and dated by the subject.
Male and female subjects of any ethnic origin between the ages of 18 and 75 years, inclusive

Male or female with a diagnosis of PBC by at least two of the following criteria:

History of ALP above ULN for at least six months
Positive Anti-Mitochondrial Antibodies (AMA) titers (>1/40 on immunofluorescence or M2 positive by enzyme linked immunosorbent assay (ELISA) or positive PBC-specific antinuclear antibodies)
For subjects with no documented liver biopsy performed within 2 years, subjects must undergo a transient elastography (Fibroscan) showing liver stiffness < 14.0 kPA
Must be on a stable dose of UDCA12-20 mg/kg/day for at least 6 months prior to Screening or intolerant of UDCA in the opinion of the Investigator (no UDCA for at least 12 weeks prior to Screening)
Alkaline Phosphatase (ALP) ≥ 1.67 × ULN and/or total bilirubin >ULN but < 2×ULN (<2.4 mg/dL)
Subjects must have Screening laboratory values for Hepatitis B surface antigen (HBsAg), anti-HCV antibodies and HCV RNA negative and Human Immunodeficiency Virus (HIV) 1 and 2 antibodies (Ab) as seronegative. Note: subjects previously infected by chronic hepatitis C and treated with direct acting antivirals (DAAs) with sustained virologic response (SVR) for at least 3 years will be allowed.
Female subjects of childbearing potential must agree to use two effective methods of contraception from the date of Screening until 90 days after the last dose of EDP-305.
All male participants who have not had a vasectomy must use effective contraception from Day -1 to 90 days after their last dose of study drug.
Male subjects must agree to refrain from sperm donation from the date of Screening until 90 days after their last dose of study drug
Screening body mass index (BMI) of ≥18 kg/m2
Subject must be willing and able to adhere to the assessments, visit schedule, prohibitions and restrictions, as described in this protocol

Exclusion Criteria:

Laboratory Screening Results:

AST >5 x ULN
ALT >5 x ULN
Patients with Gilbert's syndrome will not be allowed due to interpretability of bilirubin levels
Total white blood cells (WBC) <3000 cells/mm3
Absolute neutrophil count (ANC) <1500 cells/mm3
Platelet count <140,000/mm3
Prothrombin time (international normalized ratio, INR) >1.2
Serum creatinine >2 mg/dL or creatinine clearance <60 mL/min (based on Cockroft-Gault Method)
Suspected to have relevant nonalcoholic fatty liver disease (NAFLD) as based on the judgment of the Investigator at Screening
Use of immunosuppressants known to have an effect on the liver of patients with PBC (eg, colchicine, methotrexate, azathioprine, or systemic steroids) in the three months preceding screening
Current use of fibrates, including fenofibrates. Note: Subjects who discontinued fibrates for at least 3 months before Screening can participate
Use of an experimental treatment for PBC within the past 6 months
Co-existing liver or biliary diseases, such as primary sclerosing cholangitis, choledocholithiasis, acute or chronic hepatitis, autoimmune hepatitis, alcoholic liver disease, nonalcoholic steatohepatitis (NASH), acute infection of bile duct system or gall bladder, history of gastrointestinal bleeding (secondary to portal hypertension), cirrhosis, cholangiocarcinoma diagnosed or suspected liver cancers
Cirrhosis with or without complications, including history or presence of: spontaneous bacterial peritonitis, hepatocellular carcinoma
Hepatorenal syndrome (type I or II) or Screening serum creatinine > 2 mg/dL (178 μmol/L)
Prior variceal hemorrhage, uncontrolled encephalopathy, Child-Pugh Class A, B and C, esophageal varices, or refractory ascites within the previous 6 months of Screening (defined as date informed consent signed)
Medical conditions that may cause nonhepatic increases in ALP (e.g., Paget's disease)
Use of a new statin regimen from Screening and throughout study duration. NOTE: Subjects on a stable dose of statins for at least 3 months prior to Screening are allowed. No dose modification during the study will be allowed.
Use of immunosuppressants (eg, systemic corticosteroids) for more than 2 consecutive weeks in duration within 1 year prior to Screening.",Participants took EDP-305 2.5 mg as an oral tablet once daily for 12 weeks.,PubChem:121428882,"US10208081, Example 3",CCC1C(O)C2C3CCC(C(C)CCNC(=O)NS(=O)(=O)c4ccc(C(C)(C)C)cc4)C3(C)CCC2C2(C)CCC(O)CC12,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT03398356,NCT03398356_EG000,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 4,15,"Inclusion Criteria for treated groups ( A or B):

age: 40-65 years;
pre-diabetic status based on fasting plasma glucose (FPG) and / or OGTT;
without metformin before;
without ischemic heart disease in history;
without a stroke in a history;
without PAOD (peripheral arterial occlusive disease) in a history;
without active cancer in a history

Exclusion Criteria for treated groups (A or B):

age <40 or >65;
diabetes;
taking metformin before study;
active cancer;
history of macro-angiopathy (ischemic heart disease, stroke or TIA, PAOD);
serious gastrointestinal disease that may affect metformin tolerance;
renal failure with GFR<45 ml/min/1.73m2;
alanin transaminase > 3 x ULN

Inclusion criteria for healthy volunteers:

age: 40-65 years;
no carbo-hydrates disturbances (based on fasting plasma glucose (FPG) and/or OGTT);
without metformin before;
without ischemic heart disease in history;
without a stroke in a history;
without PAOD (peripheral arterial occlusive disease) in a history;
without active cancer in a history","metformin dose 3 x 500 mg

Metformin: for group A: 12 weeks metformin treatment in a final dose 3 x 500 mg

for group B: 3 weeks metformin treatment in a dose 3 x 500 mg, next: 3 weeks metformin treatment in a final dose 3 x 1000mg, next: 3 weeks metformin treatment in a dose 3 x 500 mg.",ChEMBL:CHEMBL1431 | DrugBank:DB00331 | PubChem:4091,Metformin,CN(C)C(=N)NC(=N)N,A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03398356,NCT03398356_EG001,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 4,21,"Inclusion Criteria for treated groups ( A or B):

age: 40-65 years;
pre-diabetic status based on fasting plasma glucose (FPG) and / or OGTT;
without metformin before;
without ischemic heart disease in history;
without a stroke in a history;
without PAOD (peripheral arterial occlusive disease) in a history;
without active cancer in a history

Exclusion Criteria for treated groups (A or B):

age <40 or >65;
diabetes;
taking metformin before study;
active cancer;
history of macro-angiopathy (ischemic heart disease, stroke or TIA, PAOD);
serious gastrointestinal disease that may affect metformin tolerance;
renal failure with GFR<45 ml/min/1.73m2;
alanin transaminase > 3 x ULN

Inclusion criteria for healthy volunteers:

age: 40-65 years;
no carbo-hydrates disturbances (based on fasting plasma glucose (FPG) and/or OGTT);
without metformin before;
without ischemic heart disease in history;
without a stroke in a history;
without PAOD (peripheral arterial occlusive disease) in a history;
without active cancer in a history","metformin dose 3 x 1000 mg

Metformin: for group A: 12 weeks metformin treatment in a final dose 3 x 500 mg

for group B: 3 weeks metformin treatment in a dose 3 x 500 mg, next: 3 weeks metformin treatment in a final dose 3 x 1000mg, next: 3 weeks metformin treatment in a dose 3 x 500 mg.",ChEMBL:CHEMBL1431 | DrugBank:DB00331 | PubChem:4091,Metformin,CN(C)C(=N)NC(=N)N,A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03416127,NCT03416127_EG001,No,All,Adult,Phase 2,12,"Inclusion Criteria:

Patients both sexes
Age between 30 and 60 years
Mild to moderate physical activity
Stable body weight for at least 12 weeks prior to the study
BMI 25.0 - 34.9 kg/m2
Diabetes mellitus type 2 of recent diagnosis without pharmacological treatment, with one of the following criteria (fasting blood glucose levels >126 mg/dl; or postprandial blood glucose levels after an oral glucose tolerance test with 75 of oral glucose >200 mg/dl
Informed consent signed

Exclusion Criteria:

Women with confirmed or suspected pregnancy
Women under lactation and/or puerperium
Previous treatment for glucose
Fasting glucose ≥250 mg/dL
Known uncontrolled renal, hepatic, heart or thyroid diseased
Hypersensibility to ingredients of intervention
Known allergies to bee stings or their derived products
Triglycerides ≥500 mg/dL
Total cholesterol ≥240 mg/dL","Metformin capsules, 850 mg, two times per day before break-fast and dinner during 12 weeks.

Metformin: Metformin capsules, 850 mg, two times per day before break-fast and dinner during 12 weeks.",ChEMBL:CHEMBL1431 | DrugBank:DB00331 | PubChem:4091,Metformin,CN(C)C(=N)NC(=N)N,A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03433703,NCT03433703_EG000,No,All,Adult | Older Adult,Phase 2,2,"Key Inclusion Criteria:

Participants must have confirmed diagnosis of unresectable Hepatocellular Carcinoma (uHCC) with any of the following criteria:

Histologically or cytologically confirmed diagnosis of uHCC
Clinically confirmed diagnosis of uHCC according to American Association for the Study of Liver Diseases criteria, including cirrhosis of any etiology or with chronic hepatitis B or C infection criteria

At least one measurable target lesion regardless if hepatic or non-hepatic according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) meeting the following criteria:

Hepatic lesion

The lesion can be accurately measured in at least one dimension as ≥1.0 centimeters (cm) (viable tumor for typical; and longest diameter for atypical), and
The lesion is suitable for repeat measurement,

Nonhepatic lesion

Lymph node lesion that measures at least one dimension as ≥1.5 cm in the short axis
Non-nodal lesion that measures ≥1.0 cm in the longest diameter Lesions previously treated with radiotherapy or locoregional therapy must show radiographic evidence of disease progression to be deemed a target lesion.
Participants categorized on the Barcelona Clinic Liver Cancer staging system to Stage B (not applicable for transarterial chemoembolization) or Stage C
Adequate bone marrow function, liver function, blood coagulation function, renal function, and pancreatic function as assessed by laboratory tests.
Adequately controlled blood pressure (BP) with up to 3 antihypertensive agents, defined as BP ≤150/90 millimeters of mercury (mmHg) at Screening and no change in antihypertensive therapy within 1 week prior to Cycle 1/Day 1
Child-Pugh A
Eastern Cooperative Oncology Group Performance Status of 0 or 1
Survival expectation of 12 weeks or longer before starting study drug

Key Exclusion Criteria:

Imaging findings for HCC corresponding to any of the following:

HCC with ≥50% liver occupation
Clear invasion into the bile duct
Portal vein invasion at the main portal branch (Vp4)
Participants who have received any systemic chemotherapy, including sorafenib, regorafenib or other anti-vascular endothelial growth factor therapy, nivolumab, or any systemic investigational anticancer agents, including lenvatinib, for advanced/uHCC.
Participants who have received any anticancer therapy (including surgery, percutaneous ethanol injection, radio frequency ablation, transarterial [chemo] embolization, hepatic intra-arterial chemotherapy, biological, immunotherapy, hormonal, or radiotherapy) or any blood enhancing treatment (including blood transfusion, blood products, or agents that stimulate blood cell production, e.g., granulocyte colony-stimulating factor) within 28 days prior to the first dose of lenvatinib study treatment.
Participants who have not recovered from toxicities as a result of prior anticancer therapy such as the local hepatic injection chemotherapy or any prior therapy for other cancer types.
Significant cardiovascular impairment within 6 months of the first dose of study drug
Prolongation of QT interval corrected for heart rate using Fridericia's correction (QTcF) to >480 milliseconds (ms)
Gastrointestinal malabsorption or any other condition that might affect the absorption of lenvatinib in the opinion of the investigator
Bleeding or thrombotic disorders or use of anticoagulants such as warfarin or similar agents requiring therapeutic international normalized ratio monitoring
Gastrointestinal bleeding event or active hemoptysis (bright red blood of at least half teaspoon) within 28 days prior to the first dose of lenvatinib study treatment
Gastric or esophageal varices that require treatment
Active malignancy (except for HCC or definitively treated melanoma in-situ, basal or squamous cell carcinoma of the skin, or carcinoma in-situ of the cervix) within the past 36 months
Any history of or current brain or subdural metastases
Participants having >1+ proteinuria on urine dipstick testing will undergo 24-hour urine collection for quantitative assessment of proteinuria. Participants with urine protein ≥1 grams/24 hour will be ineligible
Arterial-portal venous shunt or arterial-venous shunt preventing proper diagnosis of tumor
Any medical or other condition that in the opinion of the investigator would preclude the participant's participation in a clinical study
Known intolerance to lenvatinib or any of the excipients
Human immunodeficiency virus positive or active infection requiring treatment (except for hepatitis virus)
Any history of drug or alcohol dependency or abuse within the prior 2 years
Major surgery within 3 weeks prior to the first dose of lenvatinib study treatment or scheduled for surgery during the study
Participant has had a liver transplant
Females who are breastfeeding or pregnant at Screening or Baseline
Females of childbearing potential who within 28 days before study entry did not use a highly effective method of contraception or do not agree to use a highly effective method of contraception throughout the entire study period","Participants received lenvatinib 8 or 12 mg, capsule, orally, once daily in 28 day continuous cycles until PD, development of unacceptable toxicity, participant request, withdrawal of consent, or study termination by the sponsor. BW >=60 kg - lenvatinib 12 mg (taken as three 4 mg capsules); BW <60 kg - lenvatinib 8 mg (taken as two 4 mg capsules).",ChEMBL:CHEMBL1289601 | DrugBank:DB09078 | PubChem:9823820,Lenvatinib,COc1cc2nccc(Oc3ccc(NC(=O)NC4CC4)c(Cl)c3)c2cc1C(N)=O,L01EX08 | L01XE29,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT03445390,NCT03445390_EG000,No,All,Adult | Older Adult,Phase 4,27,"Inclusion Criteria:

Patients with a diagnosis of bilateral moyamoya disease scheduled for bilateral external-carotid to internal-carotid bypass surgery to be done in two stages.

Exclusion Criteria:

Allergy or history of reaction to acetaminophen. Patients with liver disease. Anyone not able to provide informed consent.",Patients were administered intravenous acetaminophen (1 g IV) twice.,ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03446846,NCT03446846_EG000,No,All,Adult | Older Adult,Phase 2,91,"Inclusion Criteria:

Participants must be able to read and understand the consent forms, complete study-related procedures, and communicate with the study staff.
Participants must have provided written consent to participate in the study and understand that they are free to withdraw from the study at any time.
Participants must have signed the informed consent form for pharmacogenomic research indicating willingness to participate in the pharmacogenomic component of the study in order to participate in the optional pharmacogenomic component of this study. Refusal to consent for this component does not exclude a participant from participation in the clinical study.
Participants must be aged 18 to 65 years, inclusive, at Screening (Visit 1).
Meet Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5) criteria for diagnosis of moderate or severe major depression with anxious distress and without psychotic features at Screening based on clinical assessment and on the Structured Clinical Interview for DSM-5 (SCID-5). Their major depressive episode must be deemed ""valid"" using the Massachusetts General Hospital (MGH) State versus trait; Assessability; Face validity; Ecological validity; and Rule of three Ps [pervasive, persistent, and pathological] (SAFER) criteria interview administered by remote, independent raters.
Participants must be within a body mass index (BMI) of ≥ 18 to < 35 kg/m2 (BMI = weight (kg)/height(m)2] at Screening (Visit 1).
Participants have a history of at least one previous episode of depression prior to the current episode.
Participant must have been treated with an antidepressant administered at an adequate dose and duration in the past for the treatment of Major Depression. An adequate treatment is defined as an antidepressant treatment for at least 4 weeks at at least the minimum therapeutic dose, for any particular antidepressant.
Current major depressive episode of at least 4 weeks in duration.
At Screening (Visit 1) and Baseline (Visit 2), participants must have a score ≥ 40 on the patient rated Inventory of Depressive Symptoms self-report (IDS-SR30).
At Screening (Visit 1) and Baseline (Visit 2), participants must have a score ≥ 18 on Hamilton Anxiety Scale (HAM-A).
At Screening (Visit 1) and Baseline (Visit 2), participants must have a score ≥ 4 on the investigator-rated Clinical Global Impression of Severity Scale (CGI-S).
Participants must be outpatients at the time of randomization (Baseline [Day 1]).
Participants must be in good general health prior to study participation with no clinically relevant abnormalities as assessed by the investigator and determined by: medical history, physical examination, vital signs, blood chemistry, hematology, urinalysis, and electrocardiogram (ECG).

If female, the participant must:

be post-menopausal, or
have had a hysterectomy or tubal ligation or be otherwise incapable of pregnancy, or
must agree to consistent use of 2 methods of contraception for the duration of the study and until 90 days after the last dose of study medication.
Female participants of childbearing potential must have a negative serum pregnancy test at Screening (Visit 1) and negative serum and urine pregnancy test at Baseline (Visit 2).

Exclusion Criteria:

A DSM-5 diagnosis of current (active): panic disorder, obsessive compulsive disorder (OCD), post-traumatic stress disorder (PTSD), anorexia nervosa, or bulimia nervosa.
History or current diagnosis of a psychotic disorder, bipolar disorder, mental retardation, or borderline personality disorders, mood disorder with postpartum onset, somatoform disorders, fibromyalgia, or idiopathic medical conditions.
At significant clinical risk for suicidal or violent behavior.
History of treatment within last 6 months with electroconvulsive therapy (ECT), Vagus Nerve Stimulation (VNS), Deep Brain Stimulation (DBS), or Transcranial Magnetic Stimulation (TMS).
Potential participant who in the opinion of the investigator should not discontinue, or participate in washout of a prohibited concomitant medication.
Potential participant who demonstrates a greater than 25% decrease in depressive symptoms as reflected by the IDS-SR30 total score from Screening visit to Baseline visit.
Active cardiovascular disease (including but not limited to: atrial fibrillation or flutter, second and third-degree atrioventricular heart block, resting supraventricular tachycardia > 100 beats per minute, unstable ischemic heart disease, valvular abnormality, sick sinus syndrome or other condition requiring pacemaker) or diastolic blood pressure > 105 mmHg.
Any serious, untreated, or unstable illnesses, such as: liver or renal insufficiency.
Any significant pulmonary, endocrine, or metabolic disturbances.
Documented disease of the central nervous system that could interfere with the study assessments (including by not limited to: stroke, tumor, multiple sclerosis, Parkinson's disease, Alzheimer's disease, Huntington's disease, seizure disorder requiring current anti-convulsants, traumatic brain injury or trauma, and neurosyphilis.
Hypothyroidism or hyperthyroidism, unless stabilized by appropriate medication for at least 3 months prior to Screening (a normal thyroid-stimulating hormone [TSH] is required prior to randomization at Baseline).
Any medical condition that can potentially alter oral enteral absorption (e.g., gastrectomy), metabolism (e.g., liver failure), or excretion (e.g., renal failure) of the study drug.
History of alcohol or substance use disorders (except nicotine and caffeine) meeting DSM-5 criteria within 1-year prior to Screening visit.
Positive alcohol and urine drug screen for opiates, cocaine, barbiturates, tetrahydrocannabinol, methadone, tricyclic antidepressants, benzodiazepines, and amphetamine/methamphetamine at Screening or Baseline. Patients with positive testing at Screening due to prescribed benzodiazepines, tricyclic antidepressants, barbiturates or opiates are accepted but must test negative at Baseline.
Male participants who have pregnant partners.
Received an experimental drug or used an experimental medical device within 60 days before the planned start of treatment (Day 1) or have participated in 2 or more clinical trials in the previous 2 years.
QT interval corrected with Fridericia's formula (QTcF) at Screening or Baseline greater than 450 msec for males and 470 msec for females.
Positive hepatitis B surface antigen, or hepatitis C antibody or Human Immunodeficiency Virus (HIV) 1 and 2 antibodies at Screening.
Employees of the investigator or study center, when the employee has direct involvement in the proposed study or other studies under the direction of that investigator or study center; also family members of the employee or the investigator.",MIN-117 5.0 mg taken as two MIN-117 2.5 mg capsules as a single dose orally once daily.,PubChem:25061466,"1-Piperidineethanol, 4-(3,4-dichlorophenyl)-alpha-(((2-(5-methyl-1,3,4-oxadiazol-2-yl)-4-benzofuranyl)oxy)methyl)-, monohydrochloride, (alphaS)-",Cc1nnc(-c2cc3c(OCC(O)CN4CCC(c5ccc(Cl)c(Cl)c5)CC4)cccc3o2)o1.Cl,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03446846,NCT03446846_EG001,No,All,Adult | Older Adult,Phase 2,92,"Inclusion Criteria:

Participants must be able to read and understand the consent forms, complete study-related procedures, and communicate with the study staff.
Participants must have provided written consent to participate in the study and understand that they are free to withdraw from the study at any time.
Participants must have signed the informed consent form for pharmacogenomic research indicating willingness to participate in the pharmacogenomic component of the study in order to participate in the optional pharmacogenomic component of this study. Refusal to consent for this component does not exclude a participant from participation in the clinical study.
Participants must be aged 18 to 65 years, inclusive, at Screening (Visit 1).
Meet Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5) criteria for diagnosis of moderate or severe major depression with anxious distress and without psychotic features at Screening based on clinical assessment and on the Structured Clinical Interview for DSM-5 (SCID-5). Their major depressive episode must be deemed ""valid"" using the Massachusetts General Hospital (MGH) State versus trait; Assessability; Face validity; Ecological validity; and Rule of three Ps [pervasive, persistent, and pathological] (SAFER) criteria interview administered by remote, independent raters.
Participants must be within a body mass index (BMI) of ≥ 18 to < 35 kg/m2 (BMI = weight (kg)/height(m)2] at Screening (Visit 1).
Participants have a history of at least one previous episode of depression prior to the current episode.
Participant must have been treated with an antidepressant administered at an adequate dose and duration in the past for the treatment of Major Depression. An adequate treatment is defined as an antidepressant treatment for at least 4 weeks at at least the minimum therapeutic dose, for any particular antidepressant.
Current major depressive episode of at least 4 weeks in duration.
At Screening (Visit 1) and Baseline (Visit 2), participants must have a score ≥ 40 on the patient rated Inventory of Depressive Symptoms self-report (IDS-SR30).
At Screening (Visit 1) and Baseline (Visit 2), participants must have a score ≥ 18 on Hamilton Anxiety Scale (HAM-A).
At Screening (Visit 1) and Baseline (Visit 2), participants must have a score ≥ 4 on the investigator-rated Clinical Global Impression of Severity Scale (CGI-S).
Participants must be outpatients at the time of randomization (Baseline [Day 1]).
Participants must be in good general health prior to study participation with no clinically relevant abnormalities as assessed by the investigator and determined by: medical history, physical examination, vital signs, blood chemistry, hematology, urinalysis, and electrocardiogram (ECG).

If female, the participant must:

be post-menopausal, or
have had a hysterectomy or tubal ligation or be otherwise incapable of pregnancy, or
must agree to consistent use of 2 methods of contraception for the duration of the study and until 90 days after the last dose of study medication.
Female participants of childbearing potential must have a negative serum pregnancy test at Screening (Visit 1) and negative serum and urine pregnancy test at Baseline (Visit 2).

Exclusion Criteria:

A DSM-5 diagnosis of current (active): panic disorder, obsessive compulsive disorder (OCD), post-traumatic stress disorder (PTSD), anorexia nervosa, or bulimia nervosa.
History or current diagnosis of a psychotic disorder, bipolar disorder, mental retardation, or borderline personality disorders, mood disorder with postpartum onset, somatoform disorders, fibromyalgia, or idiopathic medical conditions.
At significant clinical risk for suicidal or violent behavior.
History of treatment within last 6 months with electroconvulsive therapy (ECT), Vagus Nerve Stimulation (VNS), Deep Brain Stimulation (DBS), or Transcranial Magnetic Stimulation (TMS).
Potential participant who in the opinion of the investigator should not discontinue, or participate in washout of a prohibited concomitant medication.
Potential participant who demonstrates a greater than 25% decrease in depressive symptoms as reflected by the IDS-SR30 total score from Screening visit to Baseline visit.
Active cardiovascular disease (including but not limited to: atrial fibrillation or flutter, second and third-degree atrioventricular heart block, resting supraventricular tachycardia > 100 beats per minute, unstable ischemic heart disease, valvular abnormality, sick sinus syndrome or other condition requiring pacemaker) or diastolic blood pressure > 105 mmHg.
Any serious, untreated, or unstable illnesses, such as: liver or renal insufficiency.
Any significant pulmonary, endocrine, or metabolic disturbances.
Documented disease of the central nervous system that could interfere with the study assessments (including by not limited to: stroke, tumor, multiple sclerosis, Parkinson's disease, Alzheimer's disease, Huntington's disease, seizure disorder requiring current anti-convulsants, traumatic brain injury or trauma, and neurosyphilis.
Hypothyroidism or hyperthyroidism, unless stabilized by appropriate medication for at least 3 months prior to Screening (a normal thyroid-stimulating hormone [TSH] is required prior to randomization at Baseline).
Any medical condition that can potentially alter oral enteral absorption (e.g., gastrectomy), metabolism (e.g., liver failure), or excretion (e.g., renal failure) of the study drug.
History of alcohol or substance use disorders (except nicotine and caffeine) meeting DSM-5 criteria within 1-year prior to Screening visit.
Positive alcohol and urine drug screen for opiates, cocaine, barbiturates, tetrahydrocannabinol, methadone, tricyclic antidepressants, benzodiazepines, and amphetamine/methamphetamine at Screening or Baseline. Patients with positive testing at Screening due to prescribed benzodiazepines, tricyclic antidepressants, barbiturates or opiates are accepted but must test negative at Baseline.
Male participants who have pregnant partners.
Received an experimental drug or used an experimental medical device within 60 days before the planned start of treatment (Day 1) or have participated in 2 or more clinical trials in the previous 2 years.
QT interval corrected with Fridericia's formula (QTcF) at Screening or Baseline greater than 450 msec for males and 470 msec for females.
Positive hepatitis B surface antigen, or hepatitis C antibody or Human Immunodeficiency Virus (HIV) 1 and 2 antibodies at Screening.
Employees of the investigator or study center, when the employee has direct involvement in the proposed study or other studies under the direction of that investigator or study center; also family members of the employee or the investigator.",MIN-117 2.5 mg taken as one MIN-117 2.5 mg capsule and one Placebo capsule as a single dose orally once daily.,PubChem:25061466,"1-Piperidineethanol, 4-(3,4-dichlorophenyl)-alpha-(((2-(5-methyl-1,3,4-oxadiazol-2-yl)-4-benzofuranyl)oxy)methyl)-, monohydrochloride, (alphaS)-",Cc1nnc(-c2cc3c(OCC(O)CN4CCC(c5ccc(Cl)c(Cl)c5)CC4)cccc3o2)o1.Cl,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03451006,NCT03451006_EG000,No,All,Adult | Older Adult,Phase 2,7,"Inclusion Criteria:

Age ≥ 60 years
Stable CAD

Prediabetes (one of the following criteria should be met)

Fasting plasma glucose: 100-126 mg/dL
HbA1C: 5.7-6.4
Frailty (Short Physical Performance Battery: Score <9)
Able to return for follow-up
Written informed consent

Exclusion criteria:

Pre-existing or new-onset diabetes
Any active malignancy, hematological disorder, post organ transplant, immunocompromised
Cancer requiring treatment in the past 3 years (other than non-melanoma skin cancer)
Dementia [mini mental state examination (MMSE <20)]
Disability (need for assistance in >2 of any six activities on Katz activities of daily living (ADL)46
Prior stroke with disability
Acute coronary syndrome <3months or participating in cardiac rehabilitation
Severe Parkinson's
Hepatic insufficiency and/or chronic liver disease (cirrhosis)
Chronic kidney disease (GFR < 45 mL/min)
Taking metformin for any indication
Acute alcohol intoxication
Known hypersensitivity to metformin hydrochloride
Acute/chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma","Metformin 500mg tablet by mouth, every 6 to 8 hours for one year

Metformin: Oral metformin (up to 2gm) were given in divided doses",ChEMBL:CHEMBL1431 | DrugBank:DB00331 | PubChem:4091,Metformin,CN(C)C(=N)NC(=N)N,A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03456856,NCT03456856_EG000,No,All,Adult | Older Adult,Phase 4,30,"Inclusion Criteria:

Subject has provided informed consent/assent prior to initiation of any study specific activities/ procedures
Male or female subject ≥ 18 years of age, describing self as African American/Black
Must have a diagnosis of heart failure (HF) confirmed by medical records, be in stable condition, and treated with stable optimal pharmacological therapy as per their personal physician's care.
Left ventricular ejection fraction (LVEF) ≤ 35% confirmed by investigator
New York Heart Association (NYHA) class II to IV assessed at the time of screening
Electrocardiogram (ECG) documentation at the time of screening of sinus rhythm with resting heart rate (HR) ≥ 70 bpm by local ECG reading
Must be able to complete a 6-minute walk test (6MWT) and wear an accelerometer

Exclusion Criteria:

Recent myocardial infarction (≤ 2 months) or stroke (≤ 1 month) prior to enrollment
If the subject received within 3 months before or is scheduled to receive within 42 days after enrollment any of the following: revascularization, ventricular assist device, continuous or intermittent inotropic therapy, hospice care, major organ transplant, or is receiving renal replacement therapy by dialysis
If the subject received implantation of a cardioverter defibrillator or cardiac resynchronization therapy within 42 days before or is scheduled to receive implantation of a cardioverter defibrillator or cardiac resynchronization therapy within 42 days after enrollment
Severe primary valve disease or scheduled for surgery for valvular heart disease
Pacemaker with atrial or ventricular pacing (except bi-ventricular pacing) >40% of the time, or with a stimulation threshold at the atrial or ventricular level ≥ 60 bpm
Permanent atrial fibrillation or flutter
Sick sinus syndrome, sinoatrial block, or second and third degree atrio-ventricular block
History of symptomatic or sustained (≥ 30 sec) ventricular arrhythmia unless a cardioverter defibrillator was implanted
History of congenital QT syndrome
Any cardioverter defibrillator shock experienced within 1 month of enrollment
Hypertrophic obstructive cardiomyopathy, active myocarditis or constrictive pericarditis, or clinically significant congenital heart disease
Chronic antiarrhythmic therapy (except digitalis)
Scheduled outpatient intravenous (IV) infusions for HF (eg, inotropes,vasodilators [eg, nesiritide], diuretics) or routinely scheduled ultrafiltration
Evidence of digitalis intoxication within 7 days prior to screening
Systolic blood pressure > 180 mm Hg or < 90 mm Hg, or diastolic blood pressure > 110 mm Hg or < 50 mm Hg at any time during the screening phase
Known untreated hypothyroidism or hyperthyroidism, adrenal insufficiency, active vasculitis due to collagen vascular disease
Have known acute or serious co-morbid condition (e.g, major infection or hematologic, renal, hepatic, metabolic, gastrointestinal or endocrine dysfunction) that may interfere with the study, or severe concomitant non-cardiovascular disease that is expected to reduce life expectancy to less than 1 year or malignancy within 5 years prior to enrollment with the following exceptions: localized basal or squamous cell carcinoma of the skin or cervical intraepithelial neoplasia
Subjects taking QT prolonging medicinal products for cardiovascular (e.g, but not limited to, quinidine, disopyramide, bepridil, sotalol, ibutilide, amiodarone) or non-cardiovascular disease (e.g, but not limited to, pimozide, ziprasidone, sertindole, mefloquine, halofantrine, pentamidine, cisapride, IV erythromycin).
Subjects exposed to a strong CYP3A4 inhibitor (examples of strong CYP3A4 inhibitors include; azole antifungals [eg, itraconazole], macrolide antibiotics [e.g, clarithromycin, telithromycin], human immunodeficiency virus (HIV) protease inhibitors, [eg, nelfinavir], and nefazodone]) within 14 days prior to enrollment, or to a strong CYP3A4 inducer (examples of CYP3A4 inducers include; St. John's wort, rifampicin, barbiturates, and phenytoin) within 28 days prior to enrollment
Subjects who received diltiazem or verapamil within 48 hours prior to enrollment.
Previously received ivabradine prior to participation in this study
Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(ies). Other investigational procedures while participating in this study are excluded.
Female subject is pregnant or breastfeeding or planning to become pregnant or breastfeed during treatment and for an additional 14 days after the last dose of investigational product. Females of childbearing potential should only be included in the study after a confirmed menstrual period and a negative highly sensitive urine pregnancy test.
Female subjects of childbearing potential unwilling to use 1 highly effective method of contraception during treatment and for an additional 14 days after the last dose of investigational product.
Subject has known sensitivity to any of the products or components to be administered during dosing.
Subject likely not to be available to complete all protocol required study visits or procedures, and/or to comply with all required study procedures to the best of the subject and investigator's knowledge.
History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.","The starting dose of ivabradine was 5 mg twice daily (BID), although investigators had the discretion to start participants at 2.5 mg BID if participant had a history of conduction defects, or bradycardia that could lead to hemodynamic compromise. Dose was adjusted at Day 15 (and at any other clinical visit) between 2.5 - 7.5 mg BID based on heart rate and signs/symptoms of bradycardia.",ChEMBL:CHEMBL471737 | DrugBank:DB09083 | PubChem:132999,Ivabradine,COc1cc2c(cc1OC)CC(=O)N(CCCN(C)C[C@H]1Cc3cc(OC)c(OC)cc31)CC2,C01EB17 | C07FX05 | C07FX06,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT03457116,NCT03457116_EG001,No,All,Adult | Older Adult,Phase 4,70,"Inclusion Criteria:

Patients 18-70 years old undergoing septorhinoplasty or rhinoplasty for either obstructive or aesthetic reasons. All approaches to rhinoplasty and surgical techniques utilized will be included. This will include patients that undergo additional procedures during the rhinoplasty including osteotomies, turbinate reduction, septoplasty, nasal valve repair and ear cartilage graft.

Exclusion Criteria:

Patients who undergo a rhinoplasty requiring a rib cartilage graft for the procedure as this is known to cause significant pleuritic chest pain.
Patients receiving functional endoscopic sinus surgery concurrently with the rhinoplasty will be excluded.
Patients with known history of gastrointestinal bleeds, peptic ulcer disease or who have other comorbidities that prevent them from taking NSAIDs.
Patients with a history of radiation, active head and neck malignancy or other pain disorders such as various rheumatologic diseases will be excluded to decrease confounding factors in the control of pain.","Norco (hydrocodone 5mg- acetaminophen 325mg)

Norco: 20 tablets of Hydrocodone 5mg-Acetaminophen 325mg (Norco)",ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03461757,NCT03461757_EG000,No,All,Adult | Older Adult,Phase 3,1811,"Key Inclusion Criteria:

1. Subject has at least 1 year history of migraines (with or without aura), consistent with a diagnosis according to the International Classification of Headache Disorder, 3rd Edition, Beta version [1] including the following:

Migraine attacks present for more than 1 year with the age of onset prior to 50 years of age
Migraine attacks, on average, lasting about 4-72 hours if untreated
Not more than 8 attacks of moderate to severe intensity per month within the last 3 months
Consistent migraine headaches of at least 2 migraine headache attacks of moderate or severe intensity in each of the 3 months prior to the Screening Visit and maintains this requirement during the Screening period
Less than 15 days with headache (migraine or non-migraine) per month in each of the 3 months prior to the Screening Visit and maintains this requirement during the Screening Period.
Subjects on prophylactic migraine medication are permitted to remain on therapy provided they have been on a stable dose for at least 3 months prior to screening visit and the dose is not expected to change during the course of the study.
Subjects with contraindications for use of triptans may be included provided they meet all other study entry criteria.

Key Exclusion Criteria:

Subject with a history of HIV disease
Subject history with current evidence of uncontrolled, unstable or recently diagnosed cardiovascular disease, such as ischemic heart disease, coronary artery vasospasm, and cerebral ischemia. subjects with Myocardial Infarction (MI), Acute Coronary Syndrome (ACS), Percutaneous Coronary Intervention (PCI), cardiac surgery, stroke or transient ischemic attack (TIA) during the 6 months prior to screening
Uncontrolled hypertension (high blood pressure), or uncontrolled diabetes (however subjects can be included who have stable hypertension and/or diabetes for at least 3 months prior to being enrolled)
Subject has a current diagnosis of major depression, other pain syndromes, psychiatric conditions (e.g., schizophrenia), dementia, or significant neurological disorders (other than migraine) that, in the Investigator's opinion might interfere with study assessments.
Subject has a history of gastric, or small intestinal surgery (including Gastric Bypass, Gastric Banding, Gastric Sleeve, Gastric Balloon, etc.), or has disease that causes malabsorption
The subject has a history of current or evidence of any significant and/ or unstable medical conditions (e.g., history of congenital heart disease or arrhythmia, known suspected infection, hepatitis B or C, or cancer) that, in the investigator's opinion, would expose them to undue risk of a significant adverse event (AE) or interfere with assessments of safety or efficacy during the course of the trial.
History of, treatment for, or evidence of, alcohol or drug abuse within the past 12 months or subjects who have met DSM-V criteria for any significant substance use disorder within the past 12 months from the date of the screening visit.
Subjects are excluded if they have previously participated in any BHV-30000 (rimegepant) study within the last 2 years.
Participation in any other investigational clinical trial while participating in this clinical trial",Participants were administered a single sublingual dose of 75 mg of rimegepant ODT on occurrence of migraine that reached moderate or severe intensity up to 45 days after randomization.,ChEMBL:CHEMBL2178422 | DrugBank:DB12457 | PubChem:51049968,Rimegepant,N[C@@H]1c2cccnc2[C@H](OC(=O)N2CCC(n3c(=O)[nH]c4ncccc43)CC2)CC[C@H]1c1cccc(F)c1F,N02CD06,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03462641,NCT03462641_EG001,No,All,Adult | Older Adult,Phase 1 | Phase 2,36,"Inclusion Criteria:

Parkinson's disease (PD): PD diagnosis will follow the UK Parkinson's Disease Society Brain Bank Research Center (UKPDSBRC) clinical diagnostic criteria for PD.
Hoehn and Yahr stages 2-4
Absence of dementia confirmed by cognitive testing.
Abnormal 11C-Dihydrotetrabenazine ([11C]-DTBZ) PET study to demonstrate nigrostriatal dopaminergic denervation.

Exclusion Criteria:

PD with Dementia (PDD) or dementia with Lewy bodies (DLB).
Other disorders which may resemble PD, such as vascular dementia, normal pressure hydrocephalus, multiple system atrophy, corticobasal ganglionic degeneration, or toxic causes of parkinsonism. Prototypical cases have distinctive clinical profiles, like early and severe dysautonomia or appendicular apraxia, which may differentiate them from idiopathic PD. The use of the UKPDSBRC clinical diagnostic criteria for PD will mitigate the inclusion of subjects with atypical parkinsonism.
Subjects on benzodiazepine, GABA-ergic medications (baclofen, tizanidine), neuroleptic, anticholinergic (trihexyphenidyl, benztropine), or cholinesterase inhibitor drugs.
Evidence of a mass lesion on structural brain imaging (MRI).
Participants in whom MRI is contraindicated including, but not limited to, those with a pacemaker, presence of metallic fragments near the eyes or spinal cord, chest, or cochlear implant.
Severe claustrophobia precluding MR or PET imaging.
Subjects limited by participation in research procedures involving ionizing radiation.
Pregnancy (urine or serum pregnancy test within 48 hours of each PET session) or breastfeeding.
History of seizures
Significant anxiety or history of panic disorder.
History of recent suicide attempt or overdose of tricyclic antidepressants or other medications
Any other medical history determined by investigators to preclude safe participation.
Allergy to flumazenil
Significant liver disease
History of alcohol or other substance abuse within past two years.
History of regular benzodiazepine use within past year",Flumazenil 1mg in 10cc normal saline was given intravenously (iv) over 5-10 minutes. 10 cc of normal saline placebo was given intravenously (iv) over 5-10 minutes. A detailed 90 minute clinical assessment was conducted before and after treatment administration for each visit.,ChEMBL:CHEMBL407 | DrugBank:DB01205 | PubChem:3373,Flumazenil,CCOC(=O)c1ncn2c1CN(C)C(=O)c1cc(F)ccc1-2,V03AB25,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03464383,NCT03464383_EG000,No,All,Adult | Older Adult,Phase 4,3,"Inclusion Criteria:

Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures and availability for the duration of the study
Age 18 or older
Ability to take oral medication and the willing to adhere to the intervention regimen
Minimum of 1 prior clinic visit at the Comprehensive Epilepsy Center
Ability to complete questionnaires independently
Diagnosis of epilepsy: EEG with documented seizure or epileptiform discharges OR non-epileptiform EEG and seizure remission with antiseizure drug OR treating epileptologist's leading clinical impression is epilepsy
(Neurological Disorders Depression Inventory for epilepsy, NDDI-E score greater than 15 and/or Generalized Anxiety Disorder-7, GAD-7 score greater than or equal to 10

Exclusion Criteria:

Pregnancy or lactation
Known allergic reactions to escitalopram or venlafaxine
Comorbid psychogenic nonepileptic seizures
Prior psychiatric hospitalization
Prior suicide attempt
History of manic or psychotic symptoms (past manic episode (SCID-I), or psychotic symptom screen positive)
Current treatment by a psychiatrist or counselor/therapist
Active suicidality at the time of screening
Current treatment with buspirone or an SSRI/SNRI/atypical antidepressant (specifically bupropion, fluoxetine, levomilnacipran, citalopram, milnacipran, desvenlafaxine, mirtazapine, duloxetine, paroxetine, escitalopram, sertraline, fluvoxamine, venlafaxine, vilazodone, vortioxetine)","The intervention will consist of initiating a chronic care management plan in the epilepsy clinic and an initial prescription from the epileptologist for escitalopram 10mg daily. Escitalopram dose may be titrated up to a maximum of 20mg daily in 5-10mg increments every 2 weeks for treatment effect, or titrated down to 5mg if needed for adverse effects. If a participant is unable to tolerate escitalopram, then venlafaxine XR 37.5mg will be substituted, to be titrated in a similar manner biweekly based on side effects and anxiety and depression symptoms (with 37.5-75mg increment dose changes and maximum dose of 225mg daily).",PubChem:146571,Escitalopram Oxalate,CN(C)CCCC1(c2ccc(F)cc2)OCc2cc(C#N)ccc21.O=C(O)C(=O)O,,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03477162,NCT03477162_EG000,No,All,Adult | Older Adult,Early Phase 1,14,"Inclusion Criteria:

Invasive malignant solid tumor of thoracic origin (e.g., lung, esophageal, thymus, mesothelioma, chest wall, mediastinum, trachea, pleura) with the intent to treat or biopsy by surgery as standard of care. Tumor must be ≥2 centimeters (cm).
Patients with multicentric disease are eligible. Samples from all available tumors are requested for research purposes.
Patients with Type 2 diabetes mellitus being treated with metformin (any dose) for a clinical indication at the time of study enrollment are eligible, and will continue metformin treatment as clinically indicated during the presurgical study period. Their dose of metformin will NOT be changed.
Patients not on metformin at the time of study entry must be willing to take metformin extended release (Glucophage® XR, 750 mg QD for 4 days, then 750 mg BID for 3-6 days) for a total of 7-10 days prior to surgery.
Patients do not require a diagnosis of diabetes to be enrolled in the study.
All patients must be willing to keep a drug diary indicating the dates and times of metformin administration.

Patients must meet the following clinical laboratory criteria:

Absolute neutrophil count (ANC) greater than or equal to 1,500/mm3 and platelet count greater than or equal to 75,000/mm3.
Total bilirubin less than or equal to 1.5x the upper limit of the normal range (ULN).
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than or equal to 3x ULN.
Estimated glomerular filtration rate (eGFR) > 60 mL/min/1.73m2 or estimated creatinine clearance (eCrCL) > 60 mL/min
Ability to give informed consent.
Patients must be willing to provide 20 milliliters (mL) of blood for research use.
Patient must be willing to provide consent for use of archived tissue for research.

Exclusion Criteria:

History of diabetes that is currently being treated without metformin.
Patients who, at the time of study entry, are not taking metformin for a clinical indication, and who will need a radiographic analysis with an iodinated contrast agent during the metformin study treatment period.
This criterion does not apply to patients taking clinically indicated metformin at the time of study entry.
History of liver disease as defined with liver function tests (LFTs) above those in the inclusion
Known hypersensitivity to metformin.
History of reactive hypoglycemia.
Active or history of lactic acidosis, metabolic acidosis, or diabetic ketoacidosis.",Patients given Metformin prior to surgery,ChEMBL:CHEMBL1431 | DrugBank:DB00331 | PubChem:4091,Metformin,CN(C)C(=N)NC(=N)N,A10BA02 | A10BD02 | A10BD03 | A10BD05 | A10BD07 | A10BD08 | A10BD10 | A10BD11 | A10BD13 | A10BD14 | A10BD15 | A10BD16 | A10BD17 | A10BD18 | A10BD20 | A10BD22 | A10BD23 | A10BD25 | A10BD26 | A10BD27,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03496545,NCT03496545_EG000,No,All,Adult | Older Adult,Phase 1 | Phase 2,21,"Inclusion Criteria:

age ≥18 years old
weight ≥ 40 kg
one reading of body temperature ≥ 38.3 ºC
diagnosis of subarachnoid hemorrhage, intracerebral hemorrhage, traumatic brain injury, subdural hematoma, or ischemic stroke
admission to the Intensive Care Unit at UCSF Medical Center or Zuckerberg San Francisco General Hospital.

Exclusion Criteria:

bromocriptine or acetaminophen hypersensitivity or allergy
known contraindication to bromocriptine- known ergot alkaloid hypersensitivity, known history of syncopal migraine
contraindication to nasogastric tube or swallowing pills
current diagnosis of acute liver failure, acute liver injury, or prior diagnosis of cirrhosis. acute presentation (< 26 weeks), evidence of coagulation abnormality: international normalized ratio (INR) ≥ 2; evidence of liver damage: alanine aminotransferase (ALT) of 10 x normal value; and any degree of mental status alteration
currently being treated with intra or extravascular therapeutic hypothermia - or where therapeutic hypothermia treatment is anticipated during study period
hyperthermic syndromes: heat stroke, evidence of thyrotoxicosis, malignant hyperthermia, neuroleptic malignant syndrome, or other drug-induced hyperthermia
administration of acetaminophen or acetaminophen containing medications within 9 hours prior to fever presentation
administration of non-steroidal anti-inflammatory drugs (NSAIDs) within 6 hours prior to fever presentation or aspirin > 300mg less than 1 hour prior to fever presentation.
pregnancy
extracorporeal blood circuit therapies: replacement therapy, extracorporeal life support (ventricular assist device, extracorporeal membrane oxygenation) during study period
anticipated ICU stay < 48 hours'
creatinine clearance ≤ 30
severe cardiovascular disease (especially unstable angina or severe valvular disease)
patients already taking bromocriptine for other indications","Standard of care - acetaminophen 650mg every 4 hours PO/NG/FT (per oral, nasogastric tube, feeding tube) for 48 hours, initiated within 1 hour after temperature reading ≥ 38.3ºC.",ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03506048,NCT03506048_EG000,No,All,Adult | Older Adult,Phase 2,4,"Inclusion Criteria:

Prior treatment with therapeutic dose of radioactive iodine (> 50 mCi) with evidence of RAI uptake on delayed scan and with progression (biochemical or anatomic) within 12 months of RAI
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 (Karnofsky ≥ 80%)
Leukocytes ≥ 3,000/µL
Absolute neutrophil count ≥ 1,500/µL
Platelets ≥ 100,000/µL
Total bilirubin within normal institutional limits
Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) ≤ 2.5 x institutional upper limit of normal
Creatinine within normal institutional limits OR
Creatinine clearance ≥ 60 mL/min/1.73 m² for patients with creatinine levels above institutional normal
Confirmed diagnosis of differentiated thyroid cancer (follicular or papillary thyroid cancer and their variants)
Ability and willingness to use appropriate contraception; women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and for 2 weeks after completion of lenvatinib administration
Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥ 20 mm (≥ 2 cm) by chest x-ray or as ≥ 10 mm (≥ 1 cm) with computed tomography (CT) scan, magnetic resonance imaging (MRI), or calipers by clinical exam
Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

Patients who have received RAI within 12 weeks of planned retreatment
Prior receipt of cumulative RAI doses in excess of 1000 mCi
Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities > grade 1)
Patients who are receiving any other investigational agents
Patients with previously untreated and or symptomatic brain metastases are excluded from this clinical trial because of the risk of intracranial bleeding with angiogenic agents and tumoral swelling from RAI
History of allergic reactions attributed to compounds of similar chemical or biologic composition to lenvatinib
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Patients with uncontrolled hypertension (requirement for more than 2 blood pressure [BP] medications or grade 2 or higher BP elevation while on adequate doses of not more than 2 antihypertensive agents) are excluded from the study because one of the significant adverse events of lenvatinib is worsening hypertension
Fridericia's corrected QT (QTcF) interval prolongation greater than 500 ms
Recent arterial thromboembolic event within the previous 6 months
Urine dipstick proteinuria ≥ 2+ or nephrotic range proteinuria on ≥ 2 gram in 24-hour urine
History of gastrointestinal perforation, abscess or fistula
History of and or medical condition (e.g. diverticular disease; aneurysm) that predisposes to risk of major hemorrhage
Pregnant women are excluded from this study because lenvatinib is a tyrosine kinase inhibitor agent with the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with lenvatinib, breastfeeding should be discontinued if the mother is treated with lenvatinib
Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with lenvatinib","Patients receive lenvatinib PO QD for 8 weeks and up to 12 weeks in the absence of disease progression or unaccepted toxicity. Patients also receive radioactive iodine (RAI) I-131 orally as standard of care.

Lenvatinib: Given orally once daily continuously",ChEMBL:CHEMBL1289601 | DrugBank:DB09078 | PubChem:9823820,Lenvatinib,COc1cc2nccc(Oc3ccc(NC(=O)NC4CC4)c(Cl)c3)c2cc1C(N)=O,L01EX08 | L01XE29,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03510455,NCT03510455_EG000,No,All,Adult | Older Adult,Phase 2,4,"INCLUSION CRITERIA:

Patients eligible for inclusion in this study have to meet all of the following criteria:

Aged 18-85 years
Diagnosis of TIO due to a non-localized or unresectable tumor, or metastatic disease or resectable tumor that cannot be removed by minor surgical procedure. This diagnosis will be confirmed prior to enrollment on protocol 01-D-0184. Where clinically indicated, genetic testing to rule-out heritable causes of FGF23 excess will also be performed on 01-D-0184.
Willing and able to comply with scheduled visits, treatment plan and laboratory tests.
Able to swallow and retain oral medication.
Able to provide informed consent

EXCLUSION CRITERIA:

Patients eligible for this study must not meet any of the following criteria:

Have another genetic or secondary cause of hypophosphatemia.
History of any other malignancy that has not been cured/in remission for 5 years.
Patients who previously received treatment with an FGFR inhibitor other than BGJ398.
Current evidence of corneal or retinal disorder/keratopathy including, but not limited to: bullous/band keratopathy, corneal abrasion, inflammation/ulceration, keratoconjuctivitis, confirmed by ophthalmologic examination
Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral BGJ398 (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection)
Patients who are currently receiving treatment with agents that are known strong inducers or inhibitors of CYP3A4 are prohibited. This includes treatment with enzyme-inducing antiepileptic drugs including carbamazepine, phenytoin, phenobarbital, and primidone.
Consumption of grapefruit, grapefruit juice, pomegranates, star fruits, Seville oranges or products within 7 days prior to first dose
Use of amiodarone within 90 days prior to first dose
Current use of therapeutic doses of warfarin sodium or any other coumadin-derivative anticoagulants. Heparin and/or low molecular weight heparins are allowed.

Insufficient bone marrow function defined as all of the following:

ANC <1,500/mm^3 [1.0 x 10^9/L] AND
Platelets < 75,000/mm^3 [75 x 10^9/L] AND
Hemoglobin < 10.0 g/dL

Insufficient hepatic and renal function defined as one of the following:

Total bilirubin > 1.5x ULN OR
AST/SGOT and ALT/SGPT > 2x ULN OR
Blood creatinine > 1.5xULN and/or calculated eGFR < 45 ml/min/1.73 m^2 (calculated by CKD-Epi)

Clinically significant cardiac disease including any of the following:

Congestive heart failure requiring treatment (NY Heart Association grade >= 2),
History or presence of clinically significant ventricular arrhythmias, atrial fibrillation, resting bradycardia, or conduction abnormality
Unstable angina pectoris or acute myocardial infarction less than or equal to 3 months prior to starting study drug
QTcF > 450 msec (males); > 470 msec (females)
History of congenital long QT syndrome
Recent (less than or equal to 3 months) transient ischemic attack or stroke
Patients under age 21 will have a bone age assessed as part of their clinically indicated skeletal survey under 01-D-0184 and will not be offered enrollment if their growth plates are open.
Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test

Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 3 months following the discontinuation of study treatment. Highly effective contraception methods include:

Total abstinence (when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception
Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment
Male sterilization (at least 6 months prior to screening). For female subjects on the study the vasectomized male partner should be the sole partner for that subject.

Combination of the following (a+b or a+c, or b+c):

Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example hormone vaginal ring or transdermal hormone contraception
Placement of an intrauterine device (IUD) or intrauterine system (IUS)

Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository

Post-menopausal women are allowed to participate in this study. Women are considered post- menopausal and not of child-bearing potential if they have had 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH >40 mIU/ml or 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy.
Sexually active males unless they use a condom during intercourse while taking drug and for 3 months after the last dose of the study drug and should not father a child in this period. A condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid.
Patients with TIO who are currently taking BGJ398 or have been treated with BGJ398 in the past are eligible to participate in this study, provided that they discontinue BGJ398 for 2 weeks prior to the baseline visit.",TIO subjects were treated with BGJ398 for 24 weeks with optional extension phase,ChEMBL:CHEMBL1852688 | DrugBank:DB11886 | PubChem:53235510,Infigratinib,CCN1CCN(c2ccc(Nc3cc(N(C)C(=O)Nc4c(Cl)c(OC)cc(OC)c4Cl)ncn3)cc2)CC1,L01EN03,1.0,0.0,0.0,1.0,0.0,1.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT03510910,NCT03510910_EG001,No,All,Adult | Older Adult,Phase 4,100,"Inclusion Criteria:

ASA class I-II
Patients indicated and scheduled for arthroscopic hip surgery

Exclusion Criteria:

Contraindication to acetaminophen or oxycodone/acetaminophen (e.g. hypersensitivity, history of GI or bleeding disorder)
Legally incompetent or mentally impaired (e.g. minors, Alzheimer's subjects, dementia, etc.)
Younger than 18 years of age or older than 65
Any patient considered a vulnerable subject
Patients on pain medication prior to surgery","Percocet: Oxycodone/acetaminophen (Percocet) 5 mg/325 mg as needed for breakthrough pain for patients in Percocet+ Acetaminophen group.

Percocet Group will receive standard of care Percocet 5 mg/325 mg every 6 hours PRN",ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03523988,NCT03523988_EG000,Accepts Healthy Volunteers,All,Child | Adult,Phase 4,24,"Inclusion Criteria:

-Orthodontic patient presenting for orthodontic treatment

Exclusion Criteria:

History of taking an analgesic in the past six hours
Hypersensitivity to ibuprofen or acetaminophen
Aspirin-sensitive asthma
Renal or liver impairment
History of GI bleeding or ulcers
Cardiovascular disease, recent myocardial infarction, heart failure, or coronary artery bypass graft surgery
Currently taking antibiotics or other medications for a chronic systemic disease
Bleeding disorder
Pregnant or nursing","Acetaminophen 650mg powder in gel capsule taken by mouth before entering appointment

Acetaminophen: Acetaminophen gel capsule",ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03537404,NCT03537404_EG001,Accepts Healthy Volunteers,All,Adult,Phase 1,18,"Inclusion Criteria (the subject must meet all the criteria listed below for entry at baseline and at Days -1 and 1 before each treatment Period):

Subjects must be willing to give written informed consent for the trial and able to adhere to dose and visit schedules.
Subjects having a Body Mass Index (BMI) between 18,5 and 30 kg/m^2, inclusive.
Subjects should diagnosed as ""healthy"": no pathology of the gastrointestinal tract, liver, kidneys, cardiovascular system, central nervous system (previously carried out by standard clinical and lab tests which did not reveal the presence of any diseases. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) must not exceed the normal range; QT interval calculated by Bazett's formula (QTcB) for men should be ≤ 450 ms and ≤ 470 ms for women, the interval PR should be ≤ 200 ms).

Vital sign measurements (taken after ~3 minutes in a supine or sitting position) must be within the following ranges:

systolic blood pressure, 100 - 130 mm Hg;
diastolic blood pressure, 60 -90 mm Hg;
pulse rate, 60-80 bpm.

Female subjects must be:

postmenopausal (defined as 12 months with no menses; age > 40 years and with a follicle-stimulating hormone (FSH) level of >40 u/mL);
surgically sterilized at least 3 months prior to baseline (e.g., documented hysterectomy or tubal ligation).
Men must agree to use a medically accepted method of contraception (condom and spermicide) during the trial and for 3 months after stopping the medication.

Exclusion Criteria (the subject will be excluded from entry if any of the criteria listed below are met at baseline):

Females with childbearing potential.
Subjects who, in the opinion of the investigator, will not be able to participate optimally in the study.
Positive results for hepatitis B surface antigen, hepatitis C antibodies or HIV, positive RW results.
Allergic reactions in history.
Intolerance to medication.
Chronic disease of cardiovascular, bronchopulmonary, and/or neuroendocrine systems, gastrointestinal, liver, pancreas, kidney and/or blood disease.
History or presence of impaired renal function, lactase deficiency, lactose intolerance, glucose-galactose malabsorption.
History of urinary obstruction or difficulty in voiding.
Gastrointestinal surgery in history (except of appendectomy).
Acute infections less than 4 weeks before participation in the study.
Subjects with a medical history of osteopenia and/or osteoporosis.
Regular administration of any medicines less than 4 weeks before participation in the study.
Administration of medicines with marked influence on hemodynamics, liver function et al (barbiturates, omeprazole, cimetidine et al) less than 30 days before participation in the study.
Blood donation (450 ml or more of blood or plasma) less than 2 months before participation in the study.
Intake of more than 10 units of alcohol in a week (1 unit of alcohol is equal to 0.5 L of beer, 200 mL of wine or 50 mL of spirits) or history of drug abuse or alcoholism.
Smoking of more than 10 cigarettes or equivalent tobacco use per day.
Participation in phase 1 clinical trial less than 3 months before participation in the study.
Positive screen for drugs abuse and drugs use.
Subjects with a medical history of psychiatric or personality disorders that in the opinion of the investigator and sponsor, affects the subject's ability to participate in the trial.
Subjects who are part of the study staff personnel or family members of the study staff personnel.","Tenofovir Disoproxil Fumarate, 300 mg, film-coated tablets, taken as 300 mg per os daily for 5 days",PubChem:5486830 | PubChem:6398764,Tenofovir Disoproxil Fumarate,CC(C)OC(=O)OCOP(=O)(COC(C)Cn1cnc2c(N)ncnc21)OCOC(=O)OC(C)C.O=C(O)C=CC(=O)O,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03541980,NCT03541980_EG000,Accepts Healthy Volunteers,All,Child,Phase 4,71,"Inclusion Criteria:

Any patient age 4-16 years with sickle cell disease who presents the Pediatric ER with acute sickle cell pain crisis with a pain of 6/10 or higher

Exclusion Criteria:

Patient with fever (38C or 100.4F)
Patient less than age 4 years
Patient greater than age 16 years
Patient with hypersensitivity/allergy to either morphine, NSAIDs, or acetaminophen
Patient received acetaminophen within the past 4 hours
Patient with known liver disease or renal disease
Patient not requiring IV morphine (pain score 5/10 or less)
Patient enrolled in the study within the past 72 hours","Patients allocated to receive IV acetaminophen

Acetaminophen: Administration of 15 mg/kg (1000 mg max dose) of IV acetaminophen

none",ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03567980,NCT03567980_EG000,No,All,Adult | Older Adult,Phase 4,30,"Inclusion Criteria:

Capable of understanding and willing to provide signed and dated written voluntary informed consent before any protocol specific procedures are performed.
Male or female subjects 18 to 70 years of age.
Able to complete the study and to comply with study instructions.
Female subjects of childbearing potential must have a negative pregnancy test. Sexually active women of childbearing potential participating in the study must agree to use a medically acceptable form of contraception (which includes oral contraception, injectable or implantable methods, or intrauterine devices) during the entire duration of the study
Mild to moderate seborrheic dermatitis on the face with an ISGA of 2 or 3 at baseline.

Exclusion Criteria:

Use of systemic antifungal agents, corticosteroids or other immunosuppressive therapies, or systemic retinoids within 4 weeks prior to the baseline visit.
Use of topical antifungal therapy, corticosteroid therapy, or calcineurin inhibitors to the face, within 2 weeks prior to the baseline visit. Topical, over-the-counter antifungal shampoo will be allowed as long as it has remained constant for 4 weeks prior to baseline.
Use of any investigational drugs within 4 weeks prior to the baseline visit, or subjects scheduled to receive an investigative drug other than the study product during the period of the study.
History of known or suspected intolerance to any of the ingredients of the study product.
Female subjects who are pregnant, trying to become pregnant or lactating.
Any clinically relevant abnormal vital signs or findings on the physical examination which in the opinion of the investigator might interfere with the study assessments.
A clinically relevant history of abuse of alcohol or other drugs.
Any major illness within 30 days prior to the baseline visit.
Subjects with any clinically significant condition which would, in the opinion of the investigator, compromise the subject's participation in the study.
Subjects who are immunocompromised (ex: HIV).
Considered unable or unlikely to attend the necessary visits.
Currently using any medication, which in the opinion of the investigator may affect the evaluation of the study product
Subjects who have significant neurological conditions (Parkinson's disease or Stroke), who in the opinion of the investigator are not eligible for the study due to the severity of neurological condition.
Subjects with a history of non-melanoma skin cancer of the face within 6 months",Crisaborole: Application of topical crisaborole 2% ointment on the face for 4 weeks to evaluate the anti-inflammatory action of this agent and its utility in the treatment of facial seborrheic dermatitis.,ChEMBL:CHEMBL484785 | DrugBank:DB05219 | PubChem:44591583,Crisaborole,N#Cc1ccc(Oc2ccc3c(c2)COB3O)cc1,D11AH06,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03571672,NCT03571672_EG000,No,All,Adult | Older Adult,Phase 3,153,"Inclusion Criteria:

Men and women ≥ 18 years of age in sinus rhythm
Able to communicate effectively with trial personnel
Has undergone a 2D Echo with or without contrast obtained within 6 months prior to enrollment (Day 0)
Has provided signed informed consent after receiving a verbal and written explanation of this clinical trial -

Exclusion Criteria:

Female subjects who are pregnant or lactating. All women of child bearing potential [WOCBP] must have a negative urine pregnancy test at screening regardless of contraceptive use history.

Women of child-bearing potential are excluded unless they:

are post-menopausal defined as amenorrhea ≥ 12 consecutive months, OR
have undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy), OR
have been using an adequate and medically approved method of contraception to avoid pregnancy for at least 1 month prior to DEFINITY® dose administration and be willing to continue using the same method for the duration of the study.
Current illness or pathology that would prevent undergoing investigational product administration due to a significant safety risk to the patient.
Uncontrolled arterial hypertension (defined as systolic blood pressure ≥ 200 mmHg or diastolic blood pressure ≥ 110 mmHg) or arterial hypotension (defined as systolic blood pressure ≤ 90 mmHg).

Unstable cardiovascular status defined as:

myocardial infarction or unstable angina pectoris within 6 months prior to enrollment/DEFINITY® dose administration day
transient ischemic attack or stroke within 3 months prior to DEFINITY® dose administration
symptomatic valvular heart disease or moderate to severe stenotic valvular heart disease
clinically significant congenital heart defects
current uncontrolled cardiac arrhythmias causing symptoms or hemodynamic compromise
acute pulmonary embolus or pulmonary infarction
acute myocarditis or pericarditis
acute aortic dissection
atrial fibrillation
any major surgery within 4 weeks prior to screening
known contraindications to undergoing CMR or claustrophobia
participation in any investigational drug, device, or placebo study within 30 days prior to screening
known hypersensitivity to perflutren, or any of the excipients in DEFINITY®
prisoners or those who are subject to compulsory detention or involuntary incarceration for treatment of either a psychiatric or physical illness (e.g., infectious disease) -",Each patient will undergo an unenhanced ultrasound examination and a single dose DEFINITY contrast-enhanced ultrasound during the same imaging session,ChEMBL:CHEMBL1663 | DrugBank:DB00556 | PubChem:6432,Perflutren,FC(F)(F)C(F)(F)C(F)(F)F,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03575702,NCT03575702_EG000,No,All,Adult | Older Adult,Phase 3,149,"Inclusion Criteria:

Signed dated informed consent.

Confirmed overactive bladder (OAB). The OAB diagnosis was made based on characteristic symptoms of the patient:

urinary incontinence - 5 or more episodes a week;
frequent urination - 8 or more times a day;
imperative urination urge - 1 or more episodes a day.
The duration of the presence of OAB symptoms is 3 months or more (the assessment is based on patient's history and medical records).
Overactive bladder Awareness Tool Questionnaire (OAB Awareness Tool) score 8 and more at the screening visit and randomization visit.
Negative result of the urine pregnancy test at the screening and the randomization visit before receiving the first dose of the study drug in women of childbearing potential.

Female patients of childbearing potential and male patients and their female partners should use at least two birth control methods, one of those is barrier, during the entire study period and for at least 35 days following administration of the last dose of the study product. Acceptable methods of contraception:

oral, transdermal, implantation or injection hormone therapy;
effective intrauterine devices;
double barrier contraceptive methods.
Willingness and ability to follow the study visits schedule, treatment plan, laboratory tests and other study procedures.

Exclusion Criteria:

A history of hypersensitivity or suspected hypersensitivity to tolterodine or imidafenacin.
Structural abnormalities of the bladder, including bladder cancer, bladder stones, interstitial cystitis.
The volume of residual urine is 100 ml or more with bladder ultrasound.
Documented diagnosis of stress urinary incontinence.
Operative interventions on the bladder or urethra within the previous 6 months or indications for surgical treatment for OAB.
Exacerbation of gynecological diseases including endometriosis, uterine leiomyoma exceeding 3 cm in diameter.
Prostate cancer.
Prostate diseases with clinically significant urodynamics abnormality (benign prostatic hyperplasia, acute and chronic prostatitis, prostatic calculus).
Renal and urinary inflammatory disorders (pyelonephritis, bacterial cystitis, urethritis).
For male, the prostatic specific antigen (PSA) level above 4 ng/mL.
Severe liver impairment alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) level 3 and more times exceeding the upper limit of normal and/or total bilirubin level 1.5 times exceeding the upper limit of normal.
Moderate or severe renal impairment based on the medical records and/or glomerular filtration rate < 50 mL/min determined by Cockroft-Gault formula and/or blood creatinine level > 133 μmol/L at screening.
A positive test result for hepatitis B, hepatitis C and human immunodeficiency virus (HIV).
Patients suffering from a neoplastic condition without remission at least within 5 years from the start of administration of the study product.
Vascular dementia, dementia in Alzheimer's disease, dementia in other diseases, including organic amnestic syndrome.
Parkinson's disease or secondary parkinsonism.
Nonspecific ulcerative colitis, including severe ulcerative colitis.
Thyroid disorders with hyperthyroidism signs.
Chronic heart insufficiency Stage III-IV by New York Heart Association Chronic heart insufficiency classification (NYHA).
Hypotension: systolic blood pressure (SBP) < 90 mm Hg and/or diastolic blood pressure (DBP) < 60 mm Hg.
Uncontrolled medically induced hypertension.
Hemodynamically and/or clinically significant heart arrhythmias.
QTc prolongation up to 450 ms and more in men and 470 ms and more in women.
Open-angle glaucoma.
Myasthenia gravis.
Megacolon, paralytic ileus, pyloric part of the stomach/duodenal occlusion and any other conditions associated with clinically significant gastric/intestinal obstruction or depressed motility.
Necessity of intake and/or intake of prohibited products listed in the Section ""Acceptable and prohibited recent and concomitant therapy"" within 7 days before the start of therapy.
Drug abuse, chronic alcoholism, any psychotic disorders.
Participation in other studies within 3 months prior to the beginning of the current study and/or during participation in this study.
Pregnancy and/or breastfeeding.
Female patients of childbearing potential, having an unprotected sexual contact with a male person non-sterilized by vasectomy during at least 6 months, within 14 days before administration of the study product.
Inability to follow protocol procedures.
Any other acute or exacerbation and/or decompensation of chronic diseases at inclusion in the study.
Patient's behavior, any safety reasons, clinical and administrative reasons, which, according to Investigator's opinion, may potentially affect the study drug safety/efficiency assessment.
Other medical and psychiatric conditions or deviations of laboratory parameter which may increase patient risk associated with participation in the study or administration of the study product, or which can influence the interpretation of the study results and, according to Investigator's opinion, make a person ineligible for participation in this study.
Patients who are employees of the study site or patients who are employees of the Sponsor/Contract Research Organization (CRO), directly involved in this clinical trial.","one tablet orally twice a day (after breakfast and dinner) for 12 weeks

Uritos®: film-coated tablets 0.1 mg",ChEMBL:CHEMBL53366 | DrugBank:DB09262 | PubChem:6433090,Imidafenacin,Cc1nccn1CCC(C(N)=O)(c1ccccc1)c1ccccc1,G04BD14,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03584373,NCT03584373_EG001,No,All,Adult | Older Adult,Phase 3,54,"Inclusion Criteria:

Men and Women age>18 years old
Presence of renal or ureteral stones suitable for ureteroscopy or percutaneous nephrolithotomy.
Uncomplicated ureteroscopy or percutaneous nephrolithotomy

Exclusion Criteria:

Pregnant/Breastfeeding/Possibly Pregnant Patients
Pediatric Patients
Sensitive or Allergic to Opioids, Ketorolac, or Acetaminophen
Significant Renal Disease
Peptic Ulcer Disease
Chronic Pain and recovering opiate use
Inability to complete questionnaires
Non-mobile patients
Patients on methadone","Percocet - Oral; 5 mg tablet: 1 tablet every 4-6 hours, or as needed. (10 tablets prescribed).

Percocet administered post surgery to compare pain outcomes to that of the non-opioid analgesia.

Oxycodone Acetaminophen: Percocet is a prescribed opioid medication to manage pain. Percocet will be administered post surgery to compare pain outcomes to that of non-opioid analgesia.",ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03588806,NCT03588806_EG000,No,All,Adult | Older Adult,Phase 4,11,"Inclusion Criteria:

Adult subjects must have noncancer chronic pain for at least six months on a daily basis,
Be prescribed opioids on a daily basis
Have an upper dose limit of daily opioids of 200 mg of morphine equivalents. This is because at doses greater than 200 mg daily, in the investigator's experience it is much more difficult to convert completely to another opioid compound within a week. Fentanyl and methadone users will not be specifically excluded unless their dosages fall outside this range.
Ages 21-70
Reported difficulty swallowing their opioid medication on the screening form at a level determined significant by the PI.
Having a mobile phone. A smart phone is not required to respond to the text messages.
Having Internet access to be able to respond to the emailed weekly surveys.
If sexually active and able to become pregnant, must agree to use an acceptable method of birth control (hormonal methods, barrier methods with spermicide, intrauterine device (IUD) or abstinence).
Only Pain Medicine Clinic patients may participate in this study

Exclusion Criteria:

Inability to understand the surveys and complete them.
Pregnancy
High risk for opioid addiction and/or abuse behaviors
Any condition, physical or mental, that in the investigator's judgment precludes optimal participation in the study procedures. This includes any documented current history of liver disease, renal insufficiency, delirium, alcohol use disorder, breast-feeding mothers, acute or severe asthma, chronic obstructive pulmonary disease requiring home oxygen, GI obstruction, biliary tract disease, pancreatitis, cardiac arrhythmia, bladder or urethral obstruction, adrenal insufficiency, psychosis, or taking medications which are potent inhibitors of the CYP3A4 enzyme (such as protease inhibitors, macrolide antibiotics, or antifungals).
Demonstration of abusive alcohol behavior. For women, this is more than 3 drinks on any single day or more than 7 drinks per week. For men, more than 4 drinks on any single day or more than 14 drinks per week.
Currently taking fentanyl or methadone
Exhibiting the following contraindicated conditions: (1) significant respiratory depression (2) acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment (3) known or suspected gastrointestinal obstruction, including paralytic ileus (4) hypersensitivity (e.g. anaphylaxis) to oxycodone (5) patients with chronic pulmonary disease (6) elderly, cachet, or debilitated patients (7) patients with evidence of increased intracranial pressure, brain tumors, head injury, or impaired consciousness (8) patients with seizure disorders (9) pregnant and breastfeeding women, due to risks to the fetus/baby","Following baseline assessments, subjects will have their current opioid medication changed to Xtampza ER (oxycodone) for the duration of the study. A standard conversion table will be used to calculate the dose of Xtampza ER that is equivalent to the subject's current opioid medication dosage. Subjects will be converted to 75% of the calculated dose for the first 7-10 days and then to 100% of the calculated dose for the remaining 3 weeks of the study. The Xtampza ER dosage may be modified at the discretion of the PI to ensure the safety of the subject. As per manufacturer recommendations, subjects will be instructed to open the capsules, sprinkle the microspheres onto soft food such as pudding or applesauce, and then consume the food.

Xtampza ER (oxycodone): Following baseline assessments, subjects will have their current opioid medication changed to Xtampza ER (oxycodone) for the duration of the study.",ChEMBL:CHEMBL656 | DrugBank:DB00497 | PubChem:5284603,Oxycodone,COc1ccc2c3c1O[C@H]1C(=O)CC[C@@]4(O)[C@@H](C2)N(C)CC[C@]314,N02AA05 | N02AA55 | N02AA56 | N02AJ17 | N02AJ18 | N02AJ19,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03591146,NCT03591146_EG004,No,All,Adult | Older Adult,Phase 1 | Phase 2,16,"Inclusion Criteria:

Able and willing to provide a written informed consent.
Male or female between 18 and 65 years of age.
Scheduled to undergo a primary, unilateral Lichtenstein inguinal hernia repair with mesh, and be able to use the anesthesia regimen.
American society of anesthesiologists (ASA) Physical Status Classification of 1 or 2.
Female subjects are eligible only if: not pregnant; not lactating; not planning to become pregnant during the study; commits to the use of an acceptable form of birth control.
Male subjects must be sterile or commit to the use of a reliable method of birth control for the duration of the study until at least 1 week after the administration of blinded study medication.
Body mass index ≤ 35 kg/m2.

Exclusion Criteria:

Clinically significant abnormal clinical laboratory test value.
Evidence of a clinically significant 12-lead ECG.
History or evidence of orthostatic hypotension, syncope or other syncopal attacks.
History or clinical manifestations of significant renal, hepatic, gastrointestinal, cardiovascular, metabolic, neurologic, psychiatric, or other condition.
History of seizures or are currently taking anticonvulsants.
History of hypersensitivity to ropivacaine, any other amide-type local anesthetic, propofol, hydromorphone or oxycodone (or other opioids).
Persistent or recurrent nausea and/or vomiting due to other etiologies, including, but not limited to gastric outlet obstruction, hypercalcemia, or active peptic ulcer.
History of severe or refractory post-operative nausea or vomiting deemed clinically significant.
Concurrent painful condition that may require analgesic treatment during the study period.
Have been receiving or have received chronic opioid therapy.

Use of any of the following medications within 5 half-lives or as specified prior to the study surgical procedure:

Anti-platelet agents such as aspirin therapy within 7 days; clopidogrel within 5 days; Anticoagulants such as warfarin within 5 days; dabigatran etexilate mesylate within 2 days; factor Xa inhibitor within 24 hours; Class III antiarrhythmic drugs (e.g., amiodarone); Strong CYP1A2 inhibitors, such as cimetidine, ciprofloxacin, enoxacin, and fluvoxamine; CYP1A2 substrates, such as theophylline or imipramine; Strong CYP3A4 inhibitors such as voriconazole, erythromycin, ketoconazole, or ritonavir; CYP3A4 substrates, such as atazanavir, darunavir, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir, or tipranavir; Corticosteroids, either systemically, inhaled, intranasally, orally, or by intra-articular injection within 14 days before the study surgical procedure (topical corticosteroid is allowed); Non-steroidal anti-inflammatory drugs (NSAIDs) within 14 days prior to the study surgical procedure; Any investigational product within 30 days prior to administration of blinded study medication.

History of alcohol abuse or prescription and/or illicit drug abuse within 2 years.
Current report of alcohol abuse within 6 months.
Positive results on the urine drug screen or alcohol breath test indicative of illicit drug or alcohol abuse.
History of human immunodeficiency virus (HIV), hepatitis C, or hepatitis B.
Have had an inguinal hernia repair in the last 3 months before the study surgical procedure or presents with bilateral or recurrent inguinal hernia, other hernia presentations, or hernias with a large scrotal component that would be difficult to reduce surgically.","Naropin injection contains ropivacaine HCl. Strength: 150mg/ 30mL (5 mg/mL) Size: 30mL fill, in a 30mL single dose vial

Naropin: Local infiltration of Naropin to produce anesthesia for surgery and analgesia in postoperative pain management. Naropin 150mg [0.5%, 5mg/mL] x 30mL",PubChem:53262281,Naropin,CCC[NH+]1CCCCC1C(=O)Nc1c(C)cccc1C.O.[Cl-],,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,1.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03597035,NCT03597035_EG000,No,All,Adult | Older Adult,Phase 4,8,"Inclusion Criteria

Male or female patients >= 45 years and able to provide informed consent (females must be either post-menopausal for one year, surgically sterile, or using effective contraception. Oral contraceptives are disallowed.)
Patients with type II diabetes with HbA1c ≤ 9.0 on stable anti-glycemic regimen that may include oral and/or injectable therapy (GLP-1/Insulin etc.). Changes in dose of glycemic regimen is allowed during the course of the trial if felt to be clinically appropriate.
Glomerular filtration rate (GFR) <90 and evidence of proteinuria (Urine Albumin/Creatinine Ratio of >30 mg/g or equivalent) in a urine specimen within 12 months OR GFR <60 mg/g regardless of proteinuria
Patients must be on angiotensin-converting-enzyme inhibitor (ACE) and/or angiotensin-resistance-blocker (ARB) therapy with no planned dose adjustments.
Hyperkalemia defined as serum K+≥ 5.1 meq/L at visit 0 (screening).

Exclusion Criteria

Uncontrolled hypertension (Systolic Blood Pressure (SBP)>160 and/or Diastolic Blood Pressure (DBP)>95 mmHg at visit 0 (screening) and SBP >145 mm Hg at visit 2).
GFR (MDRD) of <20 at visit 0 (screening)
Hyperkalemia defined as serum K+ <5.1 meq/L at visit 0 (screening).
LDL cholesterol >150 mg/dL
Plasma triglycerides > 400 mg/dl
Contraindications to MRI (metallic implants, severe claustrophobia).
Acute coronary syndrome, Transient ischemic attack, cardiovascular accident (CVA) or critical limb ischemia during the last 6 months or coronary/peripheral revascularization within the last 3 months.
Evidence of a secondary form of hypertension.
Initiation of new therapy with statins, ACE/ARB, antioxidants, calcium channel blockers (CCBs), diuretics, β blockers.
Type I diabetes mellitus
Known contraindication, including history of allergy to Spironolactone or Patiromer
Any surgical or medical condition which might alter pharmacokinetics of drug (e.g. renal transplant, liver failure, liver transplant)
Concurrent potentially life threatening arrhythmia or symptomatic arrhythmia.
Significant hyponatremia defined as Na <130 meq/L.
History of prior malignancy including leukemia and lymphoma (but not basal cell skin cancer, cured squamous cell cancer and cured prostate cancer).
History of any severe, life-threatening disease.
Any surgical or medical conditions which place the patient at higher risk derived from his/her participation into the study, or likely to prevent patient from complying with requirements.
History of drug abuse within the last 2 years, noncompliance and unwillingness/inability to consent.
Pregnant women and nursing mothers
Class III or IV Congestive Heart Failure
Primary Hyperaldosteronism","Single arm experimental study in 50 diabetic patients with chronic kidney disease and hyperkalemia.

Spironolactone: The study participants will receive concomitant treatment with Veltassa 8.4 grams per day and Spironolactone 25 mg per day or maximum tolerated dose. If dictated by the potassium level, Veltassa can be increased to 16.8 grams per day.",ChEMBL:CHEMBL1393 | DrugBank:DB00421 | PubChem:5833,Spironolactone,[H][C@]12CC[C@]3(C)[C@]4(CCC(=O)O4)CC[C@@]3([H])[C@]1([H])[C@]([H])(SC(C)=O)CC1=CC(=O)CC[C@@]12C,C03DA01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03605914,NCT03605914_EG001,No,All,Adult | Older Adult,Phase 4,100,"Inclusion Criteria:

english speaking
candidates for endoscopic sinus surgery as determined by medical necessity by the treating rhinologist
scheduled for surgery at Texas Sinus Institute

Exclusion Criteria:

allergy to either NSAIDs or opioids
contraindication to NSAIDs (ex. gastritis, chronic kidney disease)
surgical plan exceeding basic endoscopic sinus surgery
use of anticoagulation
the presence of any pain disorder
the current usage of any analgesic medication
history of opioid addiction
pregnancy
history of chronic pain or fibromyalgia
current daily use of NSAIDs, acetaminophen, opioids or other analgesics (pregabalin, tramadol, etc)","The Opioid used in this study is Norco. Norco is a combination medication that contains both an opioid pain reliever (hydrocodone) and a non-opioid pain reliever (acetaminophen).

Norco: The opioid used in this study is Norco. Norco is a combination medication that contains both an opioid pain reliever (hydrocodone) and a non-opioid pain reliever (acetaminophen).",ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03612713,NCT03612713_EG000,Accepts Healthy Volunteers,All,Adult,Early Phase 1,20,"Inclusion Criteria:

males or females, ages 18-30
for women of a child-bearing age, acceptable birth control methods or a negative pregnancy test prior to MRI scanning
ability to provide written, informed consent
eligibility and willingness to participate in fMRI scanning and to receive oxycodone
normal weight, as indicated by a body mass index (BMI) between 18.5 to 25

Exclusion Criteria:

current DSM-5 Axis I disorder
any psychotropic medication or medication known to interfere with metabolism of opioids
medical contraindication to participate in study activities (acute low-dose opioid admin) as determined by study physician
known family history (first-degree relative) of opioid-use disorder or alcohol-use disorder
not eligible for MRI scanning
positive drug screen
recent (past 6 months) medical or non-medical opioid-use
current or previous chronic pain disorder
significant lifetime use of prescription opioids (>7 days of consecutive medical use or nonmedical use on more than 5 occasions)",one hour before fMRI scan participants will be given a single dose 15mg immediate release oxycodone,ChEMBL:CHEMBL656 | DrugBank:DB00497 | PubChem:5284603,Oxycodone,COc1ccc2c3c1O[C@H]1C(=O)CC[C@@]4(O)[C@@H](C2)N(C)CC[C@]314,N02AA05 | N02AA55 | N02AA56 | N02AJ17 | N02AJ18 | N02AJ19,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03623243,NCT03623243_EG000,No,All,Adult | Older Adult,Phase 3,185,"Key Inclusion Criteria:

Signed informed consent.
Male or female aged 18 to 65 years (inclusive).
Patients with advancing RMS as defined by the principal investigator.
Prior history of relapsing MS (RMS), with or without progressive features, according to the 2010 Revised McDonald or Lublin criteria (Lublin et al, 2013).
EDSS score of >/= 2.0 to 6.5 (inclusive).
Having been continuously treated with RMS Disease Modifying Therapies.

Key Exclusion criteria:

Pregnant or nursing (lactating) women.
Patients with any medically unstable condition as determined by the investigator.
Certain cardiac risk factors defined in the protocol
History of hypersensitivity to the study drug or to drugs of similar chemical classes.

Other protocol-defined inclusion/exclusion criteria may apply.","Participants received titrated doses of siponimod tablets, orally, once daily of 0.25 mg on Day 2, 0.5 mg on Day 3, 0.75 mg on Day 4, 1.25 mg on Day 5, and maintenance dose of siponimod 2.0 mg tablets, orally, once daily from Day 6 up to 6 months.

As of protocol amendment 3, participants entering the trial converting from fingolimod started directly with 2 mg dose of siponimod.",ChEMBL:CHEMBL2336071 | DrugBank:DB12371 | PubChem:11432307 | PubChem:44599207,Siponimod,CCc1cc(/C(C)=N/OCc2ccc(C3CCCCC3)c(C(F)(F)F)c2)ccc1CN1CC(C(=O)O)C1,L04AA42 | L04AE03,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03653208,NCT03653208_EG000,Accepts Healthy Volunteers,Male,Adult,Phase 1,56,"Inclusion Criteria:

Healthy males aged 19 to 45 years at the time of the screening visit
Individuals with a BMI of at least 18 kg/m2 and up to 27.0 kg/m2 weighed more than 55 kg and less than 90 kg at the time of the screening visit
Individuals deemed clinically healthy based on medical history, physical examination, vital signs, electrocardiography (ECG), and appropriate clinical laboratory tests (provided that individuals outside the normal range may participate subject to investigator discretion)
Individuals who have agreed to use a medically acceptable method of dual contraception and not to donate sperm from the first day until 30 days after the last day of investigational product administration
Individuals who have voluntarily decided to participate in this clinical study and have given written consent to comply with the requirements of the study

Exclusion Criteria:

Individuals with a clinically significant hepatic, renal, digestive, respiratory, musculoskeletal, endocrine, neurologic, psychological, hematologic, oncologic, cardiovascular, or other disease or history
Individuals with a clinically significant history of sensitivity to the components of hzVSF-v13, drugs containing components of the same series, or other drugs (aspirin, non-steroidal anti-inflammatory drugs, antibiotics, etc.)
Individuals testing positive in the immunogenicity test for hzVSF-v13 conducted during screening
Individuals who have a history of drug abuse, or who turns out ""positive"" in test for abuse-likely drugs in the urine drug screening test
Individuals with abnormal results for any of the following vital signs at the time of the screening visit A. Systolic blood pressure: < 90 mmHg or > 140 mmHg B. Diastolic blood pressure: < 50 mmHg or > 90 mmHg C. Heart rate: < 50 bpm or > 90 bpm
Individuals with abnormal results for any of the following ECG items at the time of the screening visit A. PR (Pulse rate): > 210 msec B. QRS complex : > 120 msec * QRS complex is the name for the combination of three of the graphical deflections seen on a typical electrocardiogram (EKG or ECG) C. QTc (Corrected QT interval): > 450 msec
Individuals who have participated in another clinical study or bioequivalence study in the 3 months prior to the first day of administration
Individuals who have donated whole blood within the 2 months prior to the first day of administration, or donated blood components or received blood within the 1 month prior to the first day of administration
Individuals who have taken barbitals or other drug-metabolizing enzyme inducers or inhibitors within the 1 month prior to screening
Individuals who have consumed grapefruit or caffeine-containing foods within 3 days of the first administration, and individuals who are unable to avoid consuming grapefruit-containing foods from 3 days prior to admission until the date of discharge
Individuals who have taken prescription drugs or oriental medications within 2 weeks prior to the first day of administration, or who have taken over-the-counter (OTC) drugs within the 1 week prior to the first day of administration (provided that individuals who meet other requirements may participate in the clinical study subject to investigator discretion)
Individuals who consume high amounts of caffeine or alcohol and individuals who are heavy smokers (caffeine > 5 units/day, alcohol > 21 units/week (1 unit = 10 mL of pure alcohol), smoking > 10 cigarettes/day)
Individuals who are unable to eat meals provided by the institution
Individuals who have participated in the present study
Individuals who test positive (for hepatitis B, human immunodeficiency virus (HIV), hepatitis C) on serological testing
Individuals with veins that are not suitable for intravenous catheter insertion or multiple venipunctures
Individuals who do not agree to use a medically acceptable method of dual contraception from the first day until 30 days after the last day of investigational product administration
Other individuals deemed unsuitable as a subject by an investigator",Group 1 received a single 10mg dose of hzVSF-v13 on Day 1.,ChEMBL:CHEMBL417 | ChEMBL:CHEMBL53463 | DrugBank:DB00445 | DrugBank:DB00997 | PubChem:1691 | PubChem:31703 | PubChem:41867,Epirubicin,COc1cccc2c1C(=O)c1c(O)c3c(c(O)c1C2=O)CC(O)(C(=O)CO)CC3OC1CC(N)C(O)C(C)O1,L01DB01 | L01DB03,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03653208,NCT03653208_EG001,Accepts Healthy Volunteers,Male,Adult,Phase 1,56,"Inclusion Criteria:

Healthy males aged 19 to 45 years at the time of the screening visit
Individuals with a BMI of at least 18 kg/m2 and up to 27.0 kg/m2 weighed more than 55 kg and less than 90 kg at the time of the screening visit
Individuals deemed clinically healthy based on medical history, physical examination, vital signs, electrocardiography (ECG), and appropriate clinical laboratory tests (provided that individuals outside the normal range may participate subject to investigator discretion)
Individuals who have agreed to use a medically acceptable method of dual contraception and not to donate sperm from the first day until 30 days after the last day of investigational product administration
Individuals who have voluntarily decided to participate in this clinical study and have given written consent to comply with the requirements of the study

Exclusion Criteria:

Individuals with a clinically significant hepatic, renal, digestive, respiratory, musculoskeletal, endocrine, neurologic, psychological, hematologic, oncologic, cardiovascular, or other disease or history
Individuals with a clinically significant history of sensitivity to the components of hzVSF-v13, drugs containing components of the same series, or other drugs (aspirin, non-steroidal anti-inflammatory drugs, antibiotics, etc.)
Individuals testing positive in the immunogenicity test for hzVSF-v13 conducted during screening
Individuals who have a history of drug abuse, or who turns out ""positive"" in test for abuse-likely drugs in the urine drug screening test
Individuals with abnormal results for any of the following vital signs at the time of the screening visit A. Systolic blood pressure: < 90 mmHg or > 140 mmHg B. Diastolic blood pressure: < 50 mmHg or > 90 mmHg C. Heart rate: < 50 bpm or > 90 bpm
Individuals with abnormal results for any of the following ECG items at the time of the screening visit A. PR (Pulse rate): > 210 msec B. QRS complex : > 120 msec * QRS complex is the name for the combination of three of the graphical deflections seen on a typical electrocardiogram (EKG or ECG) C. QTc (Corrected QT interval): > 450 msec
Individuals who have participated in another clinical study or bioequivalence study in the 3 months prior to the first day of administration
Individuals who have donated whole blood within the 2 months prior to the first day of administration, or donated blood components or received blood within the 1 month prior to the first day of administration
Individuals who have taken barbitals or other drug-metabolizing enzyme inducers or inhibitors within the 1 month prior to screening
Individuals who have consumed grapefruit or caffeine-containing foods within 3 days of the first administration, and individuals who are unable to avoid consuming grapefruit-containing foods from 3 days prior to admission until the date of discharge
Individuals who have taken prescription drugs or oriental medications within 2 weeks prior to the first day of administration, or who have taken over-the-counter (OTC) drugs within the 1 week prior to the first day of administration (provided that individuals who meet other requirements may participate in the clinical study subject to investigator discretion)
Individuals who consume high amounts of caffeine or alcohol and individuals who are heavy smokers (caffeine > 5 units/day, alcohol > 21 units/week (1 unit = 10 mL of pure alcohol), smoking > 10 cigarettes/day)
Individuals who are unable to eat meals provided by the institution
Individuals who have participated in the present study
Individuals who test positive (for hepatitis B, human immunodeficiency virus (HIV), hepatitis C) on serological testing
Individuals with veins that are not suitable for intravenous catheter insertion or multiple venipunctures
Individuals who do not agree to use a medically acceptable method of dual contraception from the first day until 30 days after the last day of investigational product administration
Other individuals deemed unsuitable as a subject by an investigator",Group 2 received a single 20mg dose of hzVSF-v13 on Day 1.,ChEMBL:CHEMBL417 | ChEMBL:CHEMBL53463 | DrugBank:DB00445 | DrugBank:DB00997 | PubChem:1691 | PubChem:31703 | PubChem:41867,Epirubicin,COc1cccc2c1C(=O)c1c(O)c3c(c(O)c1C2=O)CC(O)(C(=O)CO)CC3OC1CC(N)C(O)C(C)O1,L01DB01 | L01DB03,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03653208,NCT03653208_EG002,Accepts Healthy Volunteers,Male,Adult,Phase 1,56,"Inclusion Criteria:

Healthy males aged 19 to 45 years at the time of the screening visit
Individuals with a BMI of at least 18 kg/m2 and up to 27.0 kg/m2 weighed more than 55 kg and less than 90 kg at the time of the screening visit
Individuals deemed clinically healthy based on medical history, physical examination, vital signs, electrocardiography (ECG), and appropriate clinical laboratory tests (provided that individuals outside the normal range may participate subject to investigator discretion)
Individuals who have agreed to use a medically acceptable method of dual contraception and not to donate sperm from the first day until 30 days after the last day of investigational product administration
Individuals who have voluntarily decided to participate in this clinical study and have given written consent to comply with the requirements of the study

Exclusion Criteria:

Individuals with a clinically significant hepatic, renal, digestive, respiratory, musculoskeletal, endocrine, neurologic, psychological, hematologic, oncologic, cardiovascular, or other disease or history
Individuals with a clinically significant history of sensitivity to the components of hzVSF-v13, drugs containing components of the same series, or other drugs (aspirin, non-steroidal anti-inflammatory drugs, antibiotics, etc.)
Individuals testing positive in the immunogenicity test for hzVSF-v13 conducted during screening
Individuals who have a history of drug abuse, or who turns out ""positive"" in test for abuse-likely drugs in the urine drug screening test
Individuals with abnormal results for any of the following vital signs at the time of the screening visit A. Systolic blood pressure: < 90 mmHg or > 140 mmHg B. Diastolic blood pressure: < 50 mmHg or > 90 mmHg C. Heart rate: < 50 bpm or > 90 bpm
Individuals with abnormal results for any of the following ECG items at the time of the screening visit A. PR (Pulse rate): > 210 msec B. QRS complex : > 120 msec * QRS complex is the name for the combination of three of the graphical deflections seen on a typical electrocardiogram (EKG or ECG) C. QTc (Corrected QT interval): > 450 msec
Individuals who have participated in another clinical study or bioequivalence study in the 3 months prior to the first day of administration
Individuals who have donated whole blood within the 2 months prior to the first day of administration, or donated blood components or received blood within the 1 month prior to the first day of administration
Individuals who have taken barbitals or other drug-metabolizing enzyme inducers or inhibitors within the 1 month prior to screening
Individuals who have consumed grapefruit or caffeine-containing foods within 3 days of the first administration, and individuals who are unable to avoid consuming grapefruit-containing foods from 3 days prior to admission until the date of discharge
Individuals who have taken prescription drugs or oriental medications within 2 weeks prior to the first day of administration, or who have taken over-the-counter (OTC) drugs within the 1 week prior to the first day of administration (provided that individuals who meet other requirements may participate in the clinical study subject to investigator discretion)
Individuals who consume high amounts of caffeine or alcohol and individuals who are heavy smokers (caffeine > 5 units/day, alcohol > 21 units/week (1 unit = 10 mL of pure alcohol), smoking > 10 cigarettes/day)
Individuals who are unable to eat meals provided by the institution
Individuals who have participated in the present study
Individuals who test positive (for hepatitis B, human immunodeficiency virus (HIV), hepatitis C) on serological testing
Individuals with veins that are not suitable for intravenous catheter insertion or multiple venipunctures
Individuals who do not agree to use a medically acceptable method of dual contraception from the first day until 30 days after the last day of investigational product administration
Other individuals deemed unsuitable as a subject by an investigator",Group 3 received a single 50mg dose of hzVSF-v13 on Day 1,ChEMBL:CHEMBL417 | ChEMBL:CHEMBL53463 | DrugBank:DB00445 | DrugBank:DB00997 | PubChem:1691 | PubChem:31703 | PubChem:41867,Epirubicin,COc1cccc2c1C(=O)c1c(O)c3c(c(O)c1C2=O)CC(O)(C(=O)CO)CC3OC1CC(N)C(O)C(C)O1,L01DB01 | L01DB03,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03653208,NCT03653208_EG003,Accepts Healthy Volunteers,Male,Adult,Phase 1,56,"Inclusion Criteria:

Healthy males aged 19 to 45 years at the time of the screening visit
Individuals with a BMI of at least 18 kg/m2 and up to 27.0 kg/m2 weighed more than 55 kg and less than 90 kg at the time of the screening visit
Individuals deemed clinically healthy based on medical history, physical examination, vital signs, electrocardiography (ECG), and appropriate clinical laboratory tests (provided that individuals outside the normal range may participate subject to investigator discretion)
Individuals who have agreed to use a medically acceptable method of dual contraception and not to donate sperm from the first day until 30 days after the last day of investigational product administration
Individuals who have voluntarily decided to participate in this clinical study and have given written consent to comply with the requirements of the study

Exclusion Criteria:

Individuals with a clinically significant hepatic, renal, digestive, respiratory, musculoskeletal, endocrine, neurologic, psychological, hematologic, oncologic, cardiovascular, or other disease or history
Individuals with a clinically significant history of sensitivity to the components of hzVSF-v13, drugs containing components of the same series, or other drugs (aspirin, non-steroidal anti-inflammatory drugs, antibiotics, etc.)
Individuals testing positive in the immunogenicity test for hzVSF-v13 conducted during screening
Individuals who have a history of drug abuse, or who turns out ""positive"" in test for abuse-likely drugs in the urine drug screening test
Individuals with abnormal results for any of the following vital signs at the time of the screening visit A. Systolic blood pressure: < 90 mmHg or > 140 mmHg B. Diastolic blood pressure: < 50 mmHg or > 90 mmHg C. Heart rate: < 50 bpm or > 90 bpm
Individuals with abnormal results for any of the following ECG items at the time of the screening visit A. PR (Pulse rate): > 210 msec B. QRS complex : > 120 msec * QRS complex is the name for the combination of three of the graphical deflections seen on a typical electrocardiogram (EKG or ECG) C. QTc (Corrected QT interval): > 450 msec
Individuals who have participated in another clinical study or bioequivalence study in the 3 months prior to the first day of administration
Individuals who have donated whole blood within the 2 months prior to the first day of administration, or donated blood components or received blood within the 1 month prior to the first day of administration
Individuals who have taken barbitals or other drug-metabolizing enzyme inducers or inhibitors within the 1 month prior to screening
Individuals who have consumed grapefruit or caffeine-containing foods within 3 days of the first administration, and individuals who are unable to avoid consuming grapefruit-containing foods from 3 days prior to admission until the date of discharge
Individuals who have taken prescription drugs or oriental medications within 2 weeks prior to the first day of administration, or who have taken over-the-counter (OTC) drugs within the 1 week prior to the first day of administration (provided that individuals who meet other requirements may participate in the clinical study subject to investigator discretion)
Individuals who consume high amounts of caffeine or alcohol and individuals who are heavy smokers (caffeine > 5 units/day, alcohol > 21 units/week (1 unit = 10 mL of pure alcohol), smoking > 10 cigarettes/day)
Individuals who are unable to eat meals provided by the institution
Individuals who have participated in the present study
Individuals who test positive (for hepatitis B, human immunodeficiency virus (HIV), hepatitis C) on serological testing
Individuals with veins that are not suitable for intravenous catheter insertion or multiple venipunctures
Individuals who do not agree to use a medically acceptable method of dual contraception from the first day until 30 days after the last day of investigational product administration
Other individuals deemed unsuitable as a subject by an investigator",Group 4 received a single 100mg dose of hzVSF-v13 on Day 1.,ChEMBL:CHEMBL417 | ChEMBL:CHEMBL53463 | DrugBank:DB00445 | DrugBank:DB00997 | PubChem:1691 | PubChem:31703 | PubChem:41867,Epirubicin,COc1cccc2c1C(=O)c1c(O)c3c(c(O)c1C2=O)CC(O)(C(=O)CO)CC3OC1CC(N)C(O)C(C)O1,L01DB01 | L01DB03,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03653208,NCT03653208_EG004,Accepts Healthy Volunteers,Male,Adult,Phase 1,56,"Inclusion Criteria:

Healthy males aged 19 to 45 years at the time of the screening visit
Individuals with a BMI of at least 18 kg/m2 and up to 27.0 kg/m2 weighed more than 55 kg and less than 90 kg at the time of the screening visit
Individuals deemed clinically healthy based on medical history, physical examination, vital signs, electrocardiography (ECG), and appropriate clinical laboratory tests (provided that individuals outside the normal range may participate subject to investigator discretion)
Individuals who have agreed to use a medically acceptable method of dual contraception and not to donate sperm from the first day until 30 days after the last day of investigational product administration
Individuals who have voluntarily decided to participate in this clinical study and have given written consent to comply with the requirements of the study

Exclusion Criteria:

Individuals with a clinically significant hepatic, renal, digestive, respiratory, musculoskeletal, endocrine, neurologic, psychological, hematologic, oncologic, cardiovascular, or other disease or history
Individuals with a clinically significant history of sensitivity to the components of hzVSF-v13, drugs containing components of the same series, or other drugs (aspirin, non-steroidal anti-inflammatory drugs, antibiotics, etc.)
Individuals testing positive in the immunogenicity test for hzVSF-v13 conducted during screening
Individuals who have a history of drug abuse, or who turns out ""positive"" in test for abuse-likely drugs in the urine drug screening test
Individuals with abnormal results for any of the following vital signs at the time of the screening visit A. Systolic blood pressure: < 90 mmHg or > 140 mmHg B. Diastolic blood pressure: < 50 mmHg or > 90 mmHg C. Heart rate: < 50 bpm or > 90 bpm
Individuals with abnormal results for any of the following ECG items at the time of the screening visit A. PR (Pulse rate): > 210 msec B. QRS complex : > 120 msec * QRS complex is the name for the combination of three of the graphical deflections seen on a typical electrocardiogram (EKG or ECG) C. QTc (Corrected QT interval): > 450 msec
Individuals who have participated in another clinical study or bioequivalence study in the 3 months prior to the first day of administration
Individuals who have donated whole blood within the 2 months prior to the first day of administration, or donated blood components or received blood within the 1 month prior to the first day of administration
Individuals who have taken barbitals or other drug-metabolizing enzyme inducers or inhibitors within the 1 month prior to screening
Individuals who have consumed grapefruit or caffeine-containing foods within 3 days of the first administration, and individuals who are unable to avoid consuming grapefruit-containing foods from 3 days prior to admission until the date of discharge
Individuals who have taken prescription drugs or oriental medications within 2 weeks prior to the first day of administration, or who have taken over-the-counter (OTC) drugs within the 1 week prior to the first day of administration (provided that individuals who meet other requirements may participate in the clinical study subject to investigator discretion)
Individuals who consume high amounts of caffeine or alcohol and individuals who are heavy smokers (caffeine > 5 units/day, alcohol > 21 units/week (1 unit = 10 mL of pure alcohol), smoking > 10 cigarettes/day)
Individuals who are unable to eat meals provided by the institution
Individuals who have participated in the present study
Individuals who test positive (for hepatitis B, human immunodeficiency virus (HIV), hepatitis C) on serological testing
Individuals with veins that are not suitable for intravenous catheter insertion or multiple venipunctures
Individuals who do not agree to use a medically acceptable method of dual contraception from the first day until 30 days after the last day of investigational product administration
Other individuals deemed unsuitable as a subject by an investigator",Group 5 received a single 200mg dose of hzVSF-v13 on Day 1.,ChEMBL:CHEMBL417 | ChEMBL:CHEMBL53463 | DrugBank:DB00445 | DrugBank:DB00997 | PubChem:1691 | PubChem:31703 | PubChem:41867,Epirubicin,COc1cccc2c1C(=O)c1c(O)c3c(c(O)c1C2=O)CC(O)(C(=O)CO)CC3OC1CC(N)C(O)C(C)O1,L01DB01 | L01DB03,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03653208,NCT03653208_EG005,Accepts Healthy Volunteers,Male,Adult,Phase 1,56,"Inclusion Criteria:

Healthy males aged 19 to 45 years at the time of the screening visit
Individuals with a BMI of at least 18 kg/m2 and up to 27.0 kg/m2 weighed more than 55 kg and less than 90 kg at the time of the screening visit
Individuals deemed clinically healthy based on medical history, physical examination, vital signs, electrocardiography (ECG), and appropriate clinical laboratory tests (provided that individuals outside the normal range may participate subject to investigator discretion)
Individuals who have agreed to use a medically acceptable method of dual contraception and not to donate sperm from the first day until 30 days after the last day of investigational product administration
Individuals who have voluntarily decided to participate in this clinical study and have given written consent to comply with the requirements of the study

Exclusion Criteria:

Individuals with a clinically significant hepatic, renal, digestive, respiratory, musculoskeletal, endocrine, neurologic, psychological, hematologic, oncologic, cardiovascular, or other disease or history
Individuals with a clinically significant history of sensitivity to the components of hzVSF-v13, drugs containing components of the same series, or other drugs (aspirin, non-steroidal anti-inflammatory drugs, antibiotics, etc.)
Individuals testing positive in the immunogenicity test for hzVSF-v13 conducted during screening
Individuals who have a history of drug abuse, or who turns out ""positive"" in test for abuse-likely drugs in the urine drug screening test
Individuals with abnormal results for any of the following vital signs at the time of the screening visit A. Systolic blood pressure: < 90 mmHg or > 140 mmHg B. Diastolic blood pressure: < 50 mmHg or > 90 mmHg C. Heart rate: < 50 bpm or > 90 bpm
Individuals with abnormal results for any of the following ECG items at the time of the screening visit A. PR (Pulse rate): > 210 msec B. QRS complex : > 120 msec * QRS complex is the name for the combination of three of the graphical deflections seen on a typical electrocardiogram (EKG or ECG) C. QTc (Corrected QT interval): > 450 msec
Individuals who have participated in another clinical study or bioequivalence study in the 3 months prior to the first day of administration
Individuals who have donated whole blood within the 2 months prior to the first day of administration, or donated blood components or received blood within the 1 month prior to the first day of administration
Individuals who have taken barbitals or other drug-metabolizing enzyme inducers or inhibitors within the 1 month prior to screening
Individuals who have consumed grapefruit or caffeine-containing foods within 3 days of the first administration, and individuals who are unable to avoid consuming grapefruit-containing foods from 3 days prior to admission until the date of discharge
Individuals who have taken prescription drugs or oriental medications within 2 weeks prior to the first day of administration, or who have taken over-the-counter (OTC) drugs within the 1 week prior to the first day of administration (provided that individuals who meet other requirements may participate in the clinical study subject to investigator discretion)
Individuals who consume high amounts of caffeine or alcohol and individuals who are heavy smokers (caffeine > 5 units/day, alcohol > 21 units/week (1 unit = 10 mL of pure alcohol), smoking > 10 cigarettes/day)
Individuals who are unable to eat meals provided by the institution
Individuals who have participated in the present study
Individuals who test positive (for hepatitis B, human immunodeficiency virus (HIV), hepatitis C) on serological testing
Individuals with veins that are not suitable for intravenous catheter insertion or multiple venipunctures
Individuals who do not agree to use a medically acceptable method of dual contraception from the first day until 30 days after the last day of investigational product administration
Other individuals deemed unsuitable as a subject by an investigator",Group 6 received a single 400mg dose of hzVSF-v13 on Day 1.,ChEMBL:CHEMBL417 | ChEMBL:CHEMBL53463 | DrugBank:DB00445 | DrugBank:DB00997 | PubChem:1691 | PubChem:31703 | PubChem:41867,Epirubicin,COc1cccc2c1C(=O)c1c(O)c3c(c(O)c1C2=O)CC(O)(C(=O)CO)CC3OC1CC(N)C(O)C(C)O1,L01DB01 | L01DB03,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03653208,NCT03653208_EG006,Accepts Healthy Volunteers,Male,Adult,Phase 1,56,"Inclusion Criteria:

Healthy males aged 19 to 45 years at the time of the screening visit
Individuals with a BMI of at least 18 kg/m2 and up to 27.0 kg/m2 weighed more than 55 kg and less than 90 kg at the time of the screening visit
Individuals deemed clinically healthy based on medical history, physical examination, vital signs, electrocardiography (ECG), and appropriate clinical laboratory tests (provided that individuals outside the normal range may participate subject to investigator discretion)
Individuals who have agreed to use a medically acceptable method of dual contraception and not to donate sperm from the first day until 30 days after the last day of investigational product administration
Individuals who have voluntarily decided to participate in this clinical study and have given written consent to comply with the requirements of the study

Exclusion Criteria:

Individuals with a clinically significant hepatic, renal, digestive, respiratory, musculoskeletal, endocrine, neurologic, psychological, hematologic, oncologic, cardiovascular, or other disease or history
Individuals with a clinically significant history of sensitivity to the components of hzVSF-v13, drugs containing components of the same series, or other drugs (aspirin, non-steroidal anti-inflammatory drugs, antibiotics, etc.)
Individuals testing positive in the immunogenicity test for hzVSF-v13 conducted during screening
Individuals who have a history of drug abuse, or who turns out ""positive"" in test for abuse-likely drugs in the urine drug screening test
Individuals with abnormal results for any of the following vital signs at the time of the screening visit A. Systolic blood pressure: < 90 mmHg or > 140 mmHg B. Diastolic blood pressure: < 50 mmHg or > 90 mmHg C. Heart rate: < 50 bpm or > 90 bpm
Individuals with abnormal results for any of the following ECG items at the time of the screening visit A. PR (Pulse rate): > 210 msec B. QRS complex : > 120 msec * QRS complex is the name for the combination of three of the graphical deflections seen on a typical electrocardiogram (EKG or ECG) C. QTc (Corrected QT interval): > 450 msec
Individuals who have participated in another clinical study or bioequivalence study in the 3 months prior to the first day of administration
Individuals who have donated whole blood within the 2 months prior to the first day of administration, or donated blood components or received blood within the 1 month prior to the first day of administration
Individuals who have taken barbitals or other drug-metabolizing enzyme inducers or inhibitors within the 1 month prior to screening
Individuals who have consumed grapefruit or caffeine-containing foods within 3 days of the first administration, and individuals who are unable to avoid consuming grapefruit-containing foods from 3 days prior to admission until the date of discharge
Individuals who have taken prescription drugs or oriental medications within 2 weeks prior to the first day of administration, or who have taken over-the-counter (OTC) drugs within the 1 week prior to the first day of administration (provided that individuals who meet other requirements may participate in the clinical study subject to investigator discretion)
Individuals who consume high amounts of caffeine or alcohol and individuals who are heavy smokers (caffeine > 5 units/day, alcohol > 21 units/week (1 unit = 10 mL of pure alcohol), smoking > 10 cigarettes/day)
Individuals who are unable to eat meals provided by the institution
Individuals who have participated in the present study
Individuals who test positive (for hepatitis B, human immunodeficiency virus (HIV), hepatitis C) on serological testing
Individuals with veins that are not suitable for intravenous catheter insertion or multiple venipunctures
Individuals who do not agree to use a medically acceptable method of dual contraception from the first day until 30 days after the last day of investigational product administration
Other individuals deemed unsuitable as a subject by an investigator",Group 7 received a single 800mg dose of hzVSF-v13 on Day 1.,ChEMBL:CHEMBL417 | ChEMBL:CHEMBL53463 | DrugBank:DB00445 | DrugBank:DB00997 | PubChem:1691 | PubChem:31703 | PubChem:41867,Epirubicin,COc1cccc2c1C(=O)c1c(O)c3c(c(O)c1C2=O)CC(O)(C(=O)CO)CC3OC1CC(N)C(O)C(C)O1,L01DB01 | L01DB03,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03653208,NCT03653208_EG007,Accepts Healthy Volunteers,Male,Adult,Phase 1,56,"Inclusion Criteria:

Healthy males aged 19 to 45 years at the time of the screening visit
Individuals with a BMI of at least 18 kg/m2 and up to 27.0 kg/m2 weighed more than 55 kg and less than 90 kg at the time of the screening visit
Individuals deemed clinically healthy based on medical history, physical examination, vital signs, electrocardiography (ECG), and appropriate clinical laboratory tests (provided that individuals outside the normal range may participate subject to investigator discretion)
Individuals who have agreed to use a medically acceptable method of dual contraception and not to donate sperm from the first day until 30 days after the last day of investigational product administration
Individuals who have voluntarily decided to participate in this clinical study and have given written consent to comply with the requirements of the study

Exclusion Criteria:

Individuals with a clinically significant hepatic, renal, digestive, respiratory, musculoskeletal, endocrine, neurologic, psychological, hematologic, oncologic, cardiovascular, or other disease or history
Individuals with a clinically significant history of sensitivity to the components of hzVSF-v13, drugs containing components of the same series, or other drugs (aspirin, non-steroidal anti-inflammatory drugs, antibiotics, etc.)
Individuals testing positive in the immunogenicity test for hzVSF-v13 conducted during screening
Individuals who have a history of drug abuse, or who turns out ""positive"" in test for abuse-likely drugs in the urine drug screening test
Individuals with abnormal results for any of the following vital signs at the time of the screening visit A. Systolic blood pressure: < 90 mmHg or > 140 mmHg B. Diastolic blood pressure: < 50 mmHg or > 90 mmHg C. Heart rate: < 50 bpm or > 90 bpm
Individuals with abnormal results for any of the following ECG items at the time of the screening visit A. PR (Pulse rate): > 210 msec B. QRS complex : > 120 msec * QRS complex is the name for the combination of three of the graphical deflections seen on a typical electrocardiogram (EKG or ECG) C. QTc (Corrected QT interval): > 450 msec
Individuals who have participated in another clinical study or bioequivalence study in the 3 months prior to the first day of administration
Individuals who have donated whole blood within the 2 months prior to the first day of administration, or donated blood components or received blood within the 1 month prior to the first day of administration
Individuals who have taken barbitals or other drug-metabolizing enzyme inducers or inhibitors within the 1 month prior to screening
Individuals who have consumed grapefruit or caffeine-containing foods within 3 days of the first administration, and individuals who are unable to avoid consuming grapefruit-containing foods from 3 days prior to admission until the date of discharge
Individuals who have taken prescription drugs or oriental medications within 2 weeks prior to the first day of administration, or who have taken over-the-counter (OTC) drugs within the 1 week prior to the first day of administration (provided that individuals who meet other requirements may participate in the clinical study subject to investigator discretion)
Individuals who consume high amounts of caffeine or alcohol and individuals who are heavy smokers (caffeine > 5 units/day, alcohol > 21 units/week (1 unit = 10 mL of pure alcohol), smoking > 10 cigarettes/day)
Individuals who are unable to eat meals provided by the institution
Individuals who have participated in the present study
Individuals who test positive (for hepatitis B, human immunodeficiency virus (HIV), hepatitis C) on serological testing
Individuals with veins that are not suitable for intravenous catheter insertion or multiple venipunctures
Individuals who do not agree to use a medically acceptable method of dual contraception from the first day until 30 days after the last day of investigational product administration
Other individuals deemed unsuitable as a subject by an investigator",Group 8 received a single 1200mg dose of hzVSF-v13 on Day 1.,ChEMBL:CHEMBL417 | ChEMBL:CHEMBL53463 | DrugBank:DB00445 | DrugBank:DB00997 | PubChem:1691 | PubChem:31703 | PubChem:41867,Epirubicin,COc1cccc2c1C(=O)c1c(O)c3c(c(O)c1C2=O)CC(O)(C(=O)CO)CC3OC1CC(N)C(O)C(C)O1,L01DB01 | L01DB03,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03657810,NCT03657810_EG001,No,All,Adult | Older Adult,Phase 3,90,"Inclusion Criteria:

Informed consent: Signed informed consent form obtained at screening prior to any procedures being performed.
Gender: Male or non-pregnant and non-lactating female.
Age: 18 years or older at time of consent.
Foot condition: Primary unilateral first metatarsal bunionectomy (osteotomy and internal fixation) with no additional collateral procedures.
Pain Severity: Presence of moderate or severe pain on a categorical pain intensity scale at Baseline
Pain Confirmation: On the 0-10 numerical pain intensity scale at Baseline.
Diary Completion: Be willing and able to record safety and efficacy ratings in the Diaries.
Safe Transportation Home: Patient must have arrangements for transportation home from the research center accompanied by a responsible adult.

Exclusion Criteria:

Medical condition: Presence of a serious medical condition, intolerance to NSAIDs, or any other medical condition which, in the opinion of the Investigator, makes the patient unsuitable for participation.
Infection: Acute infection of the surgical site at the time of surgery that could confound post-surgical evaluation.
Drug Allergy: History of hypersensitivity to an opioid drug (such as hydrocodone), promethazine, acetaminophen, NSAID (such as ibuprofen or aspirin), midazolam, propofol, mepivacaine, ropivacaine or ketorolac.
Confounding and Contraindicated Drugs: Other than protocol-permitted medications administered pre-operatively or during surgery: use within 14 days before or during the surgical procedure of any systemic corticosteroid or use within 24 hours or during the surgical procedure of any confounding prescription or non-prescription drug or any drug contraindicated with hydrocodone, acetaminophen, or promethazine. [Note: Antibiotic for endocarditis prophylaxis (except if known to cause nausea) and aspirin (ASA) ≤ 325 mg for cardiovascular prophylaxis are permitted during the study.] History of consuming more than 2 alcoholic drinks per day every day for the last month or a positive urine test for opiates, benzodiazepines, barbiturates, tetrahydrocannabinol, methamphetamines, cocaine, oxycodone, cotinine at screening or the morning of surgery will exclude the patient from the trial.
Investigational Drug Use: Use of an investigational drug within the past 30 days.
Participated in Study: Previous participation in this study.
Pregnancy, Lactation: Women who are pregnant or lactating.
Compliance: Inability to swallow capsules whole.
Participant relationship: Employee at the research center, employee of the Principal Investigator, Sub-Investigators, or sponsor or relative of the Investigator, Sub-Investigators or research staff who is involved in this study.","hydrocodone 5 mg/APAP 325 mg

Norco: hydrocodone 5 mg/APAP 325 mg",ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT03670030,NCT03670030_EG000,No,All,Adult | Older Adult,Phase 2,5,"Inclusion Criteria:

Unresectable or metastatic patients with typical or atypical carcinoid tumors of the lung or low or intermediate grade gastroenteropancreatic neuroendocrine tumors (GEPNETs).
Patients must have measurable disease per RECIST 1.1.
Patients must have progressed on everolimus or been intolerant to everolimus.
Patients, ≥18 years old, must have Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.
Concurrent use of somatostatin analogs (SSAs) is allowed if currently used for symptom control.

Adequate liver function:

Total bilirubin ≤1.5 x upper limit of normal (ULN) mg/dL
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 x ULN (<5 x ULN if the patient has liver metastases).

Adequate renal function:

a. Serum creatinine ≤2 x ULN or creatinine clearance >50 cc/hr (Cockroft-Gault).

Adequate biological parameters:

Absolute neutrophil count (ANC) ≥1.5 × 109/L
Platelet count ≥100,000/mm3 (100 × 109/L)
Hemoglobin ≥9 g/dL.
Fasting serum triglyceride ≤300 mg/dL; fasting serum cholesterol ≤350 mg/dL.

Male or non-pregnant and non-breast feeding female:

Females of child-bearing potential must agree to use effective contraception without interruption from 28 days prior to starting investigational product (IP) throughout 3 months after last dose of IP and have a negative serum pregnancy test (β-hCG) result at screening and agree to ongoing pregnancy testing during the course of the study, and after the end of study treatment. A second form of birth control is required even if she has had a tubal ligation.
Male patients must practice abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study and throughout 3 months after last dose of IP. A second form of birth control is required even if he has undergone a successful vasectomy.
Life expectancy of >3 months, as determined by the investigator.
Ability to understand and sign informed consent.
Willingness and ability to comply with scheduled visits, laboratory tests, and other study procedures.

Exclusion Criteria:

Patients currently undergoing anti-cancer therapy for neuroendocrine tumors (other than SSAs for symptoms).
History of allergic reactions to compounds of similar chemical or biologic composition to ABI-009.
Known active uncontrolled or symptomatic central nervous system (CNS) metastases. A patient with controlled and asymptomatic CNS metastases may participate in this study. As such, the patient must have completed any prior treatment for CNS metastases ?28 days (including radiotherapy and/or surgery) prior to start of treatment in this study and should not be receiving chronic corticosteroid therapy for the CNS metastases.
Active gastrointestinal bleeding.
Uncontrolled serious medical or psychiatric illness. Patients with a ""currently active"" second malignancy other than non-melanoma skin cancers, carcinoma in situ of the cervix, resected incidental prostate cancer (staged pathological tumor-2 (pT2) with Gleason Score ≤6 and postoperative prostate-specific antigen (PSA) <0.5 ng/mL), or other adequately treated carcinoma-in-situ are ineligible. Patients are not considered to have a ""currently active"" malignancy if they have completed therapy and are free of disease for ≥1 year).
Recent infection requiring systemic anti-infective treatment that was completed ≤14 days prior to enrollment (with the exception of uncomplicated urinary tract infection or upper respiratory tract infection).
Uncontrolled diabetes mellitus as defined by HbA1c >8% despite adequate therapy.
Unstable coronary artery disease or myocardial infarction during preceding 6 months.
Patients with history of interstitial lung disease and/or pneumonitis, or pulmonary hypertension.
Use of strong inhibitors and inducers of CYP3A4 within the 14 days prior to receiving the first dose of ABI-009. Additionally, use of any known CYP3A4 substrates with narrow therapeutic window (such as fentanyl, alfentanil, astemizole, cisapride, dihydroergotamine, pimozide, quinidine, terfanide) within the 14 days prior to receiving the first dose of ABI-009.
Known Human Immunodeficiency Virus (HIV).
Known active Hepatitis B or Hepatitis C.","In this study, you will receive ABI-009 given through a vein (intravenous) once weekly for 2 weeks (on days 1 and 8) followed by a week of rest in a 21-day cycle.

ABI-009: rapamycin protein-bound nanoparticles for injectable suspension (albumin bound)",ChEMBL:CHEMBL413 | DrugBank:DB00877 | PubChem:134760597 | PubChem:138404388 | PubChem:21944094 | PubChem:5284616,Sirolimus,COC1CC2CCC(C)C(O)(O2)C(=O)C(=O)N2CCCCC2C(=O)OC(C(C)CC2CCC(O)C(OC)C2)CC(=O)C(C)C=C(C)C(O)C(OC)C(=O)C(C)CC(C)C=CC=CC=C1C,L01EG04 | L04AA10 | S01XA23,1.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT03693989,NCT03693989_EG000,No,All,Adult | Older Adult,Phase 3,85,"Inclusion Criteria:

Signed informed consent.
Age ≥ 18 years.
Both sexes.
Postoperative cataract surgery by phacoemulsification. o That they have met the criteria for phacoemulsification and a classification of the lens opacity classification system (LOCS) III cataract of Opalescence of the nucleus (NO) ≥2 and Kernel color (NC) ≥2.

Exclusion Criteria:

Pregnant women, lactating or planning to get pregnant.
Women of reproductive age and who do not have a hormonal contraceptive method, intrauterine device or bilateral tubal obstruction.
Participation in another clinical research study ≤ 30 days before the baseline visit.
Have previously participated in this same study with the contralateral eye.
That they can not comply with their attendance at appointments or with all the requirements of the protocol.

Medical and therapeutic criteria.

Surgery in both eyes in the same surgical shift.
Time> 24 hours after having surgery.
Intraocular lens placement outside the bag.
Presentation of rupture of the posterior capsule, with or without the presence of vitreous.
Carrying out an iridectomy, or lesion of the pupillary sphincter during phacoemulsification surgery.
Scheduled for surgical intervention in the contralateral eye during the study period.
History of glaucoma or ocular hypertension.
History of increased Intraocular pressure (IOP) with the use of steroids.
Intraocular pressure (IOP) ≥24.
History of uveitis.
Presence of corneal abrasion or corneal ulceration in the study eye.
Use of steroids or topical non steroidal anti inflammatory drugs, 24 hours prior to surgery and until the start of instillation of investigational drugs.
Use of anticoagulants, systemic steroids or immunomodulators in the last two weeks
Periocular injection of any steroid in the study eye 4 weeks before the start of the instillation of the investigational drugs.
Use of storage steroids 2 months prior to the start of instillation of investigational drugs.
Presence or suspicion of keratitis and / or viral, bacterial or fungal conjunctivitis.
Presence or suspicion of endophthalmitis.
Presence or suspicion of toxic syndrome of the anterior segment.
Severe corneal edema that does not allow assessment of the anterior chamber
Macular diseases.
Diabetes Mellitus with glycosylated hemoglobin (A1C) ≥ 6.5% (48 mmol / mol) or fasting glucose (no caloric intake by ≥ 8 hours) of ≥ 126 mg / dL (7.0 mmol / L).
Any disease or condition that requires the use of topical or systemic nonsteroidal anti-inflammatories (NSAIDs) during the time of intervention.
Any disease or condition that requires the use of steroids other than topical ophthalmic application.
Subjects with a single eye.
Any condition or disease that at the discretion of the principal investigator (IP) does not make the subject suitable for the study.
Known hypersensitivity to the components of the products under investigation.","Difluprednate 0.05%. Prepared by Sophia Laboratories, S.A. of C.V., Zapopan, Jalisco, Mexico.

Difluprednate 0.05%: Dosage: 1 drop 4 times a day (every 4 hours) during the period of vigil in the operated eye, for 14 days. Dose reduction for 14 days at the discretion of the principal investigator.",ChEMBL:CHEMBL1201749 | DrugBank:DB06781 | PubChem:443936,Difluprednate,[H][C@@]12CC[C@](OC(=O)CCC)(C(=O)COC(C)=O)[C@@]1(C)C[C@H](O)[C@@]1(F)[C@@]2([H])C[C@H](F)C2=CC(=O)C=C[C@@]21C,D07AC19,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03693989,NCT03693989_EG001,No,All,Adult | Older Adult,Phase 3,86,"Inclusion Criteria:

Signed informed consent.
Age ≥ 18 years.
Both sexes.
Postoperative cataract surgery by phacoemulsification. o That they have met the criteria for phacoemulsification and a classification of the lens opacity classification system (LOCS) III cataract of Opalescence of the nucleus (NO) ≥2 and Kernel color (NC) ≥2.

Exclusion Criteria:

Pregnant women, lactating or planning to get pregnant.
Women of reproductive age and who do not have a hormonal contraceptive method, intrauterine device or bilateral tubal obstruction.
Participation in another clinical research study ≤ 30 days before the baseline visit.
Have previously participated in this same study with the contralateral eye.
That they can not comply with their attendance at appointments or with all the requirements of the protocol.

Medical and therapeutic criteria.

Surgery in both eyes in the same surgical shift.
Time> 24 hours after having surgery.
Intraocular lens placement outside the bag.
Presentation of rupture of the posterior capsule, with or without the presence of vitreous.
Carrying out an iridectomy, or lesion of the pupillary sphincter during phacoemulsification surgery.
Scheduled for surgical intervention in the contralateral eye during the study period.
History of glaucoma or ocular hypertension.
History of increased Intraocular pressure (IOP) with the use of steroids.
Intraocular pressure (IOP) ≥24.
History of uveitis.
Presence of corneal abrasion or corneal ulceration in the study eye.
Use of steroids or topical non steroidal anti inflammatory drugs, 24 hours prior to surgery and until the start of instillation of investigational drugs.
Use of anticoagulants, systemic steroids or immunomodulators in the last two weeks
Periocular injection of any steroid in the study eye 4 weeks before the start of the instillation of the investigational drugs.
Use of storage steroids 2 months prior to the start of instillation of investigational drugs.
Presence or suspicion of keratitis and / or viral, bacterial or fungal conjunctivitis.
Presence or suspicion of endophthalmitis.
Presence or suspicion of toxic syndrome of the anterior segment.
Severe corneal edema that does not allow assessment of the anterior chamber
Macular diseases.
Diabetes Mellitus with glycosylated hemoglobin (A1C) ≥ 6.5% (48 mmol / mol) or fasting glucose (no caloric intake by ≥ 8 hours) of ≥ 126 mg / dL (7.0 mmol / L).
Any disease or condition that requires the use of topical or systemic nonsteroidal anti-inflammatories (NSAIDs) during the time of intervention.
Any disease or condition that requires the use of steroids other than topical ophthalmic application.
Subjects with a single eye.
Any condition or disease that at the discretion of the principal investigator (IP) does not make the subject suitable for the study.
Known hypersensitivity to the components of the products under investigation.","Prednefrin® SF. Prednisolone Acetate 1%. Prepared by Allergan, S.A. of C.V.

Prednefrin: 1 drop 4 times a day (every 4 hours) during the period of vigil in the operated eye, for 14 days. Dose reduction for 14 days at the discretion of the principal investigator.

- Route of administration: topical ophthalmic",ChEMBL:CHEMBL1201749 | DrugBank:DB06781 | PubChem:443936,Difluprednate,[H][C@@]12CC[C@](OC(=O)CCC)(C(=O)COC(C)=O)[C@@]1(C)C[C@H](O)[C@@]1(F)[C@@]2([H])C[C@H](F)C2=CC(=O)C=C[C@@]21C,D07AC19,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03703466,NCT03703466_EG000,No,All,Adult | Older Adult,Phase 2,24,"Inclusion Criteria:

Have a diagnosis of HR+, HER2- metastatic breast cancer (mBC).

Have all of the following:

Recurrent, locally advanced, unresectable or mBC with disease progression following anti-estrogen therapy.
Prior treatment with chemotherapy for locally advanced or metastatic disease.
No prior treatment with cyclin-dependent kinases (CDK) 4 and 6 inhibitor.
Have Eastern Cooperative Oncology Group performance status (ECOG PS) ≤1.
Have discontinued all previous treatments for cancer and recovered from the acute effects of therapy.
Have adequate organ function.
Women of child-bearing potential must have a negative pregnancy test.
Are able to swallow tablets/capsules.

Exclusion Criteria:

Are currently receiving treatment in a clinical study involving an investigational product.
Have a serious concomitant systemic disorder.
Have symptomatic central nervous system (CNS) malignancy or metastasis.
Have a symptomatic Human Immunodeficiency Virus (HIV) infection or symptomatic activated/reactivated hepatitis A, B, or C.
Have a personal history of syncope of either unexplained or cardiovascular etiology, ventricular tachycardia, ventricular fibrillation, or sudden cardiac arrest.
Have a history of any other cancer.
Had major surgery within 14 days prior to randomization.
Are breastfeeding.
Have received treatment with a drug that has not received regulatory approval for any indication within 14 or 21 days of the initial dose of study drug for a nonmyelosuppressive or myelosuppressive agent, respectively.",200 mg abemaciclib given twice a day (BID) orally with a meal.,ChEMBL:CHEMBL3301610 | DrugBank:DB12001 | PubChem:46220502,Abemaciclib,CCN1CCN(Cc2ccc(Nc3ncc(F)c(-c4cc(F)c5nc(C)n(C(C)C)c5c4)n3)nc2)CC1,L01EF03,1.0,0.0,0.0,0.0,0.0,1.0,1.0,1.0,0.0,0.0,1.0,1.0,1.0,1.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT03710187,NCT03710187_EG000,No,All,Adult | Older Adult,Phase 2,84,"Inclusion Criteria:

Critically ill medical patients requiring addition of stress dose steroid therapy (hydrocortisone) in addition to pressors for septic shock management during ICU stay
Fludrocortisone administered within 24 hours after initiation of hydrocortisone if in combination therapy group

Exclusion Criteria:

Use of fludrocortisone and/or hydrocortisone for any reason other than septic shock management during ICU stay
Fludrocortisone/hydrocortisone initiated by any service other than critical care medicine
Prior use of fludrocortisone/hydrocortisone at time of admission (home or outside facility)
Patients not appropriate for study inclusion as determined by provider discretion
Patients receiving steroid therapy not in accordance with assigned group per location (MCC1 or MCC2)
Patients re-admitted to the MCC during the same admission and restarted on vasopressor therapy will be noted during data collection and only the initial admission will be included for analysis
Any patient receiving greater than one dose of hydrocortisone 100 mg
Physical or medical contraindication to receiving PO or PER FT (per feeding tube) fludrocortisone","Hydrocortisone 50 mg IV Q6h plus Fludrocortisone 50 mcg PO/PFT Q24h

Combination (Hydrocortisone and Fludrocortisone): Hydrocortisone 50 mg IV Q6h and Fludrocortisone 50 mg PO/PFT Q24h",ChEMBL:CHEMBL389621 | DrugBank:DB00741 | PubChem:5754,Hydrocortisone,[H][C@@]12CC[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)CC[C@@]21C,A01AC03 | A07EA02 | C05AA01 | D07AA02 | D07BA04 | D07CA01 | D07XA01 | H02AB09 | R01AD60 | S01BA02 | S01BB01 | S01CA03 | S01CB03 | S02BA01 | S02CA03 | S03CA04,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03710187,NCT03710187_EG001,No,All,Adult | Older Adult,Phase 2,84,"Inclusion Criteria:

Critically ill medical patients requiring addition of stress dose steroid therapy (hydrocortisone) in addition to pressors for septic shock management during ICU stay
Fludrocortisone administered within 24 hours after initiation of hydrocortisone if in combination therapy group

Exclusion Criteria:

Use of fludrocortisone and/or hydrocortisone for any reason other than septic shock management during ICU stay
Fludrocortisone/hydrocortisone initiated by any service other than critical care medicine
Prior use of fludrocortisone/hydrocortisone at time of admission (home or outside facility)
Patients not appropriate for study inclusion as determined by provider discretion
Patients receiving steroid therapy not in accordance with assigned group per location (MCC1 or MCC2)
Patients re-admitted to the MCC during the same admission and restarted on vasopressor therapy will be noted during data collection and only the initial admission will be included for analysis
Any patient receiving greater than one dose of hydrocortisone 100 mg
Physical or medical contraindication to receiving PO or PER FT (per feeding tube) fludrocortisone","Hydrocortisone 50 mg IV Q6h

Hydrocortisone: Hydrocortisone 50 mg IV Q6h",ChEMBL:CHEMBL389621 | DrugBank:DB00741 | PubChem:5754,Hydrocortisone,[H][C@@]12CC[C@](O)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)CC[C@@]21C,A01AC03 | A07EA02 | C05AA01 | D07AA02 | D07BA04 | D07CA01 | D07XA01 | H02AB09 | R01AD60 | S01BA02 | S01BB01 | S01CA03 | S01CB03 | S02BA01 | S02CA03 | S03CA04,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03712917,NCT03712917_EG001,No,All,Child | Adult,Not Applicable,40,"Inclusion Criteria:

Migraine diagnosis according to ICHD-2
Ages between 15 -45 Volunteering
Monthly attack number between 5-14
BMI between 18-30
w/o history of nephrolithiasis
w/o history of DM, peripheral vascular disease
w/o history of chronic systemic diseases (lung, heart,liver, kidney)
w/o any detected CNS disease (including MS, movement disorders, CVD, primary or secondary tumors)
w/o history of acute or chronic psychiatric disease
w/o history of antiplatelet and anticoagulant medication
w/o any combination of medication overuse headache or other primary headaches
w/o previous medication of flunarizine and topiramate
w/o previous application of GONB

Exclusion Criteria:

Pregnancy

Lost to follow up

exited with his/her own will
detected primary headache during follow up
cessation due to adverse effects of topiramate
cessation due to adverse effects of flunarizine","Topiramate is administered twice a day at a dose of 25 mg/day, which is increased to 100 mg/day in the second week.

Topiramate: An antiepileptic agent used for migraine prophylaxis.",ChEMBL:CHEMBL220492 | DrugBank:DB00273 | PubChem:5284627,Topiramate,[H][C@@]12OC(C)(C)O[C@]1([H])CO[C@@]1(COS(N)(=O)=O)OC(C)(C)O[C@]12[H],A08AA51 | N03AX11,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03714672,NCT03714672_EG002,No,All,Adult,Phase 3,206,"Inclusion Criteria:

The participant has read the informed consent form, has understood the relevant aspects of the clinical study, and grants his/her authorization to participate by signing the informed consent form prior to the inclusion in the clinical study and the performance of any procedure.
Male and female participants above 18 years up to 60 years.
Female participants of childbearing potential must be practicing an acceptable method of birth control and must have a negative urine pregnancy test at enrollment with confirmation at the Allocation Visit.
Participants are in good health, i.e., the medical record, vital signs, physical examination, and laboratory parameter assessments do not show any abnormal deviations impeding the participation in the clinical study.
Participants requiring extraction of 3 or more third molars with 2 mandibular impacted third molars.
Clinical and radiological diagnosis of impacted lower third molars.
Class I and Class II molars according to Pell and Gregory's classification (Gay Escoda et al. 2004).
Participants must be able to swallow the IMPs.

Exclusion Criteria at Enrollment:

Findings in the medical record, vital signs, and/or physical examination demonstrating abnormal conditions of participant's general state of health preventing his/her participation in the clinical study according to the investigator's opinion.
Participant unable to speak, read, or write in Spanish language.
Clinical laboratory parameters exceed the pre-defined alert ranges (i.e., 1 standard deviation above or below the upper/lower limit of the normal ranges).
Known hypersensitivity to the IMPs, the anesthetic to be used during surgery, or to the rescue medication (ibuprofen, ketorolac).
Known alcohol or drug abuse in the last 6 months or any history of seizures. Alcohol abuse is defined as the consumption of more than 3 ounces (about 90 milliliters) of liquor or spirits or 18 ounces (about 530 milliliters) of beer per day, for 5 consecutive days during the 6-month period. Drug abuse is defined as the use of any recreational drug for 5 consecutive days during the 6 month period.
Participants who take analgesic medication for chronic pain, monoamine oxidase inhibitors, tricyclic antidepressants, neuroleptics, or other drugs that reduce the seizure threshold within 4 weeks of enrollment.
Pregnant or lactating women.
Participants who received systemic corticosteroids or opioid analgesics less than 2 weeks before surgery.
Participants with molars linked to the mandibular canal.

Participants requiring immediate dental procedures other than third and fourth molars extraction,

Exclusion Criteria at the Allocation Visit:

Participant received a long-acting non-steroidal anti-inflammatory drug within 24 hours or 5 times the elimination half-life of that drug prior to surgery, whatever the longer.
Participant received any analgesic medication other than short-acting pre-operative or intra-operative anesthetic agents within 24 hours before taking IMPs.
Participant received more than 300 mg of lidocaine in total.
Participant received any analgesic medication other than the IMPs immediately after the oral surgical procedure was completed.
Baseline pain intensity of the participant after oral surgical procedure remains below 5 points on the 11-point NRS.","Participants received 3 doses of tramadol hydrochloride 50 mg over a 24-hour period if they developed acute moderate to severe pain within 4 hours after third molar extraction.

Tramadol 50: Each dose comprised 1 capsule containing 50 mg tramadol hydrochloride and 3 placebo tablets matching the other active treatment groups. Doses were taken 8 hours apart.",ChEMBL:CHEMBL1237044 | DrugBank:DB00193 | PubChem:33741,Tramadol,COc1cccc(C2(O)CCCCC2CN(C)C)c1,N02AJ13 | N02AJ14 | N02AJ16 | N02AX02,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03718091,NCT03718091_EG000,No,All,Child | Adult | Older Adult,Phase 2,29,"Inclusion Criteria:

Participants Enrolling to the Translational Lead-in Study:

For enrollment to cohort T1: participants must have metastatic or progressive LMS with a) treatment with at least one prior systemic therapy b) ATRX mutation by NGS
For enrollment to cohorts T2 or T3: participants must have a histologically or cytologically confirmed advanced solid tumor for which no standard curative therapy is available.
For enrollment to cohort T2: participants must have a truncating ATM mutation. Testing may be completed via the DFCI/BWH OncoPanel, MGH SNaPshot, or any other CLIA-certified method.

For enrollment to cohort T3, participants must have one of the following (testing may be completed via the DFCI/BWH OncoPanel, MGH SNaPshot, or any CLIA-certified laboratory):

Germline mutation in BRCA1 or BRCA2 that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function).
A somatic mutation in BRCA1 or BRCA2, or another mutation within a known HR gene including BARD1, BRIP1, CDK12, CHEK2, FANCA, FANCC, FANCE, FANCF, FANCM, MRE11A, NBN, PALB2, RAD51B, RAD51C, or RAD51D.
A MYC amplification of greater than 6-fold.
FBXW7 truncating or missense mutation designated as deleterious.
CCNE1 amplification of greater than 8-fold.
An ARID1A mutation as determined by the DFCI/BWH OncoPanel or any other CLIA-certified method.
Other (unlisted) mutations within known HR genes may be considered with approval from the site principal investigator.
For enrollment to cohort T4: participants must have GIST with known mutation in SDHX genes or loss of expression of SDHX protein(s), as determined by standard pathology assays. Prior therapy is not required.
Age ≥ 18 years
ECOG performance status ≤ 2 (Karnofsky [KPS] ≥ 60%; KPS of 50 is not permitted)
Participants must have tumor amenable to biopsy, and be a candidate for tumor biopsy according to the treating investigator. The patient must be willing to undergo a fresh tumor biopsy for this study.
Participants must have archival tissue available for analysis. Participants without available archival tissue enrolling to the translational lead-in study may instead use tissue from the fresh pre-treatment biopsy.

Participants Enrolling to the Phase II:

For enrollment to cohort 1A: participants must have metastatic or progressive osteosarcoma treated with at least one prior systemic therapy.
For enrollment to cohort 1B: participants must have metastatic or progressive leiomyosarcoma treated with at least one prior systemic therapy.
For enrollment to cohorts 2 - 5: participants must have a histologically or cytologically confirmed advanced solid tumor for which no standard curative therapy is available.
For enrollment to cohort 2: participants must have a truncating ATM mutation. Testing may be completed via the DFCI/BWH OncoPanel, MGH SNaPshot, or any other CLIA-certified method.
For enrollment to cohort 3A: participants must have a germline mutation in BRCA1 or BRCA2 that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function). Testing may be completed via the DFCI/BWH OncoPanel, MGH SNaPshot, or any CLIA-certified laboratory.
For enrollment to cohort 3B: participants must have a somatic mutation in BRCA1 or BRCA2, or another mutation within a known HR gene including BARD1, BRIP1, CDK12, CHEK2, FANCA, FANCC, FANCE, FANCF, FANCM, MRE11A, NBN, PALB2, RAD51B, RAD51C, or RAD51D. Other (unlisted) mutations within known HR genes may be considered with approval from the site principal investigator.
For enrollment to cohort 4A: participants must have a MYC amplification of greater than 6-fold or an FBXW7 truncating or missense mutation designated as deleterious, as determined by the DFCI/BWH OncoPanel, MGH SNaPshot, or any other CLIA-certified method.
For enrollment to cohort 4B: participants must have a CCNE1 amplification of greater than 8-fold as determined by the DFCI/BWH OncoPanel, MGH SNaPshot, or any other CLIA-certified method.
For enrollment to cohort 5: participants must have an ARID1A mutation as determined by the DFCI/BWH OncoPanel, MGH SNaPshot, or any other CLIA-certified method.
For enrollment to cohort 1A: Age > 12
For enrollment to cohorts 1B - 5: Age ≥ 18
ECOG performance status ≤ 2 (Karnofsky ≥ 60%; KPS of 50 is not permitted) for participants ≥ 16 years of age, Lansky ≥ 50% for participants < 16 years of age
Participants must have archival tissue available for analysis

All Participants:

If any participant could enroll to more than one cohort based on mutational status, the cohort enrollment decision will be discussed with the overall principal investigator. For example, if a participant has both an ATM mutation and an FBXW7 mutation and thus could enroll to either Cohort 2 or Cohort 4A, the decision of which cohort to enroll to will be made in conjunction with the overall principal investigator. The decision as to which cohort the participant should be enrolled on must be made prior to the initiation of study treatment.
Participants must have RECIST 1.1 measurable disease.
Participants must have normal organ and marrow function as defined below:

All Participants:

Absolute neutrophil count ≥ 1,500/mcL
Platelets ≥ 100,000/mcL
Total bilirubin ≤ 1.5 × institutional upper limit of normal (ULN) for age

Adult Participants (Age ≥ 18 years):

AST(SGOT)/ALT(SGPT) ≤ 2.5 × institutional ULN; OR

5 × institutional ULN if liver metastases are present
Serum or plasma creatinine ≤ 1.5 × institutional ULN, OR
Creatinine clearance ≥ 60 mL/min by Cockcroft-Gault equation for participants with creatinine levels above 1.5 × institutional ULN

Pediatric Participants (Age < 18 years):

ALT (SGPT) ≤ 3 × institutional (ULN)

-for the purposes of this study, the ULN for SGPT will be defined as 45 U/L.

Serum or plasma creatinine Participants 13 - 15 years: males ≤ 1.5 mg/dL, females

≤ 1.4 mg/dL, participants 16 - 17 years: males ≤ 1.7 mg/dL, females ≤ 1.4 mg/dL; OR

Creatinine clearance ≥ 60 mL/min/1.73 m2 by Schwartz formula for participants with creatinine levels above the limits described above

The effects of M6620 on the developing human fetus are unknown. For this reason and because anti-cancer agents are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 6 months after completion of M6620 administration.
Ability to understand and the willingness to sign a written informed consent document (or parent or legally authorized representative, if minor).

Exclusion Criteria:

Participants who have had chemotherapy, immune therapy, other investigational therapy, major surgery, or radiotherapy within 3 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study, or participants who have not recovered to ≤ Grade 1 or baseline from therapies administered more than 3 weeks prior (with the exceptions of 1. Alopecia and peripheral neuropathies which may be ≤ Grade 2 at study entry and 2. Laboratory abnormalities that are not listed in 3.1 and that are not considered clinically meaningful [e.g. decreased lymphocyte count, electrolyte abnormalities]
Participants who have received oral tyrosine kinase inhibitors (TKIs) within 5 half-lives of study entry.
Participants who have previously received treatment with an ATR inhibitor, including but not limited to M6620 (VX-970).
Participants with known untreated brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. Participants with a history of brain metastases that have been treated, no longer require corticosteroids, and have been stable on imaging for at least one month following the end of treatment are permitted.
History of allergic reactions attributed to compounds of similar chemical or biologic composition to M6620.
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Pregnant women are excluded from this study because M6620 is an agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with M6620, breastfeeding should be discontinued if the mother is treated with M6620.
Known HIV-positive participants are ineligible because of the increased risk of lethal infections when treated with potentially marrow-suppressive therapy.
Patients with a history of another malignancy are excluded with the exception of 1. patients who remain disease-free for 3 years and 2. adequately treated cervical carcinoma in situ, non-melanoma skin cancer (e.g. basal cell, squamous cell carcinomas), low-risk thyroid cancer.","M6620 will administered intravenously on days 1,4, 8, 11, 15, 18, 22, 25 on a 28-day cycle.

M6620: M6620 is a drug designed to inhibit the ATR enzyme. Inhibiting ATR may block how cancers repair their naturally damaged DNA, handle cancer cell stress, and maintain cancer cell life and health.",ChEMBL:CHEMBL3989870 | DrugBank:DB11794 | PubChem:59472121,Berzosertib,CNCc1ccc(-c2cc(-c3nc(-c4ccc(S(=O)(=O)C(C)C)cc4)cnc3N)on2)cc1,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03718143,NCT03718143_EG002,No,All,Adult | Older Adult,Phase 2,1,"Inclusion:

Inclusion Criteria

Dose escalation part of trial for combined AraC + AZD1775 (Arm A)
untreated elderly (>60 years) AML if in the poor-risk cytogenetic group (please reference Appendix V).
untreated elderly (>60 years) AML if in the intermediate and poor-risk cytogenetic group (please reference Appendix V)
relapsed or refractory AML (≥ 18 years)
any MDS (≥ 18 years) having failed or been intolerant to prior hypomethylating agent (HMA) treatment.
Failure is defined as any disease progression while on HMA, relapse after HMA treatment or no response after 4 cycles of 5-Azacitidine or decitabine
Patients with isolated 5q-/5q- syndrome must have failed, not tolerated, or progressed on lenalidomide in addition to having failed or been intolerant to HMA treatment.
advanced progressive MF, defined as intermediate and high risk primary and secondary MF, or any other MF failed or intolerant to JAK2 inhibitor therapy requiring medical therapy
If appropriate, patients can have failed other prior therapies for their disease (i.e. JAK2 inhibitor, interferon, hydroxyurea or IMIDs). Patients may have failed more than one JAK2 inhibitor and JAK2 inhibitor must not have been the most recent treatment (e.g. other therapies as last therapy prior to study given after failure of previous JAK2 inhibitor).
Failure/ intolerance of Ruxolitinib
The following laboratory values obtained 7 days prior to registration.
Total bilirubin ≤ 1.5 mg/dL (except Gilbert's syndrome or known hemolysis or leukemic infiltration)
AST (SGOT) and ALT (SGPT) ≤ 2.5 x Upper Limit normal (ULN) or < 5 x ULN if organ involvement
Alkaline Phosphatase < 5 x ULN - Serum creatinine ≤1.5 x ULN, or measured creatinine clearance (CrCl) ≥45 mL/min as calculated by the Cockcroft-Gault method (confirmation of creatinine clearance is only required when creatinine is >1.5 x institutional ULN) CrCl (glomerular filtration rate [GFR]) = (140-age) x (weight/kg) x Fa (72 x serum creatinine mg/dL) a where F= 0.85 for females and F=1 for males
ECOG Performance Status (PS) 0, 1 (Appendix I).
Ability to provide informed written consent and be able to adhere to the study visit schedule and other protocol requirements.
Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study).
Willing to provide blood and bone marrow aspirate samples for correlative research purposes
Negative serum pregnancy test done ≤7 days prior to registration, for women of childbearing potential only.
Female patients who are not of child-bearing potential and fertile females of childbearing potential
Male patients should be willing to abstain or use barrier contraception (i.e., condoms) for the duration of the study drug exposure and for 3 months after study treatment discontinuation.
Patients who have undergone stem cell transplantation (SCT), autologous or allogeneic, are eligible provided that they are > 60 days from stem cell infusion, have GVHD < grade 1 and are off immunosuppressive agents for > 28 days at time of registration.

Exclusion:

AML patients who are suitable for and willing to receive intensive chemotherapy

Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown:

Pregnant women
Nursing women
Men or women of childbearing potential who are unwilling to employ adequate contraception
Subject has had prescription or non-prescription drugs or other products known to be sensitive CYP3A4 substrates or CYP3A4 substrates
The preferred azole anti-fungal medication is Fluconazole (alternatively Posaconazole) which can be given during treatment with AZD1775 (section 9.5).
Pateints may not be on an inhibitor of BCRP as outlined in Appendix VI.
Not willing to avoid grapefruit, grapefruit juices, grapefruit hybrids, Seville oranges, pummelos, and exotic citrus fruits from 7 days prior to the dose of study medication
Mean resting corrected QTc interval using the Fridericia formula (QTcF) >450 msec/male and >470 msec/female (as calculated per institutional standards) obtained from 3 electrocardiograms (ECGs) 2-5 minutes apart at study entry, or congenital long QT syndrome
Herbal preparations/medications","AZD1775 only

Relapsed/Refractory AML & HMA failure AML/ MDS and Relapsed/Refractory Primary & Secondary MF

AZD1775 only: AZD1775 days 1-5 & 8-12",ChEMBL:CHEMBL1976040 | DrugBank:DB11740 | PubChem:24856436,Adavosertib,C=CCn1c(=O)c2cnc(Nc3ccc(N4CCN(C)CC4)cc3)nc2n1-c1cccc(C(C)(C)O)n1,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03719612,NCT03719612_EG000,No,All,Adult | Older Adult,Phase 3,160,"Inclusion Criteria:

Men and women ≥ 18 years of age in sinus rhythm
Able to communicate effectively with trial personnel
LVEF measurements obtained via 2D Echo with or without contrast obtained within 6 months prior to enrollment (Day 0)
Has provided signed informed consent after receiving a verbal and written explanation of this clinical trial

Exclusion Criteria:

Female subjects who are pregnant or lactating. All women of child bearing potential [WOCBP] must have a negative urine pregnancy test at screening regardless of contraceptive use history.

Women of child-bearing potential are excluded unless they:

are post-menopausal defined as amenorrhea ≥ 12 consecutive months, OR
have undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy), OR
have been using an adequate and medically approved method of contraception to avoid pregnancy for at least 1 month prior to DEFINITY® dose administration and be willing to continue using the same method for the duration of the study.
Current illness or pathology that would prevent undergoing investigational product administration due to a significant safety risk to the patient.
Uncontrolled arterial hypertension (defined as systolic blood pressure ≥ 200 mmHg or diastolic blood pressure ≥ 110 mmHg) or arterial hypotension (defined as systolic blood pressure ≤ 90 mmHg).

Unstable cardiovascular status defined as:

myocardial infarction or unstable angina pectoris within 6 months prior to enrollment/DEFINITY® dose administration day
transient ischemic attack or stroke within 3 months prior to DEFINITY® dose administration
symptomatic valvular heart disease or moderate to severe stenotic valvular heart disease
clinically significant congenital heart defects
current uncontrolled cardiac arrhythmias causing symptoms or hemodynamic compromise
acute pulmonary embolus or pulmonary infarction
acute myocarditis or pericarditis
acute aortic dissection
atrial fibrillation
any major surgery within 4 weeks prior to screening
known contraindications to undergoing CMR (e.g. implanted pacemakers, cardioverter, defibrillators) or claustrophobia
participation in any investigational drug, device, or placebo study within 30 days prior to screening
known hypersensitivity to perflutren, or any of the excipients in DEFINITY®
prisoners or those who are subject to compulsory detention or involuntary incarceration for treatment of either a psychiatric or physical illness (e.g., infectious disease).","Each patient will undergo an unenhanced ultrasound examination and a DEFINITY® contrast-enhanced ultrasound

DEFINITY®: All subjects will receive a single dose of DEFINITY®",ChEMBL:CHEMBL1663 | DrugBank:DB00556 | PubChem:6432,Perflutren,FC(F)(F)C(F)(F)C(F)(F)F,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03720990,NCT03720990_EG000,No,All,Child | Adult,Phase 1 | Phase 2,12,"Inclusion Criteria:

Ages 2-25 years.
Participants (or their parents/legally-authorized representative) must provide signed informed consent.
Assent must be obtained from those participants ages 7-17 years who are intellectually capable of understanding this study.
Diagnosis of SLOS based on clinical features and biochemical + genetic confirmation.
Participants are capable of traveling to the STAIR study site.
Fasting plasma cholesterol ≤125 mg/dL during the Qualification Phase must be established before starting cholic acid therapy.
Clinically stable at the time of enrollment
Participants must be on a constant dietary cholesterol intake for at least 3-months prior to treatment with cholic acid.
Participants must agree to make no changes in cholesterol supplementation during the STAIR study.
SLOS participants who are taking antioxidants will be included. Participants must agree to make no changes in the antioxidant dose during this study.
For females of childbearing age (who have begun menstruating), a negative pregnancy test must be documented at the start of the study (week 0/ baseline) and at the end of cholic acid administration (week 8).

Exclusion Criteria:

Participants are unable to provide signed informed consent and/or verbal assent.
Participants have an unstable clinical condition that would prevent completion of the study. Medically unstable participants would include those with severe liver disease, complex birth defects such as severe heart disease or renal dysplasia, those with severe respiratory compromise requiring tracheostomy, or those who are not likely to survive longer than 1 year.
Participants are taking drugs, nutraceuticals, probiotics or other compounds that are known or suspected to affect sterol metabolism.
Participants have transaminase elevations (>3-fold above the reference range) at baseline.","Participants will be treated with cholic acid 10 mg/kg body weight.

Cholic Acid: Participants will be treated with cholic acid for 8 weeks",ChEMBL:CHEMBL205596 | DrugBank:DB02659 | PubChem:221493,Cholic Acid,[H][C@@]1(O)CC[C@@]2(C)[C@@]([H])(C1)C[C@@]([H])(O)[C@@]1([H])[C@]3([H])CC[C@]([H])([C@]([H])(C)CCC(=O)O)[C@@]3(C)[C@@]([H])(O)C[C@]21[H],A05AA03,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03728153,NCT03728153_EG000,No,All,Adult | Older Adult,Phase 2,34,"Inclusion Criteria:

Participant is 18 years of age or older
Participant has experienced a CT-confirmed ischemic stroke w/in 21 days of enrollment

Exclusion Criteria:

NIH Stroke Scale Score >20 points
Unconscious at presentation
Hemorrhagic conversion of ischemic infarct
transient ischemic symptoms <24h,
Current antidepressant or psychoactive drug use (e.g. SSRI, monoxidase amine inhibitor, benzodiazepine).
Current pregnancy.
History of recent head trauma.
Baseline motor deficits from other etiologies including prior stroke.
Dysphagia preventing the swallowing of a pill.
Hyponatremia (<125 mmol/L), hepatic impairment as defined by a serum alanine aminotransferase (ALT) of >120 U/L.
Renal impairment as defined by a creatinine >180 micromol/L or GFR <30mL/min/1.73m2.
Patients who are moribund for other reasons and unlikely to survive to 90 days will also be excluded from participation.
Contraindication to MRI (e.g. piercings/tattoos, electronic/metallic implants, claustrophobia)
Contraindication to lumbar puncture (e.g. infection at site of needle insertion, evidence of elevated ICP, coagulopathy/thrombocytopenia or use of therapeutic anticoagulation, or a history of LP complications).","Fluoxetine 20 MG Oral Tablet

Fluoxetine 20 MG Oral Tablet: Once-daily dosing for 90 days",ChEMBL:CHEMBL41 | DrugBank:DB00472 | PubChem:3386,Fluoxetine,CNCCC(Oc1ccc(C(F)(F)F)cc1)c1ccccc1,N06AB03 | N06CA03,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03732248,NCT03732248_EG000,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 1,21,"Inclusion Criteria:

Must be treatment-seekers
Meet criteria for alcohol use disorder
Must be able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments
Must use one of the following methods of birth control: oral contraceptives, barrier methods (diaphragm or condoms with spermicide or both), surgical sterilization, use of an intra-uterine contraceptive device, or complete abstinence from sexual intercourse
Must live within a 50-mile radius of our research program and have reliable transportation,
Must consent to remain abstinent from alcohol and all non-prescription drugs prior to medication administration and testing sessions
Must consent to fast for a two-hour period prior to medication administration
Must consent to random assignment to the rapamycin vs. placebo conditions.

Exclusion Criteria:

Cannot be undergoing other alcohol cessation treatment
Cannot be pregnant, nursing, or of childbearing potential and not using birth control
Cannot have evidence of or a history of significant endocrine, cardiovascular, pulmonary, renal, or neurological disease
Cannot have significant liver impairment
Cannot have an existing infection or immune system disorder
Cannot have a history of or current psychotic disorder, severe major depression, or bipolar affective disorder
Cannot currently take anti-arrythmic agents, psychostimulants, or any other agents known to interfere with heart rate and skin conductance monitoring
Cannot have known or suspected hypersensitivity to macrolide compounds (such as rapamycin/sirolimus)
Cannot currently take medications that could adversely interact with the study medication, including but not limited to significant inhibitors of CYP2D6 or CYP3A4 (voriconazole, fluconazole, itraconazole, erythromycin, clarithromycin, diltiazem, verapamil, etc.), or significant inducers of CYP3A4, such as anticonvulsants (carbamazepine, phenobarbital, phenytoin, etc.) and antibiotics (rifabutin, rifapentine, etc.)
Cannot have a history of thrombocytopenia, idiopathic thrombocytopenia purpura (ITP) or have a platelet count of less than 100,000 cells per mm3
Cannot have any unhealed wounds
Cannot have any planned surgeries within the next month, including surgical dental procedures
Cannot have a history of complicated alcohol withdrawal symptoms (including, but not limited to, symptoms such as seizures, hallucinations, and high blood pressure)","Rapamycin (sirolimus) is administered in three 5mg oral capsules. This administration happens once during the first visit.

Rapamycin: Immunosuppressive drug",ChEMBL:CHEMBL413 | DrugBank:DB00877 | PubChem:134760597 | PubChem:138404388 | PubChem:21944094 | PubChem:5284616,Sirolimus,COC1CC2CCC(C)C(O)(O2)C(=O)C(=O)N2CCCCC2C(=O)OC(C(C)CC2CCC(O)C(OC)C2)CC(=O)C(C)C=C(C)C(O)C(OC)C(=O)C(C)CC(C)C=CC=CC=C1C,L01EG04 | L04AA10 | S01XA23,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03746951,NCT03746951_EG000,No,All,Child | Adult,Phase 2 | Phase 3,15,"Inclusion Criteria:

ASA grade I-III
Undergoing elective orthopedic surgical procedures involving the hip and upper thigh

Exclusion Criteria:

Local anesthetic allergy
Skin or localized infection at the site of catheter insertion
Patient or parent refusal","FICB is a local anesthetic nerve block, a type of local anesthesia, used for the hip, thigh, and knee. It is performed by inserting the needle into the groin.

Ropivacaine Hcl 0.5% Inj Vil 20Ml: Anesthetic agent used in peripheral nerve block",PubChem:53262281,Naropin,CCC[NH+]1CCCCC1C(=O)Nc1c(C)cccc1C.O.[Cl-],,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03746951,NCT03746951_EG001,No,All,Child | Adult,Phase 2 | Phase 3,15,"Inclusion Criteria:

ASA grade I-III
Undergoing elective orthopedic surgical procedures involving the hip and upper thigh

Exclusion Criteria:

Local anesthetic allergy
Skin or localized infection at the site of catheter insertion
Patient or parent refusal","LPB is a local anesthetic nerve block, a type of local anesthesia, used for the hip, thigh, and knee. It is performed by inserting the needle into the back.

Ropivacaine Hcl 0.5% Inj Vil 20Ml: Anesthetic agent used in peripheral nerve block",PubChem:53262281,Naropin,CCC[NH+]1CCCCC1C(=O)Nc1c(C)cccc1C.O.[Cl-],,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03752203,NCT03752203_EG000,No,All,Child | Adult,Not Applicable,2,"Inclusion Criteria:

Age 31 days through 21 years on date of surgery
Undergoing resection of a central nervous system tumor at Children's Hospital Colorado
Parent/legal guardian (or adult subject) willing and able to complete the informed consent process

Exclusion Criteria:

Tumor in functionally eloquent cortex that precludes maximal surgical resection
Severe renal dysfunction
Preoperative serum creatinine level > than normal range and GFR < 30.
Severe liver dysfunction
History of asthma or pulmonary spasm
Known allergy to sodium fluorescein or any other contrast dye
Previous administration of sodium fluorescein within the last 72 hours
Pregnant or nursing mother
Other unspecified reasons that, in the opinion of the investigator, make the subject unsuitable for enrollment.","This study will employ the use of sodium fluorescein and an FDA approved operative microscope equipped with excitation and barrier filters for monitoring with sufficient fluorescent enhancement and contrast.

Sodium Fluorescein: Patients enrolled in this study will receive 3 mg/kg sodium fluorescein following induction of anesthesia by administration into a peripheral venous line over 10 seconds

Microscopic Resection: Resection will proceed with the use of a surgical microscope equipped with excitation and barrier filters for monitoring with sufficient fluorescent enhancement and contrast.",PubChem:10608,Fluorescein Sodium,O=C([O-])c1ccccc1-c1c2ccc(=O)cc-2oc2cc([O-])ccc12.[Na+].[Na+],,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03758365,NCT03758365_EG004,Accepts Healthy Volunteers,All,Adult,Phase 1,36,"Inclusion Criteria:

Male or female subjects aged 18 years to 50 years old having signed and dated an informed consent,
Non-smoker subjects,
Subjects demonstrating adequate vasoconstriction to Diprolene® cream within 15 days prior to dosing (unoccluded application of Diprolene® cream for 4-6 hours must show a visual score of skin blanching of at least one unit (visual scale (0-4)),
Subjects without signs of skin irritation/disease/disorders/symptoms or blemishes on test sites (e.g. erythema, dryness, roughness, scaling, scars, moles, sunburn),
Female subjects of non-childbearing potential defined as surgically sterile or post-menopausal (at least one year post cessation of menses),
Female subjects of childbearing potential who have been, in the opinion of the Investigator, using an approved method of birth control (e.g. oral contraception pill or patch, intra-uterine devices, contraceptive implants or vaginal rings, condoms, bilateral tubal ligation) at trial entry and agree to continue until the end of the last trial visit,
Female subjects of childbearing potential must have a negative urine pregnancy test at screening visit and at Day 1 to continue,
Subjects willing and able to follow all the trial procedures and complete the whole trial,
Subjects affiliated to a social security system.

Exclusion Criteria:

Female subjects who are breastfeeding,
Use of topical corticosteroids on the test areas (forearms) within 4 weeks prior to the screening phase,
Use of systemic drugs which may interfere with the blanching reaction including, but not limited to, corticosteroids and other vasoactive drugs (nitrates derivatives, antihypertensive, phenylpropanolamine, diphenhydramine, pseudo-ephedrine, antihistamines, non-steroidal anti-inflammatory drug and aspirin/acetylsalicylic acid), within two weeks prior to screening visit,
Use of any other medication would interfere with the trial results, in particular topical drugs applied on the test area within two weeks prior to screening visit,
Subjects having a caffeine (i.e. coffee, cola, soft-drinks containing caffeine) intake greater than 500mg per day (1 cup of coffee contains approximately 85mg of caffeine) within one day prior to screening visit and until the end of the last visit of the test phase,
Subjects with a history of drug or alcohol abuse/addiction.
Abnormal pigmentation of the skin or skin type, that could, in any way, confound interpretation of the trail results (skin type V to VI on the Fitzpatrick scale),
Subjects with obvious difference in skin color between arms,
Subjects with any of the following conditions present on the test areas: viral (e.g. herpes or varicella) lesions of the skin, fungal and bacterial skin infections, parasitic infections, atrophic skin, and striae atrophicae, fragility of skin veins, ichthyosis and ulcers,
Any current systemic or cutaneous disease that could in any way confound interpretation of the trial results (e.g. atopic dermatitis, contact eczema, or psoriasis),
Known or suspected hypersensitivity to any component(s) of Investigational Medical Product (IMP),
Subjects with current participation in any other interventional clinical, based on interview of the subject,
Subjects who have received treatment with any non-marketed drug substance (i.e. an agent which has not yet been made available for clinical use following registration) within the last 4 weeks prior to screening phase,
Previously enrolled in this clinical trial,
Subjects who do not accept to avoid strenuous physical activity nor alcohol intake during the study.
In the opinion of the (sub)investigator, subjects who are unlikely to comply with the Clinical Trial Protocol (e.g. alcoholism, drug dependency or psychotic state),
Subjects in close affiliation with the trial personnel (e.g. immediate family member or subordinate), subjects being a member of the clinical trial personnel, or being an employee of the sponsor or a Contract Research Organisation (CRO involved in the trial,
Subjects impossible to contact in case of emergency,
Subjects who are in an exclusion period in the National Biomedical Research Register of the French Ministry of Health at randomization,
Subjects under guardianship, hospitalized in a public or private institution, for a reason other than the research or subject deprived of freedom.","Single application of Hydrocortisone Butyrate 0.1% Cream

Hydrocortisone Butyrate 0.1% Cream: Single application, visual evaluation of skin blanching and local tolerability, physical examination and safety evaluation",ChEMBL:CHEMBL1683 | DrugBank:DB14540 | PubChem:26133,HYDROCORTISONE BUTYRATE,[H][C@@]12CC[C@](OC(=O)CCC)(C(=O)CO)[C@@]1(C)C[C@H](O)[C@@]1([H])[C@@]2([H])CCC2=CC(=O)CC[C@@]21C,D07AA02 | D07AB02 | D07BB04,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03759392,NCT03759392_EG000,No,All,Adult | Older Adult,Phase 3,185,"Inclusion Criteria

Male or female, greater than or equal to 18 to lesser than or equal to 85 years of age
History of chronic HF, defined as requiring continuous treatment with medications for HF for a minimum of 3 months before screening
New York Heart Association (NYHA) class II or III at screening
Left ventricular ejection fraction less than or equal to 35%
On maximally tolerated HF standard of care (SoC) therapies consistent with regional clinical practice guidelines, if not contraindicated and according to investigator judgment of the subject's clinical status. Beta blocker dose must be stable for 30 days prior to randomization.
N-terminal (NT)-proBNP level greater than or equal to 200 pg/mL
Peak VO2 less than or equal to 75% of the predicted normal value with respiratory exchange ratio (RER) greater than or equal to 1.05 on a screening CPET, confirmed by a CPET core laboratory

Exclusion Criteria

Severe uncorrected valvular heart disease
Paroxysmal atrial fibrillation or flutter documented within the previous 6 months, direct-current (DC) cardioversion or ablation procedure for atrial fibrillation within 6 months, or plan to attempt to restore sinus rhythm within 6 months of randomization. Subjects with persistent atrial fibrillation and no sinus rhythm documented in the prior 6 months are permitted.
Symptomatic bradycardia, second-degree Mobitz type II, or third-degree heart block without a pacemaker.
History of gastrointestinal bleeding requiring hospitalization, urgent procedure or transfusion in the prior year, or received intravenous (IV) iron, blood transfusion, or an erythropoiesis-stimulating agent (ESA) within 3 months prior to screening, or planned blood transfusion or ESA use during the study screening or treatment period. Chronic, stable use of oral iron is permitted.
Ongoing or planned enrollment in cardiac rehabilitation.
Requires assistance to walk or use of mobility assistive devices such as motorized devices, wheelchairs, or walkers. The use of canes for stability while ambulating is acceptable if the subject is deemed capable of performing CPET.
Major medical event or procedure within 3 months prior to randomization, including: hospitalization, surgery, renal replacement therapy or cardiac procedure. This includes episodes of decompensated HF that require IV HF treatment.
At screening: Resting systolic BP greater than 140 mmHg or less than 85 mmHg, or diastolic BP greater than 90 mmHg (mean of triplicate readings); Resting heart rate greater than 90 beats per minute, or less than 50 beats per minute (mean of triplicate readings); Estimated glomerular filtration rate (eGFR) less than 30 mL/min/1.73m2 (by the modified Modification of Diet in Renal Disease equation); Hepatic impairment defined by a total bilirubin (TBL) greater than or equal to 2 times the upper limit of normal (ULN), or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than or equal to 3 times ULN. Patients with documented Gilbert syndrome and TBL greater than or equal to 2 times ULN due to unconjugated hyperbilirubinemia, without other hepatic impairment, are permitted.
Room air oxygen saturation under 90% at screening
Hemoglobin less than 10.0 g/dL at screening
Significant adverse finding (e.g., exercise-induced early ischemic changes, abnormal decrease in BP [systolic BP falls by more than 10 mmHg], unexpected arrhythmia or other serious finding) during CPET at screening that precludes safe participation in the study, per investigator
Chronotropic incompetence (including inadequate pacemaker rate response) during CPET at screening, defined as a maximum heart rate <60% of the maximum predicted heart rate",Omecamtiv mecarbil was administered as an oral modified-release tablet twice daily for up to 20 weeks. Participants randomized to this arm started at an omecamtiv mecarbil dose of 25 mg twice daily. The dose could be increased based on plasma concentrations at Weeks 2 and 6.,ChEMBL:CHEMBL1800955 | DrugBank:DB11816 | PubChem:11689883,OMECAMTIV MECARBIL,COC(=O)N1CCN(Cc2cccc(NC(=O)Nc3ccc(C)nc3)c2F)CC1,C01CX10,0.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT03760250,NCT03760250_EG000,No,All,Adult | Older Adult,Phase 2,6,"Inclusion Criteria:

Age 18 or greater
Men and women who present clinically with keloids requesting excision
Any number of keloids
Keloid no larger than 5cm in diameter at the base
Clinical findings consistent with keloid formation
Location of keloid in low-risk areas - areas other than above the neck, hands, feet, or groin
Able and willing to give informed consent

Exclusion Criteria:

Age < 18
Hypersensitivity to Imiquimod or to any of the excipients (methylhydroxybenzoate, propylhydroxybenzoate, cetyl alcohol, and stearyl alcohol)
Involvement in a trial of another experimental intervention within 30 days
Life threatening disease
Use of immunosuppressive medications such as oral corticosteroids
Bleeding disorders
Not available for follow-up for 10 weeks
Pregnant, intention to become pregnant during treatment phase of trial, or breastfeeding","5% Imiquimod cream once daily to keloid area 5-times a week for 6 weeks, starting 1-week prior to keloid excision

Imiquimod 5% cream: Imiquimod 5% Cream application to keloid skin area 5-times per week for 6 weeks, starting 1-week before keloid excision",ChEMBL:CHEMBL1282 | DrugBank:DB00724 | PubChem:57469,Imiquimod,CC(C)Cn1cnc2c(N)nc3ccccc3c21,D06BB10,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03762915,NCT03762915_EG000,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 4,70,"Inclusion Criteria:

Male and Female
At least 18 years of age
ADA Class III-IV Chronic Periodontitis
Scaling and Root Planing (SRP) or localized SRP
A minimum of eight sites with pockets ≥5mm with bleeding on probing (any quadrant)

Exclusion Criteria:

Unable to comply with study protocol
Completed treatment of Scaling and Root Planing (SRP) and/or localized SRP within the last 6 months
Cigarette use within the last year
≥2 weeks of antibiotic use in the past three months. Or antibiotic use in the last six weeks.
Pregnant, planning to become pregnant, or unsure of pregnancy status (self- reported)
Diagnosed cardiac conditions (cardiovascular disease (CVD) or atherosclerotic vascular disease (ASVD) including coronary heart disease, cerebrovascular disease, and peripheral artery disease, myocardial infarction, stroke, stable or unstable angina, transient ischemic attack, or coronary or other arterial revascularization
Have any uncontrolled medical condition or immunocompromised that may impact the study (uncontrolled diabetes HbA1c > 7, HIV, etc.)
Tetracycline allergy
Any medication that may impact periodontal conditions (Phenytoin, calcium antagonists, cyclosporin, warfarin, or NSAIDS)","The intervention of minocycline HCl microspheres, 1 mg will be administered in the experimental group at baseline and the three month periodontal maintenance visit.

minocycline HCl microspheres: Minocycline HCl microspheres, 1 mg are approved by the Food and Drug Administration (FDA) as an adjunct to SRP procedures for reduction of pocket depth in patients with adult periodontitis.",PubChem:54685925,Minocycline hydrochloride,CN(C)c1ccc(O)c2c1CC1CC3C(N(C)C)C(=O)C(C(N)=O)=C(O)C3(O)C(=O)C1=C2O.Cl,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03767062,NCT03767062_EG000,No,All,Child | Adult | Older Adult,Not Applicable,45,"Inclusion Criteria:

Chronic migraine diagnosis according to International Classification of Headache-2 Disorders (ICHD)
w/o pregnancy or breastfeeding.
w/o acute or chronic psychiatric disorders.
w/o nephrolithiasis.
w/o medication of anticoagulant and antiaggregant.
w/o allergy to topiramate or bupivacaine.
w/o prophylaxis within the last three months with any of; propranolol, nebivolol, topiramate, valproate, venlafaxine, duloxetine, amitriptyline, flunarizine.
w/o previous history of peripheral nerve block, botulinum toxin or acupuncture.
w/o history of multiple sclerosis, movement disorders, epilepsy, stroke, and tumor.

J-w/o chronic systemic diseases including hypertension, cardiac insufficiency, diabetes, pulmonary disease, kidney disease, liver disease, and peripheral arterial disease.

Exclusion Criteria:

Lost to follow up within the pretreatment period during the detoxification therapy after the detoxification therapy
could not tolerate the peripheral nerve block or topiramate","Topiramate will be introduced 25 mg/day b.i.d. for the first week and increased to 100 mg/day b.i.d. for the second week.

Topamax: An antiepileptic agent used for migraine prophylaxis.",ChEMBL:CHEMBL220492 | DrugBank:DB00273 | PubChem:5284627,Topiramate,[H][C@@]12OC(C)(C)O[C@]1([H])CO[C@@]1(COS(N)(=O)=O)OC(C)(C)O[C@]12[H],A08AA51 | N03AX11,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03770091,NCT03770091_EG000,No,All,Adult | Older Adult,Phase 3,40,"Inclusion Criteria:

Thumb CMC arthritis
greater than or equal to age 18
Interested in non-operative treatment of thumb arthritis

Exclusion Criteria:

Recent corticosteroid injection into the thumb joint
Non-English speaking
skin lesions or rashes on the thumb
current use of topical anti-inflammatory medications
concomitant thumb/wrist diagnoses that would impact the results (as determined by the PI)
known allergy to magnesium","Patients will use Theraworx foam and a compression wrap

Theraworx: Theraworx foam applied to skin and/or compression wrap",DrugBank:DB12965 | PubChem:23954,Silver,[Ag],D08AL30,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03770091,NCT03770091_EG002,No,All,Adult | Older Adult,Phase 3,40,"Inclusion Criteria:

Thumb CMC arthritis
greater than or equal to age 18
Interested in non-operative treatment of thumb arthritis

Exclusion Criteria:

Recent corticosteroid injection into the thumb joint
Non-English speaking
skin lesions or rashes on the thumb
current use of topical anti-inflammatory medications
concomitant thumb/wrist diagnoses that would impact the results (as determined by the PI)
known allergy to magnesium","Patients will use Theraworx foam without compression wrap

Theraworx: Theraworx foam applied to skin and/or compression wrap",DrugBank:DB12965 | PubChem:23954,Silver,[Ag],D08AL30,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03772665,NCT03772665_EG000,No,All,Child | Adult | Older Adult,Phase 3,127,"Inclusion Criteria:

A clinical diagnosis of macular atrophy secondary to Stargardt disease (STGD)
Macular atrophy measured to fall within a defined size range
Two mutations of the ABCA4 gene. If only one mutation, a typical STGD appearance of the retina.
Visual acuity in the study eye of at least 20/320

Exclusion Criteria:

Macular atrophy secondary to a disease other than STGD
Mutations of genes, other than ABCA4, that are associated with retinal degeneration
Surgery in the study eye in the past 3 months
Prior participation in a gene therapy or stem cell clinical trial for STGD
Recent participation in a clinical trial for STGD evaluating a complement inhibitor or vitamin A derivative
Use of certain medications in the past 4 weeks that might interfere with emixustat
An abnormal electrocardiogram (ECG)
Certain abnormalities on laboratory blood testing
Female subjects who are pregnant or nursing","10 mg

Emixustat: Once daily oral tablet taken for 24 months",ChEMBL:CHEMBL2107821 | DrugBank:DB12608 | PubChem:25221720,Emixustat,NCC[C@@H](O)c1cccc(OCC2CCCCC2)c1,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03777319,NCT03777319_EG000,No,Male,Child,Phase 1,1,"Inclusion Criteria:

Duchenne muscular dystrophy (DMD) patients ≥4 to ≤7 years of age
Clinical features of DMD that include proximal predominant weakness and/or gait disturbance
Presence of a truncating mutation of the DMD gene in the patient or an affected male relative OR a muscle biopsy that demonstrates <5% dystrophin in the patient or an affected male relative
Normal left ventricular ejection fraction by screening echocardiogram
Ability to cooperate for testing
No prior treatment with glucocorticoids or vamorolone
No concomitant experimental therapies

Exclusion Criteria:

Subject amenable to or currently being treated with eteplirsen, casimersen, or viltolarsen
Hyperkalemia at screening
History of or ongoing renal failure (elevated creatinine, oliguria, anuria)
Hypersensitivity to spironolactone (rash, respiratory distress, arrhythmia, numbness or tingling of extremities)
Current treatment with an ACEi
Severe peptic ulcer disease or recent gastrointestinal perforations","Twelve subjects will be prescribed a standard clinical dose of spironolactone of 1 mg/kg/day. The spironolactone will be provided as suspension.

Spironolactone: Spironolactone will be prescribed for 6 months, after which the family and primary care physician will determine to either remain on spironolactone or transfer to prednisolone.",ChEMBL:CHEMBL1393 | DrugBank:DB00421 | PubChem:5833,Spironolactone,[H][C@]12CC[C@]3(C)[C@]4(CCC(=O)O4)CC[C@@]3([H])[C@]1([H])[C@]([H])(SC(C)=O)CC1=CC(=O)CC[C@@]12C,C03DA01,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03818919,NCT03818919_EG001,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 2,23,"Inclusion Criteria:

All adult patients over age 18 and scheduled for a primary or revision rotator cuff repair

Exclusion Criteria:

Exclusion criteria will include patients with a medical history of known allergies or intolerance to allergies or intolerance to Celebrex, Tylenol, Neurontin, dexamethasone, tramadol, substantial alcohol or drug abuse, and pregnancy, history of narcotics within 6 months of surgery, renal impairment, peptic ulcer disease, GI bleeding. Secondary exclusion criterion is an intact rotator cuff","Patients will be administered a traditional post-operative pain protocol consisting of: Hydrocodone-Acetaminophen Cap 5-500

Hydrocodone-Acetaminophen: Traditionally used narcotic pain protocol",ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03824938,NCT03824938_EG002,No,All,Adult | Older Adult,Phase 3,60,"Inclusion Criteria:

Diagnosis of relapsing-remitting MS
self-reported heat-sensitivity to exercise
Expanded Disability Status Scale (EDSS) total score ≤ 6.0
exacerbation-free (and no use of corticosteroids) for 6 weeks prior
BMI ≤ 40

Exclusion Criteria:

prior history of significant head injury, stroke, or other neurological disease/disorder
current daily use of antipyretics or pain medication
currently in a major depressive episode
vascular disease of the legs, uncontrolled high blood pressure
uncontrolled diabetes mellitus or problem with blood sugar levels
contraindications to aspirin use (history of confirmed peptic ulcer, gastrointestinal or severe gynecological bleeding)
tarry stool or known fecal occult blood
uncontrolled syndrome of asthma, rhinitis, or nasal polyps
contraindications to acetaminophen use (severe active hepatic disease, Hepatitis C Virus)","Participants received acetaminophen 650 mg capsule by mouth, single dose at any study visits, one hour before the initiation of the exercise test.",ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03826628,NCT03826628_EG000,No,All,Child | Adult | Older Adult,Phase 2 | Phase 3,36,"Inclusion Criteria:

Male and female patients aged ≥ 6 years and ≤ 65 years on the day informed consent is obtained
Patients diagnosed with TSC based on the clinical diagnostic criteria of International Tuberous Sclerosis Complex Consensus Conference 2012 and presenting visible facial angiofibroma
An FA severity score of 2 or 3 on the IGA scale
Patients or their legal representatives capable of understanding the explanation of the clinical trial and who give written informed consent for participation
Patients or their legal representatives able to maintain patient diaries following the instructions of the investigator or sub-investigator

Exclusion Criteria:

Patients who cannot carry out the treatment plan or follow-up assessment
Patients with serious skin lesions such as erosions or ulcers
Patients with known hypersensitivity to any component of the study product
Patients who have received rapamycin/sirolimus, everolimus, or temsirolimus within 3 months of enrolment
Patients who received laser therapy or surgical therapy within 6 months prior to trial enrolment
Patients who participated in any other clinical trial within 3 months prior to the day of enrolment
Patients judged unsuitable for this clinical trial by the investigator or sub-investigator
Pregnant or lactating females
Sexually active females of childbearing potential not using adequate contraception and sexually active males not using adequate contraception
Patients with immune dysfunction or receiving any form of immunosuppression
Patients with severe FA, with a score of 4 on the IGA scale
Patients with an FA severity score of less than 2 on the IGA scale","Rapamycin cream topical, 0.5% w/w, applied once daily before bed on affected area for 26 weeks

rapamycin: Apply to the affected area once a day, approximately half an hour before retiring for bed in the evening, for 26 weeks",ChEMBL:CHEMBL413 | DrugBank:DB00877 | PubChem:134760597 | PubChem:138404388 | PubChem:21944094 | PubChem:5284616,Sirolimus,COC1CC2CCC(C)C(O)(O2)C(=O)C(=O)N2CCCCC2C(=O)OC(C(C)CC2CCC(O)C(OC)C2)CC(=O)C(C)C=C(C)C(O)C(OC)C(=O)C(C)CC(C)C=CC=CC=C1C,L01EG04 | L04AA10 | S01XA23,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0
NCT03826628,NCT03826628_EG001,No,All,Child | Adult | Older Adult,Phase 2 | Phase 3,33,"Inclusion Criteria:

Male and female patients aged ≥ 6 years and ≤ 65 years on the day informed consent is obtained
Patients diagnosed with TSC based on the clinical diagnostic criteria of International Tuberous Sclerosis Complex Consensus Conference 2012 and presenting visible facial angiofibroma
An FA severity score of 2 or 3 on the IGA scale
Patients or their legal representatives capable of understanding the explanation of the clinical trial and who give written informed consent for participation
Patients or their legal representatives able to maintain patient diaries following the instructions of the investigator or sub-investigator

Exclusion Criteria:

Patients who cannot carry out the treatment plan or follow-up assessment
Patients with serious skin lesions such as erosions or ulcers
Patients with known hypersensitivity to any component of the study product
Patients who have received rapamycin/sirolimus, everolimus, or temsirolimus within 3 months of enrolment
Patients who received laser therapy or surgical therapy within 6 months prior to trial enrolment
Patients who participated in any other clinical trial within 3 months prior to the day of enrolment
Patients judged unsuitable for this clinical trial by the investigator or sub-investigator
Pregnant or lactating females
Sexually active females of childbearing potential not using adequate contraception and sexually active males not using adequate contraception
Patients with immune dysfunction or receiving any form of immunosuppression
Patients with severe FA, with a score of 4 on the IGA scale
Patients with an FA severity score of less than 2 on the IGA scale","Rapamycin cream topical, 1.0% w/w, applied once daily before bed on affected area for 26 weeks

rapamycin: Apply to the affected area once a day, approximately half an hour before retiring for bed in the evening, for 26 weeks",ChEMBL:CHEMBL413 | DrugBank:DB00877 | PubChem:134760597 | PubChem:138404388 | PubChem:21944094 | PubChem:5284616,Sirolimus,COC1CC2CCC(C)C(O)(O2)C(=O)C(=O)N2CCCCC2C(=O)OC(C(C)CC2CCC(O)C(OC)C2)CC(=O)C(C)C=C(C)C(O)C(OC)C(=O)C(C)CC(C)C=CC=CC=C1C,L01EG04 | L04AA10 | S01XA23,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0
NCT03865732,NCT03865732_EG001,No,Female,Child,Phase 2,10,"Inclusion Criteria:

Molecular confirmation of a pathogenic or likely pathogenic PCDH19 variant
Failure to control seizures despite 2 or more anti-seizure medications
12 seizures over a 12-week period of primary seizure types prior to screening
On a stable regimen of concomitant AEDs, Ketogenic diets, and modified Atkins diet should be unchanged for 3 months prior to screening)

Exclusion Criteria:

Previous exposure to ganaxolone
> 8 consecutive weeks of seizure freedom during the 12 weeks prior to screening
Concurrent use of strong inducers or inhibitors of CYP3A4/5/7 is not permitted
Use of tetrahydrocannabinol (THC) or non-approved cannabidiol (CBD) is prohibited during the double-blind phase
Exposure to any other investigational drug within 30 days or fewer than 5 half-lives prior to screening","ganaxolone suspension (50 mg/ml) 3x's /day for 17 weeks

Ganaxolone: active drug",ChEMBL:CHEMBL1568698 | DrugBank:DB05087 | PubChem:6918305,Ganaxolone,[H][C@@]12CC[C@]3([H])[C@]([H])(CC[C@]4(C)[C@@H](C(C)=O)CC[C@@]34[H])[C@@]1(C)CC[C@@](C)(O)C2,N03AX27,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT03867383,NCT03867383_EG000,No,Female,Adult,Phase 1 | Phase 2,20,"Inclusion Criteria:

Pregnant female subjects at Lucile Packard Children's hospital / Stanford hospital undergoing Cesarean will be screened for inclusion in the study based upon presence of at least 2 risk factors for uterine atony/ postpartum hemorrhage. The risk factors include the following:

intrapartum Cesarean delivery
failed operative vaginal delivery with forceps or vacuum
magnesium infusion
chorioamnionitis
multiple gestation
polyhydramnios
preterm delivery <37 weeks
prior history of postpartum hemorrhage
labor induction or augmentation with oxytocin
advanced maternal age
obesity with body mass index >40

Exclusion Criteria:

a degree of case urgency to which taking time to consent for the study could compromise patient care, determined by anesthesiologist or obstetrician
patient age <18 years or >50 years
renal dysfunction with serum Creatinine > 1.0
abnormal cardiac function or history of arrhythmia
patient taking digoxin
patient currently taking a calcium channel blocker for a cardiovascular indication","Non-participating anesthesiologist prepares the drug solution, which is 1 gram of calcium chloride diluted into a total volume of 60 milliliters normal saline, labeled only with the study ID number. The solution is administered intravenously utilizing an Alaris syringe pump and microbore tubing, with infusion starting immediately at the time of fetal delivery at a rate of 360 milliliters per hour (for a calcium infusion rate of 100 milligrams /minute until the full 1 gram dose is administered).

This is a one-time administration. Patients continue to receive all standard care during the Cesarean including 1 unit oxytocin bolus at the time of fetal delivery + continuous oxytocin infusion at 7.5 units per hour per our institution's protocol.

Calcium Chloride: All included in intervention description.

1 gram of calcium chloride in total 60 milliliters normal saline",ChEMBL:CHEMBL1200668 | DrugBank:DB01164,CALCIUM CHLORIDE,[Ca+2].[Cl-].[Cl-],A11GB01 | A12AA07 | B05XA07 | G04BA03,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0
NCT03868839,NCT03868839_EG000,No,All,Adult | Older Adult,Phase 2,6,"Inclusion Criteria:

Age 18-65 years inclusive.
Primary diagnosis of Schizophrenia or Schizoaffective Disorder established by a structured psychiatric evaluation (MINI) based on Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-V) criteria.
A Positive and Negative Syndrome Scale (PANSS) (Kay et al 1987) total score ≥ 70 with a score of > 4 on two or more of the following PANSS items: delusions, conceptual disorganization, hallucinatory behavior, suspiciousness, and unusual thought content.
A score of ≥4 on the Clinical Global Impression-Severity (CGI-S) (Guy, 1976).
Must have ongoing antipsychotic treatment for at least 8 weeks, with a stable dose for at least 4 weeks. Subjects who have failed to achieve clinically-recognized symptom reduction to at least 1 marketed antipsychotic agent at a therapeutic dose for ≥ 8 weeks during the past 12 months, will be eligible.
Women of childbearing potential must have a negative pregnancy test performed at screening visit prior to receiving the study medication. Women enrolled in this trial must use single barrier contraception.

Exclusion Criteria:

Psychiatrically unstable.
Subjects with any clinically significant abnormalities as determined by medical history, physical exam, clinical and lab evaluation suggestive of an underlying disease state that may, in the opinion of the investigator, confound the results of study, increase risk to the subject, or lead to difficulty complying with the study plan.
Current insulin treatment for diabetes.
History of immunosuppression.
Current or recent radiation or chemotherapy treatment for cancer.
Chronic use of steroids (except local use or inhaler).
Pregnancy or breastfeeding.
Women who are planning to become pregnant.
Use of diuretics, ACE inhibitors, spironolactone, potassium supplements, digoxin or warfarin because the possible drug-drug interaction with telmisartan.
Tested positive for the urine drug screen.
Subjects at imminent risk of suicide or injury to self or others, as per the opinion of the investigator, or history of significant suicide attempt within the last 6 months as per the Columbia Suicide Severity Rating Scale (C-SSRS).
Subjects that have taken an investigational drug or taken part in a clinical trial within 30 days prior to screening.
Subjects with a current (within the last 3 months) DSM-V diagnosis of alcohol or substance use disorder (excluding nicotine and caffeine) as established by the clinical assessment (MINI) at the screening visit will be excluded.
Any other reason that, in the opinion of the investigator, would compromise patient safety or integrity of the study.
Subjects with the lab values defined as exclusionary safety values.","Subjects will start telmisartan 40mg once a day during week 1; the dose will be increased to 80mg (target dose) or as tolerated during the remaining three weeks.

Telmisartan Pill: telmisartan 40mg once a day during week 1; the dose will be increased to 80mg (target dose) or as tolerated during the remaining three weeks.",ChEMBL:CHEMBL1017 | DrugBank:DB00966 | PubChem:65999,Telmisartan,CCCc1nc2c(C)cc(-c3nc4ccccc4n3C)cc2n1Cc1ccc(-c2ccccc2C(=O)O)cc1,C09CA07 | C09DA07 | C09DB04 | C09DX08,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03882788,NCT03882788_EG000,No,All,Child,Not Applicable,44,"Inclusion Criteria:

Neonates of at least 32 weeks of gestation, infants and children up to 2 years of age admitted to The Children's Hospital for treatment of cyanotic or non-cyanotic heart disease requiring surgical intervention.
Admitting diagnosis of cyanotic or non-cyanotic heart disease

Exclusion Criteria:

Neonates less than 32 weeks of gestational age, and children more than 2 years of age.
Any documented central nervous system malformations.
Any potential subject requiring unexpected postoperative Extracorporeal membrane oxygenation (ECMO) support",Participants receive fentanyl 5 mcg/kg/hr not to exceed 10 mcg/kg/hr (high dose).,ChEMBL:CHEMBL596 | DrugBank:DB00813 | PubChem:3345,Fentanyl,CCC(=O)N(c1ccccc1)C1CCN(CCc2ccccc2)CC1,N01AH01 | N01AH51 | N02AB03,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT03883607,NCT03883607_EG000,No,All,Child,Phase 2,5,"Inclusion Criteria:

Was male or female between 8 and 17 years of age (inclusive) at the time of Screening Visit (when consent for study participation is given) and at the time of Randomization;
Diagnosis of NASH confirmed by histological evaluation (with or without fibrosis) from a liver biopsy obtained within 24 months prior to Randomization;
Had an alanine aminotransferase (ALT) level greater than (>) 50 international units per liter (IU/L), at Screening;
Had a Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) greater than or equal to (>=) 5, at Screening;
Had a Body Mass Index z-score (BMI z-score) (also referred to as BMI-for-age percentile) >=85th percentile for age and gender at Screening;
Had a Hemoglobin A1C (HbA1c) less than or equal (<=) to 8.5%. If the participants had Type 2 diabetes and is taking anti-diabetic therapy (e.g., metformin or insulin), treatment must had been started at least 3 months prior to Screening and the dose must had been stable for at least 3 months prior to Screening and should remain stable through Randomization;
Sexually active female participants of childbearing potential must had agree to utilize a highly effective method of contraception per the Clinical Trial Facilitation Group Guidelines from Screening through 30 days after the last dose of study drug (1 month after the end of treatment), and agree to monthly pregnancy testing during the study up to and including end of study.

Other inclusion criteria may apply

Exclusion Criteria:

Had history of bariatric surgery or planned surgery during the study period;
Had known history of heart disease;
Had uncontrolled hypertension evidenced by sustained elevation in systolic blood pressure greater than140 mmHg or diastolic blood pressure greater than 90 mmHg despite treatment with antihypertensive therapy, prior to Randomization;
Had a known history of Type 1 diabetes;
Had a known history of acquired immunodeficiency syndrome or positive screening for human immunodeficiency virus antibodies at Screening Visit;
Had a documented weight loss of more than 5% during the 6-month period prior to Randomization;
Had a history of renal disease defined as an estimated glomerular filtration rate (eGFR) less than 90 mL/min/1.73 m^2 using the Schwartz Bedside GFR Calculator for Children or present at Screening Visit;
History of, significant alcohol consumption or inability to reliably quantify alcohol intake, and/or use of illicit drugs.

Had clinical and/or historical evidence of cirrhosis, included by not limited to:

Abnormal hemoglobin (with the exception of females with a documented history of a low hemoglobin during menstruation);
White blood cell count less than 3,500 cells/mm^3 of blood;
Platelet count less than150,000 cells/mm^3 of blood;
Direct bilirubin greater than 0.3 mg/dL;
Total bilirubin greater than 1.3 mg/dL unless the patient has a diagnosis of Gilbert disease in which case direct bilirubin, reticulocyte count and haemoglobin must be normal;
Serum albumin less than 3.5 g/dL;
International normalized ratio (INR) greater than 1.4;

Has evidence of chronic liver disease other than NASH, defined by any one of the following:

Biopsy consistent with histological evidence of autoimmune hepatitis;
Serum hepatitis A antibody positive;
Serum hepatitis B surface antigen positive;
Serum hepatitis C antibody positive;
Serum hepatitis E antibody positive;
History of or current positive Anti-Mitochondrial Antibody Test;
Known or current Iron/total iron binding capacity ratio (transferrin saturation) greater than 45% with histological evidence of iron overload;
Known or current Alpha-1-antitrypsin phenotype/genotype ZZ or SZ;
Diagnosis of Wilson's disease;
Had AST and/or ALT greater than 8 fold the upper limit of normal;
Was pregnant, lactating or is planning to become pregnant during the study;

Other exclusion criteria may apply",Participants received Elafibranor 80 mg tablets orally once daily for 12 weeks.,ChEMBL:CHEMBL3707395 | DrugBank:DB05187 | PubChem:9864881,Elafibranor,CSc1ccc(C(=O)/C=C/c2cc(C)c(OC(C)(C)C(=O)O)c(C)c2)cc1,A05AX06,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT03883607,NCT03883607_EG001,No,All,Child,Phase 2,5,"Inclusion Criteria:

Was male or female between 8 and 17 years of age (inclusive) at the time of Screening Visit (when consent for study participation is given) and at the time of Randomization;
Diagnosis of NASH confirmed by histological evaluation (with or without fibrosis) from a liver biopsy obtained within 24 months prior to Randomization;
Had an alanine aminotransferase (ALT) level greater than (>) 50 international units per liter (IU/L), at Screening;
Had a Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) greater than or equal to (>=) 5, at Screening;
Had a Body Mass Index z-score (BMI z-score) (also referred to as BMI-for-age percentile) >=85th percentile for age and gender at Screening;
Had a Hemoglobin A1C (HbA1c) less than or equal (<=) to 8.5%. If the participants had Type 2 diabetes and is taking anti-diabetic therapy (e.g., metformin or insulin), treatment must had been started at least 3 months prior to Screening and the dose must had been stable for at least 3 months prior to Screening and should remain stable through Randomization;
Sexually active female participants of childbearing potential must had agree to utilize a highly effective method of contraception per the Clinical Trial Facilitation Group Guidelines from Screening through 30 days after the last dose of study drug (1 month after the end of treatment), and agree to monthly pregnancy testing during the study up to and including end of study.

Other inclusion criteria may apply

Exclusion Criteria:

Had history of bariatric surgery or planned surgery during the study period;
Had known history of heart disease;
Had uncontrolled hypertension evidenced by sustained elevation in systolic blood pressure greater than140 mmHg or diastolic blood pressure greater than 90 mmHg despite treatment with antihypertensive therapy, prior to Randomization;
Had a known history of Type 1 diabetes;
Had a known history of acquired immunodeficiency syndrome or positive screening for human immunodeficiency virus antibodies at Screening Visit;
Had a documented weight loss of more than 5% during the 6-month period prior to Randomization;
Had a history of renal disease defined as an estimated glomerular filtration rate (eGFR) less than 90 mL/min/1.73 m^2 using the Schwartz Bedside GFR Calculator for Children or present at Screening Visit;
History of, significant alcohol consumption or inability to reliably quantify alcohol intake, and/or use of illicit drugs.

Had clinical and/or historical evidence of cirrhosis, included by not limited to:

Abnormal hemoglobin (with the exception of females with a documented history of a low hemoglobin during menstruation);
White blood cell count less than 3,500 cells/mm^3 of blood;
Platelet count less than150,000 cells/mm^3 of blood;
Direct bilirubin greater than 0.3 mg/dL;
Total bilirubin greater than 1.3 mg/dL unless the patient has a diagnosis of Gilbert disease in which case direct bilirubin, reticulocyte count and haemoglobin must be normal;
Serum albumin less than 3.5 g/dL;
International normalized ratio (INR) greater than 1.4;

Has evidence of chronic liver disease other than NASH, defined by any one of the following:

Biopsy consistent with histological evidence of autoimmune hepatitis;
Serum hepatitis A antibody positive;
Serum hepatitis B surface antigen positive;
Serum hepatitis C antibody positive;
Serum hepatitis E antibody positive;
History of or current positive Anti-Mitochondrial Antibody Test;
Known or current Iron/total iron binding capacity ratio (transferrin saturation) greater than 45% with histological evidence of iron overload;
Known or current Alpha-1-antitrypsin phenotype/genotype ZZ or SZ;
Diagnosis of Wilson's disease;
Had AST and/or ALT greater than 8 fold the upper limit of normal;
Was pregnant, lactating or is planning to become pregnant during the study;

Other exclusion criteria may apply",Participants received Elafibranor 120 mg tablets orally once daily for 12 weeks.,ChEMBL:CHEMBL3707395 | DrugBank:DB05187 | PubChem:9864881,Elafibranor,CSc1ccc(C(=O)/C=C/c2cc(C)c(OC(C)(C)C(=O)O)c(C)c2)cc1,A05AX06,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03903822,NCT03903822_EG001,No,All,Child | Adult | Older Adult,Phase 2,37,"Inclusion Criteria:

Clinical diagnosis of Atopic Dermatitis for at least 3 months
Investigator's Global Assessment (IGA) Score of 2 or 3
Eczema Area Severity Index (EASI) score of 3-21
Body Surface Area (BSA) of 2-20%
Peak pruritus-Numerical Rating Scale (PPNRS) of Grade 2 or more

Exclusion Criteria:

Other forms of dermatological diseases (other than atopic dermatitis)
Fitzpatrick skin type score greater than 5
Clinically significant abnormal ECG, vital signs, and laboratory values
Infection with HBV, HCV, herpes zoster or tuberculosis","Participants or caregivers of participants, topically applied PF-06700841 0.1 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.",ChEMBL:CHEMBL4297477 | DrugBank:DB15003 | PubChem:118878093 | PubChem:135087198 | PubChem:138108296 | PubChem:156758088,PF-06700841,Cn1cc(Nc2nccc(N3CC4CCC(C3)N4C(=O)C3CC3(F)F)n2)cn1,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT03903822,NCT03903822_EG002,No,All,Child | Adult | Older Adult,Phase 2,36,"Inclusion Criteria:

Clinical diagnosis of Atopic Dermatitis for at least 3 months
Investigator's Global Assessment (IGA) Score of 2 or 3
Eczema Area Severity Index (EASI) score of 3-21
Body Surface Area (BSA) of 2-20%
Peak pruritus-Numerical Rating Scale (PPNRS) of Grade 2 or more

Exclusion Criteria:

Other forms of dermatological diseases (other than atopic dermatitis)
Fitzpatrick skin type score greater than 5
Clinically significant abnormal ECG, vital signs, and laboratory values
Infection with HBV, HCV, herpes zoster or tuberculosis","Participants or caregivers of participants, topically applied PF-06700841 0.3 % cream on all eligible AD areas (of participants) once daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.",ChEMBL:CHEMBL4297477 | DrugBank:DB15003 | PubChem:118878093 | PubChem:135087198 | PubChem:138108296 | PubChem:156758088,PF-06700841,Cn1cc(Nc2nccc(N3CC4CCC(C3)N4C(=O)C3CC3(F)F)n2)cn1,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT03903822,NCT03903822_EG006,No,All,Child | Adult | Older Adult,Phase 2,36,"Inclusion Criteria:

Clinical diagnosis of Atopic Dermatitis for at least 3 months
Investigator's Global Assessment (IGA) Score of 2 or 3
Eczema Area Severity Index (EASI) score of 3-21
Body Surface Area (BSA) of 2-20%
Peak pruritus-Numerical Rating Scale (PPNRS) of Grade 2 or more

Exclusion Criteria:

Other forms of dermatological diseases (other than atopic dermatitis)
Fitzpatrick skin type score greater than 5
Clinically significant abnormal ECG, vital signs, and laboratory values
Infection with HBV, HCV, herpes zoster or tuberculosis","Participants or caregivers of participants, topically applied PF-06700841 0.3% cream on all eligible AD areas (of participants) twice daily for a maximum of 6 weeks. Eligibility of AD areas to be treated were determined on Day 1 by investigator. Participants were followed up for 4 weeks after last dose.",ChEMBL:CHEMBL4297477 | DrugBank:DB15003 | PubChem:118878093 | PubChem:135087198 | PubChem:138108296 | PubChem:156758088,PF-06700841,Cn1cc(Nc2nccc(N3CC4CCC(C3)N4C(=O)C3CC3(F)F)n2)cn1,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03914417,NCT03914417_EG000,No,All,Adult | Older Adult,Phase 2,19,"Inclusion Criteria:

Adults at least 18 years old.
Subjects must be in good general health as confirmed by the medical history.
Subjects must be able to read, sign, and understand the informed consent.
Prior to imiquimod therapy, subjects must have at least 4-8 actinic keratoses on the face and/or scalp.
Subject must be willing to forego any other treatments on the face and/or scalp, including tanning bed use and excessive sun exposure while in the study.
Subject is willing and able to participate in the study as an outpatient, making frequent visits to the study center during the treatment and follow-up periods and to comply with all study requirements including concomitant medication and other treatment restrictions.
If subject is a female of childbearing potential she must have a negative urine pregnancy test result prior to study treatment initiation and must agree to use an approved method of birth control while enrolled in the study.

Exclusion Criteria:

Subjects with a history of melanoma anywhere on the body.
Subjects with an unstable medical condition as deemed by the clinical investigator.
Subjects with non-melanoma skin cancer on the face and/or or scalp.
Subjects with any dermatologic disease in the treatment area that may be exacerbated by the treatment proposed or that might impair the evaluation of AKs.
Subjects who have previously been treated with imiquimod: on the face or scalp in the past 6 months; or outside of the study area within the past 30 days.
Women who are pregnant, lactating, or planning to become pregnant during the study period.
Subjects who have experienced a clinically important medical event within 90 days of the visit (e.g., stroke, myocardial infarction, etc).
Subjects who have active chemical dependency or alcoholism as assessed by the investigator.
Subjects who have known allergies to any excipient in the study cream.
Subjects who are currently participating in another clinical study or have completed another clinical study with an investigational drug or device on the study area within 30 days prior to study treatment initiation.

Subjects who have received any of the following within 90 days prior to study treatment initiation:

interferon or interferon inducers
cytotoxic drugs
immunomodulators or immunosuppressive therapies (inhaled/ intranasal steroids are permitted)
oral or parenteral corticosteroids
topical corticosteroids if greater than 2 mg/day
any dermatologic procedures or surgeries on the study area (including any AK treatments)
Subjects who have used any topical prescription medications on the study area within 30 days prior to study treatment initiation.","Imiquimod 3.75% Cream topically: Approximately two weeks after Day 0, the entire treatment area was treated with imiquimod 3.75% cream. Subjects utilized the 2 weeks on, 2 weeks off, 2 weeks on regimen.",ChEMBL:CHEMBL1282 | DrugBank:DB00724 | PubChem:57469,Imiquimod,CC(C)Cn1cnc2c(N)nc3ccccc3c21,D06BB10,1.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT03928522,NCT03928522_EG001,No,All,Adult | Older Adult,Phase 4,60,"Inclusion Criteria:

Age over 18
Total knee arthroplasty for primary osteoarthritis performed by Dr. Rick Wright.

Primary diagnosis of knee osteoarthritis

Exclusion Criteria:
Diminished mental capacity
Vancomycin allergy
Tobramycin allergy
Patient history requiring IV administration of vancomycin or tobramycin perioperatively
Chronic kidney disease stage III and stage IV","patients will receive hand mixed tobramycin cement

hand mixed tobramycin: hand mixed tobramycin into cement",ChEMBL:CHEMBL1747 | DrugBank:DB00684 | PubChem:36294,Tobramycin,NC[C@H]1O[C@H](O[C@H]2[C@H](O)[C@@H](O[C@H]3O[C@H](CO)[C@@H](O)[C@H](N)[C@H]3O)[C@H](N)C[C@@H]2N)[C@H](N)C[C@@H]1O,J01GB01 | S01AA12,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03933774,NCT03933774_EG000,Accepts Healthy Volunteers,All,Adult | Older Adult,Not Applicable,25,"Inclusion Criteria:

Age: older than 19
A patient with stable non-segmental vitiligo
A patient with symmetrical vitiligo lesions on face
A patient with the willingness to comply with the study protocol during the study period and capable of complying with it.
A patient who signed the informed consent prior to the participation of the study and who understands that he/she has a right to withdrawal from participation in the study at any time without any disadvantages.

Exclusion Criteria:

Age: lower than 20
A pregnant or lactating patient
A patient with active or spreading vitiligo
A patient who cannot understand the study or who does not sign the informed consent
Women of childbearing potential not using an effective method of contraception properly","Tretinoin 0.05% cream 25g for 1 month, applied on the half side of the face once a day every night

Tretinoin 0.05% cream: Stieva-A Cream 0.05%, 25g, GSK",ChEMBL:CHEMBL38 | ChEMBL:CHEMBL547 | ChEMBL:CHEMBL705 | DrugBank:DB00523 | DrugBank:DB00755 | DrugBank:DB00982 | PubChem:444795 | PubChem:449171 | PubChem:5282379,Tretinoin,CC(C=CC1=C(C)CCCC1(C)C)=CC=CC(C)=CC(=O)O,D10AD01 | D10AD04 | D10AD51 | D10AD54 | D10BA01 | D11AH04 | L01XF01 | L01XF02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT03938857,NCT03938857_EG000,No,All,Child | Adult,Phase 1,6,"Inclusion Criteria:

Ages 0 to <18 years at the time of enrollment.
If < 6 months postnatal age, gestational age ≥ 35 weeks.
Admitted to an intensive care unit.
Planned or anticipated mechanically ventilation for ≥2 days.
Require sedation to maintain mechanical ventilation per clinical judgment.
No contraindication to receipt of fentanyl or dexmedetomidine per clinician judgment.
Availability and willingness of the parent/legal guardian to provide written informed consent.

Exclusion Criteria:

Previous participation in this study.
Severe traumatic brain injury as the underlying etiology for critical illness requiring mechanical ventilation or baseline pediatric cerebral performance category (PCPC) >3.
Planned receipt of sedatives other than fentanyl or dexmedetomidine.
Anticipated receipt of neuromuscular blockade for >48 consecutive hours during the study period.
Receipt of fentanyl or dexmedetomidine via continuous infusion for >12 hours in the 24 hours prior to enrollment.
Extracorporeal life support (including renal replacement therapy, extracorporeal membrane oxygenation, ventricular assist device, etc.) at the time of enrollment.
Chronic use of or recent overdose of serotonergic agents (selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase (MAO) inhibitors, cyclic antidepressants)
Known pregnancy
Known liver dysfunction, defined as: aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2x the upper limit of normal for age
Known or impending renal failure defined as: anuria > or equal to 12 hours prior to enrollment or requiring renal replacement therapy
High risk children, define as: a. known heart block b. known bradyarrythmia including clinically significant bradycardia (defined as requiring chronotropic agents or cardiac pacing to treat)
Receipt of mechanical ventilation during an admission for cardiac surgery

Note: receipt of drugs other than fentanyl or dexmedetomidine for intubation, and receipt of neuromuscular blockage for intubation, will not be considered exclusionary criteria.","Fentanyl standard of care (SOC) titrated to sedation + saline placebo (bolus + infusion)

Fentanyl: Fentanyl standard of care",ChEMBL:CHEMBL596 | DrugBank:DB00813 | PubChem:3345,Fentanyl,CCC(=O)N(c1ccccc1)C1CCN(CCc2ccccc2)CC1,N01AH01 | N01AH51 | N02AB03,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0
NCT03946124,NCT03946124_EG000,No,Female,Older Adult,Phase 4,74,"Inclusion Criteria:

adults aged 65 or older, urinary urgency of quite a bit severity or more on the Overactive Bladder Questionnaire-Short Form (OABq-SF), eligible for pharmacologic therapy for overactive bladder

Exclusion Criteria:

predominant stress incontinence (on UDI-6), current/recent use (6 m) or contraindication to anti-cholinergic medication, severe voiding difficulties, men on 5-alpha reductase inhibitors, severe neurologic disease, recent anti-incontinence or prolapse surgery, other urinary tract conditions such as calculus or recurrent UTI.","Subjects (irrespective of preference) will receive a 90-day supply of open label fesoterodine 4 mg per day. Medication will start 1 week after the baseline visit. After 2 weeks of treatment, dose may be increased to 8 mg over the telephone based on symptom report. This dosing regimen is direct alignment with clinical care. Change of prescription to another anti-cholinergic may occur during the study period, if determined necessary by the physician.

Fesoterodine: Fesoterodine, the drug used in this study, is an appropriate medication for routine and standard care of overactive bladder.",ChEMBL:CHEMBL1201764 | DrugBank:DB06702 | PubChem:6918558,Fesoterodine,CC(C)C(=O)Oc1ccc(CO)cc1[C@H](CCN(C(C)C)C(C)C)c1ccccc1,G04BD11,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03956355,NCT03956355_EG000,No,All,Adult | Older Adult,Phase 3,340,"Inclusion Criteria:

Male and female subjects ages 18 to 75 years with clinical diagnosis of chronic plaque psoriasis and stable disease for at least 6 months prior to the study.
BSA involvement ≥ 3% and ≤ 20%
A PGA score of 2 (mild), 3 (moderate) or 4 (severe) at screening and baseline
Females of child bearing potential and male subjects who are engaging in sexual activity that could lead to pregnancy agree to follow the specified contraceptive guidance throughout the study, including screening, during the treatment period, and for at least 4 weeks after the last exposure to study treatment
Capable of giving written informed consent

Exclusion Criteria:

Psoriasis other than plaque variant
Any sign of infection of any of the psoriatic lesions
Concurrent conditions or history of other diseases:
Immunocompromised at Screening
Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 4 weeks prior to the Baseline visit
Acute active bacterial, fungal, or viral (herpes simplex, herpes zoster, chicken pox) skin infection within 1 week prior to the Baseline visit
Significant dermatologic or inflammatory condition other than plaque psoriasis that, in the Investigator's opinion, would make it difficult to interpret data or assessments during the study
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 1.5x the upper limit of normal (ULN)
Total bilirubin > 1.5 x ULN; total bilirubin > ULN and ≤ 1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin < 35%
Corrected QT interval > 475
Current or chronic history of liver disease, known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones), presence of hepatitis B surface antigen (HBsAg), or positive hepatitis C antibody test result, or a positive anti-hepatitis B core antigen (anti-HBc) result
Ultraviolet (UV) light therapy or prolonged exposure to natural or artificial sources of UV radiation within 4 weeks prior to the Baseline visit and/or plans to have such exposures during the study which could potentially impact the subject's psoriasis
Use of any prohibited medication within the indicated period before the first dose of study drug
Within a minimum of 5 half-lives for biologic agents:
Within 4 weeks for systemic immunosuppressive or immunomodulating agents, fumaric acid derivatives, vitamin D3 and analogs, retinoids, psoralens, corticosteroids, adrenocorticotropic hormone analogs, and tazarotene
2 weeks for immunizations with a live viral component; drugs known to possibly worsen psoriasis, unless on a stable dose for > 12 weeks
With the exception of non-medicated emollients, 2 weeks for topical treatments including corticosteroids, immunomodulators, anthralin (dithranol), vitamin D derivatives or coal tar.
Pregnant females or lactating females
History of sensitivity to the study drugs, or components thereof or a history of drug or other allergy that, in the opinion of the Investigator or Medical Monitor, contraindicates the subject's participation in the study
The subject has received an investigational product within 30 days, 5 half-lives, or twice the duration of the biological effect of the study drug (whichever is longer) prior to first dose of study drug
Current or a history of cancer within 5 years except for fully excised skin basal cell carcinoma, squamous cell carcinoma or carcinoma in situ of the cervix
Subjects with active infection that required oral, intramuscular, or intravenous administration of antibiotics, antifungal or antiviral agents within 7 days of Baseline/Day 1
Previous known participation in a clinical study with tapinarof
Evidence of significant hepatic, renal, respiratory, endocrine, hematologic, neurologic, psychiatric, or cardiovascular (CV) system abnormalities or laboratory abnormality that will affect the health of the subject or interfere with interpretation of the results","Tapinarof (DMVT-505) Cream Group

Tapinarof: Tapinarof cream, 1%, applied once daily.

All SAEs were deemed unrelated to treatment with tapinarof cream, 1%.",ChEMBL:CHEMBL259571 | DrugBank:DB06083 | PubChem:6439522,Tapinarof,CC(C)c1c(O)cc(/C=C/c2ccccc2)cc1O,D05AX07,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT03983980,NCT03983980_EG000,No,All,Adult | Older Adult,Phase 3,343,"Inclusion Criteria:

Male and female subjects ages 18 to 75 years with clinical diagnosis of chronic plaque psoriasis and stable disease for at least 6 months prior to the study.
BSA involvement ≥ 3% and ≤ 20%
A PGA score of 2 (mild), 3 (moderate) or 4 (severe) at screening and baseline
Females of child bearing potential and male subjects who are engaging in sexual activity that could lead to pregnancy agree to follow the specified contraceptive guidance throughout the study, including screening, during the treatment period, and for at least 4 weeks after the last exposure to study treatment
Capable of giving written informed consent

Exclusion Criteria:

Psoriasis other than plaque variant
Any sign of infection of any of the psoriatic lesions
Concurrent conditions or history of other diseases:
Immunocompromised at Screening
Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 4 weeks prior to the Baseline visit
Acute active bacterial, fungal, or viral (herpes simplex, herpes zoster, chicken pox) skin infection within 1 week prior to the Baseline visit
Significant dermatologic or inflammatory condition other than plaque psoriasis that, in the Investigator's opinion, would make it difficult to interpret data or assessments during the study
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 1.5x the upper limit of normal (ULN)
Total bilirubin > 1.5 x ULN; total bilirubin > ULN and ≤ 1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin < 35%
Corrected QT interval > 475
Current or chronic history of liver disease, known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones), presence of hepatitis B surface antigen (HBsAg), or positive hepatitis C antibody test result, or a positive anti-hepatitis B core antigen (anti-HBc) result
Ultraviolet (UV) light therapy or prolonged exposure to natural or artificial sources of UV radiation within 4 weeks prior to the Baseline visit and/or plans to have such exposures during the study which could potentially impact the subject's psoriasis
Use of any prohibited medication within the indicated period before the first dose of study drug

Within a minimum of 5 half-lives for biologic agents:

Within 4 weeks for systemic immunosuppressive or immunomodulating agents, fumaric acid derivatives, vitamin D3 and analogs, retinoids, psolarens, corticosteroids, adrenocorticotropic hormone analogs, and tazarotene
2 weeks for immunizations with a live viral component; drugs known to possibly worsen psoriasis, unless on a stable dose for > 12 weeks
With the exception of non-medicated emollients, 2 weeks for topical treatments including corticosteroids, immunomodulators, anthralin (dithranol), vitamin D derivatives or coal tar.
Pregnant females or lactating females
History of sensitivity to the study drugs, or components thereof or a history of drug or other allergy that, in the opinion of the Investigator or Medical Monitor, contraindicates the subject's participation in the study
The subject has received an investigational product within 30 days, 5 half-lives, or twice the duration of the biological effect of the study drug (whichever is longer) prior to first dose of study drug
Current or a history of cancer within 5 years except for fully excised skin basal cell carcinoma, squamous cell carcinoma or carcinoma in situ of the cervix
Subjects with active infection that required oral, intramuscular, or intravenous administration of antibiotics, antifungal or antiviral agents within 7 days of Baseline/Day 1
Previous known participation in a clinical study with tapinarof
Evidence of significant hepatic, renal, respiratory, endocrine, hematologic, neurologic, psychiatric, or CV system abnormalities or laboratory abnormality that will affect the health of the subject or interfere with interpretation of the results","Tapinarof cream, 1%, applied once daily

Tapinarof: Tapinarof cream, 1%, applied once daily.

All SAEs were deemed unrelated to treatment with tapinarof cream, 1%.",ChEMBL:CHEMBL259571 | DrugBank:DB06083 | PubChem:6439522,Tapinarof,CC(C)c1c(O)cc(/C=C/c2ccccc2)cc1O,D05AX07,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT03996694,NCT03996694_EG003,Accepts Healthy Volunteers,All,Adult,Phase 1,15,"Inclusion Criteria:

Male or female subjects 18 to 55 years of age, inclusive.
Subjects are in good health as indicated by medical history, PE, vital signs, oxygen saturation, clinical laboratory tests, and 12-lead ECG. A status of good health will be defined by the absence of evidence of any clinically significant, active or chronic disease based on these assessments, in the opinion of the investigator.
Subjects with a body mass index (BMI) of 18.0 to 33.0 kg/m2, inclusive, and body weight greater than 50 kg, inclusive.
Subject is able to speak, read, and understand English and voluntarily provide written informed consent to participate in the study.
Subjects have healthy oral mucosa as determined by examination at screening and admission to the clinical facility.
Subject must be a recreational opioid user who is not currently dependent on opioids (based on self-reported DSM-5 criteria and a Clinical Opiate Withdrawal Scale [COWS] score ≤5 on the Naloxone Challenge) but has experience in the use of opioids for non-therapeutic purposes (ie, for psychoactive effects) on at least 10 occasions within the last year and at least once in the 12 weeks prior to the screening visit.
Subject demonstrates adequate VRH at screening during VRH assessment, defined as a minimum increase in ETCO2 of 10 mmHg and an increase in minute ventilation appropriate per investigator's discretion.
Ability and willingness to abstain from alcohol-, caffeine-, and xanthine-containing beverages or food (eg, coffee, tea, cola, chocolate, energy drinks) as well as poppy seeds from 48 hours (2 days) prior to each admission to the clinical facility until study discharge (including clinic furloughs).
Female subjects who are non-pregnant, non-lactating, and either postmenopausal for at least 1 year or surgically sterile for at least 3 months, or, if of childbearing potential, will agree to use adequate contraception from 28 days and/or their last confirmed menstrual period prior to study enrollment (whichever is longer) until 90 days after the follow-up visit. Male subjects, if not surgically sterilized, must agree to use adequate contraception and not donate sperm from first admission to the clinical research center until 90 days after the follow-up visit. Adequate contraception (for both males and females) is defined as using spermicide with a single barrier method: diaphragm, cervical cap, or condom. For female participants and female partners of male participants, being surgically sterilized or using hormonal contraception or an intrauterine device is also acceptable. Also, total abstinence, in accordance with the lifestyle of the subject, is acceptable.
For female subjects: a negative pregnancy test at screening and Day -1 of each treatment period.
Postmenopausal females: defined as 12 months with no menses prior to screening and a serum follicle stimulating hormone (FSH) >40 IU/L at screening.
All prescribed medications, over-the-counter (OTC) medications, dietary supplements or herbal supplements (eg, St. John's Wort extract) must have been stopped at least 14 days prior to the first admission to the clinical research center. An exception is made for acetaminophen, which is allowed up to admission to the clinical research center. An exception is also made for hormonal contraceptives, which may be used throughout the study. Antiemetics may be allowed after the 4-hour VRH assessments while confined in the clinical research unit.

Exclusion Criteria:

Employee of PRA or the Sponsor.
Women who are pregnant, lactating, or planning to attempt to become pregnant during this study or within 90 days after the follow-up visit.
Male subjects with female partners who are pregnant, lactating, or planning to attempt to become pregnant during this study or within 90 days after the follow-up visit.
Has received study medication in another clinical trial within 30 days prior to the first dose of study medication.
Having any disease that, in the opinion of the investigator, poses an unacceptable risk to the subjects.
History of drug allergy diagnosed by a physician. Confirmatory circumstances would include treatment with epinephrine or an Emergency Department.
Subjects who have smoked on a daily basis within 30 days prior to the first dose of study medication. Occasional nicotine use in the form of cigarettes, cigars, or vape pen is allowable (defined as less than half a pack of cigarettes [10 cigarettes], equivalent vaping [100 puffs], or no more than 2 cigars per week). Nicotine replacement therapies (ie, patches and/or gum) may be used without restriction.
Routine or chronic use of more than 3 grams of acetaminophen daily.
Strenuous activity and contact sports within 48 hours (2 days) prior to first admission to the clinical facility and for the duration of the study.
History of donation of more than 450 mL of blood within 60 days prior to dosing in the clinical research center or planned donation before 30 days has elapsed since intake of study drug.
Plasma or platelet donation within 7 days of first dose administration and throughout the entire study.
History of or presence of alcohol dependence. This includes subjects who have never been to a drug rehabilitation program. Alcohol consumption will be prohibited 48 hours prior to admission to the clinical facility and throughout the entire study until discharge.
Positive screening test for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibodies, or antihuman immunodeficiency virus (HIV)-1 and -2 antibodies.
History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, or psychiatric disease, or any other condition, which, in the opinion of the investigator, would jeopardize the safety of the subject or the validity of the study results.
Has any condition in which an opioid is contraindicated (eg, significant respiratory depression, acute or severe bronchial asthma or hypercarbia, or has or is suspected of having paralytic ileus).
Have a history of chronic obstructive pulmonary disease or any other lung disease (eg, asthma, bronchitis, obstructive sleep apnea, exercise-induced asthma) that would cause CO2 retention.
Has participated in (within the last 5 years), is currently participating in, or is seeking treatment for substance-related disorders (excluding nicotine and caffeine).
A positive result for drugs of abuse (amphetamines, methamphetamines, barbiturates, benzodiazepines, cocaine, and opioids, including oxycodone) at screening is acceptable as long as the urine drug screen is negative for these drugs at admission to the clinical facility. A positive test for THC is not exclusionary at screening or at admission to the clinical facility. If a subject has a positive urine drug screen (except THC) upon admission to the clinic (V3-V7) the subject will be dismissed from the clinic and will be allowed to return at a later date (+14 days) to participate in the missed treatment period. A subject may only test positive once (except THC) and be allowed to return.
Has oral sores, mucositis, or inflammation in oral cavity at screening and check-in.","Subjects treated with Oxycodone 30 mg and buccal placebo will be randomized to 1 of 6 treatment sequences in a 1:1:1:1:1:1 ratio.

Oxycodone 30 mg: Oxycodone 30 mg capsule",ChEMBL:CHEMBL656 | DrugBank:DB00497 | PubChem:5284603,Oxycodone,COc1ccc2c3c1O[C@H]1C(=O)CC[C@@]4(O)[C@@H](C2)N(C)CC[C@]314,N02AA05 | N02AA55 | N02AA56 | N02AJ17 | N02AJ18 | N02AJ19,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT03996694,NCT03996694_EG004,Accepts Healthy Volunteers,All,Adult,Phase 1,16,"Inclusion Criteria:

Male or female subjects 18 to 55 years of age, inclusive.
Subjects are in good health as indicated by medical history, PE, vital signs, oxygen saturation, clinical laboratory tests, and 12-lead ECG. A status of good health will be defined by the absence of evidence of any clinically significant, active or chronic disease based on these assessments, in the opinion of the investigator.
Subjects with a body mass index (BMI) of 18.0 to 33.0 kg/m2, inclusive, and body weight greater than 50 kg, inclusive.
Subject is able to speak, read, and understand English and voluntarily provide written informed consent to participate in the study.
Subjects have healthy oral mucosa as determined by examination at screening and admission to the clinical facility.
Subject must be a recreational opioid user who is not currently dependent on opioids (based on self-reported DSM-5 criteria and a Clinical Opiate Withdrawal Scale [COWS] score ≤5 on the Naloxone Challenge) but has experience in the use of opioids for non-therapeutic purposes (ie, for psychoactive effects) on at least 10 occasions within the last year and at least once in the 12 weeks prior to the screening visit.
Subject demonstrates adequate VRH at screening during VRH assessment, defined as a minimum increase in ETCO2 of 10 mmHg and an increase in minute ventilation appropriate per investigator's discretion.
Ability and willingness to abstain from alcohol-, caffeine-, and xanthine-containing beverages or food (eg, coffee, tea, cola, chocolate, energy drinks) as well as poppy seeds from 48 hours (2 days) prior to each admission to the clinical facility until study discharge (including clinic furloughs).
Female subjects who are non-pregnant, non-lactating, and either postmenopausal for at least 1 year or surgically sterile for at least 3 months, or, if of childbearing potential, will agree to use adequate contraception from 28 days and/or their last confirmed menstrual period prior to study enrollment (whichever is longer) until 90 days after the follow-up visit. Male subjects, if not surgically sterilized, must agree to use adequate contraception and not donate sperm from first admission to the clinical research center until 90 days after the follow-up visit. Adequate contraception (for both males and females) is defined as using spermicide with a single barrier method: diaphragm, cervical cap, or condom. For female participants and female partners of male participants, being surgically sterilized or using hormonal contraception or an intrauterine device is also acceptable. Also, total abstinence, in accordance with the lifestyle of the subject, is acceptable.
For female subjects: a negative pregnancy test at screening and Day -1 of each treatment period.
Postmenopausal females: defined as 12 months with no menses prior to screening and a serum follicle stimulating hormone (FSH) >40 IU/L at screening.
All prescribed medications, over-the-counter (OTC) medications, dietary supplements or herbal supplements (eg, St. John's Wort extract) must have been stopped at least 14 days prior to the first admission to the clinical research center. An exception is made for acetaminophen, which is allowed up to admission to the clinical research center. An exception is also made for hormonal contraceptives, which may be used throughout the study. Antiemetics may be allowed after the 4-hour VRH assessments while confined in the clinical research unit.

Exclusion Criteria:

Employee of PRA or the Sponsor.
Women who are pregnant, lactating, or planning to attempt to become pregnant during this study or within 90 days after the follow-up visit.
Male subjects with female partners who are pregnant, lactating, or planning to attempt to become pregnant during this study or within 90 days after the follow-up visit.
Has received study medication in another clinical trial within 30 days prior to the first dose of study medication.
Having any disease that, in the opinion of the investigator, poses an unacceptable risk to the subjects.
History of drug allergy diagnosed by a physician. Confirmatory circumstances would include treatment with epinephrine or an Emergency Department.
Subjects who have smoked on a daily basis within 30 days prior to the first dose of study medication. Occasional nicotine use in the form of cigarettes, cigars, or vape pen is allowable (defined as less than half a pack of cigarettes [10 cigarettes], equivalent vaping [100 puffs], or no more than 2 cigars per week). Nicotine replacement therapies (ie, patches and/or gum) may be used without restriction.
Routine or chronic use of more than 3 grams of acetaminophen daily.
Strenuous activity and contact sports within 48 hours (2 days) prior to first admission to the clinical facility and for the duration of the study.
History of donation of more than 450 mL of blood within 60 days prior to dosing in the clinical research center or planned donation before 30 days has elapsed since intake of study drug.
Plasma or platelet donation within 7 days of first dose administration and throughout the entire study.
History of or presence of alcohol dependence. This includes subjects who have never been to a drug rehabilitation program. Alcohol consumption will be prohibited 48 hours prior to admission to the clinical facility and throughout the entire study until discharge.
Positive screening test for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibodies, or antihuman immunodeficiency virus (HIV)-1 and -2 antibodies.
History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, or psychiatric disease, or any other condition, which, in the opinion of the investigator, would jeopardize the safety of the subject or the validity of the study results.
Has any condition in which an opioid is contraindicated (eg, significant respiratory depression, acute or severe bronchial asthma or hypercarbia, or has or is suspected of having paralytic ileus).
Have a history of chronic obstructive pulmonary disease or any other lung disease (eg, asthma, bronchitis, obstructive sleep apnea, exercise-induced asthma) that would cause CO2 retention.
Has participated in (within the last 5 years), is currently participating in, or is seeking treatment for substance-related disorders (excluding nicotine and caffeine).
A positive result for drugs of abuse (amphetamines, methamphetamines, barbiturates, benzodiazepines, cocaine, and opioids, including oxycodone) at screening is acceptable as long as the urine drug screen is negative for these drugs at admission to the clinical facility. A positive test for THC is not exclusionary at screening or at admission to the clinical facility. If a subject has a positive urine drug screen (except THC) upon admission to the clinic (V3-V7) the subject will be dismissed from the clinic and will be allowed to return at a later date (+14 days) to participate in the missed treatment period. A subject may only test positive once (except THC) and be allowed to return.
Has oral sores, mucositis, or inflammation in oral cavity at screening and check-in.","Subjects treated with Oxycodone 60 mg and buccal placebo will be randomized to 1 of 6 treatment sequences in a 1:1:1:1:1:1 ratio.

Oxycodone 60 mg: Oxycodone 60 mg capsule",ChEMBL:CHEMBL656 | DrugBank:DB00497 | PubChem:5284603,Oxycodone,COc1ccc2c3c1O[C@H]1C(=O)CC[C@@]4(O)[C@@H](C2)N(C)CC[C@]314,N02AA05 | N02AA55 | N02AA56 | N02AJ17 | N02AJ18 | N02AJ19,0.0,0.0,0.0,0.0,0.0,1.0,1.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT03997851,NCT03997851_EG000,Accepts Healthy Volunteers,All,Adult,Phase 1 | Phase 2,17,"Inclusion Criteria:

Healthy subjects must be between 18 and 50 years of age.
Must be in general good health with no disease or physical conditions that would impair evaluation of itch and pain perception.
No history of chronic itch or pain.
Must abstain from the use of any systemic or topical anti-histamine, steroid, or pain relief medications from the week prior to the study till the completion of the study.
Must abstain from the use of moisturizers on the arms 24 hours before study visits.

Exclusion Criteria:

Individuals under 18 or over 50 years of age.
Inability to complete the required measures.
The presence of an itchy skin disease.
Diagnosis of diseased that would affect itch or pain perception (e.g. neuropathies).
Currently enrolled in any investigational study in which the subject is receiving any type of drug, biological, or non-drug therapy.
Use of oral, topical analgesics, or other medications known to interfere with itch or pain perception in the week prior to the study and throughout the study (e.g. antihistamines, anesthetics, opioids, neuroleptics, etc.).
Use of emollients on the arms a week prior to the study and throughout the study.
Known allergies to acetaminophen and cowhage.
Pregnant women. (Women of child bearing potential will undergo an hCG pregnancy test).
Currently incarcerated.","Topical 5% acetaminophen gel will be applied to one 4x4 cm predefined skin area on the ventral forearm during 2 study visits. The gel will be applied to the test area and will be allowed 30 minutes to adsorb. Following this pre-treatment, residual gel will be removed and itch induction/sensory testing will commence, strictly within the pre-treated area.

Acetaminophen: Topical acetaminophen gel",ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03997851,NCT03997851_EG001,Accepts Healthy Volunteers,All,Adult,Phase 1 | Phase 2,17,"Inclusion Criteria:

Healthy subjects must be between 18 and 50 years of age.
Must be in general good health with no disease or physical conditions that would impair evaluation of itch and pain perception.
No history of chronic itch or pain.
Must abstain from the use of any systemic or topical anti-histamine, steroid, or pain relief medications from the week prior to the study till the completion of the study.
Must abstain from the use of moisturizers on the arms 24 hours before study visits.

Exclusion Criteria:

Individuals under 18 or over 50 years of age.
Inability to complete the required measures.
The presence of an itchy skin disease.
Diagnosis of diseased that would affect itch or pain perception (e.g. neuropathies).
Currently enrolled in any investigational study in which the subject is receiving any type of drug, biological, or non-drug therapy.
Use of oral, topical analgesics, or other medications known to interfere with itch or pain perception in the week prior to the study and throughout the study (e.g. antihistamines, anesthetics, opioids, neuroleptics, etc.).
Use of emollients on the arms a week prior to the study and throughout the study.
Known allergies to acetaminophen and cowhage.
Pregnant women. (Women of child bearing potential will undergo an hCG pregnancy test).
Currently incarcerated.","Topical 2.5% acetaminophen gel will be applied to one 4x4 cm predefined skin area on the ventral forearm during 2 study visits. The gel will be applied to the test area and will be allowed 30 minutes to adsorb. Following this pre-treatment, residual gel will be removed and itch induction/sensory testing will commence, strictly within the pre-treated area.

Acetaminophen: Topical acetaminophen gel",ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03997851,NCT03997851_EG002,Accepts Healthy Volunteers,All,Adult,Phase 1 | Phase 2,17,"Inclusion Criteria:

Healthy subjects must be between 18 and 50 years of age.
Must be in general good health with no disease or physical conditions that would impair evaluation of itch and pain perception.
No history of chronic itch or pain.
Must abstain from the use of any systemic or topical anti-histamine, steroid, or pain relief medications from the week prior to the study till the completion of the study.
Must abstain from the use of moisturizers on the arms 24 hours before study visits.

Exclusion Criteria:

Individuals under 18 or over 50 years of age.
Inability to complete the required measures.
The presence of an itchy skin disease.
Diagnosis of diseased that would affect itch or pain perception (e.g. neuropathies).
Currently enrolled in any investigational study in which the subject is receiving any type of drug, biological, or non-drug therapy.
Use of oral, topical analgesics, or other medications known to interfere with itch or pain perception in the week prior to the study and throughout the study (e.g. antihistamines, anesthetics, opioids, neuroleptics, etc.).
Use of emollients on the arms a week prior to the study and throughout the study.
Known allergies to acetaminophen and cowhage.
Pregnant women. (Women of child bearing potential will undergo an hCG pregnancy test).
Currently incarcerated.","Topical 1% acetaminophen gel will be applied to one 4x4 cm predefined skin area on the ventral forearm during 2 study visits. The gel will be applied to the test area and will be allowed 30 minutes to adsorb. Following this pre-treatment, residual gel will be removed and itch induction/sensory testing will commence, strictly within the pre-treated area.

Acetaminophen: Topical acetaminophen gel",ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT03999684,NCT03999684_EG000,No,All,Adult | Older Adult,Phase 2,18,"Inclusion Criteria:

Participants must have histologically confirmed adenoid cystic carcinoma with evidence of recurrent, metastatic or advanced, unresectable disease that is not amenable to curative surgery with or without radiotherapy.
Participants must have at least one RECIST v1.1 measurable non-CNS based lesion, as defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) equal to or greater than 1 cm with CT scans or MR imaging.
Participants must be willing to undergo fresh tissue core needle biopsy prior to study registration and repeat tumor biopsy while on study for correlatives. Willingness to provide blood samples for research throughout the study is also required.
Prior systemic therapy: At least 2 weeks must have elapsed since the end of prior chemotherapy, biological agents (4 weeks for anti-cancer monoclonal antibody containing regimens) or any investigational drug product, with adequate recovery of treatment-related toxicity to NCI CTCAE Version 5.0 grade ≤ 1 (or tolerable grade 2) or back to baseline (except for alopecia or neuropathy). Any number of prior therapies for recurrent/metastatic ACC are permitted.
Be ≥ 18 years of age on day of signing informed consent.
Have a performance status of 0 or 1 on the ECOG Performance Scale (see Appendix A).
Participants must have documentation of a new or progressive lesion on a radiologic imaging study performed within 12 months prior to study registration (progression of disease over any interval is allowed) and/or new or worsening disease-related symptoms within 12 months prior to study registration. This assessment is performed by the treating investigator. Evidence of progression by RECIST v1.1 criteria is not required.

Participants must have normal organ and marrow function as defined below (within 14 days prior to study registration):

leukocytes ≥ 3,000/mcL
absolute neutrophil count ≥ 1,500/mcL
hemoglobin ≥ 9 g/dL without transfusion within 7 days of treatment
platelets ≥ 100,000/mcL
total bilirubin ≤ 2x upper limit of normal (ULN)
AST(SGOT)/ALT(SGPT) ≤ 2.5x institutional ULN or ≤ 5x ULN for those with liver metastases
serum creatinine ≤ 1.5x ULN OR
creatinine clearance ≥ 60 mL/min/1.73 m2 for participants with creatinine levels above 1.5x ULN
coagulation profile INR ≤ 1.5x ULN unless the participant is receiving an anticoagulant
triglyceride level < 500 mg/dL or < 5.7 mmol/L
cholesterol level < 400 mg/dL or < 10.34 mmol/L
Baseline tumor measurements must be documented from imaging within 28 days prior to study registration. Other non-laboratory tests must be performed within 28 days prior to study registration.
Female subjects of childbearing potential should have a negative urine or serum pregnancy test within 14 days of study registration. Female subjects of childbearing potential should have a negative urine or serum pregnancy test repeated within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
Female and male subjects of childbearing potential must agree to use an adequate method of contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and 4 months after completion of tretinoin administration. Contraception is required before starting the first dose of study medication through 120 days after the last dose of study medication. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject. There is a significant risk of fetal malformation if pregnancy occurs while on tretinoin at any dose level, even if for short exposure periods.
Be willing and able to provide written informed consent for the trial.

Exclusion Criteria:

Metastatic disease impinging on the spinal cord or threatening spinal cord compression. Patients that have had previous treatment of disease with impinging on the cord with either surgery or radiotherapy with clinical or radiographic evidence of response or stability are eligible.
Participant has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment), and have no evidence of new or enlarging brain metastases. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability, because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
Concurrent administration of other cancer specific therapy or investigational agents during the course of this study is not allowed.
Uncontrolled intercurrent illness including but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
Subjects who are pregnant, or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment. Pregnant women are excluded from this study because tretinoin has the potential for teratogenic or abortifacient effects. Breastfeeding should be discontinued if the mother is treated on this protocol. Women who could potentially become pregnant while undergoing treatment on this protocol must be willing to use 2 methods of contraception.","-Participants will receive Tretinoin orally divided over two daily doses for days 1 through 14 of a 28-day cycle

Tretinoin: ATRA control normal cell growth, cell differentiation (the normal process of making cell different from each other), and cell death during embryonic development and in certain tissues later in life. Retinoids effects on the cells are controlled by receptors on the nucleus of each cell (nuclear receptors)",ChEMBL:CHEMBL38 | ChEMBL:CHEMBL547 | ChEMBL:CHEMBL705 | DrugBank:DB00523 | DrugBank:DB00755 | DrugBank:DB00982 | PubChem:444795 | PubChem:449171 | PubChem:5282379,Tretinoin,CC(C=CC1=C(C)CCCC1(C)C)=CC=CC(C)=CC(=O)O,D10AD01 | D10AD04 | D10AD51 | D10AD54 | D10BA01 | D11AH04 | L01XF01 | L01XF02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT04003103,NCT04003103_EG001,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 2,97,"Inclusion Criteria:

Is in general good health with acceptable laboratory values at screening
Is confirmed HIV-uninfected based on negative HIV-1/HIV-2 test result before randomization
Has low risk of HIV infection, within 12 months prior to screening visit or the rescreening visit (if applicable)
Use contraceptives consistent with local regulations
Female is not pregnant or breastfeeding, and is not a woman of childbearing potential (WOCBP)
A WOCBP is using an acceptable contraceptive method, or is abstinent from heterosexual intercourse as their preferred and usual lifestyle; or has a negative pregnancy test.

Exclusion Criteria:

Has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator
Has an active diagnosis of hepatitis due to any cause
Has a history of malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.

Is taking or is anticipated to require systemic immunosuppressive therapy, immune modulators, or any prohibited therapies from 30 days prior to Day

1 through the duration of the study.

Is currently participating in or has participated in an interventional clinical study with an investigational compound or device within 30 days prior to Day1 through the duration of the study.
Has previously been randomized in a study and received islatravir (MK-8591).
Female is expecting to conceive or donate eggs at any time during the study
Has QTc interval (using Fridericia correction) >450 msec (for males) or >460 msec (for females) or deemed clinically abnormal by the investigator.",Participants receive four ISL 30 mg capsules once monthly from Day 1 to Week 24 plus 12 weeks of follow-up in the Treatment Phase. The Extended Follow-up Phase is from Week 36 to Week 68.,ChEMBL:CHEMBL517231 | DrugBank:DB15653,ISLATRAVIR,C#C[C@]1(CO)O[C@@H](n2cnc3c(N)nc(F)nc32)C[C@@H]1O,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT04042077,NCT04042077_EG000,No,All,Adult | Older Adult,Phase 3,134,"Inclusion Criteria:

Male or female patients aged more than 18 years.
Patients with a history of cardiothoracic / related leg or abdominal surgery, occurred within 30 days and no implant is left in place, and a diagnosis of superficial or deep SSI according to the CDC definition.
The severity of infection requires an IV treatment and patient hospitalization according to the Investigator's judgment.

Exclusion Criteria:

Previous IV antimicrobial therapy exceeding 24-hour duration during 72 hours prior to first dose.
Any infection expected to require systemic antimicrobial agents other than study treatment(s).
Medical history of significant hypersensitivity or allergic reaction or contraindication to the study drugs
Medical history of central nervous system (CNS) disorders
Medical history of myasthenia gravis.
Medical history of C. difficile diarrhea.
Organ-space infection.
Complicated Intra-Abdominal Infection (cIAI)
Chronic or underlying conditions at site of infection that may complicate the assessment of clinical response or would interfere with SSI healing.
Underlying disease leading to deep immunosuppressive status.
End-stage renal disease, CrCl <15 mL/min.",Delafloxacin IV with the option to switch to delafloxacin OS,ChEMBL:CHEMBL2105637 | DrugBank:DB11943 | PubChem:487101,Delafloxacin,Nc1nc(-n2cc(C(=O)O)c(=O)c3cc(F)c(N4CC(O)C4)c(Cl)c32)c(F)cc1F,J01MA23,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT04049552,NCT04049552_EG000,Accepts Healthy Volunteers,All,Adult | Older Adult,Early Phase 1,4,"Inclusion Criteria:

Subject must have at least 2 keloid scars (for at least 1 year) in similar body locations that are easy to reach to apply ointment to
Subject will be in good health with all chronic diseases (such as hypertension, coronary artery disease, etc.) clinically stable
Cognitive functioning sufficient to provide informed consent
Physically able to apply ointment to keloids daily
Able to attend monthly clinic visits for 6 months

Exclusion Criteria:

Diagnosis of diabetes
Subjects taking the following medications: systemic steroid or immunosuppressant therapy within the past 6 months
Local area steroidal treatment within the past 3 months
History of allergy to rapamycin of petrolatum-based products","Rapamycin ointment will be applied to one keloid on the subject

Rapamycin 8% Ointment: A compounded ointment containing 8% rapamycin",ChEMBL:CHEMBL413 | DrugBank:DB00877 | PubChem:134760597 | PubChem:138404388 | PubChem:21944094 | PubChem:5284616,Sirolimus,COC1CC2CCC(C)C(O)(O2)C(=O)C(=O)N2CCCCC2C(=O)OC(C(C)CC2CCC(O)C(OC)C2)CC(=O)C(C)C=C(C)C(O)C(OC)C(=O)C(C)CC(C)C=CC=CC=C1C,L01EG04 | L04AA10 | S01XA23,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT04049578,NCT04049578_EG000,No,All,Child,Phase 1,2,"Inclusion Criteria:

Diagnosis of ASD according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for ASD. Diagnostics will be performed by a team of autism experts and confirmed by Autism Diagnostic Observation ScheduleTM, Second Edition (ADOS-2) criteria. The DSM-5 criteria for diagnosis of autism must be met with the highest confidence in the opinion of the investigator. Children with ambiguous diagnostic results cannot be enrolled in the study. If the ADOS-2 assessment has been performed by a certified rater and documented within 12 months of the screening visit, it is not mandatory to repeat it unless the subject was assessed below an age of 2 years.
Hearing and vision compatible with the study assessments, as judged by the investigator
Ability for subject and the caregiver to comply with the study protocol, in the investigator's judgment
Availability of a parent or other reliable caregiver who is fluent in language of the site and has frequent and sufficient contact with the subject.

Exclusion Criteria:

Clinically significant psychiatric and/or neurologic comorbidity that may interfere with the safety or efficacy endpoints in the view of the investigator
Clinically significant regression of any acquired language and motor function skills in the opinion of the investigator throughout the subject's development
History of seizures with the exception of a single, non-complicated febrile seizure >= 6 months before screening
Clinical diagnosis of peripheral neuropathy or signs and symptoms indicative of peripheral neuropathy
Any clinically relevant cardiovascular disease
Confirmed elevation in cardiac troponin I (cTn I), high-sensitive cardiac troponin T (hs cTn T), N-terminal pro-B-type natriuretic peptide (NT-proBNP) or, if conducted, clinically relevant abnormality in Doppler echocardiogram
Confirmed clinically significant abnormality on ECG at screening, including, but not limited to, a QT interval corrected through use of Fridericia's formula (QTcF) of >= 450 ms, absence of dominating sinus rhythm, or second- or third-degree atrioventricular block
Confirmed systolic or diastolic blood pressure above the 95th percentile or below the 5th percentile according to the Centers for Disease Control and Prevention (CDC) norm tables referring to stature (height)-for-age percentiles
Confirmed heart rate: >150 bpm in 2-year old children, >135 bpm in 3-year old children, or >120 bpm in 4-year old children.
Concomitant disease or condition that could interfere with, or treatment of which might interfere with, the conduct of the study; or discontinuation of prohibited medication that might pose unacceptable risks to the subject in the opinion of the investigator
Evidence for current GI disease that would interfere with the conduct of the study or pose unacceptable risks in the opinion of the investigator
History of coagulopathies, bleeding disorders, or blood dyscrasias
Positive serology for HIV-1 or HIV-2
Confirmed clinically significant abnormality in parameters of hematology, clinical chemistry, coagulation, or urinalysis, specifically a confirmed absolute neutrophil count (ANC) <LLN Children with confirmed CPK elevations exceeding 2 x upper limit of normal (ULN) will be excluded
History of malignancy
Clinically significant loss of blood within 3 months prior to screening
Unstable use of permitted medications for 4 weeks before screening
Use of prohibited medications within 30 days (or 5 times the half-life, whichever is longer) prior to initiation of study treatment","Participants were to receive an oral dose of balovaptan once a day (QD) for a 6-week treatment period, followed by an optional extension period of 48 weeks.",ChEMBL:CHEMBL4297183 | DrugBank:DB14823 | PubChem:46200932,Balovaptan,CN1Cc2cc(Cl)ccc2-n2c(nnc2[C@H]2CC[C@H](Oc3ccccn3)CC2)C1,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0
NCT04080739,NCT04080739_EG000,No,All,Adult | Older Adult,Phase 4,100,"Inclusion criteria:

Age > 18
Able to consent for themselves
Undergoing a head and neck surgery at UAB with reconstruction using either a forearm free flap or a fibula free flap

Exclusion criteria:

Age < 18
Unable to consent for themselves
Non-English speakers
Non-resectable tumor
Have a known opioid tolerance, or are on a home opioid regimen for a chronic condition. (Short-term opioid use for diagnostic procedures (i.e. biopsy) or new cancer diagnosis will be allowed).
Patients with known hepatic failure, renal failure, or sulfa allergy, as determined by standard of care labs drawn within 30 days of enrollment","US-guided ipsilateral sciatic nerve block for fibula free flap patients utilizing ropivacaine 0.2% at 2-8 cc/hr for fibula free flap patients; US-guided infraclavicular brachial plexus nerve block for forearm free lap patients utilizing ropivacaine 0.2% at 2-8cc/hr for forearm free flap patients.

ropivicaine 0.2%: 2-8 cc/hr of 0.2% ropivicaine given as a regional block via US-guided ipsilateral sciatic nerve block for fibula free flap patients or US-guided infraclavicular brachial plexus nerve block for forearm free flap patients.",PubChem:53262281,Naropin,CCC[NH+]1CCCCC1C(=O)Nc1c(C)cccc1C.O.[Cl-],,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT04085341,NCT04085341_EG000,No,All,Adult | Older Adult,Phase 2,10,"Inclusion Criteria:

Males or females ≥ 21 years of age
Known diagnosis of macular edema secondary to diabetic macular edema or retinal vein occlusion treated with at least 3 prior IVT injections of an anti-VEGF agent (aflibercept, bevacizumab, or ranibizumab)
Demonstrated response to prior anti-VEGF treatment since diagnosis
BCVA of 31 letters or better

Exclusion Criteria:

History, within 6 months prior to screening, of any of the following: myocardial infarction, any cardiac event requiring hospitalization, treatment for acute congestive heart failure, transient ischemic attack, or stroke
Uncontrolled hypertension, diabetes mellitus or IOP
Chronic renal disease","Participants will receive intravitreal (IVT) GB-102 (1 mg) in the study eye at Baseline.

GB-102: Intravitreal injection of GB-102",PubChem:6456015,Sunitinib Malate,CCN(CC)CCNC(=O)c1c(C)[nH]c(C=C2C(=O)Nc3ccc(F)cc32)c1C.O=C(O)CC(O)C(=O)O,,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT04085341,NCT04085341_EG001,No,All,Adult | Older Adult,Phase 2,11,"Inclusion Criteria:

Males or females ≥ 21 years of age
Known diagnosis of macular edema secondary to diabetic macular edema or retinal vein occlusion treated with at least 3 prior IVT injections of an anti-VEGF agent (aflibercept, bevacizumab, or ranibizumab)
Demonstrated response to prior anti-VEGF treatment since diagnosis
BCVA of 31 letters or better

Exclusion Criteria:

History, within 6 months prior to screening, of any of the following: myocardial infarction, any cardiac event requiring hospitalization, treatment for acute congestive heart failure, transient ischemic attack, or stroke
Uncontrolled hypertension, diabetes mellitus or IOP
Chronic renal disease","Participants will receive intravitreal (IVT) GB-102 (2 mg) in the study eye at Baseline.

GB-102: Intravitreal injection of GB-102",PubChem:6456015,Sunitinib Malate,CCN(CC)CCNC(=O)c1c(C)[nH]c(C=C2C(=O)Nc3ccc(F)cc32)c1C.O=C(O)CC(O)C(=O)O,,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,1.0,1.0,1.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT04124926,NCT04124926_EG000,No,All,Adult | Older Adult,Phase 3,514,"Inclusion Criteria:

The participant is ≥18 years of age at the time of informed consent signing.
In the opinion of the investigator or subinvestigators, the participant is capable of understanding and complying with protocol requirements.
The participant signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures. The participant is informed of the full nature and purpose of the study, including possible risks and side-effects. The participant has the ability to cooperate with the investigator. Ample time and opportunity should be given to read and understand verbal and/or written instructions.
The participant is found to have endoscopically confirmed EE of LA Classification Grades A to D during the Screening Period (Visit 1) as assessed by a central adjudicator. The target number of participants with LA classification Grade C or D will be approximately 30% of the total number of participants (300 total). Enrollment of EE participants with Grade A or B will end when the number of participants with Grade A or B EE is approximately 700 or 70% of the total planned number of participants. Given the invasive nature of an endoscopy, any endoscopic confirmation performed in a routine clinical setting before signing the informed consent will be acceptable to use for the purpose of fulfilling the screening requirement if all of the following apply: (1) appropriate endoscopy pictures were taken; (2) appropriate gastric biopsy samples were taken; (3) the endoscopy pictures can be sent to the central adjudicator via the adjudication systems; and (4) all screening procedures (including the completion of adjudication) AND randomization can be completed within a 7-day period after the date of the endoscopy.
A female participant of childbearing potential who is or may be sexually active with a nonsterilized male partner agrees to routinely use adequate contraception from the signing of informed consent until 4 weeks after the last dose of study drug.

Exclusion Criteria:

The participant's endoscopic examination for entering this study fails to confirm EE within 7 days (no later than 10 days on rare occasion with sponsor approval) prior to randomization.
The participant is determined to be positive for Helicobacter pylori (HP) or has had an HP infection within 45 days of randomization.
The participant has endoscopic Barrett's esophagus (>1 cm of columnar-lined esophagus) and/or definite dysplastic changes in the esophagus.
The participant has any other condition affecting the esophagus, including eosinophilic esophagitis; esophageal varices; viral or fungal infection; esophageal stricture; a history of radiation therapy, radiofrequency ablation, endoscopic mucosal resection, or cryotherapy to the esophagus; or any history of caustic or physiochemical trauma (including sclerotherapy or esophageal variceal band ligation). However, participants diagnosed with Schatzki's ring (mucosal tissue ring around lower esophageal sphincter) are eligible to participate.
The participant has scleroderma (systemic sclerosis).
The participant has a history of surgery or endoscopic treatment affecting gastroesophageal reflux, including fundoplication and dilation for esophageal stricture (except Schatzki's ring) or a history of gastric or duodenal surgery (except endoscopic removal of benign polyps).
The participant has an active gastric or duodenal ulcer at the start of the Screening Period. Additionally, participants with gastric or duodenal erosions are permitted to participate.
The participant has received any investigational compound (including those in post marketing studies) within 30 days prior to the start of the Screening Period. A participant who has been screen failed from another clinical study and who has not been dosed may be considered for enrollment in this study.
The participant is a study site employee, an immediate family member, or is in a dependent relationship with a study site employee who is involved in the conduct of this study (eg, spouse, parent, child, sibling) or who may have consented under duress.
The participant has cutaneous lupus erythematosus or systemic lupus erythematosus.
The participant has had clinically significant upper or lower gastrointestinal bleeding within 4 weeks prior to randomization.
The participant has Zollinger-Ellison syndrome or other gastric acid hypersecretory conditions.
The participant has a history of hypersensitivity or allergies to vonoprazan (including the formulation excipients: D-mannitol, microcrystalline cellulose, hydroxypropyl cellulose, fumaric acid, croscarmellose sodium, magnesium stearate, hypromellose, macrogol 8000, titanium oxide, or red or yellow ferric oxide), PPIs, or any excipients used in the 13C-urea breath test: mannitol, citric acid, or aspartame. Skin testing may be performed according to local standard practice to confirm hypersensitivity.
The participant has a history of alcohol abuse, illegal drug use, or drug addiction within the 12 months prior to screening, or regularly consumes >21 units of alcohol (1 unit = 12 oz/300 mL beer, 1.5 oz/25 mL hard liquor/spirits, or 5 oz/100 mL wine) per week based on self-report. Participants must have a negative urine drug screen at screening.
The participant is taking any excluded medications or treatments.
If female, the participant is pregnant, lactating, or intending to become pregnant before, during, or within 4 weeks after participating in this study; or intending to donate ova during such time period.
The participant has a history or clinical manifestations of significant central nervous system, cardiovascular, pulmonary, hepatic, renal, metabolic, other gastrointestinal, urological, endocrine, or hematological disease that, in the opinion of the investigator, would confound the study results or compromise participant safety.
The participant requires hospitalization or has surgery scheduled during the course of the study or has undergone major surgical procedures within 30 days prior to the Screening Visit.
The participant has a history of malignancy (including MALToma) or has been treated for malignancy within 5 years prior to the start of the Screening Period (Visit 1). (The participant may be included in the study if he/she has cured cutaneous basal cell carcinoma or cervical carcinoma in situ).
The participant has acquired immunodeficiency syndrome or human immunodeficiency virus infection, or tests positive for the hepatitis B surface antigen, hepatitis C virus (HCV) antibody, or HCV RNA. However, participants who test positive for HCV antibody but negative for HCV RNA are permitted to participate.

The participant has any of the following abnormal laboratory test values at the start of the Screening Period:

Creatinine levels: >2 mg/dL (>177 μmol/L)
Alanine aminotransferase or aspartate aminotransferase >2 × the upper limit of normal (ULN) or total bilirubin >2 × ULN.",Participants received oral vonoprazan 20 mg QD for a maximum of 8 weeks in the Healing Phase.,ChEMBL:CHEMBL2079130 | DrugBank:DB11739 | PubChem:15981397,Vonoprazan,CNCc1cc(-c2ccccc2F)n(S(=O)(=O)c2cccnc2)c1,A02BC08 | A02BD14 | A02BD15,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT04124926,NCT04124926_EG002,No,All,Adult | Older Adult,Phase 3,296,"Inclusion Criteria:

The participant is ≥18 years of age at the time of informed consent signing.
In the opinion of the investigator or subinvestigators, the participant is capable of understanding and complying with protocol requirements.
The participant signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures. The participant is informed of the full nature and purpose of the study, including possible risks and side-effects. The participant has the ability to cooperate with the investigator. Ample time and opportunity should be given to read and understand verbal and/or written instructions.
The participant is found to have endoscopically confirmed EE of LA Classification Grades A to D during the Screening Period (Visit 1) as assessed by a central adjudicator. The target number of participants with LA classification Grade C or D will be approximately 30% of the total number of participants (300 total). Enrollment of EE participants with Grade A or B will end when the number of participants with Grade A or B EE is approximately 700 or 70% of the total planned number of participants. Given the invasive nature of an endoscopy, any endoscopic confirmation performed in a routine clinical setting before signing the informed consent will be acceptable to use for the purpose of fulfilling the screening requirement if all of the following apply: (1) appropriate endoscopy pictures were taken; (2) appropriate gastric biopsy samples were taken; (3) the endoscopy pictures can be sent to the central adjudicator via the adjudication systems; and (4) all screening procedures (including the completion of adjudication) AND randomization can be completed within a 7-day period after the date of the endoscopy.
A female participant of childbearing potential who is or may be sexually active with a nonsterilized male partner agrees to routinely use adequate contraception from the signing of informed consent until 4 weeks after the last dose of study drug.

Exclusion Criteria:

The participant's endoscopic examination for entering this study fails to confirm EE within 7 days (no later than 10 days on rare occasion with sponsor approval) prior to randomization.
The participant is determined to be positive for Helicobacter pylori (HP) or has had an HP infection within 45 days of randomization.
The participant has endoscopic Barrett's esophagus (>1 cm of columnar-lined esophagus) and/or definite dysplastic changes in the esophagus.
The participant has any other condition affecting the esophagus, including eosinophilic esophagitis; esophageal varices; viral or fungal infection; esophageal stricture; a history of radiation therapy, radiofrequency ablation, endoscopic mucosal resection, or cryotherapy to the esophagus; or any history of caustic or physiochemical trauma (including sclerotherapy or esophageal variceal band ligation). However, participants diagnosed with Schatzki's ring (mucosal tissue ring around lower esophageal sphincter) are eligible to participate.
The participant has scleroderma (systemic sclerosis).
The participant has a history of surgery or endoscopic treatment affecting gastroesophageal reflux, including fundoplication and dilation for esophageal stricture (except Schatzki's ring) or a history of gastric or duodenal surgery (except endoscopic removal of benign polyps).
The participant has an active gastric or duodenal ulcer at the start of the Screening Period. Additionally, participants with gastric or duodenal erosions are permitted to participate.
The participant has received any investigational compound (including those in post marketing studies) within 30 days prior to the start of the Screening Period. A participant who has been screen failed from another clinical study and who has not been dosed may be considered for enrollment in this study.
The participant is a study site employee, an immediate family member, or is in a dependent relationship with a study site employee who is involved in the conduct of this study (eg, spouse, parent, child, sibling) or who may have consented under duress.
The participant has cutaneous lupus erythematosus or systemic lupus erythematosus.
The participant has had clinically significant upper or lower gastrointestinal bleeding within 4 weeks prior to randomization.
The participant has Zollinger-Ellison syndrome or other gastric acid hypersecretory conditions.
The participant has a history of hypersensitivity or allergies to vonoprazan (including the formulation excipients: D-mannitol, microcrystalline cellulose, hydroxypropyl cellulose, fumaric acid, croscarmellose sodium, magnesium stearate, hypromellose, macrogol 8000, titanium oxide, or red or yellow ferric oxide), PPIs, or any excipients used in the 13C-urea breath test: mannitol, citric acid, or aspartame. Skin testing may be performed according to local standard practice to confirm hypersensitivity.
The participant has a history of alcohol abuse, illegal drug use, or drug addiction within the 12 months prior to screening, or regularly consumes >21 units of alcohol (1 unit = 12 oz/300 mL beer, 1.5 oz/25 mL hard liquor/spirits, or 5 oz/100 mL wine) per week based on self-report. Participants must have a negative urine drug screen at screening.
The participant is taking any excluded medications or treatments.
If female, the participant is pregnant, lactating, or intending to become pregnant before, during, or within 4 weeks after participating in this study; or intending to donate ova during such time period.
The participant has a history or clinical manifestations of significant central nervous system, cardiovascular, pulmonary, hepatic, renal, metabolic, other gastrointestinal, urological, endocrine, or hematological disease that, in the opinion of the investigator, would confound the study results or compromise participant safety.
The participant requires hospitalization or has surgery scheduled during the course of the study or has undergone major surgical procedures within 30 days prior to the Screening Visit.
The participant has a history of malignancy (including MALToma) or has been treated for malignancy within 5 years prior to the start of the Screening Period (Visit 1). (The participant may be included in the study if he/she has cured cutaneous basal cell carcinoma or cervical carcinoma in situ).
The participant has acquired immunodeficiency syndrome or human immunodeficiency virus infection, or tests positive for the hepatitis B surface antigen, hepatitis C virus (HCV) antibody, or HCV RNA. However, participants who test positive for HCV antibody but negative for HCV RNA are permitted to participate.

The participant has any of the following abnormal laboratory test values at the start of the Screening Period:

Creatinine levels: >2 mg/dL (>177 μmol/L)
Alanine aminotransferase or aspartate aminotransferase >2 × the upper limit of normal (ULN) or total bilirubin >2 × ULN.",Participants received oral vonoprazan 10 mg QD for 24 weeks.,ChEMBL:CHEMBL2079130 | DrugBank:DB11739 | PubChem:15981397,Vonoprazan,CNCc1cc(-c2ccccc2F)n(S(=O)(=O)c2cccnc2)c1,A02BC08 | A02BD14 | A02BD15,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT04124926,NCT04124926_EG003,No,All,Adult | Older Adult,Phase 3,296,"Inclusion Criteria:

The participant is ≥18 years of age at the time of informed consent signing.
In the opinion of the investigator or subinvestigators, the participant is capable of understanding and complying with protocol requirements.
The participant signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures. The participant is informed of the full nature and purpose of the study, including possible risks and side-effects. The participant has the ability to cooperate with the investigator. Ample time and opportunity should be given to read and understand verbal and/or written instructions.
The participant is found to have endoscopically confirmed EE of LA Classification Grades A to D during the Screening Period (Visit 1) as assessed by a central adjudicator. The target number of participants with LA classification Grade C or D will be approximately 30% of the total number of participants (300 total). Enrollment of EE participants with Grade A or B will end when the number of participants with Grade A or B EE is approximately 700 or 70% of the total planned number of participants. Given the invasive nature of an endoscopy, any endoscopic confirmation performed in a routine clinical setting before signing the informed consent will be acceptable to use for the purpose of fulfilling the screening requirement if all of the following apply: (1) appropriate endoscopy pictures were taken; (2) appropriate gastric biopsy samples were taken; (3) the endoscopy pictures can be sent to the central adjudicator via the adjudication systems; and (4) all screening procedures (including the completion of adjudication) AND randomization can be completed within a 7-day period after the date of the endoscopy.
A female participant of childbearing potential who is or may be sexually active with a nonsterilized male partner agrees to routinely use adequate contraception from the signing of informed consent until 4 weeks after the last dose of study drug.

Exclusion Criteria:

The participant's endoscopic examination for entering this study fails to confirm EE within 7 days (no later than 10 days on rare occasion with sponsor approval) prior to randomization.
The participant is determined to be positive for Helicobacter pylori (HP) or has had an HP infection within 45 days of randomization.
The participant has endoscopic Barrett's esophagus (>1 cm of columnar-lined esophagus) and/or definite dysplastic changes in the esophagus.
The participant has any other condition affecting the esophagus, including eosinophilic esophagitis; esophageal varices; viral or fungal infection; esophageal stricture; a history of radiation therapy, radiofrequency ablation, endoscopic mucosal resection, or cryotherapy to the esophagus; or any history of caustic or physiochemical trauma (including sclerotherapy or esophageal variceal band ligation). However, participants diagnosed with Schatzki's ring (mucosal tissue ring around lower esophageal sphincter) are eligible to participate.
The participant has scleroderma (systemic sclerosis).
The participant has a history of surgery or endoscopic treatment affecting gastroesophageal reflux, including fundoplication and dilation for esophageal stricture (except Schatzki's ring) or a history of gastric or duodenal surgery (except endoscopic removal of benign polyps).
The participant has an active gastric or duodenal ulcer at the start of the Screening Period. Additionally, participants with gastric or duodenal erosions are permitted to participate.
The participant has received any investigational compound (including those in post marketing studies) within 30 days prior to the start of the Screening Period. A participant who has been screen failed from another clinical study and who has not been dosed may be considered for enrollment in this study.
The participant is a study site employee, an immediate family member, or is in a dependent relationship with a study site employee who is involved in the conduct of this study (eg, spouse, parent, child, sibling) or who may have consented under duress.
The participant has cutaneous lupus erythematosus or systemic lupus erythematosus.
The participant has had clinically significant upper or lower gastrointestinal bleeding within 4 weeks prior to randomization.
The participant has Zollinger-Ellison syndrome or other gastric acid hypersecretory conditions.
The participant has a history of hypersensitivity or allergies to vonoprazan (including the formulation excipients: D-mannitol, microcrystalline cellulose, hydroxypropyl cellulose, fumaric acid, croscarmellose sodium, magnesium stearate, hypromellose, macrogol 8000, titanium oxide, or red or yellow ferric oxide), PPIs, or any excipients used in the 13C-urea breath test: mannitol, citric acid, or aspartame. Skin testing may be performed according to local standard practice to confirm hypersensitivity.
The participant has a history of alcohol abuse, illegal drug use, or drug addiction within the 12 months prior to screening, or regularly consumes >21 units of alcohol (1 unit = 12 oz/300 mL beer, 1.5 oz/25 mL hard liquor/spirits, or 5 oz/100 mL wine) per week based on self-report. Participants must have a negative urine drug screen at screening.
The participant is taking any excluded medications or treatments.
If female, the participant is pregnant, lactating, or intending to become pregnant before, during, or within 4 weeks after participating in this study; or intending to donate ova during such time period.
The participant has a history or clinical manifestations of significant central nervous system, cardiovascular, pulmonary, hepatic, renal, metabolic, other gastrointestinal, urological, endocrine, or hematological disease that, in the opinion of the investigator, would confound the study results or compromise participant safety.
The participant requires hospitalization or has surgery scheduled during the course of the study or has undergone major surgical procedures within 30 days prior to the Screening Visit.
The participant has a history of malignancy (including MALToma) or has been treated for malignancy within 5 years prior to the start of the Screening Period (Visit 1). (The participant may be included in the study if he/she has cured cutaneous basal cell carcinoma or cervical carcinoma in situ).
The participant has acquired immunodeficiency syndrome or human immunodeficiency virus infection, or tests positive for the hepatitis B surface antigen, hepatitis C virus (HCV) antibody, or HCV RNA. However, participants who test positive for HCV antibody but negative for HCV RNA are permitted to participate.

The participant has any of the following abnormal laboratory test values at the start of the Screening Period:

Creatinine levels: >2 mg/dL (>177 μmol/L)
Alanine aminotransferase or aspartate aminotransferase >2 × the upper limit of normal (ULN) or total bilirubin >2 × ULN.",Participants received oral vonoprazan 20 mg QD for 24 weeks.,ChEMBL:CHEMBL2079130 | DrugBank:DB11739 | PubChem:15981397,Vonoprazan,CNCc1cc(-c2ccccc2F)n(S(=O)(=O)c2cccnc2)c1,A02BC08 | A02BD14 | A02BD15,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT04126083,NCT04126083_EG000,No,All,Adult | Older Adult,Phase 4,6,"Inclusion Criteria:

Age 18 to 70 years.
Chronic lumbar spine pain for ≥ 3 months duration.
Scheduled for elective lumbar spine surgery.
Daily morphine equivalent dose between 50 mg and 200 mg.

Exclusion Criteria:

Cancer-related pain.
Medical or surgical conditions that could be adversely impacted by opioid tapering or use of lofexidine including, but not exclusively limited to, cardiac disease, inflammatory bowel disease, renal or hepatic impairment, vascular disease, and history of anaphylaxis. Patients may be excluded for other comorbid medical or surgical conditions based on the physician investigator's discretion.
History of schizophrenia or other chronic psychiatric disorder that could be adversely impacted by opioid tapering or use of lofexidine. Patients may be excluded for other comorbid mental health conditions based on the physician investigator's discretion.
Neurological condition that impair functioning in an ambulatory setting or could be adversely impacted by opioid tapering or use of lofexidine including, but not exclusively limited to, Parkinson's disease, amyotrophic lateral sclerosis, or a dementing illness. Patients may be excluded for other neurological conditions based on the physician investigator's discretion.
Active substance abuse disorder.
Inability to function in an ambulatory care setting due to severe deconditioning requiring use of supportive gait aids including a cane or walker. Patients may be excluded for other functional problems based on the physician investigator's discretion.
History of adverse effects attributed to opioid tapering or lofexidine use.
Use of medications from drug classes known to have adverse interactions with lofexidine including, but not exclusively limited to, beta-blockers, calcium channel blockers, alpha 1 and 2 receptor antagonists, tricyclic antidepressants, benzodiazepines, and selective serotonin reuptake inhibitors. Patients may be excluded for use of other medications based on the physician investigator's and research pharmacy's discretion.","Patients received lofexidine 0.54 mg 4 times daily and the baseline opioid dose was reduced by 10% daily.

Lofexidine Oral Tablet: lofexidine 0.54 mg 4 times daily",ChEMBL:CHEMBL17860 | DrugBank:DB04948 | PubChem:30668,Lofexidine,CC(Oc1c(Cl)cccc1Cl)C1=NCCN1,N07BC04,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT04136548,NCT04136548_EG001,Accepts Healthy Volunteers,All,Adult,Phase 1 | Phase 2,41,"Inclusion Criteria:

Healthy
Non-obese (body mass index less than 30 kg/m2)
Body mass greater than or equal to 65 kg

Exclusion Criteria:

Subjects who have cardiac, respiratory, neurological and/or metabolic illnesses
Any known history of renal or hepatic insufficiency/disease
Pregnancy or breast feeding
Current smokers, as well as individuals who regularly smoked within the past 3 years
Positive urine drug screen
Currently taking pain modifying medication(s)",Experimental visit with Fentanyl administration,ChEMBL:CHEMBL596 | DrugBank:DB00813 | PubChem:3345,Fentanyl,CCC(=O)N(c1ccccc1)C1CCN(CCc2ccccc2)CC1,N01AH01 | N01AH51 | N02AB03,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT04153435,NCT04153435_EG000,No,All,Adult | Older Adult,Phase 2,397,"Inclusion Criteria:

Out-of-hospital cardiac arrest
Age ≥ 18 years
Received at least one dose of adrenaline

Exclusion Criteria:

Traumatic cardiac arrest - including drowning and external asphyxia (e.g., hanging, strangulation, or foreign object airway obstruction)
Known or strongly suspected pregnancy
Prior enrollment in the trial
Received adrenaline during cardiac arrest before arrival of prehospital personnel with the study drug
Clinical indication for calcium administration during the cardiac arrest","The intervention will consist of 5 mmol (10 mL ampoule) of calcium chloride (CaCl2) administered intravenously or intraosseously immediately after the first dose of adrenaline and again after the second dose of adrenaline.

Calcium Chloride: Calcium chloride 5 mmol",ChEMBL:CHEMBL1200668 | DrugBank:DB01164,CALCIUM CHLORIDE,[Ca+2].[Cl-].[Cl-],A11GB01 | A12AA07 | B05XA07 | G04BA03,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT04162899,NCT04162899_EG000,No,All,Adult | Older Adult,Phase 2,35,"Inclusion Criteria:

Subjects between 18-75 years of age (inclusive), male or female, at the time of informed consent
Moderate to severe atopic dermatitis
Capable of providing a signed and dated informed consent form indicating the subject has been informed of all pertinent aspect of the study

Exclusion Criteria:

Subjects with historical or current evidence of clinically significant cardiovascular, neurological, psychiatric, renal, hepatic, immunological, gastrointestinal, urogenital, nervous system, musculoskeletal, skin, sensory, endocrine (including uncontrolled diabetes or thyroid disease) or hematological abnormalities that are uncontrolled. Significant is defined as any disease that, in the opinion of the Investigator, would put the safety of the subject at risk through participation, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study
Subject has a current diagnosis of other active skin disease (e.g., psoriasis or lupus erythematosus) or skin infection (bacterial, fungal, or viral) that may affect the evaluation of atopic dermatitis
Subject has a severe comorbidity that may require systemic steroids therapy or other interventions or requires active frequent monitoring (e.g., unstable chronic asthma)","Participants randomized in this arm will receive dose A of SHR0302 until end of study at week 12.

Drug: SHR0302: The study drug, SHR0302, is designed to block the activity of an enzyme protein called JAK-1(known as a JAK-1 inhibitor).",ChEMBL:CHEMBL5095398 | DrugBank:DB16756 | PubChem:71622431,Ivarmacitinib,[H][C@@]12C[C@@H](N(C)c3ncnc4[nH]ccc34)C[C@]1([H])CN(C(=O)Nc1nc(OC)ns1)C2,,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT04162899,NCT04162899_EG001,No,All,Adult | Older Adult,Phase 2,35,"Inclusion Criteria:

Subjects between 18-75 years of age (inclusive), male or female, at the time of informed consent
Moderate to severe atopic dermatitis
Capable of providing a signed and dated informed consent form indicating the subject has been informed of all pertinent aspect of the study

Exclusion Criteria:

Subjects with historical or current evidence of clinically significant cardiovascular, neurological, psychiatric, renal, hepatic, immunological, gastrointestinal, urogenital, nervous system, musculoskeletal, skin, sensory, endocrine (including uncontrolled diabetes or thyroid disease) or hematological abnormalities that are uncontrolled. Significant is defined as any disease that, in the opinion of the Investigator, would put the safety of the subject at risk through participation, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study
Subject has a current diagnosis of other active skin disease (e.g., psoriasis or lupus erythematosus) or skin infection (bacterial, fungal, or viral) that may affect the evaluation of atopic dermatitis
Subject has a severe comorbidity that may require systemic steroids therapy or other interventions or requires active frequent monitoring (e.g., unstable chronic asthma)","Participants randomized in this arm will receive dose B of SHR0302 until end of study at week 12.

Drug: SHR0302: The study drug, SHR0302, is designed to block the activity of an enzyme protein called JAK-1(known as a JAK-1 inhibitor).",ChEMBL:CHEMBL5095398 | DrugBank:DB16756 | PubChem:71622431,Ivarmacitinib,[H][C@@]12C[C@@H](N(C)c3ncnc4[nH]ccc34)C[C@]1([H])CN(C(=O)Nc1nc(OC)ns1)C2,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT04162899,NCT04162899_EG002,No,All,Adult | Older Adult,Phase 2,35,"Inclusion Criteria:

Subjects between 18-75 years of age (inclusive), male or female, at the time of informed consent
Moderate to severe atopic dermatitis
Capable of providing a signed and dated informed consent form indicating the subject has been informed of all pertinent aspect of the study

Exclusion Criteria:

Subjects with historical or current evidence of clinically significant cardiovascular, neurological, psychiatric, renal, hepatic, immunological, gastrointestinal, urogenital, nervous system, musculoskeletal, skin, sensory, endocrine (including uncontrolled diabetes or thyroid disease) or hematological abnormalities that are uncontrolled. Significant is defined as any disease that, in the opinion of the Investigator, would put the safety of the subject at risk through participation, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study
Subject has a current diagnosis of other active skin disease (e.g., psoriasis or lupus erythematosus) or skin infection (bacterial, fungal, or viral) that may affect the evaluation of atopic dermatitis
Subject has a severe comorbidity that may require systemic steroids therapy or other interventions or requires active frequent monitoring (e.g., unstable chronic asthma)","Participants randomized in this arm will receive Placebo of SHR0302 until end of study at week 12.

Drug: SHR0302: The study drug, SHR0302, is designed to block the activity of an enzyme protein called JAK-1(known as a JAK-1 inhibitor).",ChEMBL:CHEMBL5095398 | DrugBank:DB16756 | PubChem:71622431,Ivarmacitinib,[H][C@@]12C[C@@H](N(C)c3ncnc4[nH]ccc34)C[C@]1([H])CN(C(=O)Nc1nc(OC)ns1)C2,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT04175509,NCT04175509_EG000,No,Female,Adult | Older Adult,Phase 4,40,"Inclusion Criteria:

Willing to consent
Amendable to receive either rectal or intravenous acetaminophen
Planned hospital stay for at least 24 hours.

Exclusion Criteria:

Patients unable to provide informed consent
Patients with a history of regular opioid use prior to surgery based on their current home medication list
Patients who have required regular opioid intake for the 7 days preceding surgery
Patients with known hypersensitivity to acetaminophen
Patients with a baseline preoperative liver function enzymes (AST and ALT) that are greater than twice the upper limits
Unable to complete procedure as planned.","Patients will receive two 650mg suppositories rectally of acetaminophen for a total dose of 1300mg at the end of surgery.

Rectal acetaminophen: Rectal 1300mg",ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT04175509,NCT04175509_EG001,No,Female,Adult | Older Adult,Phase 4,40,"Inclusion Criteria:

Willing to consent
Amendable to receive either rectal or intravenous acetaminophen
Planned hospital stay for at least 24 hours.

Exclusion Criteria:

Patients unable to provide informed consent
Patients with a history of regular opioid use prior to surgery based on their current home medication list
Patients who have required regular opioid intake for the 7 days preceding surgery
Patients with known hypersensitivity to acetaminophen
Patients with a baseline preoperative liver function enzymes (AST and ALT) that are greater than twice the upper limits
Unable to complete procedure as planned.","Patients will receive one dose of 1000mg of acetaminophen, administered intravenously, at the end of surgery.

Intravenous acetaminophen: Intravenous 1000mg",ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT04175808,NCT04175808_EG000,Accepts Healthy Volunteers,All,Adult,Phase 1,70,"Inclusion Criteria:

Subject has provided informed consent before initiation of any study-specific activities/procedures.
Healthy male or healthy female subjects greater than or equal to 18 to less than or equal to 50 years of age.
No history or evidence of clinically relevant medical disorders as determined by the Investigator at Screening.
Physical examination at Screening and vital signs, clinical laboratory values, and electrocardiogram (ECG) at Screening and Day -1 of each period are clinically acceptable to the Investigator.
Body mass index (BMI) greater than, or equal to 18.0 kg/m^2 and less than, or equal to 30.0 kg/m^2.
Willing to maintain current general diet and physical activity regimen.

Exclusion Criteria:

History or evidence of clinically significant disorder, condition, or disease not otherwise excluded that, in the opinion of the Investigator, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.
Any users of tobacco- or nicotine-containing products within 6 months before Day -1 of Part A.
History suggestive of esophageal (including esophageal spasm, esophagitis), gastric, or duodenal ulceration or bowel disease (including, but not limited to, peptic ulceration, gastrointestinal bleeding, ulcerative colitis, Crohn's disease, or irritable bowel syndrome); or a history of gastrointestinal surgery other than uncomplicated appendectomy.
History or current signs or symptoms of cardiovascular disease, including but not limited to myocardial infarction, congenital heart disease, valvular heart disease, coronary revascularization, or angina.
Known substance abuse (eg, alcohol, licit or illicit drugs) within 1 year prior to Screening.
Subjects with poor peripheral venous access.
Use of any medications/substances outside the allowed timeframes as specified in Section 6.1.2.
Currently receiving treatment in another investigational device or drug study, or less than 3 months, or 5 half-lives if longer, prior to receiving the first dose of study drug. Other investigational procedures while participating in this study are excluded.
Donated blood from 3 months prior to Screening, plasma from 2 weeks prior to Screening, or platelets from 6 weeks prior to Screening.
Subjects who were previously exposed to OM.
Hepatic impairment defined by a total bilirubin (TBL) greater than or equal to 1.2 times the upper limit of normal (ULN), or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than ULN (and confirmed upon repeat).
Systolic blood pressure (BP) greater than 140 mmHg or less than 90 mmHg, or diastolic BP greater than 90 mmHg.
QTcF interval greater than 450 msec in male or greater than 470 msec in female or history/evidence of long QT syndrome, or PR of greater than or equal to 200 msec; or 2nd degree atrioventricular (AV) block or 3rd degree AV block, or heart rate greater than 100 bpm (and confirmed upon repeat, except 2nd or 3rd degree AV block, which are exclusionary based on a single finding).
Troponin I or creatine kinase MB fraction (CK-MB) greater than ULN at Screening or Check-in for Part A or B.
Estimated glomerular filtration rate (eGFR) less than 80 mL/min/1.73 m^2 at Screening as calculated by the Modified Diet in Renal Disease (MDRD) equation;
Any positive test for drugs, cotinine (tobacco or nicotine use), and/or alcohol use.
Positive hepatitis panel and/or positive human immunodeficiency virus test. Subjects whose results are compatible with prior immunization may be included.
Subject has known sensitivity to any of the products or components to be administered during dosing, including history of hypersensitivity to moxifloxacin or any member of the quinolone class of antibacterials.
History of tendon rupture or connective tissue disorders.
Female subjects with a positive pregnancy test.
Female subjects lactating/breastfeeding or who plans to breastfeed during the study through 90 days after the end of study (EOS) visit.
Unwilling to adhere to contraceptive requirements through 90 days after the EOS visit.
Unwilling to abstain from sperm and ovum donation through 90 days after the EOS visit.
Male subjects with a female partner of childbearing potential and not willing to inform his partner of his participation in this clinical study.
Male subjects with a pregnant partner or partner planning to become pregnant while the subject is on study through 90 days after the EOS visit.
Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures (eg, Clinical Outcome Assessments) to the best of the subject and Investigator's knowledge.",After an overnight fast of at least 10 hours participants received a single oral dose of 25 mg omecamtiv mecarbil on Day 1.,ChEMBL:CHEMBL1800955 | DrugBank:DB11816 | PubChem:11689883,OMECAMTIV MECARBIL,COC(=O)N1CCN(Cc2cccc(NC(=O)Nc3ccc(C)nc3)c2F)CC1,C01CX10,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT04179968,NCT04179968_EG000,No,Male,Adult | Older Adult,Phase 2,20,"Inclusion Criteria:

Patients with suspected prostate cancer (e.g., abnormal digital rectal exam, elevated and/or rising PSA) as determined by referring physician
Patients must have had a diagnostic, standard of care mpMRI of the prostate with at least one lesion with a PI-RADS v2.1 score ≥ 4
In men with PI-RADS v2.1 score 4, PSA should be ≥ 10 ng/mL. In men with at least one PI-RADS v2.1 score 5 lesion, there is no restriction on PSA level.
Patients must be scheduled for biopsy or radical prostatectomy
Patients should not have had any type of curative or palliative therapy for prostate cancer before enrolling in the study
Patients must be medically stable as judged by the patient's physician
Patients must be able to lie still for a total of 60 minutes for the PET/CT scans
Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:

Patients who have had a prior prostatectomy or radiotherapy for prostate cancer cannot participate in the study
Patients who have had a prior biopsy for prostate cancer cannot participate in the study
Patients who have been treated for cancers other than skin cancers
Subjects may not be receiving any other investigational agents for the treatment of the cancer under study
Patients may not weigh more than the maximum weight limit for the PET/CT scanner table (>200 kilograms or 440 pounds)
History of allergic reactions attributed to compounds of similar chemical or biologic composition to 68Ga PSMA-11 or other agents used in the study such as gadolinium-based intravenous contrast agent used during the mpMRI
Prior transurethral resection of the prostate (TURP)/benign prostatic hyperplasia (BPH) procedures, including steam/laser therapies","Patients with suspected prostate cancer who have at least one PI-RADS 5 lesion, or at least one PI-RADS 4 lesion and PSA ≥10 nanograms/milliliter (ng/mL), on standard of care mpMRI of the prostate, who are scheduled for biopsy or radical prostatectomy

68Ga PSMA-11 injection: Injection of 68Ga PSMA-11

Positron Emission Tomography/Computed Tomography: PET/CT scan after 68Ga PSMA-11 injection",PubChem:60143283,Gozetotide,O=C(O)CCc1ccc(O)c(CN(CCN(CC(=O)O)Cc2cc(CCC(=O)NCCCCCC(=O)NCCCCC(NC(=O)NC(CCC(=O)O)C(=O)O)C(=O)O)ccc2O)CC(=O)O)c1,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT04197986,NCT04197986_EG000,No,All,Adult | Older Adult,Phase 3,20,"Key Inclusion Criteria

Are randomized within 120 days following nephroureterectomy, distal ureterectomy or cystectomy.

Have histologically or cytologically confirmed, invasive urothelial carcinoma with susceptible FGFR3 alterations. Variant histology is allowed provided urothelial carcinoma is predominant (>50%). Neuroendocrine (including small and large cell), sarcomatoid, and plasmacytoid variants are excluded (any component).

Regarding samples and documentation of FGFR3

i. FGFR3 mutation is confirmed if: FGFR3 gene is mutated in Exon 7 (R248C, S249C), Exon 10 (G370C, A391E, Y373C), or Exon 15 (K650M/T, K650E/Q)

OR

ii. FGFR3 gene fusion or FGFR3 rearrangement is confirmed based on the following genomic criteria if:

Any fusion/rearrangement with a literature-derived known partner gene regardless of strand or frame.
Fusion/rearrangements in the same strand that are in frame with a novel partner gene.
Fusion/rearrangements with one breakpoint in the intron 17 - exon 18 hotspot region and the other breakpoint in an intergenic region or another gene. This rule excludes 3' duplications comprising only exon 18.
iii. The amino acid numbers for the FGFR3 mutations refer to the functional FGFR3 isoform 1 (NP_000133.1) that is the NCBI Refseq ID used to report genetic alterations in FGFR3 by the FoundationOne® CDx test (F1CDx, Foundation Medicine, USA).

iv. FGFR3 alteration must be confirmed by Foundation Medicine for F1CDx testing:

The tumor sample to be used should be from the definitive surgical resection (cystectomy, nephroureterectomy, or distal ureterectomy), or from an archival biopsy of confirmed invasive urothelial carcinoma (≥pT2).
If status post neoadjuvant chemotherapy, pathologic stage at surgical resection must be Stage ≥ ypT2 and/or yN+. Prior neoadjuvant therapy is defined as at least 3 cycles of neoadjuvant cisplatin-based chemotherapy with a planned cisplatin dose of 70 mg/m2/cycle. Subjects who received less than this or non-cisplatin-based neoadjuvant treatment are not excluded.
If not status post neoadjuvant chemotherapy, is ineligible to receive cisplatin-based adjuvant chemotherapy based on Galsky criteria:
Subjects who refuse cisplatin-based chemotherapy or who are ineligible to receive cisplatin-based chemotherapy based on Galsky criteria must also meet the following criteria:
Must have a centrally reviewed negative postoperative computed tomography (CT) (defined as lymph nodes with short axis <1.0 cm and without growth and no distant metastases according to [RECIST v1.1 criteria or negative biopsy within 28 days before randomization to confirm absence of disease at baseline.
Have Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.
If a woman of childbearing potential, must have a negative pregnancy test within 7 days of the first dose of study drug. Sexually active males must use a condom during intercourse while taking study drug and for 1 month after the last dose of study drug and should not father a child during this period

Key Exclusion Criteria:

Presence of positive invasive surgical margins following nephroureterectomy, distal ureterectomy, or cystectomy. In subjects not eligible for further surgery, radiotherapy, or other efficacious treatment, microscopic positive noninvasive margins (eg, carcinoma in situ) without gross residual disease are allowed.
Have received Bacillus Calmette-Guerin (BCG) or other intravesical therapy for Non-Muscle Invasive Bladder Cancer (NMIBC) within the previous 30 days.

Are currently receiving or are planning to receive during participation in this study, treatment with agents that are known moderate or strong inducers or inhibitors of CYP3A4 and medications which increase serum phosphorus and/or calcium concentration. Prior anticancer or other therapies are restricted as follows:

Prior adjuvant treatment for urothelial cancer is not allowed.
Prior neoadjuvant therapy (eg, chemotherapy, immunotherapy, or investigational) is allowed if inclusion criterion #4 is met. Prior neoadjuvant chemotherapy must have been completed within a period of time that is greater than the cycle length used for that treatment before first dose of study drug.
Prior biologic, immunotherapy, or investigational therapy should have been completed within a period that is ≥5 half-lives or 30 days, whichever is shorter, before the first dose of study drug.
Have previously or currently is receiving treatment with a mitogen-activated protein kinase (MEK) or selective FGFR inhibitor.
Have a history of primary malignancy within the past 3 years other than (1) invasive UBC or UTUC (ie, disease under study), (2) noninvasive urothelial carcinoma, (3) any adequately treated in situ carcinoma or non-melanoma carcinoma of the skin, (4) any other curatively treated malignancy that is not expected to require treatment for recurrence during participation in the study, or (5) an untreated cancer on active surveillance that may not affect the subject's survival status for ≥3 years based on clinician assessment/statement and with medical monitor approval.
Have current evidence of corneal keratopathy or retinal disorder confirmed by ophthalmic examination. Subjects with asymptomatic ophthalmic conditions assessed by the investigator to pose minimal risk for study participation may be enrolled in the study.
Have a history and/or current evidence of extensive tissue calcification
Have impaired gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral infigratinib
Have current evidence of endocrine alterations of calcium/phosphate homeostasis (eg, parathyroid disorders, history of parathyroidectomy, tumor lysis, tumoral calcinosis), unless well controlled.
Have consumed grapefruit, grapefruit juice, grapefruit hybrids, pomegranates, star fruits, pomelos, or Seville oranges or products containing juice of these fruits within 7 days before the first dose of study drug; have taken any Chinese herbal medicine or Chinese patent medicine treatments with anticancer activity within 14 days of the first dose of study drug.

Have insufficient bone marrow function:

Absolute neutrophil count (ANC) <1,000/mm3 (1.0 × 109/L).
Platelets <75,000/mm3 (<75 × 109/L).
Hemoglobin <8.5 g/dL; transfusion support is allowed if >1 week before randomization and hemoglobin remains stable.

Have insufficient hepatic and renal function:

Total bilirubin >1.5 × upper limit of normal (ULN) of the testing laboratory (for subjects with documented Gilbert syndrome, direct bilirubin must be ≤1.5 × ULN and enrollment requires approval by the medical monitor).
AST/SGOT and ALT/SGPT >2.5 × ULN of the testing laboratory.
Serum creatinine >1.5 × ULN or a calculated or measured creatinine clearance of <30 mL/min.
Have amylase or lipase >2.0 × ULN.

Have abnormal calcium or phosphorus:

Inorganic phosphorus higher than 1.02 × ULN of the testing laboratory.
Total serum calcium (can be corrected) higher than 1.02 × ULN of the testing laboratory.

Have clinically significant cardiac disease including any of the following:

New York Heart Association (NYHA) Class ≥2B; subjects with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the NYHA classification.
Uncontrolled hypertension
Presence of CTCAE v5.0 Grade ≥2 ventricular arrhythmias, atrial fibrillation, bradycardia, or conduction abnormality.
Unstable angina pectoris or acute myocardial infarction ≤3 months before the first dose of study drug.
Average QTcF >470 msec (males and females). Note: If the QTcF is >470 msec in the first ECG, a total of 3 ECGs separated by ≥5 minutes should be performed. If the average of these 3 consecutive results for QTcF is ≤470 msec, the subject meets eligibility in this regard.
History of congenital long QT syndrome.
Have had a recent (≤3 months before the first dose of study drug) transient ischemic attack or stroke.
If female, are pregnant or nursing (lactating).",Infigratinib 125 mg once daily (3 weeks on / 1 week off treatment),ChEMBL:CHEMBL1852688 | DrugBank:DB11886 | PubChem:53235510,Infigratinib,CCN1CCN(c2ccc(Nc3cc(N(C)C(=O)Nc4c(Cl)c(OC)cc(OC)c4Cl)ncn3)cc2)CC1,L01EN03,0.0,0.0,0.0,0.0,0.0,1.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,1.0,1.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT04200911,NCT04200911_EG000,Accepts Healthy Volunteers,All,Adult | Older Adult,Early Phase 1,10,"Inclusion Criteria:

Diagnosis of Mild Cognitive Impairment (MCI), Clinical Dementia Rating Scale (CDR)=0.5-1; Hopkins Verbal Learning Test-Revised (HVLT-R) Delayed Recall ≤5% based on age-adjusted normal values, clinician approved
Normal blood cell counts without clinically significant excursions
A Legally Authorized Representative (LAR) if necessary for consent
An LAR or study partner to accompany participant to all visits
Availability for all study visits
Stable dose of AD medications) Donepezil, rivastigmine, memantine, galantamine) for at least 3 months

Exclusion Criteria:

Diabetes (HbA1c≥6.5% or anti-diabetic medications)
History of skin ulcers or poor wound healing
Current tobacco or illicit drug use or alcohol abuse
Use of anti-platelet or anti-coagulant medications other than aspirin
Current medications that affect cytochrome P450 3A4
Immunosuppressant therapy within the last year
Chemotherapy or radiation treatment within the last year
Current or chronic history of liver disease or known hepatic or biliary abnormalities
Current or chronic history of pulmonary disease or abnormal pulse oximetry (<90%)
Chronic heart failure
Pregnancy
Recent history (past 6 months) of myocardial infarction, active coronary artery disease, intestinal disorders, stroke, or transient ischemic attack
significant neurological conditions other than AD
Poorly controlled blood pressure (systolic BP>160, diastolic BP>90mmHg)
Active inflammatory, autoimmune, infectious, hepatic, gastrointestinal, malignant, and/or psychiatric disease
History of, or Magnetic Resonance Imaging (MRI) positive for any space occupying lesion, including mass effect and/or abnormal intracranial pressure, which would indicate contraindication to lumbar puncture","Sirolimus 1mg orally once a day for 8 weeks

Rapamune: Sirolimus 1mg capsules",ChEMBL:CHEMBL413 | DrugBank:DB00877 | PubChem:134760597 | PubChem:138404388 | PubChem:21944094 | PubChem:5284616,Sirolimus,COC1CC2CCC(C)C(O)(O2)C(=O)C(=O)N2CCCCC2C(=O)OC(C(C)CC2CCC(O)C(OC)C2)CC(=O)C(C)C=C(C)C(O)C(OC)C(=O)C(C)CC(C)C=CC=CC=C1C,L01EG04 | L04AA10 | S01XA23,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT04208412,NCT04208412_EG000,No,All,Adult | Older Adult,Phase 2,68,"Inclusion Criteria:

Male or female adult subjects 18 years of age and older.
Confirmed diagnosis of HAE type I or II at anytime in the medical history
At least 3 documented HAE attacks in the past 93 days, as supported by medical history.
Access to and ability to use conventional attack treatment for attacks of HAE
Adequate organ functions
Females of childbearing potential must agree to use highly effective birth control from the Screening visit until the end of the trial follow-up procedures.
Females of non-childbearing potential, defined as surgically sterile (status post hysterectomy, bilateral oophorectomy, or bilateral tubal ligation) or post-menopausal for at least 12 months, do not require contraception during the study
Males with female partners of childbearing potential must agree to be abstinent or else use a highly effective method of birth control as defined in inclusion 6 from the Screening visit until the end of the trial follow-up procedures
Provide signed informed consent and are willing and capable of complying with study requirements and procedures

Exclusion Criteria:

Any concomitant diagnosis of another form of chronic angioedema, such as acquired C1 inhibitor (C1-INH) deficiency, HAE with normal C1-INH (also known as HAE type III), idiopathic angioedema, or angioedema associated with urticaria
Current use of C1INH, androgens, or tranexamic acid for HAE prophylaxis
Use of angiotensin-converting enzyme (ACE) inhibitors or any estrogen-containing medications with systemic absorption (such as oral contraceptives or hormonal replacement therapy) within 93 days prior to initial study treatment.
Use of androgens (e.g. stanozolol, danazol, oxandrolone, methyltestosterone, testosterone) or antifibrinolytics within 30 days prior to initial study treatment.
Use of lanadelumab within 10 weeks prior to initial study treatment.
Use of strong CYP3A4/CYP2C9 inhibitors and inducers during participation in the trial
Clinically significant abnormal ECG at Visit 1 and pre-dose at Visit 2. This includes, but is not limited to, a QT interval by Fredericia, QTcF > 470 msec (for women) or > 450 msec (for men), a PR > 220 msec or ventricular and/or atrial premature contractions that are more frequent than occasional and/or occur as couplets or higher in grouping
Any clinically significant history of angina, myocardial infarction, syncope, clinically significant cardiac arrhythmias, left ventricular hypertrophy, cardiomyopathy, or any other cardiovascular abnormality
Any other systemic dysfunction (e.g., gastrointestinal, renal, respiratory, cardiovascular) or significant disease or disorder which, in the opinion of the Investigator, would jeopardize the safety of the subject by taking part in the trial
History of substance abuse or dependence that would interfere with the completion of the study, as determined by the Investigator
Known lactose allergy or intolerance
Known hypersensitivity to KVD900 or placebo or to any of the excipients
Participation in an interventional investigational clinical study within 93 days or within 5 half-lives of the last dosing of investigational drug (whichever is longer) prior to initial study treatment
Any pregnant or breast-feeding subject",Subjects received a single dose of 600 mg KVD900.,ChEMBL:CHEMBL5095248 | DrugBank:DB18305 | PubChem:121365142,Sebetralstat,COCc1nn(Cc2ccc(Cn3ccccc3=O)cc2)cc1C(=O)NCc1nccc(OC)c1F,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT04220411,NCT04220411_EG001,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 1 | Phase 2,3,"Inclusion Criteria:

Phase I:

Dated and signed informed consent
Either gender, ≥ 20 years old (the legal age of consent majority is 20 years old in Taiwan)
Healthy subjects, who have no clinically relevant abnormalities, identified by medical history, physical examination, 12-lead electrocardiogram (ECG), and clinical laboratory tests
Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures
Healthy skin on which reddening can be easily recognized in the area of the test fields, evaluated by the investigator
Subject of childbearing potential must agree to use abstinence to intercourse, or highly effective contraceptives from signing informed consent to 14 days after the last dose of study drug administration

At least two forms of effective birth control must be adopted for contraception, and one of which must be a barrier method. Acceptable forms include:

Established use of oral, injected or implanted hormonal methods of contraception
Placement of an intrauterine device (IUD) or intrauterine system (IUS)
Barrier methods of contraception: condom (highly recommended with spermicide), or occlusive cap (diaphragm or cervical/vault caps)

Phase IIa:

Dated and signed informed consent
Either gender, ≥ 20 years old (the legal age of consent majority is 20 years old in Taiwan)
Confirmed clinical diagnosis of atopic dermatitis (based on the criteria of Hanifin and Rajka for AD)
With at least 0.5% body surface area (BSA) as target lesion area(s)
Clinical diagnosis of AD that has been clinically stable, which means the IGA score stays as 2 or 3 when evaluated for ≥ 4 weeks at the investigator's discretion prior to Screening Visit
With Investigator's Global Assessment (IGA) score of 2 (mild) or 3 (moderate) at screening
Subject of childbearing potential must agree to use abstinence to intercourse, or highly effective contraceptives from signing informed consent to 14 days after the last dose of study drug administration

At least two forms of effective birth control must be adopted for contraception, and one of which must be a barrier method. Acceptable forms include:

Established use of oral, injected or implanted hormonal methods of contraception
Placement of an intrauterine device (IUD) or intrauterine system (IUS)
Barrier methods of contraception: condom (highly recommended with spermicide), or occlusive cap (diaphragm or cervical/vault caps)

Exclusion Criteria:

Phase I:

Subjects who have any visible skin disease at the application site which, in the opinion of the investigator, will interfere with the evaluation of the test site reaction
Subjects who have a history of AD, psoriasis and/or active AD/eczema
Subjects who have damaged skin in or around the test sites, including sunburn, excessively deep tans, uneven skin tones, tattoos, scars, excessive hair, numerous freckles, or other disfigurations of the test site
Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing)

Phase IIa:

Unstable or actively infected AD judged by the investigator.
Active or potentially recurrent dermatologic condition other than atopic dermatitis that may confound evaluation (e.g. fungal infection), judged by the investigator.
Received systemic medication including corticosteroid, immunosuppressant, anti-histamine, phototherapy, or other therapy, which could affect AD within 4 weeks before Screening. However, subjects are allowed to enter the study if subjects have been taking at least 2 weeks of fixed dose anti-histamine prior to Screening and this application does not affect the study judged by the investigator

Received topical medication including corticosteroid, immunosuppressant, anti-histamine, phototherapy, calcineurin inhibitors, or other therapy for AD on the target lesion area(s) within 1 week before Screening

The following exclusion criteria are applied for all subjects in Phase I/IIa study:

Plan to receive immunosuppressive agents (including azathioprine, mycophenolate, cyclophosphamide, chlorambucil, methotrexate, cyclosporine), or systemic steroid with equivalent dosage higher than prednisolone 30 mg/day for more than 14 days at Screening
Unwilling or unable to comply with the criteria in Life Style Guidelines during the study
History of use of biologic therapy (including intravenous immunoglobulin) within 12 weeks or 5 half-lives (whichever is longer) prior to Screening
Received any other investigational drug within 4 weeks prior to Screening
Required or received systemic CYP3A4 inhibitors with strong potency within 1 week prior to screening, including but not limited to clarithromycin, itraconazole, nefazodone and atazanavir, evaluated by the investigator
Treatment for any type of cancer (except squamous cell carcinoma, basal cell carcinoma, or carcinoma in situ of the skin, curatively treated with cryosurgery or surgical excision only) within 5 years before screening
Had surgery within 4 weeks prior to Screening Visit, or plan to have surgery during the study
Allergies requiring acute or chronic treatment at the investigator's discretion
Known hypersensitivity to any of the components of the study drug
Active clinically serious infection or history of human immunodeficiency virus (HIV) infection

Any of the following serum test abnormalities:

Total bilirubin > 1.5 × ULN
AST or ALT > 3.0 × ULN
Serum albumin < 2.5 g/dL
Creatinine > 1.5 × ULN
Any other ≥ Grade 2 (grading of vaccine clinical trials for Phase I and NCI-CTCAE v5.0 for Phase IIa) laboratory abnormality at baseline (other than those listed above)
With ongoing acute diseases or within the past 2 years serious medical conditions (e.g. concomitant illness) such as cardiovascular (e.g. New York Heart Association (NYHA) grade III or IV), hepatic (e.g. Child-Pugh Class C), psychiatric condition (e.g. alcoholism, drug abuse), medical history, physical findings, or laboratory abnormality that in the investigators' opinion could interfere with the results of the trial or adversely affect the safety of the subject
Female subject who is lactating or has positive urine pregnancy test at screening
Other conditions not suitable for participating in this study judged by the investigator","Subjects topically apply AR100DP1 twice per day with at least 4 hour interval. The daily dosage of 2.5% AR100DP1 topical administration is 62.5 mg/day (2.5% × 1,250 × 2 = 62.5).",PubChem:38347030,Ovatodiolide,C=C1C(=O)OC2C=C(C)CC3C=C(CCC=C(C)CCC12)C(=O)O3,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT04223609,NCT04223609_EG000,Accepts Healthy Volunteers,All,Adult,Phase 1 | Phase 2,13,"Inclusion Criteria:

Participants must be able to consent to participate themselves
Be healthy male or non-pregnant female
Must be able to attend in-person sessions at the Mayo Aerospace Medicine and Vestibular Research Laboratory in Scottsdale, AZ.
Have not used opioids during the preceding 30 days
Prior use of opioids for pain management

Exclusion Criteria:

Women who are pregnant or breastfeeding.
Women who are not practicing an effective form of contraception (condoms, IUD, birth control pill, diaphragm),
Past or current history of drug or substance use.
Significant ocular disorder.
Positive drug test for marijuana, opioids, methamphetamines, cocaine, PCP or other controlled substances.
History of use of psychoactive drugs within the past 30 days.
Subjects with a history of cardiopulmonary disease including but not limited to congestive heart failure, obstructive sleep apnea, restrictive lung disease, COPD, moderate to severe asthma and oxygen dependency.
Subjects currently taking sedatives (including benzodiazepines), muscle relaxants or disassociatives.","Participants who received initial dose of oxycodone 5 mg tablet followed by a 30-minute rest period to allow for onset of medication effect. This rest period will be followed by a standardized set of oculomotor testing for 40 minutes. After the initial testing, a second dose of oxycodone 5 mg tablet will be administered followed by a 30-minute rest period to allow for the onset of the second dose. The second rest period will be followed by a second round of standardized oculomotor testing for 40 minutes.",ChEMBL:CHEMBL656 | DrugBank:DB00497 | PubChem:5284603,Oxycodone,COc1ccc2c3c1O[C@H]1C(=O)CC[C@@]4(O)[C@@H](C2)N(C)CC[C@]314,N02AA05 | N02AA55 | N02AA56 | N02AJ17 | N02AJ18 | N02AJ19,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT04238481,NCT04238481_EG000,No,All,Adult | Older Adult,Phase 2,3,"Inclusion Criteria:

Subject is scheduled to undergo laparoscopic/minimally invasive colorectal surgery.
Subject will need visualization of the ureter(s).

Female subject is not pregnant and at least 1 of the following conditions apply:

Not a woman of childbearing potential (WOCBP)
WOCBP who agrees to follow the contraceptive guidance from the time of informed consent through at least 30 days after final study treatment administration.
Female subject must agree not to breastfeed starting at screening and throughout the study period.
Female subject must not donate ova starting at first dose of investigational product (IP) and throughout the study period and for 30 days after final study treatment administration.
Male subject with female partner(s) of childbearing potential (including breastfeeding partner) must agree to use contraception throughout the treatment period and for 30 days after final study treatment administration.
Male subject must not donate sperm during the treatment period and for 30 days after final study treatment administration.
Male subject with pregnant partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy throughout the study period and for 30 days after final study treatment administration.
Subject agrees not to participate in another interventional study while participating in the present study.
Subjects enrolled after optimal dose determination:

Subject has any of the following values at screening:

Body mass index > 25
Estimated glomerular filtration rate (eGFR) ≥ 15 mL/min/1.73 m^2 and < 60. Subjects with an eGFR ≥ 60 mL/min/1.73 m^2 may be considered after discussion with the medical monitor.

Exclusion Criteria:

Subject is anticipated to require ureteral stenting during surgery.
Subject has a history of known retroperitoneal fibrosis.
Subject has an active urinary tract infection.
Subject has received any investigational therapy within 28 days or 5 half-lives, whichever is longer, prior to screening.
Subject has any condition that makes the subject unsuitable for study participation.
Subject has a known or suspected hypersensitivity to ASP5354, indocyanine green (ICG) or any components of the formulation used.
Subject has had previous exposure to ASP5354.
Subject has moderate to severe cardiac disease that limits daily functioning (New York Heart Association Class III-IV) or other medical conditions that the investigator feels would impact safety or study compliance.
Subject has a mean resting heart rate ≤ 45 bpm or ≥ 115 bpm, mean systolic blood pressure (SBP) ≥ 160 mmHg or mean diastolic blood pressure (DBP) ≥ 100 mmHg on day -1. If the mean blood pressure exceeds the limits above, repeat readings can be taken. Subject who has adequately controlled blood pressure is eligible.
Subject has a mean corrected QT interval (Triplicate electrocardiogram [ECG]) using Fridericia's formula (QTcF) > 430 msec (for male subjects) and > 450 msec (for female subjects) on day -1. If the mean QTcF exceeds the limits above, the mean of 1 additional triplicate ECG may be taken.

Subject has any of the following screening laboratory values:

Hemoglobin ≤ 9 g/dL
Absolute neutrophil count ≤ 1500/µL
Platelet count ≤ 100000/µL
eGFR < 60 mL/min/1.73 m^2 (Not applicable to subjects enrolled after optimal dose determination.)
Serum bilirubin ≥ 2 × upper limit of normal (ULN)
Aspartate aminotransferase (AST) or serum glutamic oxaloacetic transaminase ≥ 2.5 × ULN
Alanine aminotransferase (ALT) or serum glutamic pyruvic transaminase ≥ 2.5 × ULN
Subject has taken ICG or other near-infrared fluorescence (NIR)-F imaging agents within 48 hours prior to study treatment administration.
Subject has taken diuretics or inhibitors of renal transporters defined by Food and Drug Administration (FDA) within 48 hours prior to study treatment administration.
Subject has used any illicit drugs, unless legally prescribed and is not being abused (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine and opiates) within 1 month prior to day -1.
Subject has a history of alcohol abuse. Subject should not have consumed any alcohol within 48 hours of surgery.",Participants received single dose of pudexacianinium chloride at dose level A by IV bolus infusion on day 1 once the surgical area of interest is in view.,PubChem:145996611 | PubChem:165411958,ASP5354 chloride,COC1=C(C=CC2=[N+](CCC(=O)NCCCOC3C(O)C4OC(CO)C3OC3OC(CO)C(OC5OC(CO)C(OC6OC(CO)C(OC7OC(CO)C(OC8OC(CO)C(OC9OC(CO)C(O4)C(O)C9O)C(O)C8O)C(O)C7O)C(O)C6O)C(O)C5O)C(O)C3O)c3ccc4ccccc4c3C2(C)C)CCCC1=CC=C1N(CCC(=O)NCCCOC2C3OC(CO)C(OC4OC(CO)C(OC5OC(CO)C(OC6OC(CO)C(OC7OC(CO)C(OC8OC(CO)C(OC9OC(CO)C(O3)C(O)C9O)C(O)C8O)C(O)C7O)C(O)C6O)C(O)C5O)C(O)C4O)C2O)c2ccc3ccccc3c2C1(C)C.[Cl-],,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT04238481,NCT04238481_EG001,No,All,Adult | Older Adult,Phase 2,3,"Inclusion Criteria:

Subject is scheduled to undergo laparoscopic/minimally invasive colorectal surgery.
Subject will need visualization of the ureter(s).

Female subject is not pregnant and at least 1 of the following conditions apply:

Not a woman of childbearing potential (WOCBP)
WOCBP who agrees to follow the contraceptive guidance from the time of informed consent through at least 30 days after final study treatment administration.
Female subject must agree not to breastfeed starting at screening and throughout the study period.
Female subject must not donate ova starting at first dose of investigational product (IP) and throughout the study period and for 30 days after final study treatment administration.
Male subject with female partner(s) of childbearing potential (including breastfeeding partner) must agree to use contraception throughout the treatment period and for 30 days after final study treatment administration.
Male subject must not donate sperm during the treatment period and for 30 days after final study treatment administration.
Male subject with pregnant partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy throughout the study period and for 30 days after final study treatment administration.
Subject agrees not to participate in another interventional study while participating in the present study.
Subjects enrolled after optimal dose determination:

Subject has any of the following values at screening:

Body mass index > 25
Estimated glomerular filtration rate (eGFR) ≥ 15 mL/min/1.73 m^2 and < 60. Subjects with an eGFR ≥ 60 mL/min/1.73 m^2 may be considered after discussion with the medical monitor.

Exclusion Criteria:

Subject is anticipated to require ureteral stenting during surgery.
Subject has a history of known retroperitoneal fibrosis.
Subject has an active urinary tract infection.
Subject has received any investigational therapy within 28 days or 5 half-lives, whichever is longer, prior to screening.
Subject has any condition that makes the subject unsuitable for study participation.
Subject has a known or suspected hypersensitivity to ASP5354, indocyanine green (ICG) or any components of the formulation used.
Subject has had previous exposure to ASP5354.
Subject has moderate to severe cardiac disease that limits daily functioning (New York Heart Association Class III-IV) or other medical conditions that the investigator feels would impact safety or study compliance.
Subject has a mean resting heart rate ≤ 45 bpm or ≥ 115 bpm, mean systolic blood pressure (SBP) ≥ 160 mmHg or mean diastolic blood pressure (DBP) ≥ 100 mmHg on day -1. If the mean blood pressure exceeds the limits above, repeat readings can be taken. Subject who has adequately controlled blood pressure is eligible.
Subject has a mean corrected QT interval (Triplicate electrocardiogram [ECG]) using Fridericia's formula (QTcF) > 430 msec (for male subjects) and > 450 msec (for female subjects) on day -1. If the mean QTcF exceeds the limits above, the mean of 1 additional triplicate ECG may be taken.

Subject has any of the following screening laboratory values:

Hemoglobin ≤ 9 g/dL
Absolute neutrophil count ≤ 1500/µL
Platelet count ≤ 100000/µL
eGFR < 60 mL/min/1.73 m^2 (Not applicable to subjects enrolled after optimal dose determination.)
Serum bilirubin ≥ 2 × upper limit of normal (ULN)
Aspartate aminotransferase (AST) or serum glutamic oxaloacetic transaminase ≥ 2.5 × ULN
Alanine aminotransferase (ALT) or serum glutamic pyruvic transaminase ≥ 2.5 × ULN
Subject has taken ICG or other near-infrared fluorescence (NIR)-F imaging agents within 48 hours prior to study treatment administration.
Subject has taken diuretics or inhibitors of renal transporters defined by Food and Drug Administration (FDA) within 48 hours prior to study treatment administration.
Subject has used any illicit drugs, unless legally prescribed and is not being abused (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine and opiates) within 1 month prior to day -1.
Subject has a history of alcohol abuse. Subject should not have consumed any alcohol within 48 hours of surgery.",Participants received single dose of pudexacianinium chloride at dose level B by IV bolus infusion on day 1 once the surgical area of interest is in view.,PubChem:145996611 | PubChem:165411958,ASP5354 chloride,COC1=C(C=CC2=[N+](CCC(=O)NCCCOC3C(O)C4OC(CO)C3OC3OC(CO)C(OC5OC(CO)C(OC6OC(CO)C(OC7OC(CO)C(OC8OC(CO)C(OC9OC(CO)C(O4)C(O)C9O)C(O)C8O)C(O)C7O)C(O)C6O)C(O)C5O)C(O)C3O)c3ccc4ccccc4c3C2(C)C)CCCC1=CC=C1N(CCC(=O)NCCCOC2C3OC(CO)C(OC4OC(CO)C(OC5OC(CO)C(OC6OC(CO)C(OC7OC(CO)C(OC8OC(CO)C(OC9OC(CO)C(O3)C(O)C9O)C(O)C8O)C(O)C7O)C(O)C6O)C(O)C5O)C(O)C4O)C2O)c2ccc3ccccc3c2C1(C)C.[Cl-],,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT04238481,NCT04238481_EG002,No,All,Adult | Older Adult,Phase 2,3,"Inclusion Criteria:

Subject is scheduled to undergo laparoscopic/minimally invasive colorectal surgery.
Subject will need visualization of the ureter(s).

Female subject is not pregnant and at least 1 of the following conditions apply:

Not a woman of childbearing potential (WOCBP)
WOCBP who agrees to follow the contraceptive guidance from the time of informed consent through at least 30 days after final study treatment administration.
Female subject must agree not to breastfeed starting at screening and throughout the study period.
Female subject must not donate ova starting at first dose of investigational product (IP) and throughout the study period and for 30 days after final study treatment administration.
Male subject with female partner(s) of childbearing potential (including breastfeeding partner) must agree to use contraception throughout the treatment period and for 30 days after final study treatment administration.
Male subject must not donate sperm during the treatment period and for 30 days after final study treatment administration.
Male subject with pregnant partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy throughout the study period and for 30 days after final study treatment administration.
Subject agrees not to participate in another interventional study while participating in the present study.
Subjects enrolled after optimal dose determination:

Subject has any of the following values at screening:

Body mass index > 25
Estimated glomerular filtration rate (eGFR) ≥ 15 mL/min/1.73 m^2 and < 60. Subjects with an eGFR ≥ 60 mL/min/1.73 m^2 may be considered after discussion with the medical monitor.

Exclusion Criteria:

Subject is anticipated to require ureteral stenting during surgery.
Subject has a history of known retroperitoneal fibrosis.
Subject has an active urinary tract infection.
Subject has received any investigational therapy within 28 days or 5 half-lives, whichever is longer, prior to screening.
Subject has any condition that makes the subject unsuitable for study participation.
Subject has a known or suspected hypersensitivity to ASP5354, indocyanine green (ICG) or any components of the formulation used.
Subject has had previous exposure to ASP5354.
Subject has moderate to severe cardiac disease that limits daily functioning (New York Heart Association Class III-IV) or other medical conditions that the investigator feels would impact safety or study compliance.
Subject has a mean resting heart rate ≤ 45 bpm or ≥ 115 bpm, mean systolic blood pressure (SBP) ≥ 160 mmHg or mean diastolic blood pressure (DBP) ≥ 100 mmHg on day -1. If the mean blood pressure exceeds the limits above, repeat readings can be taken. Subject who has adequately controlled blood pressure is eligible.
Subject has a mean corrected QT interval (Triplicate electrocardiogram [ECG]) using Fridericia's formula (QTcF) > 430 msec (for male subjects) and > 450 msec (for female subjects) on day -1. If the mean QTcF exceeds the limits above, the mean of 1 additional triplicate ECG may be taken.

Subject has any of the following screening laboratory values:

Hemoglobin ≤ 9 g/dL
Absolute neutrophil count ≤ 1500/µL
Platelet count ≤ 100000/µL
eGFR < 60 mL/min/1.73 m^2 (Not applicable to subjects enrolled after optimal dose determination.)
Serum bilirubin ≥ 2 × upper limit of normal (ULN)
Aspartate aminotransferase (AST) or serum glutamic oxaloacetic transaminase ≥ 2.5 × ULN
Alanine aminotransferase (ALT) or serum glutamic pyruvic transaminase ≥ 2.5 × ULN
Subject has taken ICG or other near-infrared fluorescence (NIR)-F imaging agents within 48 hours prior to study treatment administration.
Subject has taken diuretics or inhibitors of renal transporters defined by Food and Drug Administration (FDA) within 48 hours prior to study treatment administration.
Subject has used any illicit drugs, unless legally prescribed and is not being abused (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine and opiates) within 1 month prior to day -1.
Subject has a history of alcohol abuse. Subject should not have consumed any alcohol within 48 hours of surgery.",Participants received single dose pudexacianinium chloride at dose level C by IV bolus infusion on day 1 once the surgical area of interest is in view.,PubChem:145996611 | PubChem:165411958,ASP5354 chloride,COC1=C(C=CC2=[N+](CCC(=O)NCCCOC3C(O)C4OC(CO)C3OC3OC(CO)C(OC5OC(CO)C(OC6OC(CO)C(OC7OC(CO)C(OC8OC(CO)C(OC9OC(CO)C(O4)C(O)C9O)C(O)C8O)C(O)C7O)C(O)C6O)C(O)C5O)C(O)C3O)c3ccc4ccccc4c3C2(C)C)CCCC1=CC=C1N(CCC(=O)NCCCOC2C3OC(CO)C(OC4OC(CO)C(OC5OC(CO)C(OC6OC(CO)C(OC7OC(CO)C(OC8OC(CO)C(OC9OC(CO)C(O3)C(O)C9O)C(O)C8O)C(O)C7O)C(O)C6O)C(O)C5O)C(O)C4O)C2O)c2ccc3ccccc3c2C1(C)C.[Cl-],,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT04238481,NCT04238481_EG003,No,All,Adult | Older Adult,Phase 2,3,"Inclusion Criteria:

Subject is scheduled to undergo laparoscopic/minimally invasive colorectal surgery.
Subject will need visualization of the ureter(s).

Female subject is not pregnant and at least 1 of the following conditions apply:

Not a woman of childbearing potential (WOCBP)
WOCBP who agrees to follow the contraceptive guidance from the time of informed consent through at least 30 days after final study treatment administration.
Female subject must agree not to breastfeed starting at screening and throughout the study period.
Female subject must not donate ova starting at first dose of investigational product (IP) and throughout the study period and for 30 days after final study treatment administration.
Male subject with female partner(s) of childbearing potential (including breastfeeding partner) must agree to use contraception throughout the treatment period and for 30 days after final study treatment administration.
Male subject must not donate sperm during the treatment period and for 30 days after final study treatment administration.
Male subject with pregnant partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy throughout the study period and for 30 days after final study treatment administration.
Subject agrees not to participate in another interventional study while participating in the present study.
Subjects enrolled after optimal dose determination:

Subject has any of the following values at screening:

Body mass index > 25
Estimated glomerular filtration rate (eGFR) ≥ 15 mL/min/1.73 m^2 and < 60. Subjects with an eGFR ≥ 60 mL/min/1.73 m^2 may be considered after discussion with the medical monitor.

Exclusion Criteria:

Subject is anticipated to require ureteral stenting during surgery.
Subject has a history of known retroperitoneal fibrosis.
Subject has an active urinary tract infection.
Subject has received any investigational therapy within 28 days or 5 half-lives, whichever is longer, prior to screening.
Subject has any condition that makes the subject unsuitable for study participation.
Subject has a known or suspected hypersensitivity to ASP5354, indocyanine green (ICG) or any components of the formulation used.
Subject has had previous exposure to ASP5354.
Subject has moderate to severe cardiac disease that limits daily functioning (New York Heart Association Class III-IV) or other medical conditions that the investigator feels would impact safety or study compliance.
Subject has a mean resting heart rate ≤ 45 bpm or ≥ 115 bpm, mean systolic blood pressure (SBP) ≥ 160 mmHg or mean diastolic blood pressure (DBP) ≥ 100 mmHg on day -1. If the mean blood pressure exceeds the limits above, repeat readings can be taken. Subject who has adequately controlled blood pressure is eligible.
Subject has a mean corrected QT interval (Triplicate electrocardiogram [ECG]) using Fridericia's formula (QTcF) > 430 msec (for male subjects) and > 450 msec (for female subjects) on day -1. If the mean QTcF exceeds the limits above, the mean of 1 additional triplicate ECG may be taken.

Subject has any of the following screening laboratory values:

Hemoglobin ≤ 9 g/dL
Absolute neutrophil count ≤ 1500/µL
Platelet count ≤ 100000/µL
eGFR < 60 mL/min/1.73 m^2 (Not applicable to subjects enrolled after optimal dose determination.)
Serum bilirubin ≥ 2 × upper limit of normal (ULN)
Aspartate aminotransferase (AST) or serum glutamic oxaloacetic transaminase ≥ 2.5 × ULN
Alanine aminotransferase (ALT) or serum glutamic pyruvic transaminase ≥ 2.5 × ULN
Subject has taken ICG or other near-infrared fluorescence (NIR)-F imaging agents within 48 hours prior to study treatment administration.
Subject has taken diuretics or inhibitors of renal transporters defined by Food and Drug Administration (FDA) within 48 hours prior to study treatment administration.
Subject has used any illicit drugs, unless legally prescribed and is not being abused (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine and opiates) within 1 month prior to day -1.
Subject has a history of alcohol abuse. Subject should not have consumed any alcohol within 48 hours of surgery.",Participants who were enrolled in the dose expansion group received single dose of pudexacianinium chloride at dose level B by IV bolus infusion on day 1 once the surgical area of interest is in view.,PubChem:145996611 | PubChem:165411958,ASP5354 chloride,COC1=C(C=CC2=[N+](CCC(=O)NCCCOC3C(O)C4OC(CO)C3OC3OC(CO)C(OC5OC(CO)C(OC6OC(CO)C(OC7OC(CO)C(OC8OC(CO)C(OC9OC(CO)C(O4)C(O)C9O)C(O)C8O)C(O)C7O)C(O)C6O)C(O)C5O)C(O)C3O)c3ccc4ccccc4c3C2(C)C)CCCC1=CC=C1N(CCC(=O)NCCCOC2C3OC(CO)C(OC4OC(CO)C(OC5OC(CO)C(OC6OC(CO)C(OC7OC(CO)C(OC8OC(CO)C(OC9OC(CO)C(O3)C(O)C9O)C(O)C8O)C(O)C7O)C(O)C6O)C(O)C5O)C(O)C4O)C2O)c2ccc3ccccc3c2C1(C)C.[Cl-],,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT04246996,NCT04246996_EG000,No,Female,Adult | Older Adult,Phase 2,183,"Inclusion Criteria:

Adult women undergoing pelvic organ prolapse surgery and/or stress urinary incontinence surgery with surgical plan for at least 1 cystoscopy and will leave the operating room with a standard-of-care transurethral catheter.
Negative urine culture within 4 weeks or completion of UTI treatment ≥48 hours prior to surgery

Exclusion Criteria:

History of allergic reaction or anaphylaxis to gentamicin sulfate or to sodium metabisulfite (one of the preservatives in the gentamicin sulfate product)
Abnormal intraoperative urinary tract finding (e.g. bladder mass, stone, or fistula)
Intraoperative urinary tract injury
Suppressive recurrent UTI treatment
Chronic indwelling catheter/self-catheterization
Unable to provide informed consent
Severe renal impairment - glomerular filtration rate of less than 30 mL / minute
Current pregnancy
Currently incarcerated","At the completion of the subjects surgery but prior to awakening from anesthesia, 80mg of gentamicin in 50 mL of normal saline will be infused into the subject's bladder through the standard-of-care transurethral catheter by the surgeon. The surgeon will then clamp the catheter and label the catheter with the clamping time. The catheter will be clamped to prevent the gentamicin from immediately flowing out of the bladder and thus allow the gentamicin time to have an effect. The subject will then proceed as usual to the postoperative anesthesia care unit. A member of the subject's care team will unclamp the catheter after 1 hour. The subject will otherwise have usual pre-operative and post-operative care.

gentamicin sulfate: Subjects in the gentamicin arm will receive an bladder instillation of 80mg of gentamicin sulfate in 50 mL of normal saline through a standard-of-care Foley catheter.",PubChem:44134730 | PubChem:44420324 | PubChem:44563965 | PubChem:53245640 | PubChem:5702059,Garamycin solution,CNC(C)C1CCC(N)C(OC2C(N)CC(N)C(OC3OCC(C)(O)C(NC)C3O)C2O)O1.O=S(=O)(O)O,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT04285853,NCT04285853_EG000,No,All,Child | Adult,Phase 4,49,"Inclusion Criteria:

Males and females
Aged 14-40 years
Scheduled for primary (Anterior cruciate ligament) ACL reconstruction using quadriceps tendon autograft.

Exclusion Criteria:

Revision and/or contralateral ACL reconstruction procedures
Allergies to local anesthetics
Chronic pain medication use
Weight <50 kg, local infections
Known coagulopathies,
Liver dysfunction or renal failure","Patients in this opioid group will receive 15 oral opioid tablets (5 mg oxycodone) Patients will also receive 8 ""rescue"" medications, in the Oxycodone arm will be placebo ""rescue"" medications.

All participants will also receive the following as part of standard of care:

Oral non-opioid (1000 mg acetaminophen), every 8 hours.
Prescription of non-opioid non-steroidal anti-inflammatory medication (naproxen 500 mg) to be used 2x/day post-surgery.
Standardized multimodal intra- and post-operative protocols, including an adductor canal peripheral nerve block.
Intraoperative education on post-surgical pain management.

Oxycodone: 5 mg oxycodone pills every 4-6 hrs if pain level 7 or higher on Numeric rating scale 1-10",ChEMBL:CHEMBL656 | DrugBank:DB00497 | PubChem:5284603,Oxycodone,COc1ccc2c3c1O[C@H]1C(=O)CC[C@@]4(O)[C@@H](C2)N(C)CC[C@]314,N02AA05 | N02AA55 | N02AA56 | N02AJ17 | N02AJ18 | N02AJ19,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT04297631,NCT04297631_EG000,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 4,20,"Inclusion Criteria:

Age over 18
Total knee arthroplasty for primary osteoarthritis. Primary diagnosis of knee osteoarthritis

Exclusion Criteria:

Diminished mental capacity
Vancomycin allergy
Tobramycin allergy
Chronic kidney disease stage III and stage IV","All patients getting vancomycin and tobramycin to see serum concentration after 24hrs in knee drain and serum levels.

Vancomyscin: Everyone gets the vancomyscin powder.

Tobramycin Powder: Everyone gets tobramycin powder.",ChEMBL:CHEMBL1747 | DrugBank:DB00684 | PubChem:36294,Tobramycin,NC[C@H]1O[C@H](O[C@H]2[C@H](O)[C@@H](O[C@H]3O[C@H](CO)[C@@H](O)[C@H](N)[C@H]3O)[C@H](N)C[C@@H]2N)[C@H](N)C[C@@H]1O,J01GB01 | S01AA12,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT04303156,NCT04303156_EG000,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 1,6,"Inclusion Criteria:

Healthy participants must have the following:

Is in good health
Has a body mass index (BMI) ≥18.5 and ≤40 kg/m2.
Female is not pregnant or breastfeeding, and is not one of the following: a woman of childbearing potential (WOCBP); if a WOCBP, is using an acceptable contraceptive method, or is abstinent from heterosexual intercourse as their preferred and usual lifestyle; a WOCBP must have a negative highly sensitive pregnancy test within 24 hours before the first dose of study intervention

Renally impaired participants must have the following:

With the exception of renal impairment, is in generally good health
Has a BMI ≥ 18.5 and ≤ 40 kg/m2
Female is not pregnant or breastfeeding, and is not one of the following: a woman of childbearing potential (WOCBP); if a WOCBP, is using an acceptable contraceptive method, or is abstinent from heterosexual intercourse as their preferred and usual lifestyle; a WOCBP must have a negative highly sensitive pregnancy test within 24 hours before the first dose of study intervention

Exclusion Criteria:

Healthy participants must have the following:

Has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases.
Is mentally or legally incapacitated, has significant emotional problems
Has known hypersensitivity to the active substance or any of the excipients of the study drug
Has a history of significant multiple and/or severe allergies (e.g. food, drug, latex allergy), or has had an anaphylactic reaction or significant intolerability (i.e. systemic allergic reaction) to prescription or non-prescription drugs or food.
Is positive for hepatitis B surface antigen, hepatitis C antibodies or HIV.
Had major surgery, donated or lost 1 unit of blood (approximately 500 mL) within prior 4 weeks
Is taking medications to treat chronic medical conditions and/or conditions associated with renal disease
Has participated in another investigational study within prior 4 weeks

Other exclusions for healthy participants:

Does not agree to follow the smoking restrictions
Consumes greater than 1 glass for women, or 2 glasses for men of alcoholic beverages per day
Consumes excessive amounts,of caffeinated beverages per day.
Is a regular user of cannabis, any illicit drugs or has a history of drug (including alcohol) abuse within approximately prior 3 months.

Renally impaired participants must have the following:

Has a history or presence of renal artery stenosis.
Has had a renal transplant or nephrectomy.
Has rapidly fluctuating renal function as determined by historical measurements.
Has known hypersensitivity to the active substance or any of the excipients of the study drug.
Has a history of cancer (malignancy).
Has a history of significant multiple and/or severe allergies (e.g. food, drug, latex allergy), or has had an anaphylactic reaction or significant intolerability (i.e. systemic allergic reaction) to prescription or non-prescription drugs or food.
Is positive for hepatitis B surface antigen, hepatitis C antibodies or human immunodeficiency virus (HIV).
Had major surgery, donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to the prestudy (screening) visit.
Is taking medications to treat chronic medical conditions and/or conditions associated with renal disease and has not been on a stable regimen for at least 1 month and/or is unable to withhold the use of the medication(s) within 4 hours prior to and 8 hours after administration of the study drug.
Has participated in another investigational study within 4 weeks (or 5 half-lives, whichever is greater) prior to the prestudy (screening) visit.

Other exclusions for renally impaired participants

Does not agree to follow the smoking restrictions.
Consumes greater than 1 glass for women, or 2 glasses for men of alcoholic beverages per day.
Consumes excessive amounts of caffeinated beverages per day.
Is a regular user of cannabis, any illicit drugs or has a history of drug (including alcohol) abuse within approximately 3 months.",Participants with severe renal impairment received a single oral dose of 60 mg Islatravir administered in capsule form.,ChEMBL:CHEMBL517231 | DrugBank:DB15653,ISLATRAVIR,C#C[C@]1(CO)O[C@@H](n2cnc3c(N)nc(F)nc32)C[C@@H]1O,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT04303156,NCT04303156_EG001,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 1,6,"Inclusion Criteria:

Healthy participants must have the following:

Is in good health
Has a body mass index (BMI) ≥18.5 and ≤40 kg/m2.
Female is not pregnant or breastfeeding, and is not one of the following: a woman of childbearing potential (WOCBP); if a WOCBP, is using an acceptable contraceptive method, or is abstinent from heterosexual intercourse as their preferred and usual lifestyle; a WOCBP must have a negative highly sensitive pregnancy test within 24 hours before the first dose of study intervention

Renally impaired participants must have the following:

With the exception of renal impairment, is in generally good health
Has a BMI ≥ 18.5 and ≤ 40 kg/m2
Female is not pregnant or breastfeeding, and is not one of the following: a woman of childbearing potential (WOCBP); if a WOCBP, is using an acceptable contraceptive method, or is abstinent from heterosexual intercourse as their preferred and usual lifestyle; a WOCBP must have a negative highly sensitive pregnancy test within 24 hours before the first dose of study intervention

Exclusion Criteria:

Healthy participants must have the following:

Has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases.
Is mentally or legally incapacitated, has significant emotional problems
Has known hypersensitivity to the active substance or any of the excipients of the study drug
Has a history of significant multiple and/or severe allergies (e.g. food, drug, latex allergy), or has had an anaphylactic reaction or significant intolerability (i.e. systemic allergic reaction) to prescription or non-prescription drugs or food.
Is positive for hepatitis B surface antigen, hepatitis C antibodies or HIV.
Had major surgery, donated or lost 1 unit of blood (approximately 500 mL) within prior 4 weeks
Is taking medications to treat chronic medical conditions and/or conditions associated with renal disease
Has participated in another investigational study within prior 4 weeks

Other exclusions for healthy participants:

Does not agree to follow the smoking restrictions
Consumes greater than 1 glass for women, or 2 glasses for men of alcoholic beverages per day
Consumes excessive amounts,of caffeinated beverages per day.
Is a regular user of cannabis, any illicit drugs or has a history of drug (including alcohol) abuse within approximately prior 3 months.

Renally impaired participants must have the following:

Has a history or presence of renal artery stenosis.
Has had a renal transplant or nephrectomy.
Has rapidly fluctuating renal function as determined by historical measurements.
Has known hypersensitivity to the active substance or any of the excipients of the study drug.
Has a history of cancer (malignancy).
Has a history of significant multiple and/or severe allergies (e.g. food, drug, latex allergy), or has had an anaphylactic reaction or significant intolerability (i.e. systemic allergic reaction) to prescription or non-prescription drugs or food.
Is positive for hepatitis B surface antigen, hepatitis C antibodies or human immunodeficiency virus (HIV).
Had major surgery, donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to the prestudy (screening) visit.
Is taking medications to treat chronic medical conditions and/or conditions associated with renal disease and has not been on a stable regimen for at least 1 month and/or is unable to withhold the use of the medication(s) within 4 hours prior to and 8 hours after administration of the study drug.
Has participated in another investigational study within 4 weeks (or 5 half-lives, whichever is greater) prior to the prestudy (screening) visit.

Other exclusions for renally impaired participants

Does not agree to follow the smoking restrictions.
Consumes greater than 1 glass for women, or 2 glasses for men of alcoholic beverages per day.
Consumes excessive amounts of caffeinated beverages per day.
Is a regular user of cannabis, any illicit drugs or has a history of drug (including alcohol) abuse within approximately 3 months.",Healthy participants received a single oral dose of 60 mg Islatravir administered in capsule form.,ChEMBL:CHEMBL517231 | DrugBank:DB15653,ISLATRAVIR,C#C[C@]1(CO)O[C@@H](n2cnc3c(N)nc(F)nc32)C[C@@H]1O,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT04328961,NCT04328961_EG001,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 2 | Phase 3,407,"Inclusion Criteria:

Men or women 18 to 80 years of age inclusive, at the time of signing the informed consent
Willing and able to provide informed consent

Had a close contact of a person (index) with known PCR-confirmed SARS-CoV-2 infection or who is currently being assessed for COVID-19. Close contact defined as:

Household contact (i.e., residing with the index case in the 14 days prior to index diagnosis)
Medical staff, first responders, or other care persons who cared for the index case without personal protection (mask and gloves)
Less than 4 days since last exposure (close contact with a person with SARS-CoV-2 infection) to the index case
Body weight < 100 kg (self-reported)
Access to device and internet for Telehealth visits

Exclusion Criteria:

Known hypersensitivity to HCQ or other 4-aminoquinoline compounds
Currently hospitalized
Symptomatic with subjective fever, cough, or sore throat
Current medications exclude concomitant use of HCQ
Concomitant use of other anti-malarial treatment or chemoprophylaxis
History of retinopathy of any etiology
Psoriasis
Porphyria
Known bone marrow disorders with significant neutropenia (polymorphonuclear leukocytes < 1500) or thrombocytopenia (< 100 K)
Concomitant use of digoxin, cyclosporin, cimetidine, or tamoxifen
Known liver disease
Known long QT syndrome
Use of any investigational or non-registered drug or vaccine within 30 days preceding the first dose of the study drugs, or planned use during the study period","Hydrochloroquine 400 mg orally daily for 3 days, then 200 mg orally daily for an additional 11 days

Hydroxychloroquine Sulfate: Eligible participants in a household randomized to this study arm will receive hydrochloroquine therapy",PubChem:12947,Hydroxychloroquine Sulfate,CCN(CCO)CCCC(C)Nc1ccnc2cc(Cl)ccc12.O=S(=O)(O)O,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT04334460,NCT04334460_EG001,No,All,Adult | Older Adult,Phase 2,38,"Inclusion Criteria:

At least 18 years of age at the time of signing the ICF.

Hospitalized for COVID-19.

Diagnosed with COVID-19 as defined by having at least 2 of the following signs or symptoms within the past 2 days:

Fever defined as a body temperature of ≥ 38.0 °C oral, or ≥ 38.3 °C rectal, ≥37.7 °C forehead or ≥38.7°C aural (axillary temperatures are not allowable);
Cough;
Fatigue;
Shortness of breath.

Radiographic evidence (chest x-ray or CT scan) of one the following:

Ground-glass opacities, or
Local or bilateral patchy infiltrates, or
Interstitial pulmonary infiltrates.

Oxygen requirements:

SpO2 ≤ 94% on ambient air OR
Requires supplemental oxygen administration by nasal cannula, simple face mask, or other similar oxygen delivery device.

Male and/or female subjects.

- Contraception use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

All subjects (male or female) who are of childbearing potential must agree to use highly effective contraception during the study. Female subjects and male partners of female subjects must continue to use highly effective contraception for 30 days after the last dose of study drug. Female subjects should not donate oocytes during this time. Male subjects and female partners of male subjects must continue to use highly effective contraception for 90 days. Male subjects must agree not to donate sperm during this time.

Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.

Note: Ethinyl estradiol is the primary estrogen used in hormonal contraceptives. The progestin component consists of norethindrone, levonorgestrel, norgestrel, norethindrone acetate, ethynodiol diacetate, norgestimate, desogestrel, and drospirenone. As BLD-2660 is a weak CYP3A4 inducer, exposure to both the estrogen and progestin components in hormonal contraceptives may be decreased, resulting in an increased risk of pregnancy. As such, it is recommended that subjects who are on hormonal contraceptives for birth control should use an alternate means of contraception (condoms, diaphragms, intrauterine device (IUD), other barrier methods, sexual abstinence, etc.) during participation in the study.

Women of childbearing potential must have a negative serum pregnancy test at Screening within 72 hours prior to first administration of study drug.

Women not of childbearing potential must be postmenopausal (defined as cessation of regular menstrual periods for at least 1 year

Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol

Exclusion Criteria:

Active bacterial pneumonia infection

Known active tuberculosis (TB).

History of Child-Pugh B or C cirrhosis.

History of ischemic heart disease or myocardial infarction or acute coronary syndrome.

Subjects requiring supplemental oxygen ≥0.75 FiO2.

It is not in the best interest of the subjects to participate, in the opinion of the treating Investigator.

Female subjects who are pregnant or breastfeeding or expecting to conceive within the projected duration of the study, starting with the screening visit through 90 days after the last dose of study drug.

The following laboratory parameters are excluded:

Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >5 x upper limit of normal (ULN);
Creatinine clearance < 50 mL/min.

Requiring, or expected to require mechanical ventilation at screening.

Treatment with chloroquine or hydroxychloroquine at study entry.

Treatment with anti-IL 6, anti-IL-6 receptor antagonists, or with Janus kinase inhibitors (JAKi) in the past 30 days or plans to receive during the study period.

Participation in any other clinical study of an experimental drug treatment for COVID-19 within 6 half-lives of the experimental treatment.

Note: Subjects participating in an observational study are an exception to this criterion and may qualify for the study with Sponsor approval.

Note: Subjects who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent.

Unable to swallow solid oral medication or known malabsorption disorder.
Subjects who have allergy to BLD-2660 or inactive components of BLD-2660.",Placebo to Match (PTM) the active BLD-2660,DrugBank:DB18301 | PubChem:134397000,Dazcapistat,Cc1nc(-c2ccccc2F)c(C(=O)NC(Cc2ccccc2)C(=O)C(N)=O)o1,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT04336332,NCT04336332_EG001,No,All,Adult | Older Adult,Phase 2,30,"Inclusion Criteria:

Patients with proven SARS-CoV-2 infection by an accepted assay with symptoms consistent with COVID-19
Ability to measure and quantify viral load by quantitative PCR
Age 18 to 89
Ability to swallow oral medications
Patients must read, understand and sign IRB approved informed consent

Exclusion Criteria:

Pregnancy or women who are breast feeding
Two consecutive negative assays for SARS-CoV-2 infection
Patients that lack decision-making capacity will not be approached to participate in this study
Inability to tolerate oral medications
Allergy or prior adverse reaction to either azithromycin or hydroxychloroquine sulfate
QTc interval > 470 mSEC
History of ongoing ventricular cardiac dysrhythmias of grade 2 as described by NCI CTCAE 5.0 criteria
History of serious ventricular arrhythmia (VT or VF > 3 beats in a row)","• Hydroxychloroquine sulfate 200 mg taken by mouth three (3) times a day for 10 days

Hydroxychloroquine Sulfate: Given PO",PubChem:12947,Hydroxychloroquine Sulfate,CCN(CCO)CCCC(C)Nc1ccnc2cc(Cl)ccc12.O=S(=O)(O)O,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT04341675,NCT04341675_EG000,No,All,Adult | Older Adult,Phase 2,18,"Inclusion Criteria:

Subjects enrolled in the trial must meet all of the following criteria.

Confirmed COVID-19 pneumonia
Hypoxia as defined by room air oxygen saturation less than 92% or supplemental oxygen requirement
Presence of at least one additional biomarker that has been shown to predict poor prognosis: a) serum ferritin ≥500ug/l, b) LDH ≥250U/L, c) d-dimer ≥1ug/L, or d) lymphopenia as defined by absolute lymphocyte count <1,000/uL
Age ≥ 18 years
Completed informed consent

Exclusion Criteria:

Subjects who meet ANY of the following criteria are not eligible for enrollment as study participants:

Known allergy or hypersensitivity to sirolimus
Inability or refusal to provide informed consent
Advanced respiratory support (high flow oxygen ≥ 15 L/min, CPAP, non-invasive or invasive mechanical ventilation)
Active enrollment in other interventional clinical drug trials. Co-enrollment in observational studies and biorepositories is allowed.
Pregnant women
Breast feeding
On chronic immunosuppression for other medical conditions such as rheumatological disorders, inflammatory bowel disease, or in patients with organ transplants. A list of these medications is provided in Section 12.3.4

Any clinically significant medical disease which in the opinion of the investigator precludes the patient from enrolling in the trial, including (but not limited to):

History of liver cirrhosis
End stage renal disease or need for renal replacement therapy
Decompensated heart failure
Known active tuberculosis or history of incompletely treated tuberculosis
Uncontrolled systemic bacterial or fungal infections
Active viral infection other than COVID-19","Sirolimus 6mg on day 1 followed by 2mg daily for the next 13 days or until hospital discharge, whatever happens sooner.

Sirolimus: Sirolimus 6mg daily on Day 1 followed by 2mg daily for the next 13 days for a total treatment duration of 14 days or hospital discharge, whatever happens sooner.",ChEMBL:CHEMBL413 | DrugBank:DB00877 | PubChem:134760597 | PubChem:138404388 | PubChem:21944094 | PubChem:5284616,Sirolimus,COC1CC2CCC(C)C(O)(O2)C(=O)C(=O)N2CCCCC2C(=O)OC(C(C)CC2CCC(O)C(OC)C2)CC(=O)C(C)C=C(C)C(O)C(OC)C(=O)C(C)CC(C)C=CC=CC=C1C,L01EG04 | L04AA10 | S01XA23,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT04345653,NCT04345653_EG000,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 2,46,"Inclusion Criteria:

Volunteers ages 18 to 99 years,
Able to sign own informed consent form,
Considered high-risk healthcare care providers in a hospital setting with active exposure to COVID-19 infection.

High-risk healthcare providers are defined as those actively working during the study duration in the Emergency Department and in the Intensive Care Setting, for the purpose of this study.

Exclusion Criteria:

Inability to tolerate an oral medication or known allergy to chloroquine or hydroxychloroquine
Pregnancy or breast-feeding
Immunocompromised status, hepatic failure, electrolytic imbalance
Creatinine clearance (CCL) <30 mL/min
Prolonged QT interval (QTc > 450ms for males and QTc > 470 for females)
Confirmed COVID-19 infection on baseline testing
Has another known contraindication to treatment with the study drug, including retinopathy.","HCQ sulfate HCQ 400mg (2x 200mg tablets) by mouth 6-12 hours apart on day 1, followed by 3 weeks of weekly 400mg (2x 200mg tablets) by mouth

Hydroxychloroquine Sulfate (HCQ): Open-label, consecutive at-risk subjects allocation with chemoprophylaxis with HCQ.",PubChem:12947,Hydroxychloroquine Sulfate,CCN(CCO)CCCC(C)Nc1ccnc2cc(Cl)ccc12.O=S(=O)(O)O,,0.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT04351373,NCT04351373_EG000,No,All,Adult | Older Adult,Phase 2,12,"Inclusion Criteria

Patient with a suspected VS
Recurrent VS with prior microsurgical resection or radiation therapy
Clinical indication for microsurgical resection

Exclusion Criteria

History of allergy to FS
History of renal failure
Pregnant women
Those with inability to give informed consent
Prisoners and inmates","Subjects undergoing clinically planned vestibular schwannoma, Meningioma, Head and Neck Paraganglioma, or Head and Neck Schwannoma, removal surgery will have contrast agent fluorescein sodium administered intravenously after tumor exposure, and a special filter called YELLOW560 will be used on the operating microscope to see the fluorescent coloring of the contrast.

Fluorescein Sodium: Intravenous administration 1 mg/kg initial dosing if insufficient additional doses of 1 mg/kg may be administered.

YELLOW560 filter: Integrated fluorescence module serves to make fluorescent areas visible to assist in visualizing tumor during the resection.",PubChem:10608,Fluorescein Sodium,O=C([O-])c1ccccc1-c1c2ccc(=O)cc-2oc2cc([O-])ccc12.[Na+].[Na+],,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT04364763,NCT04364763_EG000,No,All,Adult | Older Adult,Phase 2,28,"Inclusion Criteria:

Male or female, ≥18 years of age at Screening.
Confirmed infection with SARS-CoV-2.

High risk of COVID-19 disease progression, defined as:

18-69 years of age with lymphopenia AND 1 additional risk factor (described below)
18-69 years of age without lymphopenia AND 2 risk factors (described below)
≥70 years of age with lymphopenia OR 1 other risk factor (described below)

Risk Factors:

Documented history of coronary artery disease
Heart failure (New York Heart Association Class 3 or 4)
Chronic lung disease (eg, asthma or chronic obstructive pulmonary disease) requiring treatment
Documented history of stroke
Diabetes mellitus, requiring at least 1 prescription medicine for management
Documented chronic kidney disease with an estimated glomerular filtration rate <30 mL/min, not on dialysis
Obesity (Class 2 or 3; body mass index >34.9 kg/m2)
On immunosuppressive therapy
Oxygen saturation between 90 and 95% with or without supplemental oxygen
Admitted to a hospital for observation and/or treatment (controlled facility may include an emergency room, urgent care facility, temporary/modular hospital, infusion center, clinical research unit, etc).
If female, must be postmenopausal, surgically sterile, or if of childbearing potential, must be practicing 2 effective methods of birth control during the study and through 30 days after completion of the study.
For females of childbearing potential, a urine pregnancy test must be negative at the Screening Visit.
If male, must be surgically sterile or willing to practice 2 effective methods of birth control during the study and through 30 days after completion of the study.
Must be willing and able to give informed consent and comply with all study procedures.

Exclusion Criteria:

Anticipated need for ICU care and/or ventilatory support (invasive or noninvasive) within 24 hours.
Evidence of acute cardiac injury, as determined by the Investigator at the time of Screening. This may be based upon clinical signs and symptoms, ECG findings, or elevated troponin I levels.
Evidence of acute kidney injury not due to pre-renal azotemia or urinary tract obstruction at the time of Screening.
Oxygen saturation <90% on supplemental oxygen with a nasal cannula, including high-flow oxygen at the time of Screening.
Requires non-invasive ventilation at the time of Screening.
Requires dialysis at the time of Screening.
Has received or is receiving anti-IL-6 therapies (eg, Tocilizumab, Sarilumab, Siltuximab, etc) for the treatment of COVID-19; subjects receiving anti-IL-6 therapies for underlying medical conditions unrelated to COVID-19 are not excluded from eligibility.
Pregnant or lactating.
History of photosensitivity or active skin disease that, in the opinion of the Investigator, could be worsened by RBT-9.
Known hypersensitivity or previous anaphylaxis to RBT-9 (stannous protoporphyrin) or any tin-based product.
Treatment with an investigational drug or participation in an interventional trial within 30 days prior to the first dose of study drug.
Inability to comply with the requirements of the study protocol.","RBT-9 (90mg) will be administered intravenously over a 120-minute period on Day 1.

RBT-9 (90 mg): Subjects will receive a single dose and study duration will be approximately 60 days per subject.",PubChem:154731616,Stannous protoporphyrin,C=CC1=C(C)c2cc3[n-]c(cc4[n-]c(cc5nc(cc1n2)C(C)=C5C=C)c(C)c4CCC(=O)O)c(CCC(=O)O)c3C.[Sn+2],,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT04378010,NCT04378010_EG000,No,All,Adult | Older Adult,Phase 2,32,"Inclusion Criteria:

Informed consent documentation signed and dated by the participant.
Male and female participants, of all ethnic origins, between the ages of 18 and 75 years, inclusive.
Participants of all ethnic origins had to have a Body Mass Index (BMI) > 25 kg/m2 and ≤ 45 except Asian participants who qualified for the study with BMI > 23 kg/m2.
Histological evidence of definite NASH based on NASH Clinical Research Network (CRN) criteria obtained from assessment of a liver biopsy by the central histopathologist. The biopsy may be obtained either 1) during the Screening window or 2) within 26 weeks prior to the Screening visit.
NAFLD Activity Score (NAS) of 4 or greater with a score of at least 1 in each component of the NAS (steatosis scored 0-3, lobular inflammation scored 0-3, ballooning scored 0-2).
Fibrosis stage 2 or 3 using the NASH CRN Histologic Scoring System.
Participants had to have Screening laboratory values for Hepatitis B surface antigen (HBsAg), anti-HCV antibodies and HCV RNA, and Human Immunodeficiency Virus (HIV) 1 and 2 antibodies (Ab) as seronegative. [Note: participants previously infected by chronic hepatitis C and treated with direct acting antivirals (DAAs) with sustained virologic response (SVR) for at least 3 years were allowed.]
A woman of childbearing potential who was sexually active with a male had to agree to use two effective methods of contraception from the date of Screening until 30 days after the last dose of study drug.
A male participant who had not had a vasectomy and was sexually active with a woman of childbearing potential had to agree to use effective contraception from the date of Screening to 90 days after the last dose of study drug.
Participant had to be willing and able to adhere to the assessments, visit schedules, prohibitions and restrictions, as described in this protocol.

Exclusion Criteria:

Laboratory Screening results as indicated below:

Total white blood cells (WBC) <3000 cells/mm3
Absolute neutrophil count (ANC) <1500 cells/mm3
Platelet count <140,000/mm3
International Normalized Ratio, INR >1.2 (unless due to use of anticoagulants)
Estimated glomerular filtration rate (eGFR) < 60 mL/min according to the Modification of Diet in Renal Disease (MDRD) equation
AST ≥5× ULN
ALT ≥5× ULN
ALP ≥2× ULN
Total bilirubin > 1.5 times ULN during Screening. [Note: Patients with Gilbert's syndrome were allowed following review by the Medical Monitor if they had a known history of Gilbert's syndrome with a normal direct bilirubin value and normal reticulocyte count.]
Pregnant or nursing females.
MELD: Model for End-stage Liver Disease score >12.
Clinical or laboratory evidence of known chronic liver disease such as alcoholic liver disease, primary biliary cholangitis (PBC), primary sclerosing cholangitis (PSC), autoimmune hepatitis, Wilson disease, iron overload, alpha-1-antitrypsin deficiency, drug-induced liver injury, known or suspected hepatocellular carcinoma (HCC).
History of acute liver complications due to gallstones (e.g., acute cholecystitis or acute biliary obstruction) unless the participant had a cholecytectomy (more than 3 months prior to screening).
History of liver transplant, or current placement on a liver transplant list.
Hepatorenal syndrome (type I or II).
Prior variceal hemorrhage, uncontrolled encephalopathy, liver cirrhosis Child-Pugh Class A, B, and C, esophageal varices, or refractory ascites within the previous 26 weeks of Screening and/or histological presence of liver cirrhosis.
Prior or planned ileal resection, or prior or planned bariatric surgery. [Note: Participants who had undergone gastric surgeries that did not affect drug absorption (e.g., gastric band or gastric sleeve procedures) were allowed if they were stable for at least 1 year prior to Screening. Gastrectomy or Roux-en-Y bypass was allowed if stable for at least 3 years prior to Screening.]
Participants with clinically or otherwise documented cardiovascular or cerebrovascular disease including clinically significant anomalies of rhythm or pattern of ECG, that in the judgement of the Principal Investigator (PI) could affect the safety of the participant or their ability to comply with the study requirements.
HbA1c ≥ 9.5% within 60 days prior to Day 1.
Use of a new antidiabetic regimen in the months prior to Screening including metformin, glucagon-like peptide (GLP) 1 agonists, sodium glucose cotransporter-2 (SGLT2) inhibitors, sulfonylureas, or dipeptidyl peptidase 4 (DPP4) inhibitors, insulin or peroxisome proliferator-activated receptor (PPAR)γ agonists (e.g., pioglitazone or rosiglitazone). For pre-existing antidiabetic treatment, participants were to be on a stable dose of antidiabetic drugs: (1) for at least 8 weeks (for metformin and/or sulfonylureas), (2) 12 weeks (for SGLT2 or DPP4 inhibitors), or (3) 12 weeks (for GLP-1 receptor agonists and thiazolidinediones) prior to Screening with the intention to keep the regimen stable during the study.
Use of a new statin regimen or other lipid lowering agents from 12 weeks prior to Screening.
Use of a new fibrate regimen from 12 weeks prior to Screening.
Participants with contraindications to MRI imaging, or not being able to have the MRI performed.
Participant had received any investigational agent (including investigational vaccine) or biological product within 30 days or 5 times the half-life (whichever was longer) prior to the planned first dose of study drug.
Use of an experimental or approved treatment for NASH within 26 weeks of Screening.
Prior use of OCA within 26 weeks of Screening and/or concurrent treatment with OCA (or any other FXR agonists).
Use of systemic immunosuppressant (e.g., corticosteroids) for more than 4 weeks in duration within 1 year prior to Screening with the intention to continue during the study (chronic use of inhaled, topical, ophthalmological, nasal corticosteroids was allowed)
Use of any prohibited concomitant medications, including systemic CYP3A4 inhibitors and inducers, within 14 days prior to the first dose of study drug and for the duration of the study.
Clinically significant history of drug sensitivity or drug allergy, as determined by the PI.
Current or history of significant alcohol consumption defined as: >14 standard drinks per week and/or ≥4 standard drinks per occasion for males and >7 standard drinks per week and/or ≥3 standard drinks per occasion for females.
History of substance (including alcohol) abuse and in the judgement of the PI, the participant was not suitable for participation in the study.
Any other condition(s) that would compromise the safety of the participant or compromise the quality of the clinical study, as judged by the PI.
Use of medication for weight loss or appetite reduction (e.g., orlistat, bupropion/naltrexone, phentermine-topiramate, phentermine, lorcaserin, non-prescription supplements) at Screening.
History of malignancy of any organ system (other than localized and considered cured cutaneous basal or squamous cell carcinoma, or in situ cervical cancer), treated or untreated, within 5 years of Screening.","Once a day orally for 72 weeks

EDP-305 1.5 mg: Tablet",PubChem:121428882,"US10208081, Example 3",CCC1C(O)C2C3CCC(C(C)CCNC(=O)NS(=O)(=O)c4ccc(C(C)(C)C)cc4)C3(C)CCC2C2(C)CCC(O)CC12,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT04378010,NCT04378010_EG001,No,All,Adult | Older Adult,Phase 2,33,"Inclusion Criteria:

Informed consent documentation signed and dated by the participant.
Male and female participants, of all ethnic origins, between the ages of 18 and 75 years, inclusive.
Participants of all ethnic origins had to have a Body Mass Index (BMI) > 25 kg/m2 and ≤ 45 except Asian participants who qualified for the study with BMI > 23 kg/m2.
Histological evidence of definite NASH based on NASH Clinical Research Network (CRN) criteria obtained from assessment of a liver biopsy by the central histopathologist. The biopsy may be obtained either 1) during the Screening window or 2) within 26 weeks prior to the Screening visit.
NAFLD Activity Score (NAS) of 4 or greater with a score of at least 1 in each component of the NAS (steatosis scored 0-3, lobular inflammation scored 0-3, ballooning scored 0-2).
Fibrosis stage 2 or 3 using the NASH CRN Histologic Scoring System.
Participants had to have Screening laboratory values for Hepatitis B surface antigen (HBsAg), anti-HCV antibodies and HCV RNA, and Human Immunodeficiency Virus (HIV) 1 and 2 antibodies (Ab) as seronegative. [Note: participants previously infected by chronic hepatitis C and treated with direct acting antivirals (DAAs) with sustained virologic response (SVR) for at least 3 years were allowed.]
A woman of childbearing potential who was sexually active with a male had to agree to use two effective methods of contraception from the date of Screening until 30 days after the last dose of study drug.
A male participant who had not had a vasectomy and was sexually active with a woman of childbearing potential had to agree to use effective contraception from the date of Screening to 90 days after the last dose of study drug.
Participant had to be willing and able to adhere to the assessments, visit schedules, prohibitions and restrictions, as described in this protocol.

Exclusion Criteria:

Laboratory Screening results as indicated below:

Total white blood cells (WBC) <3000 cells/mm3
Absolute neutrophil count (ANC) <1500 cells/mm3
Platelet count <140,000/mm3
International Normalized Ratio, INR >1.2 (unless due to use of anticoagulants)
Estimated glomerular filtration rate (eGFR) < 60 mL/min according to the Modification of Diet in Renal Disease (MDRD) equation
AST ≥5× ULN
ALT ≥5× ULN
ALP ≥2× ULN
Total bilirubin > 1.5 times ULN during Screening. [Note: Patients with Gilbert's syndrome were allowed following review by the Medical Monitor if they had a known history of Gilbert's syndrome with a normal direct bilirubin value and normal reticulocyte count.]
Pregnant or nursing females.
MELD: Model for End-stage Liver Disease score >12.
Clinical or laboratory evidence of known chronic liver disease such as alcoholic liver disease, primary biliary cholangitis (PBC), primary sclerosing cholangitis (PSC), autoimmune hepatitis, Wilson disease, iron overload, alpha-1-antitrypsin deficiency, drug-induced liver injury, known or suspected hepatocellular carcinoma (HCC).
History of acute liver complications due to gallstones (e.g., acute cholecystitis or acute biliary obstruction) unless the participant had a cholecytectomy (more than 3 months prior to screening).
History of liver transplant, or current placement on a liver transplant list.
Hepatorenal syndrome (type I or II).
Prior variceal hemorrhage, uncontrolled encephalopathy, liver cirrhosis Child-Pugh Class A, B, and C, esophageal varices, or refractory ascites within the previous 26 weeks of Screening and/or histological presence of liver cirrhosis.
Prior or planned ileal resection, or prior or planned bariatric surgery. [Note: Participants who had undergone gastric surgeries that did not affect drug absorption (e.g., gastric band or gastric sleeve procedures) were allowed if they were stable for at least 1 year prior to Screening. Gastrectomy or Roux-en-Y bypass was allowed if stable for at least 3 years prior to Screening.]
Participants with clinically or otherwise documented cardiovascular or cerebrovascular disease including clinically significant anomalies of rhythm or pattern of ECG, that in the judgement of the Principal Investigator (PI) could affect the safety of the participant or their ability to comply with the study requirements.
HbA1c ≥ 9.5% within 60 days prior to Day 1.
Use of a new antidiabetic regimen in the months prior to Screening including metformin, glucagon-like peptide (GLP) 1 agonists, sodium glucose cotransporter-2 (SGLT2) inhibitors, sulfonylureas, or dipeptidyl peptidase 4 (DPP4) inhibitors, insulin or peroxisome proliferator-activated receptor (PPAR)γ agonists (e.g., pioglitazone or rosiglitazone). For pre-existing antidiabetic treatment, participants were to be on a stable dose of antidiabetic drugs: (1) for at least 8 weeks (for metformin and/or sulfonylureas), (2) 12 weeks (for SGLT2 or DPP4 inhibitors), or (3) 12 weeks (for GLP-1 receptor agonists and thiazolidinediones) prior to Screening with the intention to keep the regimen stable during the study.
Use of a new statin regimen or other lipid lowering agents from 12 weeks prior to Screening.
Use of a new fibrate regimen from 12 weeks prior to Screening.
Participants with contraindications to MRI imaging, or not being able to have the MRI performed.
Participant had received any investigational agent (including investigational vaccine) or biological product within 30 days or 5 times the half-life (whichever was longer) prior to the planned first dose of study drug.
Use of an experimental or approved treatment for NASH within 26 weeks of Screening.
Prior use of OCA within 26 weeks of Screening and/or concurrent treatment with OCA (or any other FXR agonists).
Use of systemic immunosuppressant (e.g., corticosteroids) for more than 4 weeks in duration within 1 year prior to Screening with the intention to continue during the study (chronic use of inhaled, topical, ophthalmological, nasal corticosteroids was allowed)
Use of any prohibited concomitant medications, including systemic CYP3A4 inhibitors and inducers, within 14 days prior to the first dose of study drug and for the duration of the study.
Clinically significant history of drug sensitivity or drug allergy, as determined by the PI.
Current or history of significant alcohol consumption defined as: >14 standard drinks per week and/or ≥4 standard drinks per occasion for males and >7 standard drinks per week and/or ≥3 standard drinks per occasion for females.
History of substance (including alcohol) abuse and in the judgement of the PI, the participant was not suitable for participation in the study.
Any other condition(s) that would compromise the safety of the participant or compromise the quality of the clinical study, as judged by the PI.
Use of medication for weight loss or appetite reduction (e.g., orlistat, bupropion/naltrexone, phentermine-topiramate, phentermine, lorcaserin, non-prescription supplements) at Screening.
History of malignancy of any organ system (other than localized and considered cured cutaneous basal or squamous cell carcinoma, or in situ cervical cancer), treated or untreated, within 5 years of Screening.","Once a day orally for 72 weeks

EDP-305 2 mg: Tablet",PubChem:121428882,"US10208081, Example 3",CCC1C(O)C2C3CCC(C(C)CCNC(=O)NS(=O)(=O)c4ccc(C(C)(C)C)cc4)C3(C)CCC2C2(C)CCC(O)CC12,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0
NCT04388826,NCT04388826_EG000,No,All,Adult | Older Adult,Phase 2,19,"Inclusion Criteria:

Provide informed consent
Be able to communicate effectively with the study personnel
Aged ≥18 years
Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) infection confirmed by polymerase chain reaction (PCR) test
Patients at high risk for ARDS, with known comorbidities for being at high risk, such as, Asthma (moderate to severe), Chronic Lung Disease, Diabetes, Chronic Kidney Disease being treated with dialysis, Severe Obesity (BMI ≥40), 65 years of age or older, primarily reside in a nursing home or long-term care facility, immunocompromised
Peripheral capillary oxygen saturation (SpO2) ≤ 94% on room air at screening

Subjects must agree to use acceptable methods of contraception

If subject is female or the male subject's partner could become pregnant, use acceptable methods of contraception from the time of the first administration of study medication until 6 months following administration of the last dose of study medication. Acceptable methods of contraception are as follows: Condom with spermicidal foam/gel/film/cream/suppository [i.e., barrier method of contraception], surgical sterilization (vasectomy with documentation of azospermia) and a barrier method {condom used with spermicidal foam/gel/film/cream/suppository}, the female partner uses oral contraceptives (combination estrogen/progesterone pills), injectable progesterone or subdermal implants and a barrier method (condom used with spermicidal foam/gel/film/cream/suppository)
If female subject or the female partner of a male subject has undergone documented tubal ligation (female sterilization), a barrier method (condom used with spermicidal foam/gel/film/cream/suppository) should also be used
If female subject or the female partner of a male subject has undergone documented placement of an intrauterine device (IUD) or intrauterine system (IUS), a barrier method (condom with spermicidal foam/gel/film/cream/suppository) should also be used
Subject is willing to comply with the requirements of the protocol through the end of the study

Exclusion Criteria:

Known hypersensitivity or allergy to colchicine
Participation in any other clinical trial of an experimental treatment for COVID-19
Concurrent treatment with other experimental agents with actual or possible direct acting antiviral activity against COVID-19 is prohibited < 24 hours prior to study drug dosing (except standard of care) Remdesivir and convalescent plasma is allowed as standard of care.
Requiring mechanical ventilation at screening
Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) >2 X upper limit of normal (ULN)
Total bilirubin > ULN
Creatinine clearance < 60 mL/min
Documented medical history of liver disease, including but not limited to, prior diagnosis of hepatitis of any etiology, cirrhosis, portal hypertension, or confirmed or suspected esophageal varices
Moderate to severe renal impairment
Hepatic impairment
Positive for HbsAg, or HCV antibodies at screening
Any comorbid disease or condition (medical or surgical) which might compromise the hematologic, cardiovascular, endocrine, pulmonary, renal, gastrointestinal, hepatic, or central nervous system; or other conditions that may interfere with the absorption, distribution, metabolism or excretion of study drug, or would place the subject at increased risk
Participants must agree to refrain from prolonged exposure to the sun or agree to use at least SPF 50 on all exposed skin and protective clothing during prolonged sun exposure throughout participation in this study and/or treatment with VERU-111.","Veru-111 18mg capsules

Veru-111: Respiratory Distress Syndrome, Adult",ChEMBL:CHEMBL2163631 | PubChem:53379371,SABIZABULIN,COc1cc(C(=O)c2cnc(-c3c[nH]c4ccccc34)[nH]2)cc(OC)c1OC,,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT04388826,NCT04388826_EG001,No,All,Adult | Older Adult,Phase 2,20,"Inclusion Criteria:

Provide informed consent
Be able to communicate effectively with the study personnel
Aged ≥18 years
Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) infection confirmed by polymerase chain reaction (PCR) test
Patients at high risk for ARDS, with known comorbidities for being at high risk, such as, Asthma (moderate to severe), Chronic Lung Disease, Diabetes, Chronic Kidney Disease being treated with dialysis, Severe Obesity (BMI ≥40), 65 years of age or older, primarily reside in a nursing home or long-term care facility, immunocompromised
Peripheral capillary oxygen saturation (SpO2) ≤ 94% on room air at screening

Subjects must agree to use acceptable methods of contraception

If subject is female or the male subject's partner could become pregnant, use acceptable methods of contraception from the time of the first administration of study medication until 6 months following administration of the last dose of study medication. Acceptable methods of contraception are as follows: Condom with spermicidal foam/gel/film/cream/suppository [i.e., barrier method of contraception], surgical sterilization (vasectomy with documentation of azospermia) and a barrier method {condom used with spermicidal foam/gel/film/cream/suppository}, the female partner uses oral contraceptives (combination estrogen/progesterone pills), injectable progesterone or subdermal implants and a barrier method (condom used with spermicidal foam/gel/film/cream/suppository)
If female subject or the female partner of a male subject has undergone documented tubal ligation (female sterilization), a barrier method (condom used with spermicidal foam/gel/film/cream/suppository) should also be used
If female subject or the female partner of a male subject has undergone documented placement of an intrauterine device (IUD) or intrauterine system (IUS), a barrier method (condom with spermicidal foam/gel/film/cream/suppository) should also be used
Subject is willing to comply with the requirements of the protocol through the end of the study

Exclusion Criteria:

Known hypersensitivity or allergy to colchicine
Participation in any other clinical trial of an experimental treatment for COVID-19
Concurrent treatment with other experimental agents with actual or possible direct acting antiviral activity against COVID-19 is prohibited < 24 hours prior to study drug dosing (except standard of care) Remdesivir and convalescent plasma is allowed as standard of care.
Requiring mechanical ventilation at screening
Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) >2 X upper limit of normal (ULN)
Total bilirubin > ULN
Creatinine clearance < 60 mL/min
Documented medical history of liver disease, including but not limited to, prior diagnosis of hepatitis of any etiology, cirrhosis, portal hypertension, or confirmed or suspected esophageal varices
Moderate to severe renal impairment
Hepatic impairment
Positive for HbsAg, or HCV antibodies at screening
Any comorbid disease or condition (medical or surgical) which might compromise the hematologic, cardiovascular, endocrine, pulmonary, renal, gastrointestinal, hepatic, or central nervous system; or other conditions that may interfere with the absorption, distribution, metabolism or excretion of study drug, or would place the subject at increased risk
Participants must agree to refrain from prolonged exposure to the sun or agree to use at least SPF 50 on all exposed skin and protective clothing during prolonged sun exposure throughout participation in this study and/or treatment with VERU-111.","Placebo capsules

Veru-111: Respiratory Distress Syndrome, Adult",ChEMBL:CHEMBL2163631 | PubChem:53379371,SABIZABULIN,COc1cc(C(=O)c2cnc(-c3c[nH]c4ccccc34)[nH]2)cc(OC)c1OC,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT04409873,NCT04409873_EG000,No,All,Adult | Older Adult,Phase 2,12,"Inclusion Criteria:

Tested positive for COVID-19 with a sample collected in the prior 7 days
Ability to read and speak English or Spanish
Ability to participate in the study for 4 weeks
Being asymptomatic or having mild or moderate symptoms (for example, sore throat, coughing, fever, fatigue)
Ability to rinse/gargle
Not having any condition that might worsen with gargling solutions
Not having a history of mouthwash sensitivity
Not having an allergy to any mouthwash that has been used before
Not using another mouthwash/gargling solution since the most recent positive test
Not taking antimicrobial medications (antibacterial, antiviral, antibiotics including off-label FDA-approved medications such as hydroxychloroquine)
Anticipated ability to participate in the study for 4 weeks
Have a cellphone and agree to receive text messages for reminders to use mouthwash during the day and for follow-up visits, and can videoconference (like zoom) on a cellphone, tablet, or computer for sample collection instructions

Exclusion Criteria:

People who because of their symptoms intend to receive antiviral medications that could potentially affect viral load in their saliva samples
Pregnant or lactating women due to potential aversions to mouthwash solution taste/smell.",Over the counter: Distilled water,ChEMBL:CHEMBL1098659 | DrugBank:DB09145 | PubChem:10129877 | PubChem:24602 | PubChem:962,Water,O,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT04463680,NCT04463680_EG000,Accepts Healthy Volunteers,Female,Adult,Phase 4,24,"Inclusion Criteria:

Healthy women, who have had an ENG implant for 12-36 months at the time of enrollment and will maintain their implant during the study without modifications.

Exclusion Criteria:

o Women who are taking any known cytochrome P-450 3A4 enzyme inducers or inhibitors.

Women with a known allergy or insensitivity to rifampin.

Women with a body mass index (BMI) <18.5, as underweight women may have altered metabolism. The investigators will not have an upper BMI cut-off as studies have shown that overweight and obese women have equivalent metabolism and efficacy with the ENG contraceptive implant6,7.

• Exclusions Criteria (screening laboratory testing)

Women with any hepatic or renal dysfunction as determined by a comprehensive metabolic panel. For purposes of this study, liver function tests will be evaluated and evidence of hepatic dysfunction will be defined as an ALT >52 or AST >39, which are beyond the reference range of normal values used by the University of Colorado clinical laboratory. Renal function will be assessed by a serum creatinine and a value >1.2 will be evidence of renal dysfunction as this is greater than the reference range used by the University of Colorado clinical laboratory.
Women with any abnormal hematology as determined by a complete blood count. For purposes of this study, abnormal hematology will be defined as a WBC, RBC, or PLT value beyond the reference range of normal values used by the University of Colorado clinical laboratory.
Women with abnormal coagulation factors as determined by coagulation factor tests (PT/INR, PTT). For purposes of this study, abnormal coagulation factors will be defined as any test value beyond the reference range of normal values used by the University of Colorado clinical laboratory.","Will receive 2 week regimen of rifampin 600mg per day

Rifampin 600 MG: Administered daily for 2 weeks",ChEMBL:CHEMBL374478 | DrugBank:DB01045 | PubChem:135398735 | PubChem:135403807 | PubChem:135441414 | PubChem:135449527 | PubChem:135476790 | PubChem:135512673 | PubChem:135550179 | PubChem:135876149 | PubChem:135900090 | PubChem:135921123 | PubChem:135921134 | PubChem:135925261 | PubChem:135925741 | PubChem:135932822 | PubChem:136122621 | PubChem:136136478 | PubChem:136246612 | PubChem:136601293 | PubChem:136619758 | PubChem:136709103 | PubChem:137016821 | PubChem:137086834 | PubChem:137225336 | PubChem:137270779 | PubChem:137286743 | PubChem:137287990 | PubChem:154825551 | PubChem:163059759,RIFAMPIN,COC1C=COC2(C)Oc3c(C)c(O)c4c(O)c(c(C=NN5CCN(C)CC5)c(O)c4c3C2=O)NC(=O)C(C)=CC=CC(C)C(O)C(C)C(O)C(C)C(OC(C)=O)C1C,J04AB02 | J04AM02 | J04AM05 | J04AM06 | J04AM07 | J04BA50 | J04BA51,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT04495712,NCT04495712_EG000,No,All,Adult | Older Adult,Phase 4,44,"Inclusion Criteria:

-Patients were considered eligible for enrollment only if they had received

an ICD therapy, either a shock or antitachycardia pacing (ATP),
VT/VF in the previous 2 years or
received an ICD for secondary prevention of sustained VT/VF in the previous 6 months.

Exclusion Criteria:

-Important exclusion criteria were

an indication for spironolactone based on the RALES trial (EF of <35% and -New York Heart Association (NYHA) class III or IV),
unstable angina,
primary hepatic failure,
known intolerance to spironolactone,
a serum creatinine concentration of >2.5 mg/dL,
a serum potassium concentration of >5.0 mmol/L, and
a life expectancy of <2 years.","Patients randomized to active therapy with spironolactone

spironolactone: aldosterone blocker",ChEMBL:CHEMBL1393 | DrugBank:DB00421 | PubChem:5833,Spironolactone,[H][C@]12CC[C@]3(C)[C@]4(CCC(=O)O4)CC[C@@]3([H])[C@]1([H])[C@]([H])(SC(C)=O)CC1=CC(=O)CC[C@@]12C,C03DA01,0.0,1.0,0.0,0.0,1.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0
NCT04548349,NCT04548349_EG000,Accepts Healthy Volunteers,All,Adult,Phase 4,25,"Inclusion Criteria:

A confirmed diagnosis of acne that warrants initiating topical medications.
Denies use of any prescribed systemic acne treatments in the past 30 days.
Denies use of any prescribed topical medications in the past 30 days.
Denies use of any OTC topical acne medications in the past 14 days.
Denies use of any emollients in the past 24 hours (if feasible).
Denies bathing or facial washing in the past 12 hours (if feasible).
Willingness to adhere to the recommended topical regimen during the duration of the study.

Exclusion Criteria:

Women who are pregnant, breastfeeding, or planning to get pregnant during the study.
Use of any investigational drug(s) in the past 3 months.",Altreno 0.05% lotion: Acne patients will be assigned to Altreno once daily.,ChEMBL:CHEMBL38 | ChEMBL:CHEMBL547 | ChEMBL:CHEMBL705 | DrugBank:DB00523 | DrugBank:DB00755 | DrugBank:DB00982 | PubChem:444795 | PubChem:449171 | PubChem:5282379,Tretinoin,CC(C=CC1=C(C)CCCC1(C)C)=CC=CC(C)=CC(=O)O,D10AD01 | D10AD04 | D10AD51 | D10AD54 | D10BA01 | D11AH04 | L01XF01 | L01XF02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT04561375,NCT04561375_EG001,No,All,Adult | Older Adult,Phase 4,61,"Inclusion Criteria:

Adults aged 18 years or older;
Scheduled for elective knee arthroscopy without anticipated ligamentous repair;
Planned general anesthesia without a regional block or wound infiltration with local anesthesia;
Planned day-of-surgery discharge.

Exclusion Criteria:

Opioid tolerance defined by ≥15 mg of oral morphine daily or equianalgesic dose of another opioid within 30 days of surgery;
Known hypersensitivity to sufentanil or components of DSUVIA;
Patients with an allergy or hypersensitivity to opioids;
Pregnancy or actively breastfeeding;
Patients who are currently taking monoamine oxidase inhibitors (MAOIs) or have taken MAOIs within 14 days of the first dose of study drug;
Patients with a medical condition that, in the Investigator's opinion, could adversely impact the patient's participation or safety, conduct of the study, or interfere with the pain assessments, including chronic pain or active infection.","placebo sublingual sufentanil preoperatively and 50 µg fentanyl at induction of anesthesia

Fentanyl: 50 µg fentanyl",ChEMBL:CHEMBL596 | DrugBank:DB00813 | PubChem:3345,Fentanyl,CCC(=O)N(c1ccccc1)C1CCN(CCc2ccccc2)CC1,N01AH01 | N01AH51 | N02AB03,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT04567407,NCT04567407_EG000,Accepts Healthy Volunteers,All,Child,Phase 4,40,"Inclusion Criteria:

Scheduled as part of the cardiac surgical ERAS program: Patients scheduled for elective surgeries for the following congenital anomalies, or similar: atrial septal defects (all types), partial anomalous pulmonary venous connection (non-obstructed), cor-triatriatum, VSD, partial AV canal, sub-aortic membrane resection, anomalous aortic origin of the coronary arteries, and pulmonary valve/conduit implantation
Scheduled for a primary sternotomy.
Ages 2 years through 17 years.

Exclusion Criteria:

Single ventricle physiology.
Significant scoliosis or other anatomic contraindications to ESB.
Significant intraoperative hemodynamic instability or bleeding, as ascertained by clinicians taking care of the patient.
Patients with severe neurodevelopmental delays.
Patients with previous chronic pain syndromes.
Patients with a history of greater than 24 hours of postoperative or post-procedural opioid treatment at any point in the 2 months prior to surgery.
Lack of parental consent and/or child assent.","All enrolled patients will have bilateral erector spinae blocks (with catheters for postoperative local anesthetic infusion) placed by the by a member of the clinical regional anesthesia team (under the supervision of a member of the research team) in a sterile fashion after the cardiac surgical procedure is completed. Postoperative continuous infusion of local anesthetic (ropivacaine) via the nerve block catheter is initiated and managed by the Acute Pain Service (per standardized, clinical weight-based protocols).

Bilateral erector spinae blocks using ropivacaine: Bilateral chest wall nerve blocks using ropivacaine.",PubChem:53262281,Naropin,CCC[NH+]1CCCCC1C(=O)Nc1c(C)cccc1C.O.[Cl-],,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT04570670,NCT04570670_EG000,Accepts Healthy Volunteers,All,Adult,Phase 1,50,"Inclusion Criteria:

Continuous non-smoker who had not used nicotine-containing products for at least 3 months prior to the first dose and throughout the study.
Body mass index (BMI) ≥ 18.5 and ≤ 29.9 kg/m2 at Screening.
Medically healthy as determined by the Investigator or designee with no clinically significant medical history, physical examination, laboratory profiles, vital signs or electrocardiograms (ECGs), as deemed by the Investigator or designee.

Females of childbearing potential: not pregnant and either sexually inactive (abstinent) for 14 days prior to the first dose and throughout the study or using one of the following acceptable birth control methods: hormonal oral contraceptives, vaginal ring, transdermal patch, or nonhormone or hormone releasing intrauterine device for at least 3 months prior to the first dose with either a physical (e.g., condom, diaphragm, or other) or a chemical (e.g., spermicide) barrier method from the time of Screening and throughout the study; depot/implantable hormone (e.g., Depo Provera®, Implanon®) for at least 3 months prior to the first dose and throughout the study.

In addition, female subjects of childbearing potential were advised to remain sexually inactive or to keep the same birth control method for at least 7 days following the last dose.

Females of non-childbearing potential: had undergone one of the following sterilization procedures at least 6 months prior to the first dose: hysteroscopic sterilization; bilateral tubal ligation or bilateral salpingectomy; hysterectomy; bilateral oophorectomy or were postmenopausal with amenorrhea for at least 1 year prior to the first dose and follicle-stimulating hormone (FSH) serum levels consistent with postmenopausal status as per Investigator's or designee's judgment.
Non-vasectomized male subjects agreed to use a condom with spermicide or abstain from sexual intercourse during the study until 90 days beyond the last dose of study drug. (No restrictions were required for a vasectomized male provided his vasectomy had been performed 4 months or more prior to the first dose of study drug. A male who had been vasectomized less than 4 months prior to the first dose of study drug, followed the same restrictions as a non-vasectomized male.)
Males agreed not to donate sperm from the first dose until 90 days after dosing.
Understood the study procedures in the Informed Consent Form (ICF), and were willing and able to comply with the protocol.

Exclusion Criteria:

Subject was mentally or legally incapacitated or had significant emotional problems at the time of the Screening visit or expected during the conduct of the study.
History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the Investigator or designee.
History of any illness that, in the opinion of the Investigator or designee, might have confounded the results of the study or posed an additional risk to the subject by their participation in the study.
History or presence of alcoholism or drug abuse within the past 2 years prior to the first dose.
History or presence of hypersensitivity or idiosyncratic reaction to the study drugs or related compounds.
Female subjects with a positive serum pregnancy test at Screening or Check-in, or who were lactating.
Positive urine drug, alcohol, or cotinine results at Screening or Check-in.
Positive results at Screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV).
Seated blood pressure was less than 90/40 mmHg or greater than 140/90 mmHg at Screening.
Seated heart rate was lower than 40 beats per minute (bpm) or higher than 99 bpm at Screening.
Abnormal 12-lead ECG deemed clinically significant by the Investigator or designee at Screening or prior to the first dose.
Unable to refrain from or anticipated the use of any drug, including prescription and non-prescription medications, or herbal remedies, beginning 14 days prior to the first dose and throughout the study. Medication listed as part of acceptable birth control methods was allowed. Hormone replacement therapy was also allowed. Acetaminophen (up to 2 g per 24-hour period) may have been permitted, as necessary during the study.
Had been on a diet incompatible with the on study diet, in the opinion of the Investigator or designee, within the 28 days prior to the first dose and throughout the study.
Donation of blood or significant blood loss within 30 days prior to the first dose.
Plasma donation within 7 days prior to the first dose.
Participation in another clinical study within 28 days prior to the first dose. The 28-day window was derived from the date of the last blood collection or dosing, whichever was later, in the previous study to Day 1 of Period 1 of the current study.","A single oral dose administration of BLS-11 190 mg (2 × 95 mg monomethyl fumarate delayed-release capsules) at Hour 0 on Day 1

monomethyl fumarate 190 mg",ChEMBL:CHEMBL589586 | DrugBank:DB14219 | PubChem:5369209,MONOMETHYL FUMARATE,COC(=O)/C=C/C(=O)O,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT04574362,NCT04574362_EG000,No,All,Adult | Older Adult,Phase 3,668,"Inclusion Criteria:

Subject has at least 1 year history of migraines (with or without aura), consistent with a diagnosis according to the International Classification of Headache Disorder, 3rd Edition, Beta version including the following:

Migraine attacks present for more than 1 year with the age of onset prior to 50 years of age
Migraine attacks, on average, lasting about 4-72 hours if untreated
Not more than 8 attacks of moderate to severe intensity per month within the last 3 months
Consistent migraine headaches of at least 2 migraine headache attacks of moderate or severe intensity in each of the 3 months prior to the Screening Visit and maintains this requirement during the Screening period
Less than 15 days with headache (migraine or non-migraine) per month in each of the 3 months prior to the Screening Visit and maintains this requirement during the Screening Period.
Subjects on prophylactic migraine medication are permitted to remain on therapy provided they have been on a stable dose for at least 3 months prior to screening visit and the dose is not expected to change during the course of the study.
Subjects with contraindications for use of triptans may be included provided they meet all other study entry criteria.

Key Exclusion Criteria:

Subject with a history of HIV disease
Subject history with current evidence of uncontrolled, unstable or recently diagnosed cardiovascular disease, such as ischemic heart disease, coronary artery vasospasm, and cerebral ischemia. subjects with Myocardial Infarction (MI), Acute Coronary Syndrome (ACS), Percutaneous Coronary Intervention (PCI), cardiac surgery, stroke or transient ischemic attack (TIA) during the 6 months prior to screening
Uncontrolled hypertension (high blood pressure), or uncontrolled diabetes (however subjects can be included who have stable hypertension and/or diabetes for at least 3 months prior to being enrolled)
Subject has a current diagnosis of major depression, other pain syndromes, psychiatric conditions (e.g., schizophrenia), dementia, or significant neurological disorders (other than migraine) that, in the Investigator's opinion might interfere with study assessments.
Subject has a history of gastric, or small intestinal surgery (including Gastric Bypass, Gastric Banding, Gastric Sleeve, Gastric Balloon, etc.), or has disease that causes malabsorption
The subject has a history of current or evidence of any significant and/ or unstable medical conditions (e.g., history of congenital heart disease or arrhythmia, known suspected infection, hepatitis B or C, or cancer) that, in the investigator's opinion, would expose them to undue risk of a significant adverse event (AE) or interfere with assessments of safety or efficacy during the course of the trial.
History of, treatment for, or evidence of, alcohol or drug abuse within the past 12 months or subjects who have met DSM-V criteria for any significant substance use disorder within the past 12 months from the date of the screening visit.
Subjects are excluded if they have previously participated in any study of rimegepant or other experimental CGRP-antagonist study, or have been prescribed CGRP-antibodies within the last 6 months
Participation in any other investigational clinical trial while participating in this clinical trial",Participants were randomized to receive 1 orally disintegrating tablet of rimegepant 75 mg. Participants were followed up to for 7 days post-dose.,ChEMBL:CHEMBL2178422 | DrugBank:DB12457 | PubChem:51049968,Rimegepant,N[C@@H]1c2cccnc2[C@H](OC(=O)N2CCC(n3c(=O)[nH]c4ncccc43)CC2)CC[C@H]1c1cccc(F)c1F,N02CD06,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT04594759,NCT04594759_EG000,No,All,Child | Adult | Older Adult,Phase 1 | Phase 2,19,"Inclusion Criteria:

All patients 12 years and older with the diagnosis of moderate acne vulgaris

Exclusion Criteria:

Patients who are at baseline on long-term tetracycline antibiotics, long-term trimethoprim-sulfamethoxazole, or on spironolactone for any reason
Patients who have taken isotretinoin in the past 6 months
Patients with hypersensitivity to isotretinoin or to any of its components
Females who are pregnant, likely to become pregnant, or will be breast-feeding during the study period
Patients with a history of major depression, mania, or psychosis with an active episode during the past year including current psychotic symptoms and/or current suicidal ideation
Adult patients with cognitive impairment
Patients with baseline kidney or liver disease
Patients with baseline hypertriglyceridemia
Patients with history of or current pseudotumor cerebri
Patients with any clinically significant unstable medical condition which could pose a risk to the safety of the patient
Inability or unwillingness of subject or legal guardian/representative to give informed consent",Isotretinoin: Participants will be getting isotretinoin (1-1.5 mg/kg/week),ChEMBL:CHEMBL38 | ChEMBL:CHEMBL547 | ChEMBL:CHEMBL705 | DrugBank:DB00523 | DrugBank:DB00755 | DrugBank:DB00982 | PubChem:444795 | PubChem:449171 | PubChem:5282379,Tretinoin,CC(C=CC1=C(C)CCCC1(C)C)=CC=CC(C)=CC(=O)O,D10AD01 | D10AD04 | D10AD51 | D10AD54 | D10BA01 | D11AH04 | L01XF01 | L01XF02,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT04608448,NCT04608448_EG000,Accepts Healthy Volunteers,All,Older Adult,Early Phase 1,22,"Inclusion Criteria:

65-95 years of age.
Good health with all chronic diseases (hypertension, coronary artery disease, etc.) clinically stable.
Selected subjects will be in good health (Per the World Health Organization, good health will be defined as complete physical, mental, and social well-being and not merely the absence of disease or infirmity).
All diseases or infirmities will be clinically stable whether managed by medications or not.
CLOX score of 10 or greater
Women will be postmenopausal
Postmenopausal women taking hormone replacement will be included if they have been on a stable dose for ≥6 months
Live within a 20 mile drive of the UTHSA campus (7703 Floyd Curl Drive, San Antonio, TX)

Exclusion Criteria:

Diabetes.
History of skin ulcers or poor wound healing, or keloid formers.
Smoking.
Liver disease.
Coumadin anti-coagulation.
Treatment with drugs known to affect cytochrome P450 3A (diltiazem, erythromycin, etc. - due to role in rapamycin metabolism).
Treatment with an immunosuppressant (prednisone, etc.) within 6 months.
History of recent (within 6 months) Myocardial Infarction or active Coronary Disease.
Hypersensitivity to rapamycin or petrolatum (ointment vehicle)
Arm tattoos or scars in application area","Ointment is applied to a color coded area on the subject forearm daily.

Rapamycin Topical Ointment: 8% topical rapamycin ointment",ChEMBL:CHEMBL413 | DrugBank:DB00877 | PubChem:134760597 | PubChem:138404388 | PubChem:21944094 | PubChem:5284616,Sirolimus,COC1CC2CCC(C)C(O)(O2)C(=O)C(=O)N2CCCCC2C(=O)OC(C(C)CC2CCC(O)C(OC)C2)CC(=O)C(C)C=C(C)C(O)C(OC)C(=O)C(C)CC(C)C=CC=CC=C1C,L01EG04 | L04AA10 | S01XA23,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT04676867,NCT04676867_EG001,No,All,Adult | Older Adult,Phase 2,55,"Inclusion Criteria:

Patients must satisfy all of the following criteria unless otherwise stated:

Willing and able to provide informed consent
Male or female patients > 18 years of age on the day of informed consent
Have received a confirmed diagnosis of COVID-19 (positive for SARS CoV 2), as assessed by PCR or point-of-care within 72 hours of first dose on Day 1

Have mild to moderate signs or symptoms of COVID-19 with onset within 5 days of first dose on Day 1, at least two of the following symptoms:

stuffy or runny nose
sore throat
shortness of breath
cough
fatigue
myalgia
headache
chills or shivering
feeling hot or feverish
nausea
vomiting
diarrhea
anosmia
ageusia
Outpatient with COVID-19 disease (not requiring oxygen therapy [WHO COVID-19 Clinical Improvement Ordinal Scale, score of 3])
Patient is aware of the investigational nature of this study and willing to comply with protocol treatments, blood tests, and other evaluations listed in the informed consent form (ICF).

Exclusion Criteria:

Patients will be excluded from the study if they satisfy any of the following criteria unless otherwise stated:

Females who are pregnant (negative pregnancy test required for all women of child bearing potential at Screening) or breast-feeding
Male patients and women of childbearing potential (women who are not surgically sterile or postmenopausal defined as amenorrhea for >12 months) who are not using at least one protocol specified method of contraception
Severe COVID-19 disease as defined by the WHO COVID-19 Clinical Improvement Ordinal Scale, scores of 5 (non invasive ventilation or high-flow oxygen), 6 (intubation and mechanical ventilation), or 7 (ventilation + additional organ support pressors, renal replacement therapy [RRT], extracorporeal membrane oxygenation [ECMO])
Expected survival less than 72 hours
Peripheral capillary oxygen saturation (SpO2) <90% while breathing room air
Treatment with other drugs thought to possibly have activity against SARS CoV 2 infection like remdesivir, favipiravir, within 7 days prior to enrollment or concurrently
History of abuse of drugs or alcohol that could interfere with adherence to study requirements as judged by the Investigator
Use of any other concurrent investigational drugs while participating in the present study
Patient requires frequent or prolonged use of systemic corticosteroids (≥20 mg of prednisone/day or equivalent for >4 weeks) or other immunosuppressive drugs (e.g., for organ transplantation or autoimmune conditions)
Known renal disease with an estimated glomerular filtration rate (eGFR) <50 mL/min based on local laboratory results
Patients with clinically apparent liver disease, e.g., jaundice, cholestasis, hepatic synthetic impairment, or active hepatitis
Alanine transaminase (ALT) or aspartate transaminase (AST) >3 × upper limit of normal (ULN) or alkaline phosphatase or bilirubin levels > 2 × ULN based on local laboratory results
Co administration of clinical doses of orlistat with dalcetrapib
Inability to swallow oral medications or a gastrointestinal disorder with diarrhea (e.g., Crohn's disease) or malabsorption at Screening
Any other clinically significant medical condition or laboratory abnormality that, in the opinion of the Investigator, would jeopardize the safety of the patient or potentially impact patient compliance or the safety/efficacy observations in the study
History of an allergic reaction or hypersensitivity to the study drug or any component of the study drug formulation.","Participants received dalcetrapib 900 mg (three 300 mg tablets) and 9 placebo tablets orally daily for 10 days

Dalcetrapib: Dalcetrapib 300 mg film-coated tablets Placebo: Dalcetrapib matching placebo tablets",ChEMBL:CHEMBL313006 | DrugBank:DB12181 | PubChem:6918540,Dalcetrapib,CCC(CC)CC1(C(=O)Nc2ccccc2SC(=O)C(C)C)CCCCC1,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT04676867,NCT04676867_EG002,No,All,Adult | Older Adult,Phase 2,48,"Inclusion Criteria:

Patients must satisfy all of the following criteria unless otherwise stated:

Willing and able to provide informed consent
Male or female patients > 18 years of age on the day of informed consent
Have received a confirmed diagnosis of COVID-19 (positive for SARS CoV 2), as assessed by PCR or point-of-care within 72 hours of first dose on Day 1

Have mild to moderate signs or symptoms of COVID-19 with onset within 5 days of first dose on Day 1, at least two of the following symptoms:

stuffy or runny nose
sore throat
shortness of breath
cough
fatigue
myalgia
headache
chills or shivering
feeling hot or feverish
nausea
vomiting
diarrhea
anosmia
ageusia
Outpatient with COVID-19 disease (not requiring oxygen therapy [WHO COVID-19 Clinical Improvement Ordinal Scale, score of 3])
Patient is aware of the investigational nature of this study and willing to comply with protocol treatments, blood tests, and other evaluations listed in the informed consent form (ICF).

Exclusion Criteria:

Patients will be excluded from the study if they satisfy any of the following criteria unless otherwise stated:

Females who are pregnant (negative pregnancy test required for all women of child bearing potential at Screening) or breast-feeding
Male patients and women of childbearing potential (women who are not surgically sterile or postmenopausal defined as amenorrhea for >12 months) who are not using at least one protocol specified method of contraception
Severe COVID-19 disease as defined by the WHO COVID-19 Clinical Improvement Ordinal Scale, scores of 5 (non invasive ventilation or high-flow oxygen), 6 (intubation and mechanical ventilation), or 7 (ventilation + additional organ support pressors, renal replacement therapy [RRT], extracorporeal membrane oxygenation [ECMO])
Expected survival less than 72 hours
Peripheral capillary oxygen saturation (SpO2) <90% while breathing room air
Treatment with other drugs thought to possibly have activity against SARS CoV 2 infection like remdesivir, favipiravir, within 7 days prior to enrollment or concurrently
History of abuse of drugs or alcohol that could interfere with adherence to study requirements as judged by the Investigator
Use of any other concurrent investigational drugs while participating in the present study
Patient requires frequent or prolonged use of systemic corticosteroids (≥20 mg of prednisone/day or equivalent for >4 weeks) or other immunosuppressive drugs (e.g., for organ transplantation or autoimmune conditions)
Known renal disease with an estimated glomerular filtration rate (eGFR) <50 mL/min based on local laboratory results
Patients with clinically apparent liver disease, e.g., jaundice, cholestasis, hepatic synthetic impairment, or active hepatitis
Alanine transaminase (ALT) or aspartate transaminase (AST) >3 × upper limit of normal (ULN) or alkaline phosphatase or bilirubin levels > 2 × ULN based on local laboratory results
Co administration of clinical doses of orlistat with dalcetrapib
Inability to swallow oral medications or a gastrointestinal disorder with diarrhea (e.g., Crohn's disease) or malabsorption at Screening
Any other clinically significant medical condition or laboratory abnormality that, in the opinion of the Investigator, would jeopardize the safety of the patient or potentially impact patient compliance or the safety/efficacy observations in the study
History of an allergic reaction or hypersensitivity to the study drug or any component of the study drug formulation.","Participants received dalcetrapib 1800 mg (six 300 mg tablets) and six placebo tablets orally daily for 10 days

Dalcetrapib: Dalcetrapib 300 mg film-coated tablets Placebo: Dalcetrapib matching placebo tablets",ChEMBL:CHEMBL313006 | DrugBank:DB12181 | PubChem:6918540,Dalcetrapib,CCC(CC)CC1(C(=O)Nc2ccccc2SC(=O)C(C)C)CCCCC1,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT04676867,NCT04676867_EG003,No,All,Adult | Older Adult,Phase 2,52,"Inclusion Criteria:

Patients must satisfy all of the following criteria unless otherwise stated:

Willing and able to provide informed consent
Male or female patients > 18 years of age on the day of informed consent
Have received a confirmed diagnosis of COVID-19 (positive for SARS CoV 2), as assessed by PCR or point-of-care within 72 hours of first dose on Day 1

Have mild to moderate signs or symptoms of COVID-19 with onset within 5 days of first dose on Day 1, at least two of the following symptoms:

stuffy or runny nose
sore throat
shortness of breath
cough
fatigue
myalgia
headache
chills or shivering
feeling hot or feverish
nausea
vomiting
diarrhea
anosmia
ageusia
Outpatient with COVID-19 disease (not requiring oxygen therapy [WHO COVID-19 Clinical Improvement Ordinal Scale, score of 3])
Patient is aware of the investigational nature of this study and willing to comply with protocol treatments, blood tests, and other evaluations listed in the informed consent form (ICF).

Exclusion Criteria:

Patients will be excluded from the study if they satisfy any of the following criteria unless otherwise stated:

Females who are pregnant (negative pregnancy test required for all women of child bearing potential at Screening) or breast-feeding
Male patients and women of childbearing potential (women who are not surgically sterile or postmenopausal defined as amenorrhea for >12 months) who are not using at least one protocol specified method of contraception
Severe COVID-19 disease as defined by the WHO COVID-19 Clinical Improvement Ordinal Scale, scores of 5 (non invasive ventilation or high-flow oxygen), 6 (intubation and mechanical ventilation), or 7 (ventilation + additional organ support pressors, renal replacement therapy [RRT], extracorporeal membrane oxygenation [ECMO])
Expected survival less than 72 hours
Peripheral capillary oxygen saturation (SpO2) <90% while breathing room air
Treatment with other drugs thought to possibly have activity against SARS CoV 2 infection like remdesivir, favipiravir, within 7 days prior to enrollment or concurrently
History of abuse of drugs or alcohol that could interfere with adherence to study requirements as judged by the Investigator
Use of any other concurrent investigational drugs while participating in the present study
Patient requires frequent or prolonged use of systemic corticosteroids (≥20 mg of prednisone/day or equivalent for >4 weeks) or other immunosuppressive drugs (e.g., for organ transplantation or autoimmune conditions)
Known renal disease with an estimated glomerular filtration rate (eGFR) <50 mL/min based on local laboratory results
Patients with clinically apparent liver disease, e.g., jaundice, cholestasis, hepatic synthetic impairment, or active hepatitis
Alanine transaminase (ALT) or aspartate transaminase (AST) >3 × upper limit of normal (ULN) or alkaline phosphatase or bilirubin levels > 2 × ULN based on local laboratory results
Co administration of clinical doses of orlistat with dalcetrapib
Inability to swallow oral medications or a gastrointestinal disorder with diarrhea (e.g., Crohn's disease) or malabsorption at Screening
Any other clinically significant medical condition or laboratory abnormality that, in the opinion of the Investigator, would jeopardize the safety of the patient or potentially impact patient compliance or the safety/efficacy observations in the study
History of an allergic reaction or hypersensitivity to the study drug or any component of the study drug formulation.","Participants received dalcetrapib 900 mg (twelve 300 mg tablets) orally daily for 10 days

Dalcetrapib: Dalcetrapib 300 mg film-coated tablets Placebo: Dalcetrapib matching placebo tablets",ChEMBL:CHEMBL313006 | DrugBank:DB12181 | PubChem:6918540,Dalcetrapib,CCC(CC)CC1(C(=O)Nc2ccccc2SC(=O)C(C)C)CCCCC1,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT04678505,NCT04678505_EG000,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 1,4,"Inclusion Criteria:

Is in good health based on medical history, physical examination, vital signs (VS) measurements, and electrocardiogram (ECG)s performed before randomization.
Is in good health based on laboratory safety tests obtained at the screening visit and before administration of the initial dose of study drug.
Has a body mass index (BMI) ≥18 kg/m2 and ≤40 kg/m2. BMI = weight (kg)/height (m)2.

Male participants are eligible to participate if they agree to the following during the intervention period and for at least 90 days after the last dose of study intervention:

Refrain from donating sperm
Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent or must agree to use contraception unless confirmed to be azoospermic (vasectomized or secondary to medical cause)
A female participant is eligible to participate if she is a woman of non-childbearing potential.
Panel A: Has a baseline estimated glomerular filtration rate (eGFR) ≥60 and <90 mL/min/1.73 m2 based on the Modification of Diet in Renal Disease (MDRD) equation.
Panel B: Has a baseline eGFR ≥30 and <60 mL/min/1.73 m2 based on the MDRD equation.
Panel C: Has a baseline eGFR ≥15 and <30 mL/min/1.73 m2 based on the MDRD equation.
Panels A, B and C: Has had no clinically significant change in renal status at least 1 month prior to dosing and is not currently receiving or has not previously been on hemodialysis (HD).
Panel D: Has an eGFR ≥90 mL/min/1.73 m2 based on the MDRD equation.
Panel E: Has end stage renal disease (ESRD) and maintained on a stable regimen of at least 3 times per week HD for at least 3 months prior to first dosing.

Exclusion Criteria:

Panels A, B, C and E: Has a history of any clinically significant concomitant disease or condition (including treatment for such conditions) or diseases whose current condition is considered clinically unstable that, in the opinion of the investigator, could either interfere with the study drug, compromise interpretation of study data, or pose an unacceptable risk to the patient.
Panel D: Has a history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases. Participants with a remote history of uncomplicated medical events (eg, uncomplicated kidney stones, as defined as spontaneous passage and no recurrence in the last 5 years, or childhood asthma) may be enrolled in the study at the discretion of the investigator.
Is mentally or legally incapacitated, has significant emotional problems at the time of prestudy (screening) visit or expected during the conduct of the study or has a history of clinically significant psychiatric disorder that would impact study conduct. Participants who have had situational depression may be enrolled in the study at the discretion of the investigator.

Has a history of cancer (malignancy).

Exceptions: (1) Adequately treated nonmelanomatous skin carcinoma or carcinoma in situ of the cervix or; (2) Other malignancies that have been successfully treated with appropriate follow up and therefore unlikely to recur for the duration of the study, in the opinion of the investigator and with agreement of the Sponsor (eg, malignancies that have been successfully treated ≥10 years prior to the prestudy screening visit).
Has a history of significant multiple and/or severe allergies (eg, food, drug, latex allergy), or has had an anaphylactic reaction or significant intolerability (ie, systemic allergic reaction) to prescription or nonprescription drugs or food.
Is positive for hepatitis B surface antigen (HBsAg), hepatitis C antibodies or human immunodeficiency virus (HIV).
Had major surgery, donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to the prestudy (screening) visit.
Panels A, B, C and E: Is unable to refrain from or anticipates the use of any medication, including prescription and nonprescription drugs or herbal remedies for the prohibited time period.
Panel D: Is unable to refrain from or anticipates the use of any medication, including prescription and nonprescription drugs or herbal remedies beginning approximately 2 weeks (or 5 half-lives) prior to administration of the initial dose of study drug, throughout the study (including washout intervals between treatment periods), until the poststudy visit. There may be certain medications that are permitted.
Has participated in another investigational study within 4 weeks (or 5 half-lives, whichever is greater) prior to study drug administration. The window will be derived from the date of the last dose of study medication in the previous study.",Participants with mild renal impairment will receive a single dose of 100 mg MK-3402 via intravenous (IV) infusion on Day 1.,PubChem:135311801,MK-3402 Free base anhydrous,NCC(O)CNS(=O)(=O)c1ccc(-c2ccc(N)nc2)c(-c2nn[nH]n2)c1S(N)(=O)=O,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT04678505,NCT04678505_EG001,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 1,5,"Inclusion Criteria:

Is in good health based on medical history, physical examination, vital signs (VS) measurements, and electrocardiogram (ECG)s performed before randomization.
Is in good health based on laboratory safety tests obtained at the screening visit and before administration of the initial dose of study drug.
Has a body mass index (BMI) ≥18 kg/m2 and ≤40 kg/m2. BMI = weight (kg)/height (m)2.

Male participants are eligible to participate if they agree to the following during the intervention period and for at least 90 days after the last dose of study intervention:

Refrain from donating sperm
Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent or must agree to use contraception unless confirmed to be azoospermic (vasectomized or secondary to medical cause)
A female participant is eligible to participate if she is a woman of non-childbearing potential.
Panel A: Has a baseline estimated glomerular filtration rate (eGFR) ≥60 and <90 mL/min/1.73 m2 based on the Modification of Diet in Renal Disease (MDRD) equation.
Panel B: Has a baseline eGFR ≥30 and <60 mL/min/1.73 m2 based on the MDRD equation.
Panel C: Has a baseline eGFR ≥15 and <30 mL/min/1.73 m2 based on the MDRD equation.
Panels A, B and C: Has had no clinically significant change in renal status at least 1 month prior to dosing and is not currently receiving or has not previously been on hemodialysis (HD).
Panel D: Has an eGFR ≥90 mL/min/1.73 m2 based on the MDRD equation.
Panel E: Has end stage renal disease (ESRD) and maintained on a stable regimen of at least 3 times per week HD for at least 3 months prior to first dosing.

Exclusion Criteria:

Panels A, B, C and E: Has a history of any clinically significant concomitant disease or condition (including treatment for such conditions) or diseases whose current condition is considered clinically unstable that, in the opinion of the investigator, could either interfere with the study drug, compromise interpretation of study data, or pose an unacceptable risk to the patient.
Panel D: Has a history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases. Participants with a remote history of uncomplicated medical events (eg, uncomplicated kidney stones, as defined as spontaneous passage and no recurrence in the last 5 years, or childhood asthma) may be enrolled in the study at the discretion of the investigator.
Is mentally or legally incapacitated, has significant emotional problems at the time of prestudy (screening) visit or expected during the conduct of the study or has a history of clinically significant psychiatric disorder that would impact study conduct. Participants who have had situational depression may be enrolled in the study at the discretion of the investigator.

Has a history of cancer (malignancy).

Exceptions: (1) Adequately treated nonmelanomatous skin carcinoma or carcinoma in situ of the cervix or; (2) Other malignancies that have been successfully treated with appropriate follow up and therefore unlikely to recur for the duration of the study, in the opinion of the investigator and with agreement of the Sponsor (eg, malignancies that have been successfully treated ≥10 years prior to the prestudy screening visit).
Has a history of significant multiple and/or severe allergies (eg, food, drug, latex allergy), or has had an anaphylactic reaction or significant intolerability (ie, systemic allergic reaction) to prescription or nonprescription drugs or food.
Is positive for hepatitis B surface antigen (HBsAg), hepatitis C antibodies or human immunodeficiency virus (HIV).
Had major surgery, donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to the prestudy (screening) visit.
Panels A, B, C and E: Is unable to refrain from or anticipates the use of any medication, including prescription and nonprescription drugs or herbal remedies for the prohibited time period.
Panel D: Is unable to refrain from or anticipates the use of any medication, including prescription and nonprescription drugs or herbal remedies beginning approximately 2 weeks (or 5 half-lives) prior to administration of the initial dose of study drug, throughout the study (including washout intervals between treatment periods), until the poststudy visit. There may be certain medications that are permitted.
Has participated in another investigational study within 4 weeks (or 5 half-lives, whichever is greater) prior to study drug administration. The window will be derived from the date of the last dose of study medication in the previous study.",Participants with moderate renal impairment will receive a single dose of 100 mg MK-3402 via IV infusion on Day 1.,PubChem:135311801,MK-3402 Free base anhydrous,NCC(O)CNS(=O)(=O)c1ccc(-c2ccc(N)nc2)c(-c2nn[nH]n2)c1S(N)(=O)=O,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT04688164,NCT04688164_EG000,No,All,Adult | Older Adult,Phase 3,113,"Inclusion Criteria:

Adults 18 to 65 years, inclusive.
Diagnosed with Major Depressive Disorder (MDD) based on structured clinical interview for Diagnostic and Statistical Manual of Mental Disorders, DSM-5 (SCID-5) for MDD.
Current major depressive episode.
With inadequate response to 1-3 first-line antidepressants administered at an adequate and stable dose

Exclusion Criteria:

Any current and primary psychiatric disorder other than Major Depressive Disorder.
Severe alcohol or substance use disorder.
History of bipolar I and II disorder, psychosis, and/or mania.
Acute or chronic condition that, in the Investigator's opinion, would limit the subject's ability to complete or participate in this clinical study.
Prior participation in a ketamine, esketamine, dextromethorphan or any other NMDAR- antagonist study, or received esketamine at any time.","A 75 mg REL-1017 loading dose (three 25 mg REL-1017 tablets) will be administered on Day-1 of the 28-day treatment period. From Day-2 to Day-28, participants will take 25 mg REL-1017 in addition to their ongoing antidepressant.

REL-1017: REL-1017 tablet",ChEMBL:CHEMBL350719 | ChEMBL:CHEMBL651 | DrugBank:DB00333 | DrugBank:DB15198 | PubChem:4095 | PubChem:643985,Methadone,CCC(=O)C(CC(C)N(C)C)(c1ccccc1)c1ccccc1,N02AC52 | N07BC02,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT04749745,NCT04749745_EG000,Accepts Healthy Volunteers,All,Adult | Older Adult,Early Phase 1,11,"Inclusion Criteria:

Adult, aged between 18 and 65 years old;
Able to read/speak English and give informed consent
No current or history of Axis I psychiatric disorders by DSM-5.
Free of psychotropic medication use

Exclusion Criteria:

History of significant acute or chronic neurological or medical disorder or condition that increases risk for seizure with TMS;
History of alcohol use disorder, nicotine dependence, adjustment disorder;
History of allergic reactions to L-theanine or green tea;
Pregnancy;
Unable/unwilling to abstain from nutraceutical supplements and psychotropic agents during participation in the study
Unable/ unwillingness to refrain from recreational substance use (e.g. alcohol or marijuana) during participation in the study;
Meet criteria for exclusion from TMS or MRI procedures, including intracranial metal implants or nonremovable ferromagnetic items in the head/neck.","Subject will receive 400mg single dose of L-theanine, by oral ingestion with water. The capsules are prepared and dispensed by hospital pharmacy, with the investigator and participant both blinded.",DrugBank:DB12444 | PubChem:439378,Theanine,CCNC(=O)CC[C@H](N)C(=O)O,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT04757584,NCT04757584_EG000,No,All,Older Adult,Phase 4,9,"Inclusion Criteria:

Ambulatory adults ≥65 years of age with Heart Failure with Preserved Ejection Fraction (HFpEF) according to ACC/AHA guidelines: (signs and symptoms of Heart failure [HF] and ejection fraction [EF] ≥50%)
Taking Beta blocker

Exclusion Criteria:

Alternate Causes of HFpEF Syndrome:

Severe valvular disease
Constrictive pericarditis
High output heart failure
Infiltrative cardiomyopathy

Other compelling indication for beta blocker:

Prior EF < 50%
Hypertrophic cardiomyopathy
Angina symptoms
Acute coronary syndrome, myocardial infarction or coronary artery bypass surgery in prior 3 year
History of ventricular tachycardia
Atrial arrhythmia with hospitalization for rapid ventricular response, prior 1 year
Sinus tachycardia > 100 beats per minute (bpm), atrial arrhythmia with ventricular rate >90 bpm, systolic blood pressure > 160 mmHg

Clinical instability (N-of-1 trials are appropriate for stable conditions only)

Decompensated HF
Hospitalized in past 30 days
Medication changes or procedures in prior 14 days (to prevent confounding from other interventions), at PI discretion
Estimated life expectancy <6 months
Moderate-severe dementia or psychiatric disorder precluding informed consent
Any condition that, in Principal Investigator's opinion, makes the patient unsuitable for study participation","This arm will follow an ABAB sequence. ""A"" representing ON beta blockers and ""B"" representing OFF beta blockers. Subjects in this arm will continue their home dose during the initial A period, they will then crossover into Period 2, where dose reduction will begin until they are off of beta blockers. After Period 2, the subjects have the option to decide if they want to be on or off their beta blocker and proceed with the Follow-Up Phase, or continue to Period 3 if they don't feel ready to make that decision to stay on or go off their beta blocker yet. During Period 3, they will restart beta-blockers, gradually up-titrating until reaching their home dose. Finally, during Period 4, we will again conduct a dose reduction until off of beta blockers.

Beta blockers: The intervention is a two-arm crossover withdrawal/ reversal design (On [A] vs Off [B]) with up to 4 periods, each period lasting up to 6 weeks. During the On period (A), subjects will be on their beta blocker. During the Off period (B), their beta blockers will be down-titrated and subsequently discontinued.

Subjects will be randomized into either ABAB or BABA sequences.",ChEMBL:CHEMBL1201274 | ChEMBL:CHEMBL423 | DrugBank:DB00195 | DrugBank:DB09351 | PubChem:2369 | PubChem:60657,Betaxolol,CC(C)NCC(O)COc1ccc(CCOCC2CC2)cc1,C07AB05 | S01ED02 | S01ED52,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT04757584,NCT04757584_EG001,No,All,Older Adult,Phase 4,9,"Inclusion Criteria:

Ambulatory adults ≥65 years of age with Heart Failure with Preserved Ejection Fraction (HFpEF) according to ACC/AHA guidelines: (signs and symptoms of Heart failure [HF] and ejection fraction [EF] ≥50%)
Taking Beta blocker

Exclusion Criteria:

Alternate Causes of HFpEF Syndrome:

Severe valvular disease
Constrictive pericarditis
High output heart failure
Infiltrative cardiomyopathy

Other compelling indication for beta blocker:

Prior EF < 50%
Hypertrophic cardiomyopathy
Angina symptoms
Acute coronary syndrome, myocardial infarction or coronary artery bypass surgery in prior 3 year
History of ventricular tachycardia
Atrial arrhythmia with hospitalization for rapid ventricular response, prior 1 year
Sinus tachycardia > 100 beats per minute (bpm), atrial arrhythmia with ventricular rate >90 bpm, systolic blood pressure > 160 mmHg

Clinical instability (N-of-1 trials are appropriate for stable conditions only)

Decompensated HF
Hospitalized in past 30 days
Medication changes or procedures in prior 14 days (to prevent confounding from other interventions), at PI discretion
Estimated life expectancy <6 months
Moderate-severe dementia or psychiatric disorder precluding informed consent
Any condition that, in Principal Investigator's opinion, makes the patient unsuitable for study participation","This arm will follow a BABA sequence. ""A"" representing ON beta blockers and ""B"" representing OFF of beta blockers. Subjects in this arm will have their previously prescribed beta blocker dose reduced until they are completely off of beta blockers during Period 1. They will then crossover into Period 2, where uptitration will begin until they are back on their previously prescribed dose of beta blockers. After Period 2, the subjects have the option to decide if they want to be on or off their beta blocker and proceed with the Follow-Up Phase, or continue to Period 3 if they don't feel ready to make that decision to stay on or go off their beta blocker yet. During Period 3, we will again conduct a dose reduction, until the subject is off of beta blockers. Finally, during Period 4, we will up-titrate them back to their home dose of beta blockers.

Beta blockers: The intervention is a two-arm crossover withdrawal/ reversal design (On [A] vs Off [B]) with up to 4 periods, each period lasting up to 6 weeks. During the On period (A), subjects will be on their beta blocker. During the Off period (B), their beta blockers will be down-titrated and subsequently discontinued.

Subjects will be randomized into either ABAB or BABA sequences.",ChEMBL:CHEMBL1201274 | ChEMBL:CHEMBL423 | DrugBank:DB00195 | DrugBank:DB09351 | PubChem:2369 | PubChem:60657,Betaxolol,CC(C)NCC(O)COc1ccc(CCOCC2CC2)cc1,C07AB05 | S01ED02 | S01ED52,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT04764669,NCT04764669_EG000,No,All,Adult | Older Adult,Phase 2,10,"Inclusion Criteria:

Male or female, age 50 to 85 years, inclusive at time of consent
Meet criteria for probable DLB (as defined by the 4th report of the DLB Consortium) or meet criteria for probable PDD (as defined by the task force of the Movement Disorder Society).
Mini-mental state examination (MMSE) greater than (>) 14 and less than (<) 26 at Screening Visit
For DLB participants, have experienced visual hallucinations since onset of their DLB
If receiving acetylcholinesterase inhibitors (AChEIs), must have been on a stable dose for at least 12 weeks before Screening Visit, with no plans for dose adjustment during the study. Treatment naive participants can be entered into the study but there should be no plans to initiate treatment with AChEIs from Screening to the end of the study.
If receiving memantine, must have been on a stable dose for at least 12 weeks before Screening Visit, with no plans for dose adjustment during the study. Treatment naive participants can be entered into the study but there should be no plans to initiate treatment with memantine from Screening to the end of the study.
If receiving Parkinson's disease medications, must have been on a stable dose for at least 4 weeks before Screening Visit, with no plans for dose adjustment during the study.
Must have an identified caregiver or informant who is willing and able to provide follow up information on the participant throughout the course of the study.
Provide written informed consent.

Exclusion Criteria:

Any neurological condition that may be contributing to cognitive impairment above and beyond those caused by the participant's DLB or PDD, including any comorbidities detected by clinical assessment or magnetic resonance imaging (MRI) (identification of amyloid copathology is not exclusionary)
History of transient ischemic attacks or stroke within 12 months of Screening
Modified Hachinski Ischemic Scale >4
Parkinsonian (extrapyramidal) features with Hoehn and Yahr Scale (HYS) stage 4 or higher
Any major psychiatric diagnosis, including schizophrenia, bipolar disorder and current major depressive disorder as per Diagnostic and Statistical Manual of Mental Disorders Fifth Edition
Geriatric Depression Scale (GDS) score >8
Severe visual or hearing impairment that may interfere with the participant study assessments including cognitive testing
Any contraindications to lumbar puncture
History of deep brain stimulation or other neurosurgical procedure for Parkinson's disease
Has thyroid stimulating hormone (TSH) above normal range
Abnormally low serum vitamin B12 levels (< the lower limit of normal [LLN]) for the testing laboratory
Contraindications to MRI scanning
Evidence of other clinically significant lesions that suggest a dementia diagnosis other than DLB or PDD on brain MRI at Screening
Other significant pathological findings on brain MRI at Screening
Hypersensitivity to E2027 or any of the excipients
A prolonged corrected QT interval calculated using Fridericia's formula (QTcF) as demonstrated by triplicate ECG at the Screening or Baseline Visit (that is, mean value >450 millisecond [msec])
Had symptomatic orthostatic hypotension or symptomatic orthostatic tachycardia which resulted in hospitalization or urgent medical review in hospital in the past 12 months before Screening
Any other clinically significant abnormalities in vital signs, ECG and laboratory values that in the opinion of the investigator, require further investigation or treatment or that may interfere with study procedures or safety
Malignant neoplasms within 3 years of Screening (except for basal or squamous cell carcinoma of the skin, or localized prostate cancer in male participants). Participants who had malignant neoplasms but who have had at least 3 years of documented uninterrupted remission before Screening need not be excluded.
Has a ""yes"" answer to C-SSRS suicidal ideation Type 4 or 5, or any suicidal behavior assessment within 6 months before Screening, at Screening, or at the Baseline Visit, or has been hospitalized or treated for suicidal behavior in the past 5 years before Screening
Known or suspected history of drug or alcohol dependency or abuse within 2 years before Screening, current use of recreational drugs or a positive urine drug test at Screening.
Any other medical conditions (example, cardiac, respiratory, gastrointestinal, renal disease) which are not stably and adequately controlled, or which in the opinion of the investigator may affect the participant's safety or interfere with the study assessments
Taking any of the prohibited medications or not meeting the requirements regarding stable doses of permitted medications
Participation in a clinical study involving any investigational drug/device for DLB or PDD within 6 months before Screening or any other investigational drug/device in the 8 weeks or 5 half-lives (whichever is longer) of the study medication before Screening unless it can be documented that the participant was in a placebo treatment arm
Planned surgery which requires general, spinal or epidural anesthesia that will take place during the study.
Males who have not had a successful vasectomy (confirmed azoospermia) if their female partners are of childbearing potential and are not willing to use a highly effective contraceptive method throughout the study period and for 98 days after study drug discontinuation. No sperm donation is allowed during the study period and for 98 days after study drug discontinuation.
Females who are breastfeeding or pregnant at Screening or Baseline

Females of childbearing potential who:

Within 28 days before study entry, did not use a highly effective method of contraception
Do not agree to use a highly effective method of contraception throughout the entire study period and for 28 days after study drug discontinuation","Participants with DLB (without amyloid copathology) received E2027 50 mg capsules, orally, once daily up to 12 weeks.",ChEMBL:CHEMBL4650368 | PubChem:136253996,IRSENONTRINE,COc1ncc(C)c(-c2ccc3c(c2)[nH]c(=O)c2cnn([C@H]4CCOC4)c23)c1C,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT04764669,NCT04764669_EG001,No,All,Adult | Older Adult,Phase 2,11,"Inclusion Criteria:

Male or female, age 50 to 85 years, inclusive at time of consent
Meet criteria for probable DLB (as defined by the 4th report of the DLB Consortium) or meet criteria for probable PDD (as defined by the task force of the Movement Disorder Society).
Mini-mental state examination (MMSE) greater than (>) 14 and less than (<) 26 at Screening Visit
For DLB participants, have experienced visual hallucinations since onset of their DLB
If receiving acetylcholinesterase inhibitors (AChEIs), must have been on a stable dose for at least 12 weeks before Screening Visit, with no plans for dose adjustment during the study. Treatment naive participants can be entered into the study but there should be no plans to initiate treatment with AChEIs from Screening to the end of the study.
If receiving memantine, must have been on a stable dose for at least 12 weeks before Screening Visit, with no plans for dose adjustment during the study. Treatment naive participants can be entered into the study but there should be no plans to initiate treatment with memantine from Screening to the end of the study.
If receiving Parkinson's disease medications, must have been on a stable dose for at least 4 weeks before Screening Visit, with no plans for dose adjustment during the study.
Must have an identified caregiver or informant who is willing and able to provide follow up information on the participant throughout the course of the study.
Provide written informed consent.

Exclusion Criteria:

Any neurological condition that may be contributing to cognitive impairment above and beyond those caused by the participant's DLB or PDD, including any comorbidities detected by clinical assessment or magnetic resonance imaging (MRI) (identification of amyloid copathology is not exclusionary)
History of transient ischemic attacks or stroke within 12 months of Screening
Modified Hachinski Ischemic Scale >4
Parkinsonian (extrapyramidal) features with Hoehn and Yahr Scale (HYS) stage 4 or higher
Any major psychiatric diagnosis, including schizophrenia, bipolar disorder and current major depressive disorder as per Diagnostic and Statistical Manual of Mental Disorders Fifth Edition
Geriatric Depression Scale (GDS) score >8
Severe visual or hearing impairment that may interfere with the participant study assessments including cognitive testing
Any contraindications to lumbar puncture
History of deep brain stimulation or other neurosurgical procedure for Parkinson's disease
Has thyroid stimulating hormone (TSH) above normal range
Abnormally low serum vitamin B12 levels (< the lower limit of normal [LLN]) for the testing laboratory
Contraindications to MRI scanning
Evidence of other clinically significant lesions that suggest a dementia diagnosis other than DLB or PDD on brain MRI at Screening
Other significant pathological findings on brain MRI at Screening
Hypersensitivity to E2027 or any of the excipients
A prolonged corrected QT interval calculated using Fridericia's formula (QTcF) as demonstrated by triplicate ECG at the Screening or Baseline Visit (that is, mean value >450 millisecond [msec])
Had symptomatic orthostatic hypotension or symptomatic orthostatic tachycardia which resulted in hospitalization or urgent medical review in hospital in the past 12 months before Screening
Any other clinically significant abnormalities in vital signs, ECG and laboratory values that in the opinion of the investigator, require further investigation or treatment or that may interfere with study procedures or safety
Malignant neoplasms within 3 years of Screening (except for basal or squamous cell carcinoma of the skin, or localized prostate cancer in male participants). Participants who had malignant neoplasms but who have had at least 3 years of documented uninterrupted remission before Screening need not be excluded.
Has a ""yes"" answer to C-SSRS suicidal ideation Type 4 or 5, or any suicidal behavior assessment within 6 months before Screening, at Screening, or at the Baseline Visit, or has been hospitalized or treated for suicidal behavior in the past 5 years before Screening
Known or suspected history of drug or alcohol dependency or abuse within 2 years before Screening, current use of recreational drugs or a positive urine drug test at Screening.
Any other medical conditions (example, cardiac, respiratory, gastrointestinal, renal disease) which are not stably and adequately controlled, or which in the opinion of the investigator may affect the participant's safety or interfere with the study assessments
Taking any of the prohibited medications or not meeting the requirements regarding stable doses of permitted medications
Participation in a clinical study involving any investigational drug/device for DLB or PDD within 6 months before Screening or any other investigational drug/device in the 8 weeks or 5 half-lives (whichever is longer) of the study medication before Screening unless it can be documented that the participant was in a placebo treatment arm
Planned surgery which requires general, spinal or epidural anesthesia that will take place during the study.
Males who have not had a successful vasectomy (confirmed azoospermia) if their female partners are of childbearing potential and are not willing to use a highly effective contraceptive method throughout the study period and for 98 days after study drug discontinuation. No sperm donation is allowed during the study period and for 98 days after study drug discontinuation.
Females who are breastfeeding or pregnant at Screening or Baseline

Females of childbearing potential who:

Within 28 days before study entry, did not use a highly effective method of contraception
Do not agree to use a highly effective method of contraception throughout the entire study period and for 28 days after study drug discontinuation","Participants with DLB (with amyloid copathology) received E2027 50 mg capsules, orally, once daily up to 12 weeks.",ChEMBL:CHEMBL4650368 | PubChem:136253996,IRSENONTRINE,COc1ncc(C)c(-c2ccc3c(c2)[nH]c(=O)c2cnn([C@H]4CCOC4)c23)c1C,,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT04764669,NCT04764669_EG002,No,All,Adult | Older Adult,Phase 2,10,"Inclusion Criteria:

Male or female, age 50 to 85 years, inclusive at time of consent
Meet criteria for probable DLB (as defined by the 4th report of the DLB Consortium) or meet criteria for probable PDD (as defined by the task force of the Movement Disorder Society).
Mini-mental state examination (MMSE) greater than (>) 14 and less than (<) 26 at Screening Visit
For DLB participants, have experienced visual hallucinations since onset of their DLB
If receiving acetylcholinesterase inhibitors (AChEIs), must have been on a stable dose for at least 12 weeks before Screening Visit, with no plans for dose adjustment during the study. Treatment naive participants can be entered into the study but there should be no plans to initiate treatment with AChEIs from Screening to the end of the study.
If receiving memantine, must have been on a stable dose for at least 12 weeks before Screening Visit, with no plans for dose adjustment during the study. Treatment naive participants can be entered into the study but there should be no plans to initiate treatment with memantine from Screening to the end of the study.
If receiving Parkinson's disease medications, must have been on a stable dose for at least 4 weeks before Screening Visit, with no plans for dose adjustment during the study.
Must have an identified caregiver or informant who is willing and able to provide follow up information on the participant throughout the course of the study.
Provide written informed consent.

Exclusion Criteria:

Any neurological condition that may be contributing to cognitive impairment above and beyond those caused by the participant's DLB or PDD, including any comorbidities detected by clinical assessment or magnetic resonance imaging (MRI) (identification of amyloid copathology is not exclusionary)
History of transient ischemic attacks or stroke within 12 months of Screening
Modified Hachinski Ischemic Scale >4
Parkinsonian (extrapyramidal) features with Hoehn and Yahr Scale (HYS) stage 4 or higher
Any major psychiatric diagnosis, including schizophrenia, bipolar disorder and current major depressive disorder as per Diagnostic and Statistical Manual of Mental Disorders Fifth Edition
Geriatric Depression Scale (GDS) score >8
Severe visual or hearing impairment that may interfere with the participant study assessments including cognitive testing
Any contraindications to lumbar puncture
History of deep brain stimulation or other neurosurgical procedure for Parkinson's disease
Has thyroid stimulating hormone (TSH) above normal range
Abnormally low serum vitamin B12 levels (< the lower limit of normal [LLN]) for the testing laboratory
Contraindications to MRI scanning
Evidence of other clinically significant lesions that suggest a dementia diagnosis other than DLB or PDD on brain MRI at Screening
Other significant pathological findings on brain MRI at Screening
Hypersensitivity to E2027 or any of the excipients
A prolonged corrected QT interval calculated using Fridericia's formula (QTcF) as demonstrated by triplicate ECG at the Screening or Baseline Visit (that is, mean value >450 millisecond [msec])
Had symptomatic orthostatic hypotension or symptomatic orthostatic tachycardia which resulted in hospitalization or urgent medical review in hospital in the past 12 months before Screening
Any other clinically significant abnormalities in vital signs, ECG and laboratory values that in the opinion of the investigator, require further investigation or treatment or that may interfere with study procedures or safety
Malignant neoplasms within 3 years of Screening (except for basal or squamous cell carcinoma of the skin, or localized prostate cancer in male participants). Participants who had malignant neoplasms but who have had at least 3 years of documented uninterrupted remission before Screening need not be excluded.
Has a ""yes"" answer to C-SSRS suicidal ideation Type 4 or 5, or any suicidal behavior assessment within 6 months before Screening, at Screening, or at the Baseline Visit, or has been hospitalized or treated for suicidal behavior in the past 5 years before Screening
Known or suspected history of drug or alcohol dependency or abuse within 2 years before Screening, current use of recreational drugs or a positive urine drug test at Screening.
Any other medical conditions (example, cardiac, respiratory, gastrointestinal, renal disease) which are not stably and adequately controlled, or which in the opinion of the investigator may affect the participant's safety or interfere with the study assessments
Taking any of the prohibited medications or not meeting the requirements regarding stable doses of permitted medications
Participation in a clinical study involving any investigational drug/device for DLB or PDD within 6 months before Screening or any other investigational drug/device in the 8 weeks or 5 half-lives (whichever is longer) of the study medication before Screening unless it can be documented that the participant was in a placebo treatment arm
Planned surgery which requires general, spinal or epidural anesthesia that will take place during the study.
Males who have not had a successful vasectomy (confirmed azoospermia) if their female partners are of childbearing potential and are not willing to use a highly effective contraceptive method throughout the study period and for 98 days after study drug discontinuation. No sperm donation is allowed during the study period and for 98 days after study drug discontinuation.
Females who are breastfeeding or pregnant at Screening or Baseline

Females of childbearing potential who:

Within 28 days before study entry, did not use a highly effective method of contraception
Do not agree to use a highly effective method of contraception throughout the entire study period and for 28 days after study drug discontinuation","Participants with PDD (without amyloid copathology) received E2027 50 mg capsules, orally, once daily up to 12 weeks.",ChEMBL:CHEMBL4650368 | PubChem:136253996,IRSENONTRINE,COc1ncc(C)c(-c2ccc3c(c2)[nH]c(=O)c2cnn([C@H]4CCOC4)c23)c1C,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT04764669,NCT04764669_EG003,No,All,Adult | Older Adult,Phase 2,3,"Inclusion Criteria:

Male or female, age 50 to 85 years, inclusive at time of consent
Meet criteria for probable DLB (as defined by the 4th report of the DLB Consortium) or meet criteria for probable PDD (as defined by the task force of the Movement Disorder Society).
Mini-mental state examination (MMSE) greater than (>) 14 and less than (<) 26 at Screening Visit
For DLB participants, have experienced visual hallucinations since onset of their DLB
If receiving acetylcholinesterase inhibitors (AChEIs), must have been on a stable dose for at least 12 weeks before Screening Visit, with no plans for dose adjustment during the study. Treatment naive participants can be entered into the study but there should be no plans to initiate treatment with AChEIs from Screening to the end of the study.
If receiving memantine, must have been on a stable dose for at least 12 weeks before Screening Visit, with no plans for dose adjustment during the study. Treatment naive participants can be entered into the study but there should be no plans to initiate treatment with memantine from Screening to the end of the study.
If receiving Parkinson's disease medications, must have been on a stable dose for at least 4 weeks before Screening Visit, with no plans for dose adjustment during the study.
Must have an identified caregiver or informant who is willing and able to provide follow up information on the participant throughout the course of the study.
Provide written informed consent.

Exclusion Criteria:

Any neurological condition that may be contributing to cognitive impairment above and beyond those caused by the participant's DLB or PDD, including any comorbidities detected by clinical assessment or magnetic resonance imaging (MRI) (identification of amyloid copathology is not exclusionary)
History of transient ischemic attacks or stroke within 12 months of Screening
Modified Hachinski Ischemic Scale >4
Parkinsonian (extrapyramidal) features with Hoehn and Yahr Scale (HYS) stage 4 or higher
Any major psychiatric diagnosis, including schizophrenia, bipolar disorder and current major depressive disorder as per Diagnostic and Statistical Manual of Mental Disorders Fifth Edition
Geriatric Depression Scale (GDS) score >8
Severe visual or hearing impairment that may interfere with the participant study assessments including cognitive testing
Any contraindications to lumbar puncture
History of deep brain stimulation or other neurosurgical procedure for Parkinson's disease
Has thyroid stimulating hormone (TSH) above normal range
Abnormally low serum vitamin B12 levels (< the lower limit of normal [LLN]) for the testing laboratory
Contraindications to MRI scanning
Evidence of other clinically significant lesions that suggest a dementia diagnosis other than DLB or PDD on brain MRI at Screening
Other significant pathological findings on brain MRI at Screening
Hypersensitivity to E2027 or any of the excipients
A prolonged corrected QT interval calculated using Fridericia's formula (QTcF) as demonstrated by triplicate ECG at the Screening or Baseline Visit (that is, mean value >450 millisecond [msec])
Had symptomatic orthostatic hypotension or symptomatic orthostatic tachycardia which resulted in hospitalization or urgent medical review in hospital in the past 12 months before Screening
Any other clinically significant abnormalities in vital signs, ECG and laboratory values that in the opinion of the investigator, require further investigation or treatment or that may interfere with study procedures or safety
Malignant neoplasms within 3 years of Screening (except for basal or squamous cell carcinoma of the skin, or localized prostate cancer in male participants). Participants who had malignant neoplasms but who have had at least 3 years of documented uninterrupted remission before Screening need not be excluded.
Has a ""yes"" answer to C-SSRS suicidal ideation Type 4 or 5, or any suicidal behavior assessment within 6 months before Screening, at Screening, or at the Baseline Visit, or has been hospitalized or treated for suicidal behavior in the past 5 years before Screening
Known or suspected history of drug or alcohol dependency or abuse within 2 years before Screening, current use of recreational drugs or a positive urine drug test at Screening.
Any other medical conditions (example, cardiac, respiratory, gastrointestinal, renal disease) which are not stably and adequately controlled, or which in the opinion of the investigator may affect the participant's safety or interfere with the study assessments
Taking any of the prohibited medications or not meeting the requirements regarding stable doses of permitted medications
Participation in a clinical study involving any investigational drug/device for DLB or PDD within 6 months before Screening or any other investigational drug/device in the 8 weeks or 5 half-lives (whichever is longer) of the study medication before Screening unless it can be documented that the participant was in a placebo treatment arm
Planned surgery which requires general, spinal or epidural anesthesia that will take place during the study.
Males who have not had a successful vasectomy (confirmed azoospermia) if their female partners are of childbearing potential and are not willing to use a highly effective contraceptive method throughout the study period and for 98 days after study drug discontinuation. No sperm donation is allowed during the study period and for 98 days after study drug discontinuation.
Females who are breastfeeding or pregnant at Screening or Baseline

Females of childbearing potential who:

Within 28 days before study entry, did not use a highly effective method of contraception
Do not agree to use a highly effective method of contraception throughout the entire study period and for 28 days after study drug discontinuation","Participants with PDD (with amyloid copathology) received E2027 50 mg capsules, orally, once daily up to 12 weeks.",ChEMBL:CHEMBL4650368 | PubChem:136253996,IRSENONTRINE,COc1ncc(C)c(-c2ccc3c(c2)[nH]c(=O)c2cnn([C@H]4CCOC4)c23)c1C,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0
NCT04771611,NCT04771611_EG000,No,All,Adult | Older Adult,Phase 2,29,"Inclusion Criteria:

Males and females, at least 18 years of age, capable and willing to provide informed consent;
Patient must have received a diagnosis of COVID-19 infection within the last 3 days;
Outpatient setting (not currently hospitalized);
Patient must possess at least one of the following high-risk criteria: 60 years or more of age, obesity (BMI ≥ 30 kg/m2), diabetes mellitus, uncontrolled hypertension (systolic blood pressure ≥150 mm Hg), known respiratory disease (including asthma, chronic obstructive pulmonary disease, or present or past smoking), known heart failure, known coronary disease, fever of ≥38.4°C within the last 48 hours, dyspnea at the time of presentation, the combination of high neutrophil count and low lymphocyte count;
Female patient is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile, or is of childbearing potential and practicing at least one method of contraception and preferably two complementary forms of contraception including a barrier method (e.g. male or female condoms, spermicides, sponges, foams, jellies, diaphragm, intrauterine device (IUD)) throughout the study and for 30 days after study completion;
Patient or their caregiver must be able and willing to comply with the requirements of this study protocol.

Exclusion Criteria:

Patient currently hospitalized or under immediate consideration for hospitalization;
Patient currently in shock or with hemodynamic instability;
Patient with severe hepatic disease (as per clinical judgement) and liver enzymes >10x the upper limit of normal;
Female patient who is pregnant, breast-feeding, or is considering becoming pregnant during the study or for 1 day after the last dose of study medication;
Patient currently taking Sirolimus, Tacrolimus, or other mTOR inhibitors for other indications (mainly chronic indications represented by organ transplantation or autoimmune diseases);
On Warfarin therapy;
Patient with a history of an allergic reaction or significant sensitivity to Fisetin;
Patient undergoing chemotherapy for cancer;
Patient is considered by the investigator, for any reason, to be an unsuitable study candidate.","Subjects who received treatment drug Fisetin

Fisetin: ~20mg/kg /day oral for four days (days 0,1 and days 8,9)",DrugBank:DB07795 | PubChem:5281614,Fisetin,O=c1c(O)c(-c2ccc(O)c(O)c2)oc2cc(O)ccc12,,0.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0
NCT04791514,NCT04791514_EG000,No,All,Adult | Older Adult,Phase 2,1,"Inclusion Criteria:

Participant must be ≥ 18 years of age at the time of signing the informed consent

Participants must have a diagnosis of World Health Organization Group 1 Pulmonary Hypertension (PH) (PAH) with the following characteristics

Etiology of idiopathic, heritable, drug/toxin-induced or connective tissue disease (CTD)-related PAH
Right heart catheterization with the following hemodynamic findings:
Mean pulmonary arterial pressure (mPAP) > 20 mmHg at rest,
Pulmonary capillary wedge pressure (PCWP) ≤ 15 mmHg, and
Pulmonary vascular resistance (PVR) of ≥ 3 Wood Units (WU)
No change in pulmonary hypertension medications (eg, ambrisentan, bosentan, macitentan, sildenafil, tadalafil, riociguat) or dosage for at least 90 days prior to Screening
No change in diuretic use or dosage for at least 30 days prior to Screening
Body mass index (BMI) within the range 18.0 - 32.0 kg/m^2 (inclusive)
Male participants: Male participants and their female partners of childbearing potential must agree to use highly effective contraception from Study Day 1 to at least 90 days after dosing
Female participants: Women of child-bearing potential (WOCPB, defined as premenopausal, not surgically sterile for at least 3 months prior to Screening) must use a highly effective contraception method and agree to be tested for pregnancy from at Screening, Baseline, and 30 days after dosing
Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol.

Exclusion Criteria:

Any PH other than idiopathic, hereditary, drug/toxin-induced, or connective tissue disease (CTD) associated PAH (eg, congenital heart disease-associated PAH, portal hypertension-associated PAH, PH belonging to Groups 2 through 5)
Allergy, or documented hypersensitivity or contraindication, to the ingredients of treprostinil palmitil inhalation powder (TPIP) or treprostinil (TRE)
Previous intolerance to prostacyclin analogs or receptor agonists (eg, selexipag) per investigator discretion
History of anaphylaxis or previously documented hypersensitivity reaction to any drug per Investigator discretion
History of heart disease including left ventricular ejection fraction (LVEF) ≤ 40% or clinically significant valvular, constrictive, or atherosclerotic heart disease (myocardial infarction, etc)

Active liver disease or hepatic dysfunction manifested as:

Elevated liver function test results (ALT or AST > 2 × ULN) at Screening
Bilirubin > 1.5 × ULN (isolated bilirubin > 1.5 × ULN; ULN is acceptable if bilirubin is fractionated and direct bilirubin < 35%) at Screening.
Known hepatic or biliary abnormalities, not including Gilbert's syndrome or asymptomatic gallstones at Screening.
History of HIV infection/positive HIV serology test result at Screening
History of active/chronic Hepatitis B or C/ positive hepatitis B or C serology test result at Screening
History of abnormal bleeding or bruising
Known or suspected immunodeficiency disorder, including history of invasive opportunistic infections (eg, tuberculosis, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis) despite infection resolution, or otherwise recurrent infections of abnormal frequency, or prolonged infections suggesting an immune-compromised status, as judged by the investigator
Active and current symptomatic infection by SARS CoV 2
Participants with current or recent (past 4 weeks) lower respiratory tract infection
History of malignancy in the past 5 years, with exception of completely treated in situ carcinoma of the cervix and completely treated non-metastatic squamous or basal cell carcinoma of the skin
Participants receiving triple combination therapy for PAH consisting of endothelin receptor agonists, phosphoesterase type 5 inhibitors, and guanylate cyclase stimulators (riociguat)
Participants receiving prostanoids/prostacyclin agonists
Participants receiving potent CYP2C8 inhibitors, such as gemfibrozil
Have participated in any other interventional clinical studies within 30 days of Baseline
Current or history of substance and/or alcohol abuse
Current user of cigarettes or e-cigarettes
Pregnant or breastfeeding","Participant received a single dose of TPIP 112.5 μg via oral inhalation on Day 1. The participant then entered into a 16-week EUT Period during which TPIP, administered via oral inhalation, was titrated up to a mean daily dose of 320 μg.",ChEMBL:CHEMBL4650232,TREPROSTINIL PALMITIL,CCCCCCCCCCCCCCCCOC(=O)COc1cccc2c1C[C@H]1C[C@@H](O)[C@H](CC[C@@H](O)CCCCC)[C@H]1C2,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT04792970,NCT04792970_EG000,No,All,Adult | Older Adult,Phase 4,2,"Inclusion Criteria:

Male or female, at least 18 years of age, inclusive.

Subject has a symptomatic MPE requiring intervention. For an effusion to be defined as malignant, at least one of the following must be true:

There is histocytological confirmation of pleural malignancy
The effusion is an exudate (per Light's criteria) in the context of histocytologically proven malignancy elsewhere, with no other clear cause for fluid identified.
Subject has a history of at least 1 ipsilateral pleural effusion causing dyspnea that responded to thoracentesis where the lung expanded and the dyspnea was improved.
Subject is willing and able to provide written informed consent.
Subject is willing and able to meet all study requirements, including follow-up visits and receiving study-related telephone calls.
Subject has sufficient pleural fluid to allow safe insertion of an IPC.
Subject has negative pregnancy test if appropriate.
Subject or caregiver is able to perform home drainage of the pleural effusion (a caregiver can be a friend, family member, or paid healthcare professional).

Exclusion Criteria:

Subject has significant trapped lung, or a proximal bronchial obstruction which is likely to lead to trapped lung. For a subject to be eligible for this study, two separate study center clinicians must agree that there is no significant trapped lung on the same CXR using visual estimation (reference guide). The CXR used to make this decision must have been performed ≤30 days preceding the consent form being signed, and must have been performed preferably on the same day, but no more than 7 calendar days after tunneled pleural catheter insertion. Significant trapped lung is deemed present if any 1 of the following criteria is met:

A CXR shows hydropneumothorax other than small (< 1 cm between chest wall and pleural line) apical pneumothoraces.
A CXR shows ≥20% of the affected hemithorax to be free of the expected lung parenchymal markings and there is no suggestion of pleural fluid.
A CXR shows ≥20% of the affected hemithorax to be occupied with pleural fluid AFTER a pleural aspiration which resulted in symptoms suggestive of trapped lung (e.g., chest pain or cough).
Subject has a Karnofsky score <50, or a World Health Organization (WHO)/ Eastern Cooperative Oncology Group (ECOG) performance status ≥3. Subjects who have a performance status of 3 may be considered for the study if the removal of their fluid would likely improve their performance score by 1 or more.
Subject is pregnant, planning to become pregnant, or is lactating.
Subject has a history of empyema.
Subject has a history of chylothorax.
Subject has an uncorrected coagulopathy.","This arm consists of eligible participants who are randomized to the Talc arm and would receive Talc therapy instilled into the pleural catheter.

Talc: All patients randomized to the Talc arm will receive Talc therapy through the pleural catheter.",ChEMBL:CHEMBL3990276 | DrugBank:DB09511,TALC,[H][O-].[H][O-].[Mg+2].[Mg+2].[Mg+2].[O-2].[O-2].[O-2].[O-2].[O-2].[O-2].[O-2].[O-2].[O-2].[O-2].[Si+4].[Si+4].[Si+4].[Si+4],,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0
NCT04799158,NCT04799158_EG000,No,All,Adult | Older Adult,Phase 2,457,"Inclusion Criteria for Run-In Period

The participant is ≥18 years of age at the time of informed consent signing.
In the opinion of the investigator or sub investigators, the participant is capable of understanding and complying with protocol requirements.
The participant signs and dates a written informed consent form (ICF) and any required privacy authorization prior to the initiation of any study procedures. The participant is informed of the full nature and purpose of the study, including possible risks and side effects. The participant has the ability to cooperate with the investigator. Ample time and opportunity should be given to read and understand verbal and/or written instructions.
The participant identified their main symptom as heartburn, a burning sensation in the retrosternal area (behind the breastbone).
History of episodes of heartburn for 6 months or longer prior to screening.
Heartburn reported on 4 or more days during any 7 consecutive days in the Screening Period as recorded in the electronic diary.
A female participant of childbearing potential who is or may be sexually active with a non sterilized male partner agrees to routinely use adequate contraception from the signing of informed consent until 4 weeks after the last dose of study drug.

Inclusion Criteria for On-Demand Treatment Period

The participant completes the Run-In Period, during which the participant was at least 80% compliant with open-label study drug.
The participant has stable disease, ie, no heartburn the last 7 days of the Run-In Period.
The participant continues to fulfill all eligibility criteria for the Run-In Period (except Inclusion Criteria 4).
Participant completes at least 80% of diary entries during Run-In Period, including 80% of diary entries over the last 7 days.

Exclusion Criteria for Run-In Period

Endoscopically confirmed erosive esophagitis (EE) during the Screening Period assessed by the investigator. Endoscopy should be performed after participants meet Inclusion Criteria 6. Any endoscopic confirmation performed in a routine clinical setting within 7 days before signing the informed consent is acceptable to use for the purpose of fulfilling the screening requirement.
The participant has active irritable bowel syndrome (IBS) or had a flare of IBS requiring therapy within the prior 6 months.
The participant has a history of or is suspected of having functional heartburn diagnosed by the Rome IV criteria.
The participant has a history of or is suspected of having functional dyspepsia diagnosed by the Rome IV criteria.
The participant has endoscopic Barrett's esophagus (>1 cm of columnar-lined esophagus) and/or definite dysplastic changes in the esophagus.
The participant has any other clinically significant condition affecting the esophagus, including eosinophilic esophagitis; esophageal varices; viral or fungal infection; esophageal stricture; a history of radiation therapy, radiofrequency ablation, endoscopic mucosal resection, or cryotherapy to the esophagus; or any history of caustic or physiochemical trauma (including sclerotherapy or esophageal variceal band ligation). However, participants diagnosed with Schatzki's ring (mucosal tissue ring around lower esophageal sphincter) or hiatal hernia are eligible to participate.
The participant has scleroderma (systemic sclerosis).
The participant has a history of surgery or endoscopic treatment affecting gastroesophageal reflux, including fundoplication and dilation for esophageal stricture (except Schatzki's ring) or a history of gastric or duodenal surgery (except endoscopic removal of benign polyps).
The participant has an active gastric or duodenal ulcer within 4 weeks before the first dose of study drug.
Use of prescription or non-prescription proton pump inhibitors (PPIs) or histamine-2 receptor antagonists (H2RAs) throughout the study.
The participant has received vonoprazan in a clinical trial at any time or any other investigational compound (including those in post-marketing studies) within 30 days prior to the start of the Screening Period. A participant who has been screen failed from another clinical study and who has not been dosed may be considered for enrollment in this study.
The participant is a study site employee, an immediate family member, or is in a dependent relationship with a study site employee who is involved in the conduct of this study (eg, spouse, parent, child, sibling) or who may have consented under duress.
The participant has cutaneous lupus erythematosus or systemic lupus erythematosus.
The participant has had clinically significant upper or lower gastrointestinal bleeding within 4 weeks prior to screening.
The participant has Zollinger-Ellison syndrome or other gastric acid hypersecretory conditions.
The participant has a history of hypersensitivity or allergies to vonoprazan (including the formulation excipients: D-mannitol, microcrystalline cellulose, hydroxypropyl cellulose, fumaric acid, croscarmellose sodium, magnesium stearate, hypromellose, macrogol 8000, titanium oxide, or red or yellow ferric oxide). Skin testing may be performed according to local standard practice to confirm hypersensitivity.
The participant has a history of alcohol abuse, illegal drug use, drug addiction, or regularly consumes >21 units of alcohol (1 unit = 12 oz/300 mL beer, 1.5 oz/25 mL hard liquor/spirits, or 5 oz/100 mL wine) per week based on self-report within the 12 months prior to screening. Participants must have a negative urine drug screen for cannabinoids/ tetrahydrocannabinol and nonprescribed medications at screening. Participants taking prescription drugs (except prescription cannabinoids/tetrahydrocannabinol) will be allowed.
The participant is taking any excluded medications or treatments listed in the protocol.
If female, the participant is pregnant, lactating, or intending to become pregnant before, during, or within 4 weeks after participating in this study, or intending to donate ova during such time period.
The participant has a history or clinical manifestations of significant central nervous system, cardiovascular, pulmonary, hepatic, renal, metabolic, other gastrointestinal, urological, endocrine, or hematological disease that, in the opinion of the investigator, would confound the study results or compromise participant safety.
The participant requires hospitalization or has surgery scheduled during the course of the study or has undergone major surgical procedures within 30 days prior to the Screening Visit.
The participant has a history of malignancy or has been treated for malignancy within 5 years prior to the start of the Screening Period (Visit 1). (The participant may be included in the study if he/she has recovered from cutaneous basal cell carcinoma or cervical carcinoma in situ).
The participant has acquired immune deficiency syndrome (AIDS) or human immunodeficiency virus (HIV) infection, or tests positive for the hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or HCV ribonucleic acid (HCV-RNA). However, participants who test positive for HCV antibody but negative for HCV-RNA are permitted to participate.

The participant has any of the following abnormal laboratory test values at the start of the Screening Period:

Creatinine levels: >2 mg/dL (>177 μmol/L)
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2 × the upper limit of normal (ULN) or total bilirubin >2 × ULN (except participants with Gilbert Syndrome)",Participants received oral vonoprazan 20 mg QD for up to 4 weeks.,ChEMBL:CHEMBL2079130 | DrugBank:DB11739 | PubChem:15981397,Vonoprazan,CNCc1cc(-c2ccccc2F)n(S(=O)(=O)c2cccnc2)c1,A02BC08 | A02BD14 | A02BD15,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT04799158,NCT04799158_EG001,No,All,Adult | Older Adult,Phase 2,49,"Inclusion Criteria for Run-In Period

The participant is ≥18 years of age at the time of informed consent signing.
In the opinion of the investigator or sub investigators, the participant is capable of understanding and complying with protocol requirements.
The participant signs and dates a written informed consent form (ICF) and any required privacy authorization prior to the initiation of any study procedures. The participant is informed of the full nature and purpose of the study, including possible risks and side effects. The participant has the ability to cooperate with the investigator. Ample time and opportunity should be given to read and understand verbal and/or written instructions.
The participant identified their main symptom as heartburn, a burning sensation in the retrosternal area (behind the breastbone).
History of episodes of heartburn for 6 months or longer prior to screening.
Heartburn reported on 4 or more days during any 7 consecutive days in the Screening Period as recorded in the electronic diary.
A female participant of childbearing potential who is or may be sexually active with a non sterilized male partner agrees to routinely use adequate contraception from the signing of informed consent until 4 weeks after the last dose of study drug.

Inclusion Criteria for On-Demand Treatment Period

The participant completes the Run-In Period, during which the participant was at least 80% compliant with open-label study drug.
The participant has stable disease, ie, no heartburn the last 7 days of the Run-In Period.
The participant continues to fulfill all eligibility criteria for the Run-In Period (except Inclusion Criteria 4).
Participant completes at least 80% of diary entries during Run-In Period, including 80% of diary entries over the last 7 days.

Exclusion Criteria for Run-In Period

Endoscopically confirmed erosive esophagitis (EE) during the Screening Period assessed by the investigator. Endoscopy should be performed after participants meet Inclusion Criteria 6. Any endoscopic confirmation performed in a routine clinical setting within 7 days before signing the informed consent is acceptable to use for the purpose of fulfilling the screening requirement.
The participant has active irritable bowel syndrome (IBS) or had a flare of IBS requiring therapy within the prior 6 months.
The participant has a history of or is suspected of having functional heartburn diagnosed by the Rome IV criteria.
The participant has a history of or is suspected of having functional dyspepsia diagnosed by the Rome IV criteria.
The participant has endoscopic Barrett's esophagus (>1 cm of columnar-lined esophagus) and/or definite dysplastic changes in the esophagus.
The participant has any other clinically significant condition affecting the esophagus, including eosinophilic esophagitis; esophageal varices; viral or fungal infection; esophageal stricture; a history of radiation therapy, radiofrequency ablation, endoscopic mucosal resection, or cryotherapy to the esophagus; or any history of caustic or physiochemical trauma (including sclerotherapy or esophageal variceal band ligation). However, participants diagnosed with Schatzki's ring (mucosal tissue ring around lower esophageal sphincter) or hiatal hernia are eligible to participate.
The participant has scleroderma (systemic sclerosis).
The participant has a history of surgery or endoscopic treatment affecting gastroesophageal reflux, including fundoplication and dilation for esophageal stricture (except Schatzki's ring) or a history of gastric or duodenal surgery (except endoscopic removal of benign polyps).
The participant has an active gastric or duodenal ulcer within 4 weeks before the first dose of study drug.
Use of prescription or non-prescription proton pump inhibitors (PPIs) or histamine-2 receptor antagonists (H2RAs) throughout the study.
The participant has received vonoprazan in a clinical trial at any time or any other investigational compound (including those in post-marketing studies) within 30 days prior to the start of the Screening Period. A participant who has been screen failed from another clinical study and who has not been dosed may be considered for enrollment in this study.
The participant is a study site employee, an immediate family member, or is in a dependent relationship with a study site employee who is involved in the conduct of this study (eg, spouse, parent, child, sibling) or who may have consented under duress.
The participant has cutaneous lupus erythematosus or systemic lupus erythematosus.
The participant has had clinically significant upper or lower gastrointestinal bleeding within 4 weeks prior to screening.
The participant has Zollinger-Ellison syndrome or other gastric acid hypersecretory conditions.
The participant has a history of hypersensitivity or allergies to vonoprazan (including the formulation excipients: D-mannitol, microcrystalline cellulose, hydroxypropyl cellulose, fumaric acid, croscarmellose sodium, magnesium stearate, hypromellose, macrogol 8000, titanium oxide, or red or yellow ferric oxide). Skin testing may be performed according to local standard practice to confirm hypersensitivity.
The participant has a history of alcohol abuse, illegal drug use, drug addiction, or regularly consumes >21 units of alcohol (1 unit = 12 oz/300 mL beer, 1.5 oz/25 mL hard liquor/spirits, or 5 oz/100 mL wine) per week based on self-report within the 12 months prior to screening. Participants must have a negative urine drug screen for cannabinoids/ tetrahydrocannabinol and nonprescribed medications at screening. Participants taking prescription drugs (except prescription cannabinoids/tetrahydrocannabinol) will be allowed.
The participant is taking any excluded medications or treatments listed in the protocol.
If female, the participant is pregnant, lactating, or intending to become pregnant before, during, or within 4 weeks after participating in this study, or intending to donate ova during such time period.
The participant has a history or clinical manifestations of significant central nervous system, cardiovascular, pulmonary, hepatic, renal, metabolic, other gastrointestinal, urological, endocrine, or hematological disease that, in the opinion of the investigator, would confound the study results or compromise participant safety.
The participant requires hospitalization or has surgery scheduled during the course of the study or has undergone major surgical procedures within 30 days prior to the Screening Visit.
The participant has a history of malignancy or has been treated for malignancy within 5 years prior to the start of the Screening Period (Visit 1). (The participant may be included in the study if he/she has recovered from cutaneous basal cell carcinoma or cervical carcinoma in situ).
The participant has acquired immune deficiency syndrome (AIDS) or human immunodeficiency virus (HIV) infection, or tests positive for the hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or HCV ribonucleic acid (HCV-RNA). However, participants who test positive for HCV antibody but negative for HCV-RNA are permitted to participate.

The participant has any of the following abnormal laboratory test values at the start of the Screening Period:

Creatinine levels: >2 mg/dL (>177 μmol/L)
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2 × the upper limit of normal (ULN) or total bilirubin >2 × ULN (except participants with Gilbert Syndrome)",Participants who had stable disease (no heartburn on the last 7 days of the Run-In Period) received oral vonoprazan 10 mg when heartburn occurred during the 6 week On-Demand Treatment Period. Participants could take no more than one dose in a 24-hour period.,ChEMBL:CHEMBL2079130 | DrugBank:DB11739 | PubChem:15981397,Vonoprazan,CNCc1cc(-c2ccccc2F)n(S(=O)(=O)c2cccnc2)c1,A02BC08 | A02BD14 | A02BD15,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT04799158,NCT04799158_EG002,No,All,Adult | Older Adult,Phase 2,49,"Inclusion Criteria for Run-In Period

The participant is ≥18 years of age at the time of informed consent signing.
In the opinion of the investigator or sub investigators, the participant is capable of understanding and complying with protocol requirements.
The participant signs and dates a written informed consent form (ICF) and any required privacy authorization prior to the initiation of any study procedures. The participant is informed of the full nature and purpose of the study, including possible risks and side effects. The participant has the ability to cooperate with the investigator. Ample time and opportunity should be given to read and understand verbal and/or written instructions.
The participant identified their main symptom as heartburn, a burning sensation in the retrosternal area (behind the breastbone).
History of episodes of heartburn for 6 months or longer prior to screening.
Heartburn reported on 4 or more days during any 7 consecutive days in the Screening Period as recorded in the electronic diary.
A female participant of childbearing potential who is or may be sexually active with a non sterilized male partner agrees to routinely use adequate contraception from the signing of informed consent until 4 weeks after the last dose of study drug.

Inclusion Criteria for On-Demand Treatment Period

The participant completes the Run-In Period, during which the participant was at least 80% compliant with open-label study drug.
The participant has stable disease, ie, no heartburn the last 7 days of the Run-In Period.
The participant continues to fulfill all eligibility criteria for the Run-In Period (except Inclusion Criteria 4).
Participant completes at least 80% of diary entries during Run-In Period, including 80% of diary entries over the last 7 days.

Exclusion Criteria for Run-In Period

Endoscopically confirmed erosive esophagitis (EE) during the Screening Period assessed by the investigator. Endoscopy should be performed after participants meet Inclusion Criteria 6. Any endoscopic confirmation performed in a routine clinical setting within 7 days before signing the informed consent is acceptable to use for the purpose of fulfilling the screening requirement.
The participant has active irritable bowel syndrome (IBS) or had a flare of IBS requiring therapy within the prior 6 months.
The participant has a history of or is suspected of having functional heartburn diagnosed by the Rome IV criteria.
The participant has a history of or is suspected of having functional dyspepsia diagnosed by the Rome IV criteria.
The participant has endoscopic Barrett's esophagus (>1 cm of columnar-lined esophagus) and/or definite dysplastic changes in the esophagus.
The participant has any other clinically significant condition affecting the esophagus, including eosinophilic esophagitis; esophageal varices; viral or fungal infection; esophageal stricture; a history of radiation therapy, radiofrequency ablation, endoscopic mucosal resection, or cryotherapy to the esophagus; or any history of caustic or physiochemical trauma (including sclerotherapy or esophageal variceal band ligation). However, participants diagnosed with Schatzki's ring (mucosal tissue ring around lower esophageal sphincter) or hiatal hernia are eligible to participate.
The participant has scleroderma (systemic sclerosis).
The participant has a history of surgery or endoscopic treatment affecting gastroesophageal reflux, including fundoplication and dilation for esophageal stricture (except Schatzki's ring) or a history of gastric or duodenal surgery (except endoscopic removal of benign polyps).
The participant has an active gastric or duodenal ulcer within 4 weeks before the first dose of study drug.
Use of prescription or non-prescription proton pump inhibitors (PPIs) or histamine-2 receptor antagonists (H2RAs) throughout the study.
The participant has received vonoprazan in a clinical trial at any time or any other investigational compound (including those in post-marketing studies) within 30 days prior to the start of the Screening Period. A participant who has been screen failed from another clinical study and who has not been dosed may be considered for enrollment in this study.
The participant is a study site employee, an immediate family member, or is in a dependent relationship with a study site employee who is involved in the conduct of this study (eg, spouse, parent, child, sibling) or who may have consented under duress.
The participant has cutaneous lupus erythematosus or systemic lupus erythematosus.
The participant has had clinically significant upper or lower gastrointestinal bleeding within 4 weeks prior to screening.
The participant has Zollinger-Ellison syndrome or other gastric acid hypersecretory conditions.
The participant has a history of hypersensitivity or allergies to vonoprazan (including the formulation excipients: D-mannitol, microcrystalline cellulose, hydroxypropyl cellulose, fumaric acid, croscarmellose sodium, magnesium stearate, hypromellose, macrogol 8000, titanium oxide, or red or yellow ferric oxide). Skin testing may be performed according to local standard practice to confirm hypersensitivity.
The participant has a history of alcohol abuse, illegal drug use, drug addiction, or regularly consumes >21 units of alcohol (1 unit = 12 oz/300 mL beer, 1.5 oz/25 mL hard liquor/spirits, or 5 oz/100 mL wine) per week based on self-report within the 12 months prior to screening. Participants must have a negative urine drug screen for cannabinoids/ tetrahydrocannabinol and nonprescribed medications at screening. Participants taking prescription drugs (except prescription cannabinoids/tetrahydrocannabinol) will be allowed.
The participant is taking any excluded medications or treatments listed in the protocol.
If female, the participant is pregnant, lactating, or intending to become pregnant before, during, or within 4 weeks after participating in this study, or intending to donate ova during such time period.
The participant has a history or clinical manifestations of significant central nervous system, cardiovascular, pulmonary, hepatic, renal, metabolic, other gastrointestinal, urological, endocrine, or hematological disease that, in the opinion of the investigator, would confound the study results or compromise participant safety.
The participant requires hospitalization or has surgery scheduled during the course of the study or has undergone major surgical procedures within 30 days prior to the Screening Visit.
The participant has a history of malignancy or has been treated for malignancy within 5 years prior to the start of the Screening Period (Visit 1). (The participant may be included in the study if he/she has recovered from cutaneous basal cell carcinoma or cervical carcinoma in situ).
The participant has acquired immune deficiency syndrome (AIDS) or human immunodeficiency virus (HIV) infection, or tests positive for the hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or HCV ribonucleic acid (HCV-RNA). However, participants who test positive for HCV antibody but negative for HCV-RNA are permitted to participate.

The participant has any of the following abnormal laboratory test values at the start of the Screening Period:

Creatinine levels: >2 mg/dL (>177 μmol/L)
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2 × the upper limit of normal (ULN) or total bilirubin >2 × ULN (except participants with Gilbert Syndrome)",Participants who had stable disease (no heartburn on the last 7 days of the Run-In Period) received oral vonoprazan 20 mg when heartburn occurred during the 6 week On-Demand Treatment Period. Participants could take no more than one dose in a 24-hour period.,ChEMBL:CHEMBL2079130 | DrugBank:DB11739 | PubChem:15981397,Vonoprazan,CNCc1cc(-c2ccccc2F)n(S(=O)(=O)c2cccnc2)c1,A02BC08 | A02BD14 | A02BD15,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT04799158,NCT04799158_EG003,No,All,Adult | Older Adult,Phase 2,48,"Inclusion Criteria for Run-In Period

The participant is ≥18 years of age at the time of informed consent signing.
In the opinion of the investigator or sub investigators, the participant is capable of understanding and complying with protocol requirements.
The participant signs and dates a written informed consent form (ICF) and any required privacy authorization prior to the initiation of any study procedures. The participant is informed of the full nature and purpose of the study, including possible risks and side effects. The participant has the ability to cooperate with the investigator. Ample time and opportunity should be given to read and understand verbal and/or written instructions.
The participant identified their main symptom as heartburn, a burning sensation in the retrosternal area (behind the breastbone).
History of episodes of heartburn for 6 months or longer prior to screening.
Heartburn reported on 4 or more days during any 7 consecutive days in the Screening Period as recorded in the electronic diary.
A female participant of childbearing potential who is or may be sexually active with a non sterilized male partner agrees to routinely use adequate contraception from the signing of informed consent until 4 weeks after the last dose of study drug.

Inclusion Criteria for On-Demand Treatment Period

The participant completes the Run-In Period, during which the participant was at least 80% compliant with open-label study drug.
The participant has stable disease, ie, no heartburn the last 7 days of the Run-In Period.
The participant continues to fulfill all eligibility criteria for the Run-In Period (except Inclusion Criteria 4).
Participant completes at least 80% of diary entries during Run-In Period, including 80% of diary entries over the last 7 days.

Exclusion Criteria for Run-In Period

Endoscopically confirmed erosive esophagitis (EE) during the Screening Period assessed by the investigator. Endoscopy should be performed after participants meet Inclusion Criteria 6. Any endoscopic confirmation performed in a routine clinical setting within 7 days before signing the informed consent is acceptable to use for the purpose of fulfilling the screening requirement.
The participant has active irritable bowel syndrome (IBS) or had a flare of IBS requiring therapy within the prior 6 months.
The participant has a history of or is suspected of having functional heartburn diagnosed by the Rome IV criteria.
The participant has a history of or is suspected of having functional dyspepsia diagnosed by the Rome IV criteria.
The participant has endoscopic Barrett's esophagus (>1 cm of columnar-lined esophagus) and/or definite dysplastic changes in the esophagus.
The participant has any other clinically significant condition affecting the esophagus, including eosinophilic esophagitis; esophageal varices; viral or fungal infection; esophageal stricture; a history of radiation therapy, radiofrequency ablation, endoscopic mucosal resection, or cryotherapy to the esophagus; or any history of caustic or physiochemical trauma (including sclerotherapy or esophageal variceal band ligation). However, participants diagnosed with Schatzki's ring (mucosal tissue ring around lower esophageal sphincter) or hiatal hernia are eligible to participate.
The participant has scleroderma (systemic sclerosis).
The participant has a history of surgery or endoscopic treatment affecting gastroesophageal reflux, including fundoplication and dilation for esophageal stricture (except Schatzki's ring) or a history of gastric or duodenal surgery (except endoscopic removal of benign polyps).
The participant has an active gastric or duodenal ulcer within 4 weeks before the first dose of study drug.
Use of prescription or non-prescription proton pump inhibitors (PPIs) or histamine-2 receptor antagonists (H2RAs) throughout the study.
The participant has received vonoprazan in a clinical trial at any time or any other investigational compound (including those in post-marketing studies) within 30 days prior to the start of the Screening Period. A participant who has been screen failed from another clinical study and who has not been dosed may be considered for enrollment in this study.
The participant is a study site employee, an immediate family member, or is in a dependent relationship with a study site employee who is involved in the conduct of this study (eg, spouse, parent, child, sibling) or who may have consented under duress.
The participant has cutaneous lupus erythematosus or systemic lupus erythematosus.
The participant has had clinically significant upper or lower gastrointestinal bleeding within 4 weeks prior to screening.
The participant has Zollinger-Ellison syndrome or other gastric acid hypersecretory conditions.
The participant has a history of hypersensitivity or allergies to vonoprazan (including the formulation excipients: D-mannitol, microcrystalline cellulose, hydroxypropyl cellulose, fumaric acid, croscarmellose sodium, magnesium stearate, hypromellose, macrogol 8000, titanium oxide, or red or yellow ferric oxide). Skin testing may be performed according to local standard practice to confirm hypersensitivity.
The participant has a history of alcohol abuse, illegal drug use, drug addiction, or regularly consumes >21 units of alcohol (1 unit = 12 oz/300 mL beer, 1.5 oz/25 mL hard liquor/spirits, or 5 oz/100 mL wine) per week based on self-report within the 12 months prior to screening. Participants must have a negative urine drug screen for cannabinoids/ tetrahydrocannabinol and nonprescribed medications at screening. Participants taking prescription drugs (except prescription cannabinoids/tetrahydrocannabinol) will be allowed.
The participant is taking any excluded medications or treatments listed in the protocol.
If female, the participant is pregnant, lactating, or intending to become pregnant before, during, or within 4 weeks after participating in this study, or intending to donate ova during such time period.
The participant has a history or clinical manifestations of significant central nervous system, cardiovascular, pulmonary, hepatic, renal, metabolic, other gastrointestinal, urological, endocrine, or hematological disease that, in the opinion of the investigator, would confound the study results or compromise participant safety.
The participant requires hospitalization or has surgery scheduled during the course of the study or has undergone major surgical procedures within 30 days prior to the Screening Visit.
The participant has a history of malignancy or has been treated for malignancy within 5 years prior to the start of the Screening Period (Visit 1). (The participant may be included in the study if he/she has recovered from cutaneous basal cell carcinoma or cervical carcinoma in situ).
The participant has acquired immune deficiency syndrome (AIDS) or human immunodeficiency virus (HIV) infection, or tests positive for the hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or HCV ribonucleic acid (HCV-RNA). However, participants who test positive for HCV antibody but negative for HCV-RNA are permitted to participate.

The participant has any of the following abnormal laboratory test values at the start of the Screening Period:

Creatinine levels: >2 mg/dL (>177 μmol/L)
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2 × the upper limit of normal (ULN) or total bilirubin >2 × ULN (except participants with Gilbert Syndrome)",Participants who had stable disease (no heartburn on the last 7 days of the Run-In Period) received oral vonoprazan 40 mg when heartburn occurred during the 6 week On-Demand Treatment Period. Participants could take no more than one dose in a 24-hour period.,ChEMBL:CHEMBL2079130 | DrugBank:DB11739 | PubChem:15981397,Vonoprazan,CNCc1cc(-c2ccccc2F)n(S(=O)(=O)c2cccnc2)c1,A02BC08 | A02BD14 | A02BD15,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT04842747,NCT04842747_EG000,No,All,Adult | Older Adult,Phase 3,130,"Inclusion Criteria:

Provide informed consent from the subject or the subject's Legally Authorized Representative (LAR)
Aged ≥18 years
Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) infection confirmed by polymerase chain reaction (PCR) test
Patients with a WHO Ordinal Scale for Clinical Improvement score of 4 at high risk for ARDS, must have at least one of the known comorbidities for being at high risk, such as, Asthma (moderate to severe), Chronic Lung Disease, Diabetes, Hypertension, Severe Obesity (BMI ≥40), 65 years of age or older, primarily reside in a nursing home or long-term care facility, or immunocompromised and patients with a WHO Ordinal Scale for Clinical Improvement score of 5 or 6 regardless of presence of comorbidities.
WHO Ordinal Scale for Clinical Improvement score of 4 (Oxygen by mask or nasal prongs), 5 (Non-invasive ventilation or high-flow oxygen) or 6 (Intubation and mechanical ventilation)
Peripheral capillary oxygen saturation (SpO2) ≤ 94% on room air at screening. If patient is on oxygen therapy at the time of presentation for screening and the SpO2 levels were ≤94% prior to introduction to oxygen therapy with proper documentation example EMT notes or ER/ED notes, then the patient is considered to have met this inclusion criterion. If patient is on oxygen therapy at the time of presentation for screening and the SpO2 levels prior to introduction to oxygen therapy are unknown, the patient may be considered to have met this inclusion criterion if oxygen therapy is removed and the SpO2 levels fall to ≤94%, then the patient is considered to have met this inclusion criterion. However, removal of the oxygen therapy should only be done if it is considered medically reasonable
Subjects must agree to follow doctor's recommendation for oxygen supplementation

Subjects must agree to use acceptable methods of contraception:

If female of childbearing potential or a male subject's partner could become pregnant, use acceptable methods of contraception from the time of the first administration of study medication until 6months following administration of the last dose of study medication. Acceptable methods of contraception are as follows: Condom with spermicidal foam/gel/film/cream/suppository [i.e., barrier method of contraception], surgical sterilization (vasectomy with documentation of azospermia) and a barrier method {condom used with spermicidal foam/gel/film/cream/suppository}, the female partner uses oral contraceptives (combination estrogen/progesterone pills), injectable progesterone or subdermal implants and a barrier method (condom used with spermicidal foam/gel/film/cream/suppository)
If the female partner of a male subject has undergone documented tuballigation (female sterilization), a barrier method (condom used with spermicidal foam/gel/film/cream/suppository)should also be used
If female partner of a male subject has undergone documented placement of an intrauterine device (IUD) or intrauterine system (IUS),a barrier method (condom with spermicidal foam/gel/film/cream/suppository)should also be used
Subject is willing to comply with the requirements of the protocol through the end of the study

Exclusion Criteria:

Known hypersensitivity or allergy to colchicine
Pregnant or currently breast feeding
Participation in any other clinical trial of an experimental treatment for COVID- 19. Convalescent plasma, dexamethasone and remdesivir are allowed in this study.
Concurrent treatment with other experimental agents with actual or possible direct acting antiviral activity against COVID-19is prohibited <24 hours prior to study drug dosing(except standard of care). Remdesivir, dexamethasone and convalescent plasma are allowed in the study.
Requiring ventilation + additional organ support - pressors, RRT, ECMO(WHO Ordinal Scale for Clinical Improvement - Score of 7). NOTE: short term (PRN) use of pressors is allowed
Alanine Aminotransferase (ALT) or aspartate aminotransferase(AST) >3X upper limit of normal (ULN)
Total bilirubin > ULN
Creatinine clearance < 60 mL/min
Documented medical history of liver disease, including but not limited to, prior diagnosis of hepatitis of any etiology, cirrhosis, portal hypertension, or confirmed or suspected esophageal varices
Moderate to severe renal impairment
Hepatic impairment
History of hepatitis - (Hepatitis B and C) NOTE: treated and controlled hepatitis C is allowed
Any comorbid disease or condition (medical or surgical) which might compromise the hematologic, cardiovascular, endocrine, pulmonary, renal, gastrointestinal, hepatic, or central nervous system; or other conditions that may interfere with the absorption, distribution, metabolism or excretion of study drug, or would place the subject at increased risk
Participants must agree to refrain from prolonged exposure to the sun or agree to use at least SPF 50 on all exposed skin and protective clothing during prolonged sun exposure throughout participation in this study and/or treatment with VERU-111","9mg of VERU-111

VERU-111: Subjects in the VERU-111 treatment groups will receive standard of care, plus oral daily VERU-111 9mg for 21 days or until released from hospital.",ChEMBL:CHEMBL2163631 | PubChem:53379371,SABIZABULIN,COc1cc(C(=O)c2cnc(-c3c[nH]c4ccccc34)[nH]2)cc(OC)c1OC,,1.0,1.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0
NCT04871425,NCT04871425_EG001,Accepts Healthy Volunteers,Female,Child | Adult | Older Adult,Phase 4,110,"Inclusion Criteria:

Aged 14 years or older
Voluntarily requesting surgical pregnancy termination
Intrauterine pregnancy up to 13 weeks 6 days by transabdominal or transvaginal ultrasound performed on day of procedure
Eligible for suction curettage
English or Spanish speaking
Able and willing to give informed consent and agree to terms of the study

Exclusion Criteria:

Age less than 14 years
Reaspiration procedure or failed medication abortion
Early pregnancy loss
Alcohol use disorder or acute alcohol intoxication
Currently incarcerated
Gestational age 14 weeks or more
Requesting a specific pain regimen
Premedication with misoprostol
Contraindications or allergies to ketamine or fentanyl","Participant will receive 2mg IV midazolam and 0.5-1mcg/kg IV fentanyl over 2 minutes, which can be repeated q5m until appropriate analgesia is achieved.

Fentanyl: IV fentanyl",ChEMBL:CHEMBL596 | DrugBank:DB00813 | PubChem:3345,Fentanyl,CCC(=O)N(c1ccccc1)C1CCN(CCc2ccccc2)CC1,N01AH01 | N01AH51 | N02AB03,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT04905563,NCT04905563_EG000,No,All,Child,Phase 4,30,"Inclusion Criteria:

isolated supracondylar humerus fracture
undergoing closed reduction with percutaneous pinning (CRPP)

Exclusion Criteria:

Allergies to acetaminophen, ibuprofen, and/or acetaminophen-HYDROcodone
Liver or renal disease
history of bleeding disorder
medical diagnosis of juvenile arthritis
on chronic NSAIDs or Opioids PRIOR to the procedure
medical diagnosis of coagulopathies, open fractures, other injuries at time of diagnosis (multi-system trauma)
vascular compromise and/or compartment syndrome upon admission","Standard of care- weight based dose of liquid acetaminophen-hydrocodone- 0.15 mg/kg/dose every six hours with a max dose of 10 mg/dose

Acetaminophen-Hydrocodone: Narcotic",ChEMBL:CHEMBL112 | DrugBank:DB00316 | PubChem:1983,Acetaminophen,CC(=O)Nc1ccc(O)cc1,N02AJ01 | N02AJ06 | N02AJ13 | N02AJ17 | N02BE01 | N02BE51 | N02BE71,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT05004077,NCT05004077_EG000,No,All,Adult | Older Adult,Phase 4,3,"Inclusion Criteria:

Subject must be 18 years old or older
Subject must be willing to give written informed consent
Subject must undergo or scheduled for non-emergent cardiac surgery, including coronary artery bypass grafting (CABG), non-infectious valve repair or replacement, atrial or septal defect repair, thoracic aortic replacement surgery, or any combination of these procedures

Exclusion Criteria:

Documented allergy to amiodarone or iodine
History of atrial fibrillation or other heart conduction system abnormality
History of cardiac maze, pulmonary vein isolation, or other procedure affecting the conduction system
Scheduled cardiac maze, pulmonary vein isolation, or other procedure affecting the conduction system
Low cardiac index or cardiogenic shock requiring pharmacologic or mechanical support
History of pre-existing respiratory system disease requiring oxygen therapy prior to admission
History of cirrhosis or other chronic liver diseases
Pregnancy or breastfeeding mothers
Prisoner status","Initial amiodarone bolus of 150 mg IV over 10 minutes then a 24-hour amiodarone loading infusion (1 mg/min for 6 hours followed by 0.5 mg/min for 18 hours), followed by enteral (400 mg amiodarone oral or per tube three times daily or 2 times daily if the patient has gastrointestinal intolerance when taking the drug three times daily) or intravenous amiodarone (0.5 mg/min continuous infusion) to complete an 8-gm total amiodarone load. Maintenance amiodarone (200 mg amiodarone oral or per tube once daily) at discretion of attending physician.

AMIODARONE: Assess the effectiveness of different dosing strategies of amiodarone.",ChEMBL:CHEMBL633 | DrugBank:DB01118 | PubChem:2157,Amiodarone,CCCCc1oc2ccccc2c1C(=O)c1cc(I)c(OCCN(CC)CC)c(I)c1,C01BD01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT05004077,NCT05004077_EG001,No,All,Adult | Older Adult,Phase 4,3,"Inclusion Criteria:

Subject must be 18 years old or older
Subject must be willing to give written informed consent
Subject must undergo or scheduled for non-emergent cardiac surgery, including coronary artery bypass grafting (CABG), non-infectious valve repair or replacement, atrial or septal defect repair, thoracic aortic replacement surgery, or any combination of these procedures

Exclusion Criteria:

Documented allergy to amiodarone or iodine
History of atrial fibrillation or other heart conduction system abnormality
History of cardiac maze, pulmonary vein isolation, or other procedure affecting the conduction system
Scheduled cardiac maze, pulmonary vein isolation, or other procedure affecting the conduction system
Low cardiac index or cardiogenic shock requiring pharmacologic or mechanical support
History of pre-existing respiratory system disease requiring oxygen therapy prior to admission
History of cirrhosis or other chronic liver diseases
Pregnancy or breastfeeding mothers
Prisoner status","Initial amiodarone bolus of 150 mg IV over 10 minutes, then 1.0 mg/min IV amiodarone infusion for 6 hours, then a 0.5 mg/min IV amiodarone infusion for 18 hours, followed by enteral (400 mg amiodarone oral or per tube three times daily or 2 times daily if the patient has gastrointestinal intolerance when taking the drug three times daily) or intravenous amiodarone (0.5 mg/min continuous infusion) to complete an 8-gm total amiodarone load. In addition, patients in the RBDR will receive an additional 150 mg IV amiodarone bolus whenever the patient develops tachycardia (Heart Rate (HR) = 110 beats per minute) lasting more than 10 minutes. This bolus may be repeated up to a total of 5 times (6 total boluses) over the first 24 hours. Maintenance amiodarone (200 mg amiodarone oral or per tube once daily) at discretion of attending physician.

AMIODARONE: Assess the effectiveness of different dosing strategies of amiodarone.",ChEMBL:CHEMBL633 | DrugBank:DB01118 | PubChem:2157,Amiodarone,CCCCc1oc2ccccc2c1C(=O)c1cc(I)c(OCCN(CC)CC)c(I)c1,C01BD01,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT05044234,NCT05044234_EG001,No,All,Adult | Older Adult,Phase 2,39,"Inclusion Criteria:

- Participants with stable moderate to severe plaque psoriasis of at least 6 months duration and who are candidates for systemic therapy or phototherapy.

Exclusion Criteria:

Primary non-responders to previous anti-interleukin (IL)-17 (e.g., secukinumab, ixekizumab, brodalumab), anti-IL-23 (e.g., guselkumab, tildrakizumab, risankizumab), or anti-IL-12/23 (e.g., ustekinumab) treatment for chronic plaque psoriasis.
Diagnosis of erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication exacerbated psoriasis, or new onset guttate psoriasis or any other skin disease which may interfere with assessment of chronic plaque psoriasis.",Participants received 75 mg cedirogant orally once daily (QD) for 16 weeks.,ChEMBL:CHEMBL5095174 | PubChem:124123797,CEDIROGANT,O=C(O)CC1CCN(C(=O)c2ccc(Cl)c(Cn3ccc4cc(C(F)(F)F)cc(Cl)c43)c2Cl)CC1,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT05044234,NCT05044234_EG002,No,All,Adult | Older Adult,Phase 2,39,"Inclusion Criteria:

- Participants with stable moderate to severe plaque psoriasis of at least 6 months duration and who are candidates for systemic therapy or phototherapy.

Exclusion Criteria:

Primary non-responders to previous anti-interleukin (IL)-17 (e.g., secukinumab, ixekizumab, brodalumab), anti-IL-23 (e.g., guselkumab, tildrakizumab, risankizumab), or anti-IL-12/23 (e.g., ustekinumab) treatment for chronic plaque psoriasis.
Diagnosis of erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication exacerbated psoriasis, or new onset guttate psoriasis or any other skin disease which may interfere with assessment of chronic plaque psoriasis.",Participants received 150 mg cedirogant orally once daily (QD) for 16 weeks.,ChEMBL:CHEMBL5095174 | PubChem:124123797,CEDIROGANT,O=C(O)CC1CCN(C(=O)c2ccc(Cl)c(Cn3ccc4cc(C(F)(F)F)cc(Cl)c43)c2Cl)CC1,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT05044234,NCT05044234_EG003,No,All,Adult | Older Adult,Phase 2,39,"Inclusion Criteria:

- Participants with stable moderate to severe plaque psoriasis of at least 6 months duration and who are candidates for systemic therapy or phototherapy.

Exclusion Criteria:

Primary non-responders to previous anti-interleukin (IL)-17 (e.g., secukinumab, ixekizumab, brodalumab), anti-IL-23 (e.g., guselkumab, tildrakizumab, risankizumab), or anti-IL-12/23 (e.g., ustekinumab) treatment for chronic plaque psoriasis.
Diagnosis of erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication exacerbated psoriasis, or new onset guttate psoriasis or any other skin disease which may interfere with assessment of chronic plaque psoriasis.",Participants received 375 mg cedirogant orally once daily (QD) for 16 weeks.,ChEMBL:CHEMBL5095174 | PubChem:124123797,CEDIROGANT,O=C(O)CC1CCN(C(=O)c2ccc(Cl)c(Cn3ccc4cc(C(F)(F)F)cc(Cl)c43)c2Cl)CC1,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT05053126,NCT05053126_EG001,Accepts Healthy Volunteers,All,Adult,Phase 4,58,"Inclusion Criteria:

Male and female participants must be 18 to 55 years of age, inclusive, at the time of screening. There must be no less than 20% female participants in the Treatment Phase.
Male and female participants who are overtly healthy. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, vital signs, 12-lead ECG, and/or clinical laboratory tests.
Participants must have drug abuse experience with opioids; ie, must have used opioids for non-therapeutic purposes (ie, for psychoactive effects) on at least 10 occasions within the last year and at least once in the 8 weeks before the Screening Visit (Visit 1).
Participants must satisfactorily complete both the Naloxone Challenge and the Drug Discrimination.
Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.

Body mass index (BMI) of 17.5 to 34 kg/m2, inclusive; and a total body weight

≥50 kg (110 lb).

Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent document (ICD).

Exclusion Criteria:

Current or past diagnosis of any type of drug dependence within the past year. Diagnosis of substance and/or alcohol dependence (excluding caffeine and nicotine) will be assessed by the Investigator using the Diagnostic and Statistical Manual-4 (DSM-4) criteria performed at Screening. Current drug use will be allowed if the candidate can produce a negative urine sample and are free of any signs/symptoms of withdrawal. The candidate will be informed if they have a positive breathalyzer test.
Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
Any condition possibly affecting drug absorption (eg, gastrectomy) excluding cholecystectomy within 1 year prior to study.
Abnormal baseline EtCO2 <35mm Hg or >45 mm Hg.
Clinical or laboratory evidence of active hepatitis A infection or a history of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C and/or positive testing for HIV, hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or hepatitis C antibody (HCVAb).
Participants with active suicidal ideation or suicidal behavior within 5 year prior to Screening as determined through the use of the Columbia-Suicide Severity Rating Scale (C-SSRS) or active ideation identified at Screening or on Day 0.
Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
Patients with: sleep apnea, myasthenia gravis and glaucoma.
Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of investigational product.
Herbal supplements and herbal medications must be discontinued at least 28 days prior to the first dose of study medication.
Previous administration with an investigational drug within 30 days (or as determined by the local requirement) or 5 half-lives (whichever is longer) preceding the first dose of investigational product used in this study.
Positive urine drug screen (UDS) for substances of abuse at each admission in the Qualification and Treatment Phase, excluding tetrahydrocannabinol (THC). If a participant presents with a positive UDS excluding THC at any admission or any visit, the investigator, at his/her discretion, may reschedule a repeat of UDS until the UDS is negative, excluding THC, before the participant is permitted to participate in any phase of the study.
Unable to abstain from using THC during the Qualification and Treatment Phase of the study.
Has participated in, is currently participating in, or is seeking treatment for substance-and/or alcohol-related disorders (excluding nicotine and caffeine).
Has a positive alcohol breathalyzer or urine test at each admission to the study center during qualification and treatment phase. Positive results may be repeated and/or participants re-scheduled at the Investigator's discretions.
Participants are heavy smokers or users of other types of nicotine products (>20 cigarettes equivalents per day).
Participants are unable to abstain from smoking for at least 2 hours before and at least 8 hours after study drug administration.

Screening sitting blood pressure (BP) ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic), following at least 5 minutes rest. If BP is ≥140 mm Hg (systolic) or

≥90 mm Hg (diastolic), the BP should be repeated 2 more times and the average of the 3 BP values should be used to determine the participant's eligibility. Repeated BP tests should be spaced at least 5 minutes apart.

Baseline (screening) 12-lead electrocardiogram (ECG) that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results (eg, baseline corrected QT (QTc) interval as determined by the Fridericia method (QTcF) >450 msec, complete left bundle branch block [LBBB], signs of an acute or indeterminate-age myocardial infarction, ST-T interval changes suggestive of myocardial ischemia, second- or third-degree atrioventricular [AV] block, or serious bradyarrhythmias or tachyarrhythmias). If the baseline uncorrected QT interval is >450 msec, this interval should be rate-corrected using the Fridericia method and the resulting QTcF should be used for decision making and reporting. If QTcF exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated 2 more times and the average of the 3 QTcF or QRS values should be used to determine the participant's eligibility. Computer-interpreted ECGs should be overread by a physician experienced in reading ECGs before excluding participants.
Participants with ANY of the following abnormalities in clinical laboratory tests at screening, as assessed by the study-specific laboratory and confirmed by a single repeat test, if deemed necessary: Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level 1.5 × upper limit of normal (ULN); Total bilirubin level ≥1.5 × ULN; participants with a history of Gilbert's syndrome may have direct bilirubin measured and would be eligible for this study provided the direct bilirubin level is ≤ ULN.
Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing.
History of sensitivity to heparin or heparin-induced thrombocytopenia.
Unwilling or unable to comply with the criteria in the Lifestyle Considerations section of this protocol.
History of hypersensitivity to pregabalin or oxycodone or any of the components in the formulation of the study products.
Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or Sponsor employees, including their family members, directly involved in the conduct of the study.",Participants received a single oral dose of oxycodone 20 mg,ChEMBL:CHEMBL656 | DrugBank:DB00497 | PubChem:5284603,Oxycodone,COc1ccc2c3c1O[C@H]1C(=O)CC[C@@]4(O)[C@@H](C2)N(C)CC[C@]314,N02AA05 | N02AA55 | N02AA56 | N02AJ17 | N02AJ18 | N02AJ19,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT05081167,NCT05081167_EG000,No,All,Adult | Older Adult,Phase 3,116,"Inclusion Criteria:

Adults 18 to 65 years, inclusive.
Diagnosed with Major Depressive Disorder (MDD) based on Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, DSM-5 (SCID-5) for MDD.
Current major depressive episode.

Exclusion Criteria:

Any current and primary psychiatric disorder other than Major Depressive Disorder.
Severe alcohol or substance use disorder.
History of bipolar I and II disorder, psychosis, and/or mania.
Acute or chronic condition that, in the Investigator's opinion, would limit the subject's ability to complete or participate in this clinical study.
Prior participation in a ketamine, esketamine, dextromethorphan or any other NMDAR- antagonist study, or received esketamine at any time.","A 75 mg REL-1017 loading dose (three 25 mg REL-1017 tablets) will be administered on Day-1 of the 28-day treatment period. From Day-2 to Day-28, participants will take 25 mg REL-1017.

REL-1017: REL-1017 tablet",ChEMBL:CHEMBL350719 | ChEMBL:CHEMBL651 | DrugBank:DB00333 | DrugBank:DB15198 | PubChem:4095 | PubChem:643985,Methadone,CCC(=O)C(CC(C)N(C)C)(c1ccccc1)c1ccccc1,N02AC52 | N07BC02,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT05175131,NCT05175131_EG001,No,All,Adult | Older Adult,Phase 3,155,"Inclusion Criteria:

Signed Informed Consent Form;
Males and females aged 18 to 75 years old (inclusive);
Abdominal pain and bloating/flatulence due to functional bowel disorder (including IBS, chronic functional constipation, chronic functional diarrhea or functional abdominal bloating);
Episodes of abdominal pain for at least 3 months, with a frequency of at least 3 times a month;
Abdominal pain intensity of 4 to 9 points (inclusive) when assessed on the NRS-11 scale (i.e. weekly average, with daily recording of the worst pain for the last 24 hours during last week of Screening and Run-in period);
Bloating/flatulence intensity of of 4 to 9 points (inclusive) when assessed on the NRS-11 scale (i.e. weekly average, with daily recording of the worst bloating episode for the last 24 hours during last week of Screening and Run-in period);

Patients' consent to use adequate contraception methods throughout the study. Adequate contraception methods include:

oral contraceptives or contraceptive patches,
condom or diaphragm (barrier method) with spermicide, or
an intrauterine device

Exclusion Criteria:

Hypersensitivity to mebeverine, simethicone, drotaverine, excipients of the studied products, or contraindications;
Intake of tricyclic antidepressants, eluxadoline, linaclotide, selective serotonin re-uptake inhibitors, rifaximin, lubriprostone within the last week before screening;
New prescription or any change in probiotic drug therapy (including change in the drug or dosage regimen) during the last month before screening;
History of intestinal obstruction, stricture, toxic megacolon, GI (gastro-intestinal) perforation, fecal impaction, gastric banding, bariatric surgery, adhesions, ischemic colitis, or impaired intestinal circulation (e.g. aorto-iliac disease);
History of major gastric, hepatic, pancreatic or intestinal surgery (appendectomy, hemorrhoidectomy, or polypectomy allowed as long as occurred > 3 months prior to trial screening; uncomplicated laparoscopic or open cholecystectomy is allowed if no history of post-operative biliary tract pain and surgery occurred > 3 months prior to screening);
Significant and progressive enlargement of the liver, spleen, lymph nodes; ascites; palpable tumor formation in the abdominal cavity / pelvis according to physical examination, hepatic cirrhosis;
Significant concomitant acute or chronic disease (cardiovascular, gastrointestinal, endocrine, immunological, metabolic, bronchopulmonary, urinary system) or any condition that, according to Investigator, is a contraindication for the patient to participate in the study if interference with the study performance;
Any inflammatory bowel disease (Crohn's disease, ulcerative colitis, any infection including bacterial, viral, protozoa, helminthosis);
Elevated fecal calprotectin level 1 month before or at screening which indicates the presence of inflammatory GIT disease;
Unexplained GI bleeding within 3 months prior to screening;
Confirmed diagnosis of bile acids malabsorption;
History of any malignant disease except basal cell carcinoma of skin and vesical cervix carcinoma in situ which were cured ≥ 5 years ago;
Confirmed diagnosis of celiac disease;
Confirmed hereditary galactose or fructose intolerance , total lactase deficiency, sucrase-isomaltose insufficiency, glucose-galactose malabsorption syndrome;
Diet changes (e.g, switching to fermented foods, a gluten-free diet) within the 1 months prior to screening;
Planned elective surgery during the study;
Pancreatic exocrine insufficiency or acute pancreatitis;
Endometriosis in women;
Positive results of tests for HIV, hepatitis B or C, at the moment of screening;
Drugs or alcohol abuse at screening or in the past, which, in the Investigator's opinion, makes the patient not eligible for participation in the study;
Participation in another clinical study or another study drug administration within 30 days prior to screening;
Pregnant or lactating women, or women planning to get pregnant during the clinical study; women of child-bearing potential (including those without history of surgical sterilization and women with <2 years post-menopause) not using adequate contraception methods;
Inability to read or right; unwillingness to understand and comply with Protocol procedures; non-compliance with medication dosing regimen or procedures which, in the Investigator's opinion, may affect study results or the patient's safety and prevent the patient's participation in the study; any other concomitant diseases or severe mental disorders, which make the patient ineligible for study participation, limit the legal basis for Informed Consent procedure, or may affect the patient's ability to participate in the study.","three times a day per os

Mebeverine: Duspatalin®, coated tablets 135 mg",DrugBank:DB12554 | PubChem:4031,Mebeverine,CCN(CCCCOC(=O)c1ccc(OC)c(OC)c1)C(C)Cc1ccc(OC)cc1,A03AA04,0.0,0.0,0.0,0.0,0.0,0.0,1.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT05292755,NCT05292755_EG000,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 4,80,"Inclusion Criteria:

Adults above age 18 of either sex who can self-administer artificial tears and return for follow-up at the UF Oaks Eye Clinic.

Exclusion Criteria:

Individuals with active eye infections or have prosthetic eyes.
Are immunocompromised, or are diagnosed with autoimmune diseases or malignant neoplasms about the eye.
Individuals who take immunomodulatory therapy, steroids, antibiotics, medicated eyedrops, or are already using CMC eyedrops within 1 week of the study will also be excluded.","Refresh brand artificial tears containing 0.5% carboxymethylcellulose will be self-administered three times a day in each eye by the participants for 1 week in the experimental arm.

Carboxymethylcellulose (CMC) Artificial Tears: A pack of 21 vials of artificial tears containing carboxymethylcellulose 0.5% will be given to subjects in the treatment group.",PubChem:6328154,Carmellose sodium,CC(=O)O.O=CC(O)C(O)C(O)C(O)CO.[Na],,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT05319756,NCT05319756_EG001,Accepts Healthy Volunteers,All,Adult,Phase 4,52,"Inclusion Criteria:

Male and female participants must be 18 to 55 years of age, inclusive, at the time of screening. Participants must meet reproductive criteria as outlined in the protocol.
Male and female participants who are overtly healthy. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, complete physical examination, vital signs, 12-lead ECG, and/or clinical laboratory tests.
Participants must have drug abuse experience with opioids; ie, must have used opioids for non-therapeutic purposes (ie, for psychoactive effects) on at least 10 occasions within the last year and at least once in the 8 weeks before the Screening Visit (Visit 1).
Participants must satisfactorily complete both the Naloxone Challenge and the Drug Discrimination.
Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
Body mass index (BMI) of 17.5 to 34 kg/m2, inclusive; and a total body weight ≥50 kg (110 lb).
Capable of giving signed informed consent as described in the protocol, which includes compliance with the requirements and restrictions listed in the informed consent document (ICD) and in this protocol.

Exclusion Criteria:

Current or past diagnosis of any type of drug dependence within the past year. Diagnosis of substance and/or alcohol dependence (excluding caffeine and nicotine) will be assessed by the Investigator using the Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) criteria performed at Screening. Current drug use will be allowed if the candidate can produce a negative urine sample and are free of any signs/symptoms of withdrawal. The candidate will be informed if they have a positive breathalyzer test.
Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
Any condition possibly affecting drug absorption (eg, gastrectomy) excluding cholecystectomy within 1 year prior to study.
Abnormal baseline EtCO2 <35mm Hg or >45 mm Hg.
Clinical or laboratory evidence of active hepatitis A infection or a history of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C, and/or positive testing for HIV, hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or hepatitis C antibody (HCVAb).
Participants with active suicidal ideation or suicidal behavior within 5 years prior to Screening as determined through the use of the Columbia Suicide Severity Rating Scale (C-SSRS) or active ideation identified at Screening or on Day 0.
Participants with any history of sleep apnea, myasthenia gravis or glaucoma.
Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half lives (whichever is longer) prior to the first dose of investigational product. (Refer to Section 6.5 for additional details).
Herbal supplements, herbal medications and hormone replacement therapy must be discontinued at least 28 days prior to the first dose of study medication.
Previous administration with an investigational drug within 30 days (or as determined by the local requirement) or 5 half lives (whichever is longer) preceding the first dose of investigational product used in this study.
Positive urine drug screen (UDS) for substances of abuse at each admission in Qualification and Treatment Phase, excluding tetrahydrocannabinol (THC). If a participant presents with a positive UDS excluding THC at any admission or any visit, the investigator, at his/her discretion, may reschedule a repeat of UDS until the UDS is negative, excluding THC, before the participate is permitted to participate in any phase of the study.
Unable to abstain from using THC during the Qualification and Treatment Phase of the study.
Has participated in, is currently participating in, or is seeking treatment for substance and/or alcohol related disorders (excluding nicotine and caffeine).
Has a positive alcohol breathalyzer or urine test at each admission to the study center during Qualification and Treatment Phases. Positive results may be repeated and/or participants re scheduled at the Investigator's discretions.
Participants are heavy smokers or users of other types of nicotine products (>20 cigarettes equivalents per day).
Participants are unable to abstain from smoking for at least 2 hours before and at least 8 hours after study drug administration.
Screening sitting blood pressure (BP) >=140 mm Hg (systolic) or >=90 mm Hg (diastolic), following at least 5 minutes rest. If BP is >=140 mm Hg (systolic) or >=90 mm Hg (diastolic), the BP should be repeated 2 more times and the average of the 3 BP values should be used to determine the participant's eligibility. Repeated BP tests should be spaced at least 5 minutes apart.
Baseline (screening) 12 lead electrocardiogram (ECG) that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results (eg, baseline corrected QT (QTc) interval as determined by the Fridericia method (QTcF) >450 msec, complete left bundle branch block [LBBB], signs of an acute or indeterminate age myocardial infarction, ST T interval changes suggestive of myocardial ischemia, second or third degree atrioventricular [AV] block, or serious bradyarrhythmias or tachyarrhythmias). If the baseline uncorrected QT interval is >450 msec, this interval should be rate corrected using the Fridericia method and the resulting QTcF should be used for decision making and reporting. If QTcF exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated 2 more times and the average of the 3 QTcF or QRS values should be used to determine the participant's eligibility. Computer interpreted ECGs should be overread by a physician experienced in reading ECGs before excluding participants.

Participants with ANY of the following abnormalities in clinical laboratory tests at screening, as assessed by the study specific laboratory and confirmed by a single repeat test, if deemed necessary:

Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level >=1.5 × upper limit of normal (ULN);
Total bilirubin level >=1.5 × ULN; participants with a history of Gilbert's syndrome may have direct bilirubin measured and would be eligible for this study provided the direct bilirubin level is <= ULN.
Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing.
History of sensitivity to heparin or heparin induced thrombocytopenia.
Unwilling or unable to comply with the criteria in the Lifestyle Considerations section of this protocol.
History of hypersensitivity to gabapentin or oxycodone or any of the components in the formulation of the study products.
Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or Sponsor employees, including their family members, directly involved in the conduct of the study.",Participants received a single oral dose of oxycodone HCl 20 mg and a placebo that looks like gabapentin,PubChem:5462350,Oxycodone Hydrochloride,COc1ccc2c3c1OC1C(=O)CCC4(O)C(C2)N(C)CCC314.Cl,,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT05327777,NCT05327777_EG001,Accepts Healthy Volunteers,All,Adult | Older Adult,Phase 4,129,"Inclusion Criteria:

Opioid naïve patients
Age > 18
Being scheduled for an outpatient elective inguinal hernia repair or cholecystectomy

Exclusion Criteria:

Urgent/emergent status
Previous cholecystostomy tube placement","Providers required to prescribe 10 narcotic pills only

Oxycodone: Investigators provided set opioid prescriptions for 10 pills each patient.",ChEMBL:CHEMBL656 | DrugBank:DB00497 | PubChem:5284603,Oxycodone,COc1ccc2c3c1O[C@H]1C(=O)CC[C@@]4(O)[C@@H](C2)N(C)CC[C@]314,N02AA05 | N02AA55 | N02AA56 | N02AJ17 | N02AJ18 | N02AJ19,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT05379179,NCT05379179_EG000,No,All,Adult | Older Adult,Phase 4,3,"Inclusion Criteria:

Ages ≥ 18 years.
Able to speak and understand English.
RSE requiring IV pain medication for NRS pain score > 5.
No allergy to ketamine or fentanyl.
Ability to provide informed consent.
≤ 24 hours from envenomation.

Exclusion Criteria:

Pregnant or lactating.
Prisoners.
Refugees.
History of schizophrenia.
Clinically intoxicated.
On buprenorphine therapy.
History of uncontrolled hypertension
Increased intracranial pressure
Systemic envenomation","Drug administration: A single dose of fentanyl 1mcg/kg IV, maximum 100 mcg, over 15 minutes.

Time drug given will be documented Data obtained prior to med administration and then following medication administration at intervals of 15, 30, 60 and 120 minutes

Record vital signs (HR, B/P, resp rate, O2 sat)

Obtain and assess pain response scores

Pain Numerical Rating Score (NRS - 0-10)
Richmond Agitation Sedation Scale (RASS)
Side Effect Rating Scale for Dissociative Anesthesia (SERSDA)
Record any airway interventions required? If yes what? new supplemental O2/BVM/intubation, jaw thrust
Record any rescue meds, dose and time (Rescue medication - Fentanyl):
1 mcg/kg IV fentanyl (0.5 mcg/kg if age >55 yrs)
Defined as rescue if given <30 min post study intervention for pain score >5 or patient requesting additional medication.
Patient pain satisfaction score at discharge

Fentanyl: This study will compare patient-reported pain scores after receiving either ketamine or fentanyl for the treatment of acute pain due to a rattlesnake bite.",ChEMBL:CHEMBL596 | DrugBank:DB00813 | PubChem:3345,Fentanyl,CCC(=O)N(c1ccccc1)C1CCN(CCc2ccccc2)CC1,N01AH01 | N01AH51 | N02AB03,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0
NCT05399290,NCT05399290_EG000,Accepts Healthy Volunteers,All,Child,Phase 4,11,"Inclusion Criteria:

Documented moderate to severe facial acne

Exclusion Criteria:

Other skin conditions on the face
Previous antibiotic treatment for acne
Use of antibiotics for any reason within the past month
Use of new prescription regiment for acne within the last 3 months
Positive pregnancy test in the clinic
Cognitive impairments","Oral, 12 weeks

Doxycycline Hyclate: 100 mg vs 20 mg doxycycline hyclate BID for 12 weeks",PubChem:54686183,Doxycycline hyclate,CC1c2cccc(O)c2C(O)=C2C(=O)C3(O)C(O)=C(C(N)=O)C(=O)C(N(C)C)C3C(O)C21.CC1c2cccc(O)c2C(O)=C2C(=O)C3(O)C(O)=C(C(N)=O)C(=O)C(N(C)C)C3C(O)C21.CCO.Cl.Cl.O,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0
NCT05399290,NCT05399290_EG001,Accepts Healthy Volunteers,All,Child,Phase 4,11,"Inclusion Criteria:

Documented moderate to severe facial acne

Exclusion Criteria:

Other skin conditions on the face
Previous antibiotic treatment for acne
Use of antibiotics for any reason within the past month
Use of new prescription regiment for acne within the last 3 months
Positive pregnancy test in the clinic
Cognitive impairments","Oral, 12 weeks

Doxycycline Hyclate: 100 mg vs 20 mg doxycycline hyclate BID for 12 weeks",PubChem:54686183,Doxycycline hyclate,CC1c2cccc(O)c2C(O)=C2C(=O)C3(O)C(O)=C(C(N)=O)C(=O)C(N(C)C)C3C(O)C21.CC1c2cccc(O)c2C(O)=C2C(=O)C3(O)C(O)=C(C(N)=O)C(=O)C(N(C)C)C3C(O)C21.CCO.Cl.Cl.O,,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,0.0,1.0,0.0,0.0,0.0,0.0